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WO2024236294A1 - Produit à administration par voie orale - Google Patents

Produit à administration par voie orale Download PDF

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Publication number
WO2024236294A1
WO2024236294A1 PCT/GB2024/051260 GB2024051260W WO2024236294A1 WO 2024236294 A1 WO2024236294 A1 WO 2024236294A1 GB 2024051260 W GB2024051260 W GB 2024051260W WO 2024236294 A1 WO2024236294 A1 WO 2024236294A1
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WO
WIPO (PCT)
Prior art keywords
weight
combination
oral product
magnesium
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/GB2024/051260
Other languages
English (en)
Inventor
Deborah Smith
Tora Mitra GANGULI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nicoventures Trading Ltd
Original Assignee
Nicoventures Trading Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nicoventures Trading Ltd filed Critical Nicoventures Trading Ltd
Publication of WO2024236294A1 publication Critical patent/WO2024236294A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/174—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/20—Inorganic substances, e.g. oligoelements
    • A23K20/24—Compounds of alkaline earth metals, e.g. magnesium
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives

Definitions

  • the present disclosure relates to a melatonin-free oral product, a process for producing the oral product, as well as to uses of said oral product.
  • the present disclosure relates to products and compositions intended for human use.
  • the products are configured for oral use and deliver substances such as active ingredients and/or flavours during use.
  • confectionary-type products e.g. gummies or pastilles
  • vitamins or other moodenhancing actives provide a convenient and pleasant mode of administration for such active ingredients.
  • Other convenient modes of administration are food and beverages, for example energy drinks.
  • Such products may include active ingredients that are delivered to the user in order to cause a biological response in the user that may enhance physical or mental wellbeing and/or performance of the user.
  • Other beverages such as chamomile tea and other herbal teas, are consumed by some users to aid a physiological response such as sleep and relaxation.
  • the present disclosure generally provides products configured for oral use, the products comprising a combination of active ingredients.
  • the oral products may be in any form suitable for oral use, such as in tablet or lozenge form, as a loose powder, or liquid form (e.g. as a beverage, such as a shot).
  • liquid form e.g. as a beverage, such as a shot.
  • the oral products are in liquid form, e.g. as a beverage, such as shot).
  • a melatonin- free oral product comprising a combination of active ingredients, wherein the combination comprises: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower.
  • a process for preparing a melatonin-free oral product comprising: (a) combining active ingredients, wherein the active ingredients include: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower; (b) contacting the active ingredients with water; and (c) mixing the active ingredients with water to prepare an oral product.
  • active ingredients include: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower; (b) contacting the active ingredients with water; and (c) mixing the active ingredients with water to prepare an oral product.
  • a use of a combination of active ingredients to promote sleep in a human or animal wherein the combination of active ingredients comprises: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower, and wherein the combination of active ingredients is free from melatonin.
  • the promotion of sleep may include at least one of inducing sleep and maintaining sleep.
  • each of the oral products of the above embodiments may be provided in the form of a liquid dosage form, such as a shot (i.e. a liquid having a volume of up to about 100mL).
  • a shot i.e. a liquid having a volume of up to about 100mL.
  • Figure 1 is a plot from Example 9 showing the results from the State-Trait Anxiety Inventory Scale measurement (STAI-S) during a consumer study comparing the oral product of Example 8 with a placebo.
  • STAI-S State-Trait Anxiety Inventory Scale measurement
  • Figure 2 is a plot from Example 9 showing the results from the PROMIS Sleep disturbance measurement during a consumer study comparing the oral product of Example 8 with a placebo.
  • Figure 3 is a plot from Example 9 showing the results from the PROMIS Sleep Impairment measurement during a consumer study comparing the oral product of Example 8 with a placebo.
  • Figure 4 is a plot from Example 9 showing the results from the Athens Insomnia Scale (AIS) measurement during a consumer study comparing the oral product of Example 8 with a placebo.
  • AIS Athens Insomnia Scale
  • Figure 5 is a plot from Example 9 showing the results from the Profile of Mood States (POMS) - Short Form (SF) measurement during a consumer study comparing the oral product of Example 8 with a placebo.
  • POMS Profile of Mood States
  • SF Short Form
  • the term "about” modifying the quantity of an ingredient in the oral product of the invention or employed in the methods of the invention refers to variation in the numerical quantity that can occur, for example, through typical measuring and liquid handling procedures used for making concentrates or use solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients employed to make the oral product, or to carry out the methods; and the like.
  • the term “about” also encompasses amounts that differ due to different equilibrium conditions for a product or composition resulting from a particular initial mixture. Whether or not modified by the term "about”, the claims include equivalents to the quantities.
  • a melatonin-free oral product comprising a combination of active ingredients, wherein the combination comprises: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower.
  • melatonin-free and “free from melatonin” are used interchangeably herein and mean that the oral product does not contain melatonin - either as an active ingredient or otherwise.
  • the oral product is configured for oral use, and thus for insertion into the mouth of the user (i.e. oral cavity).
  • oral in connection to a product refers to a product which, in normal use, is suited to be ingested or placed somewhere in the oral cavity of the user.
  • the product may be in the form of a liquid that may be consumed orally by the user (i.e. in the form of a beverage), or the product may be placed in the mouth (e.g. in the form of a tablet, lozenge, pouch, or the like).
  • the product may be in the form of a liquid that may be consumed orally by the user (i.e. in the form of a beverage, particularly in the form of a liquid shot).
  • the ranges provided herein may be taken alone or combined with one or more other component ranges to provide a preferred aspect of the invention.
  • the product as disclosed herein includes active ingredients.
  • the active ingredients may be naturally occurring or synthetically obtained.
  • the combination of active ingredients comprises suitable active ingredients that cause a physiological response in a human or animal.
  • the combination of active ingredients comprises at least (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower, wherein the combination of active ingredients is free from melatonin.
  • the oral product promotes sleep in a subject, i.e. a human or animal.
  • each of the active ingredients may be present in an amount suitable to provide the desired response in a human or animal.
  • the specific combination of active ingredients included in the oral product has been found by the inventors to promote sleep and/or aid in sleep quality in a subject.
  • the specific combination of active ingredients in the oral product has been found to promote sleep by inducing and/or maintaining sleep. Sleep promotion may also increase overall feelings of enjoyment and wellbeing, with feelings of relaxation, confidence, pleasure and motivation being increased.
  • Magnesium is both an essential dietary nutrient and one of the most abundant minerals in animal bodies. It is crucial to the normal functioning of physiological processes; acts as an electrolyte; as an enzyme co-factor in hundreds of enzyme systems; and plays a crucial role in numerous central biological processes including energy production, protein, DNA and RNA synthesis, ion (e.g. calcium and potassium) active cell membrane transport, bone growth and maintenance, muscle and nerve function and blood glucose and blood pressure regulation.
  • ion e.g. calcium and potassium
  • Magnesium interacts with the primary inhibitory neurotransmitter gamma-aminobutyric acid (also known as GABA), which can modulate the ability of nerve cells to receive, create or conduct chemical signaling from other nerve cells.
  • GABA gamma-aminobutyric acid
  • magnesium may be present in a salt form.
  • the identity of the magnesium salt is not limited and includes any magnesium salt suitable for human or animal consumption.
  • Such salts may be organic salts or inorganic salts.
  • the salts may also be in a solvate form, e.g. hydrate.
  • salt is therefore meant “salt or solvate thereof’.
  • the magnesium salt may be selected from magnesium sulfate, magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurate, magnesium malate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium chloride, magnesium ascorbate, magnesium (L-)threonate, magnesium carbonate, magnesium phosphate, magnesium pidolate, or a combination thereof.
  • the magnesium salt is selected from magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurate, magnesium malate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium ascorbate, magnesium (L-)threonate, or a combination thereof.
  • the magnesium salt is selected from magnesium oxide, magnesium glycinate, magnesium citrate, magnesium gluconate, magnesium chloride, magnesium sulfate, magnesium lactate, magnesium L-threonate, magnesium aspartate, or a combination thereof. Particularly preferred are magnesium oxide and magnesium glycinate.
  • Other preferred salts include magnesium chloride and magnesium sulfate.
  • Magnesium salts are commercially available and known for their various benefits. Magnesium glycinate, for instance, is known for its beneficial effects on anxiety, sleep and stress. It is commercially available in the bisglycinate form. Magnesium oxide is known for its antacid properties and is typically taken to relieve heartburn, sour stomach, or acid indigestion. Magnesium oxide may also be used as a laxative. Magnesium chloride is known for its relaxation effects; it can help in detoxifying the body, reducing aches and pains, relieving stress and anxiety, and providing the muscles with energy. Magnesium sulfate is used as a medication to treat and prevent low blood magnesium.
  • magnesium or a salt thereof is believed to contribute to sleep promotion.
  • Magnesium or a salt thereof is present in the combination of active ingredients in any suitable amount. In some embodiments, magnesium or a salt thereof is present in an amount of at least about 0.01 % by weight, at least about 0.05% by weight, or at least about 0.1 % by weight of the oral product. In some embodiments, magnesium or a salt thereof is present in an amount of no greater than about 20% by weight, no greater than about 15% by weight, or no greater than about 10% by weight of the oral product.
  • magnesium or a salt thereof is present in an amount of from about 0.01 % to about 20% by weight of the oral product.
  • magnesium or a salt thereof is present in an amount of from about 0.05% to about 15% by weight of the oral product.
  • Magnesium or a salt thereof may preferably be present in an amount of from about 0.1 % to about 10% by weight of the oral product.
  • magnesium or a salt thereof is present in any suitable amount, such as in an amount of at least about 10% by weight, at least about 15% by weight, or at least about 20% by weight of the dry weight of the combination.
  • dry weight is defined above; the “dry weight of the combination” refers to the total weight of the dry ingredients in the combination of actives without water.
  • magnesium or a salt thereof is present in an amount of no greater than about 60%, no greater than about 50% or no greater than about 40% by weight of the dry weight of the combination.
  • magnesium or a salt thereof is present in an amount of from about 10% by weight to about 60% by weight of the dry weight of the combination.
  • magnesium or a salt thereof is present in an amount of from about 15% by weight to about 50% by weight of the dry weight of the combination.
  • Magnesium or a salt thereof may preferably be present in an amount of from about 20% by weight to about 40% by weight of the dry weight of the combination.
  • the magnesium or salt thereof comprises magnesium sulfate, magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurate, magnesium malate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium chloride, magnesium ascorbate, magnesium (L-)threonate, or a combination thereof, and is present in the combination of actives at an amount from about 0.01 wt% to about 20 wt% of the oral product.
  • the magnesium or salt thereof comprises magnesium oxide, magnesium glycinate, magnesium citrate, magnesium gluconate, magnesium chloride, magnesium sulfate, magnesium lactate, magnesium L-threonate, magnesium aspartate, or a combination thereof, and is present in the combination of actives at an amount from about 0.05 wt% to about 15 wt%, preferably from about 0.1 wt% to about 10 wt% of the oral product.
  • Particularly preferred are magnesium oxide and magnesium glycinate, which may be present from about 0.1 wt% to about 10 wt% of the oral product.
  • Other preferred embodiments include magnesium chloride which may be present from about 0.1 wt% to about 10 wt% of the oral product.
  • ginseng is preferably present as Panax ginseng (Korean ginseng).
  • Passionflower may in some embodiments (e.g. where the oral product is a liquid oral dosage form) be present in an amount of from about 0.01 % to about 10% by weight of the oral product. In some embodiments (e.g. where the oral product is a liquid oral dosage form), passionflower is present in an amount of from about 0.05% to about 5% by weight, preferably from about 0.1 % to about 2.5% by weight of the oral product.
  • the combination of active ingredients may include one or more additional active ingredients.
  • the additional active ingredients may be any suitable active ingredient that promotes sleep, including promoting sleep by inducing sleep and/or maintaining sleep, and may for example be selected from further nutraceuticals, nootropics, and psycho-actives.
  • the additional active ingredient may be naturally occurring or synthetically obtained.
  • Non-limiting examples of additional active ingredients include those falling in the categories of botanical ingredients (e.g. Bacopa Monieri or Rhodiola rosea, or the like), amino acids or analogues (e.g.
  • L-theanine and/or nutraceutical, and/or medicinal ingredients (e.g., further vitamins, such as A, C, D, E or K, and/or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)).
  • additional active ingredients are selected from botanical ingredients, amino acids, further vitamins and a combination thereof.
  • the combination of active ingredients further comprises L- theanine (also known as L-Y-glutamylethylamide, N 5 -ethyl-L-glutamine or simply theanine).
  • L- theanine is a naturally occurring, non-protein amino acid analogue of L-glutamate and L- glutamine. It can be found in tea leaves and has historically been used to promote relaxation by reducing stress and anxiety levels. L-theanine significantly increases activity in the alpha frequency band of brainwaves, indicating relaxation. L-theanine can also be metabolized to glutamate and further to glutamine or decarboxylated to give gamma-aminobutyric acid. L- theanine in the present oral product may be naturally or synthetically produced. L-theanine is commercially available from various sources. In the present oral product L-theanine, when present, was found to contribute to sleep promotion.
  • L-theanine may be present in any suitable amount, such as in an amount of at least about 1 % by weight, at least about 2% by weight, or at least about 5% by weight of the dry weight of the combination. In some embodiments, L-theanine may be present in an amount of no greater than about 40%, no greater than about 35% or no greater than about 30% by weight of the dry weight of the combination.
  • L-theanine may be present in an amount of from about 1 % by weight to about 40% by weight of the dry weight of the combination.
  • L-theanine may be present in an amount of from about 2% by weight to about 35% by weight of the dry weight of the combination.
  • L-theanine may be preferably present in an amount of from about 5% by weight to about 30% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise chamomile.
  • Chamomile is the common name for plants of the Asteraceae family that exhibit daisy-like flowers.
  • Chamomile particularly, Matricaria chamomilla and Chamaemelum nobile, has been commonly used in traditional medicinal preparations.
  • Chamomile as an herbal supplement has historically been used to reduce stress and anxiety, promote sleep, and ease indigestion discomfort.
  • Chamomile is available as infusions, teas, liquid extracts and tinctures and the herbal supplement is typically composed of the flowers of the plant.
  • Chamomile may be present in the oral product in any of these forms.
  • chamomile may be present in the form of chamomile extract, chopped or shredded chamomile, or powdered chamomile. In some embodiments, chamomile is not used in the form of a tincture.
  • chamomile when present, may be from Matricaria chamomilla and/or Chamaemelum nobile.
  • chamomile when present, may be in the form of chamomile extract. It has been found that the addition of chamomile in the present oral product can contribute to promoting sleep.
  • the chamomile may be in any suitable amount to achieve the desired function, such as in an amount of at least about 0.001 % by weight, at least about 0.0025% by weight, or at least about 0.01% by weight of the oral product. In some embodiments, the chamomile may be present in an amount of no greater than about 10% by weight, no greater than about 5% by weight, or no greater than about 1 % by weight of the oral product.
  • chamomile may be in an amount of from about 0.001 % to about 10% by weight, or from about 0.0025% to about 5% by weight of the oral product.
  • Chamomile may preferably be present in an amount of from about 0.01 % to about 1% by weight of the oral product.
  • chamomile may be present in any suitable amount to achieve the desired function, such as in an amount of at least about 0.1 % by weight, at least about 0.25% by weight, or at least about 0.5% by weight of the dry weight of the combination. In some embodiments, chamomile may be present in an amount of no greater than about 20%, no greater than about 15% or no greater than about 10% by weight of the dry weight of the combination.
  • chamomile may be present in an amount of from about 0.1 % by weight to about 20% by weight of the dry weight of the combination.
  • chamomile may be present in an amount of from about 0.25% by weight to about 15% by weight of the dry weight of the combination.
  • Chamomile may be preferably present in an amount of from about 0.5% by weight to about 10% by weight of the dry weight of the combination.
  • Valerian may also be present in the oral product.
  • Valerian particularly valerian root and valerian root extract, has traditionally been used as a sedative. It is available as infusions, teas, liquid extracts, tablets, capsules and tinctures and the herbal supplement is typically composed of the roots, rhizomes and stolons of the plant.
  • Valerian may be present in the oral product in any of these forms.
  • valerian may be present in the form of valerian extract, chopped or shredded valerian (whether from the roots, rhizomes and/or stolons of the plant), or powdered form. In some embodiments, valerian is not used in the form of a tincture.
  • valerian when present, may be in the form of valerian root extract. It has been found that the addition of valerian in the present oral product can contribute to promoting sleep. Valerian is not, however, essential to the desired function of the combination of actives in the oral product.
  • valerian may be in any suitable amount to achieve the desired function, such as in an amount of at least about 0.01 % by weight, at least about 0.025% by weight, or at least about 0.05% by weight of the oral product. In some embodiments, valerian may be present in an amount of no greater than about 5% by weight, no greater than about 2.5% by weight, or no greater than about 1 % by weight of the oral product.
  • valerian may be in an amount of from about 0.01 % to about 5% by weight of the oral product.
  • valerian may be present in an amount of from about 0.025% to about 2.5% by weight of the oral product, preferably in an amount of from about 0.05% to about 1 % by weight of the oral product.
  • valerian in terms of dry weight in the combination of active ingredients, valerian may be present in any suitable amount, such as in an amount of at least about 0.1 % by weight, at least about 0.5% by weight, or at least about 1 % by weight of the dry weight of the combination.
  • holy basil may be present in an amount of no greater than about 15%, no greater than about 10% or no greater than about 5% by weight of the dry weight of the combination.
  • valerian maybe present in an amount of from about 0.1 % to about 15% by weight of the dry weight of the combination.
  • valerian may be present in an amount from about 0.5% to about 10% by weight of the dry weight of the combination.
  • Valerian may be preferably present in an amount of from about 1% to about 5% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise holy basil (Ocimum tenuiflorum or Ocimum sanctum).
  • Holy basil is also known as tulsi or tulasi.
  • Holy basil is a member of the Lamiaceae basil family.
  • Holy basil is an herbal supplement used historically, particularly in Ayurvedic medicine, to reduce stress and anxiety, promote sleep, improve memory, and ease exhaustion. All parts of the holy basil plant are thought to act as an adaptogen, promoting enhanced metabolism, reduction in tissue damage and stress reduction.
  • Holy basil includes nutrients such as vitamin A and C, calcium, zinc, iron and chlorophyll. It is available as infusions, teas, liquid extracts and tinctures and the herbal supplement is typically composed of the flowers, leaves and stems of the plant.
  • Holy basil may be present in the oral product in any of these forms.
  • holy basil may be present in the form of holy basil extract, chopped or shredded holy basil (whether from flowers, leaves and/or stems of the plant), or powdered form.
  • holy basil is not used in the form of a tincture.
  • holy basil when present, may be in the form of holy basil extract. It has been found that the addition of holy basil in the present oral product can contribute to promoting sleep.
  • Holy basil is not, however, essential to the desired function of the combination of actives in the oral product.
  • holy basil may be in any suitable amount to achieve the desired function, such as in an amount of at least about 0.01 % by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, holy basil may be present in an amount of no greater than about 10% by weight, no greater than about 5% by weight, or no greater than about 2.5% by weight of the oral product.
  • holy basil may be in an amount of from about 0.01 % to about 10% by weight, or from about 0.05% to about 5% by weight of the oral product.
  • Holy basil may preferably be present in an amount of from about 0.1 % to about 2.5% by weight of the oral product.
  • holy basil may be present in any suitable amount, such as in an amount of at least about 1 % by weight, at least about 2% by weight, or at least about 5% by weight of the dry weight of the combination. In some embodiments, holy basil may be present in an amount of no greater than about 40%, no greater than about 35% or no greater than about 30% by weight of the dry weight of the combination.
  • holy basil may be present in an amount of from about 1 % by weight to about 40% by weight of the dry weight of the combination.
  • holy basil may be present in an amount of from about 2% by weight to about 35% by weight of the dry weight of the combination.
  • Holy basil may be preferably present in an amount of from about 5% by weight to about 30% by weight of the dry weight of the combination.
  • the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passionflower and L-theanine.
  • the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passionflower, L-theanine and chamomile extract.
  • the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passionflower, L-theanine, and chamomile extract and/or holy basil.
  • the combination of active ingredients comprises (i) from about 0.01 % to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.001% to about 2% by weight of the oral product, (iii) from about 0.01 % to about 10% ginseng by weight of the oral product, and (iv) from about 0.01 % to about 10% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.05% to about 15% magnesium ora salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.05% to about 5% ginseng by weight of the oral product, and (iv) from about 0.05% to about 5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.1 % to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.004% to about 0.5% by weight of the oral product, (iii) from about 0.1 % to about 2.5% ginseng by weight of the oral product, and (iv) from about 0.1 % to about 2.5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.05% to about 15% magnesium ora salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.001 % to about 2% by weight of the oral product, (iii) from about 0.01 % to about 10% ginseng by weight of the oral product, and (iv) from about 0.01 % to about 10% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.01 % to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.01 % to about 10% ginseng by weight of the oral product, and (iv) from about 0.01% to about 10% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.01 % to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.001% to about 2% by weight of the oral product, (iii) from about 0.05% to about 5% ginseng by weight of the oral product, and (iv) from about 0.01% to about 10% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.01 % to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.001% to about 2% by weight of the oral product, (iii) from about 0.01 % to about 10% ginseng by weight of the oral product, and (iv) from about 0.05% to about 5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.1 % to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.05% to about 5% ginseng by weight of the oral product, and (iv) from about 0.05% to about 5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.004% to about 0.5% by weight of the oral product, (iii) from about 0.05% to about 5% ginseng by weight of the oral product, and (iv) from about 0.05% to about 5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.1 % to about 2.5% ginseng by weight of the oral product, and (iv) from about 0.05% to about 5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.05% to about 5% ginseng by weight of the oral product, and (iv) from about 0.1 % to about 2.5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 0.1 % to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.0025% to about 1 % by weight of the oral product, (iii) from about 0.1 % to about 2.5% ginseng by weight of the oral product, and (iv) from about 0.1 % to about 2.5% passionflower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients may further comprise chamomile extract in an amount of from about 0.001 % to about 10% by weight of the oral product.
  • the combination of active ingredients may further comprise chamomile extract in an amount of from about 0.0025% to about 5% by weight of the oral product, preferably in an amount of from about 0.01 % to about 1 % by weight of the oral product.
  • the combination of active ingredients may further comprise holy basil in an amount of from about 0.01 % to about 10% by weight of the oral product.
  • the combination of active ingredients may further comprise holy basil in an amount of from about 0.05% to about 5% by weight of the oral product, preferably in an amount of from about 0.1 % to about 2.5% by weight of the oral product.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 0.01 % to about 10% by weight of the oral product and chamomile extract in an amount of from about 0.001 % to about 10% by weight of the oral product.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 0.01 % to about 10% by weight of the oral product.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 0.05% to about 5% by weight of the oral product, preferably each in a respective amount of from about 0.1 % to about 2.5% by weight of the oral product.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 0.01 % to about 10% by weight of the oral product and chamomile extract in an amount of from about 0.001 % to about 10% by weight of the oral product.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 0.05% to about 5% by weight of the oral product and chamomile extract in an amount of from about 0.0025% to about 5% by weight of the oral product, preferably L-theanine in an amount of from about 0.1 % to about 2.5% by weight of the oral product and chamomile extract in an amount of from about 0.01 % to about 1% by weight of the oral product.
  • the combination of active ingredients comprises (i) from about 10% to about 60% magnesium or a salt thereof by weight of the dry weight of the combination, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.1 % to about 5% by weight of the dry weight of the combination, (iii) from about 1 % to about 40% ginseng by weight of the dry weight of the combination, and (iv) from about 1 % to about 40% passionflower by weight of the dry weight of the combination, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 15% to about 50% magnesium or a salt thereof by weight of the dry weight of the combination, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.2% to about 4% by weight of the dry weight of the combination, (iii) from about 2.5% to about 30% ginseng by weight of the dry weight of the combination, and (iv) from about 2% to about 30% passionflower by weight of the dry weight of the combination, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients comprises (i) from about 20% to about 40% magnesium or a salt thereof by weight of the dry weight of the combination, (ii) a combination of B vitamins, where the total amount of B vitamins is from about 0.4% to about 2% by weight of the dry weight of the combination, (iii) from about 5% to about 20% ginseng by weight of the dry weight of the combination, and (iv) from about 5% to about 20% passionflower by weight of the dry weight of the combination, wherein the B vitamins are defined according to any of the embodiments discussed above, which comprises at least vitamin B2 and vitamin B6, wherein the magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product is free from melatonin.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 1 % to about 40% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 2% to about 35% by weight of the dry weight of the combination, preferably in an amount of from about 5% to about 30% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise chamomile extract in an amount of from about 0.1 % to about 20% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise chamomile extract in an amount of from about 0.5% to about 15% by weight of the dry weight of the combination, preferably in an amount of from about 1 % to about 10% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise holy basil in an amount of from about 1 % to about 40% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise holy basil in an amount of from about 2% to about 35% by weight of the dry weight of the combination, preferably in an amount of from about 5% to about 30% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 1 % to about 40% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 0.1% to about 20% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine in an amount of from about 2% to about 35% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 0.5% to about 15% by weight of the dry weight of the combination, preferably L-theanine in an amount of from about 5% to about 30% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 1 % to about 10% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 1 % to about 40% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 2% to about 35% by weight of the dry weight of the combination, preferably each in a respective amount of from about 5% to about 30% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 1 % to about 40% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 0.1 % to about 20% by weight of the dry weight of the combination.
  • the combination of active ingredients may further comprise L-theanine and holy basil, each in a respective amount of from about 2% to about 35% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 0.5% to about 15% by weight of the dry weight of the combination, preferably L-theanine and holy basil, each in a respective amount of from about 5% to about 30% by weight of the dry weight of the combination, and chamomile extract in an amount of from about 1 % to about 10% by weight of the dry weight of the combination.
  • ginseng is preferably present as Panax ginseng (Korean ginseng).
  • the amounts of the active ingredients as described above have been found by the inventors to provide a beneficial effect of promoting sleep, including by inducing sleep and/or maintaining sleep, while providing a safe product with reduced side effects.
  • the amounts may be tailored such that the product has high efficacy while also ensuring consumer safety and T1 avoiding any overdose of actives.
  • the combination of active ingredients further comprises a botanical active ingredient.
  • botanical active ingredient refers to any plant material or fungal-derived material, including plant material in its natural form and plant material derived from natural plant materials, such as extracts or isolates from plant materials or treated plant materials (e.g., plant materials subjected to heat treatment, fermentation, bleaching, or other treatment processes capable of altering the physical and/or chemical nature of the material).
  • a “botanical” includes, but is not limited to, "herbal materials,” which refer to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory characteristics (e.g., teas or tisanes).
  • the botanical materials useful in the present disclosure may comprise, without limitation, any of the compounds and sources set forth herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals” or “functional foods.” Certain botanicals, as the plant material or an extract thereof, have found use in traditional herbal medicine, and are described further herein.
  • Non-limiting examples of botanicals or botanical-derived materials include Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, cherry blossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, Grif.fonia simplicifolia, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, matcha, Nardostachys chinensis, oilbased extract of Viola odorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, Guyasa, matcha tea, beetroot juice, Rhodiola,
  • the combination of active ingredients further comprises Echinacea, which is a genus of herbaceous flowering plants in the daisy family, commonly referred to as coneflowers.
  • Echinacea may be present in an amount of from about 0.001% to about 3% by weight of the oral product, and preferably from about 0.01% to about 1 % by weight of the oral product.
  • the combination of active ingredients may further comprise a vitamin selected from vitamin A, vitamin D, vitamin E and vitamin K, or mixtures thereof.
  • the combination of active ingredients further comprises vitamin D, optionally in an amount of from about 0.00001 % to about 0.1 % by weight of the oral product.
  • the combination of active ingredients may further comprise an amino acid, such as an amino acid selected from the group consisting of alanine, arginine, asparagine, aspartic acid, beta-alanine, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, and hydroxyproline.
  • the combination of active ingredients comprises L- glycine.
  • the combination of active ingredients comprises a cannabinoid.
  • the cannabinoid may be a derivative or extract of cannabis.
  • Cannabinoids are a class of natural or synthetic chemical compounds which act on cannabinoid receptors (i.e. , CB1 and CB2) in cells that repress neurotransmitter release in the brain.
  • Cannabinoids are cyclic molecules exhibiting particular properties such as the ability to easily cross the blood-brain barrier.
  • Cannabinoids may be naturally occurring (Phytocannabinoids) from plants such as cannabis, (endocannabinoids) from animals, or artificially manufactured (synthetic cannabinoids).
  • Cannabis species express at least 85 different phytocannabinoids, and these may be divided into subclasses, including cannabigerols, cannabichromenes, cannabidiols, tetrahydrocannabinols, cannabinols and cannabinodiols, and other cannabinoids.
  • the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), tetrahydrocannabivarinic acid (THCV A), and mixtures thereof.
  • CBG
  • the combination of active ingredients comprises a cannabinoid (such as cannabidiol) in an amount of at least about 0.001 % by weight of the oral product, such as in a range from about 0.001 % to about 10% by weight, such as from about 0.01 % to about 5% by weight, such as from about 0.1 % to about 2.5% by weight, such as from 0.5% to about 1 % by weight of the oral product.
  • a cannabinoid such as cannabidiol
  • the combination of active ingredients comprises an electrolyte.
  • An electrolyte is a medium containing ions that is electrically conducting through the movement of those ions. This includes most soluble salts, acids and bases dissolved in a polar solvent such as water. Upon dissolving, the substance separates into cations and anions, which disperse uniformly throughout the solvent.
  • electrolyte beverages containing sodium and potassium salts replenish the body’s water and electrolyte concentrations after dehydration caused by e.g. exercise, excessive alcohol consumption, diaphoresis, diarrhea, vomiting, intoxication or starvation.
  • the combination of active ingredients comprises an electrolyte, optionally wherein the electrolyte comprises sodium, and/or potassium salts.
  • the electrolyte may be included in an amount of from 0.01 % to about 30% by weight of the oral product, such as from 0.1 % to about 20% by weight, or from about 0.5% to about 10% of the oral product.
  • the ratios of the active ingredients in the oral product may be selected to increase the effects of the oral product on the consumer. This is a particularly advantageous aspect of the present disclosure.
  • the magnesium or a salt thereof and total B vitamins are present in a weight ratio of from about 250:1 to about 10:1 , such as from about 200:1 to about 25:1 , preferably from about 200:1 to about 50:1 .
  • the magnesium or a salt thereof and ginseng are present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 5:1 to about 1 :1. In some embodiments, the magnesium ora salt thereof and ginseng are present in a weight ratio of from about 10:1 to about 1 :10, such as from about 10:1 to about 1 :5, preferably from about 10:1 to about 1 :1. [0141] In some embodiments, the magnesium or a salt thereof and passionflower are present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 5: 1 to about 1 :1.
  • the ginseng and total vitamin B are present in a weight ratio of from about 100:1 to about 10:1 , such as from about 75:1 to about 15:1 , preferably from about 50:1 to about 25:1. In some embodiments, the ginseng and total vitamin B are present in a weight ratio of from about 50:1 to about 1 :1 , such as from about 30:1 to about 2:1 , preferably from about 25:1 to about 5: 1 .
  • the ginseng and passionflower are present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 3:1 to about 1 :5.
  • the passionflower and total vitamin B are present in a weight ratio of from about 100:1 to about 10:1 , such as from about 80:1 to about 15:1 , preferably from about 75:1 to about 25:1. In some embodiments, the passionflower and total vitamin B are present in a weight ratio of from about 100:1 to about 10:1 , such as from about 80:1 to about 15:1 , preferably from about 75:1 to about 20:1.
  • the combination of actives may include L-theanine, and the magnesium or a salt thereof and L-theanine may be present in a weight ratio of from about 10: 1 to about 1 :10, such as from about 10:1 to about 1 :5, preferably from about 10:1 to about 1 :1 .
  • the ginseng and L-theanine may be present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 2:1 to about 1 :4.
  • the passionflower and L-theanine may be present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5: 1 to about 1 :5, preferably from about 3: 1 to about 1 :3.
  • the total vitamin B and L-theanine may be present in a weight ratio of from about 2:1 to about 1 :1000, such as from about 1 :1 to about 1 :500, preferably from about 1 :2 to about 1 :200.
  • the combination of actives may comprise chamomile extract, and the magnesium or a salt thereof and chamomile extract may be present in a weight ratio of from about 50:1 to about 1 :10, such as from about 35:1 to about 1 :1 , preferably from about 25:1 to about 5: 1 .
  • the ginseng and chamomile extract may be present in a weight ratio of from about 20:1 to about 1 :5, such as from about 15:1 to about 1 :2, preferably from about 10:1 to about 1 :1.
  • the passionflower and chamomile extract may be present in a weight ratio of from about 25:1 to about 1 :5, such as from about 20:1 to about 1 :2, preferably from about 15: 1 to about 1 :1.
  • the total vitamin B and chamomile extract may be present in a weight ratio of from about 2:1 to about 1 :100, such as from about 1 :1 to about 1 :50, preferably from about 1 :2 to about 1 :25.
  • the combination of actives may further comprise L-theanine and the L-theanine and chamomile extract may be present in a weight ratio of from about 25:1 to about 1 :5, such as from about 20:1 to about 1 :2, preferably from about 15:1 to about 1 :1.
  • the combination of actives may comprise holy basil, and the magnesium or a salt thereof and holy basil may be present in a weight ratio of from about 25:1 to about 1 :5, such as from about 10:1 to about 1 :2, preferably from about 5:1 to about 1 :1.
  • the ginseng and holy basil may be present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 4:1 to about 1 :4.
  • the passionflower and holy basil may be present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5: 1 to about 1 :5, preferably from about 4: 1 to about 1 :4.
  • the total vitamin B and holy basil may be present in a weight ratio of from about 2:1 to about 1 :1000, such as from about 1 :1 to about 1 :500, preferably from about 1 :2 to about 1 :200.
  • the combination of actives may comprise L-theanine and holy basil and the L-theanine and holy basil may be present in a weight ratio of from about 10:1 to about 1 :10, such as from about 5:1 to about 1 :5, preferably from about 4:1 to about 1 :4.
  • the weight ratios of the other actives may be defined according to the above embodiments.
  • the combination of actives may comprise chamomile extract and holy basil, and the chamomile extract and holy basil may be present in a weight ratio of from about 2:1 to about 1 :1000, such as from about 1 :1 to about 1 :100, preferably from about 1 :2 to about 1 :50.
  • the weight ratios of the other actives may be defined according to the above embodiments.
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 50:1 to about 1 :10; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 250:1 to about 10:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 100:1 to about 10:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :10; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 250:1 to about 10:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 100:1 to about 10:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :10; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 250:1 to about 10:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 50:1 to about 1 :1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 25:1 to about 1 :5; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 25:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 75:1 to about 15:1 , wherein the combination of B vitamins is as described in any of the embodiments, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to gins
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 5:1 to about 1 :5; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 25:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 75:1 to about 15:1 , wherein the combination of B vitamins is as described in any of the embodiments, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to gins
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 5:1 to about 1 :5; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 25:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 30:1 to about 2:1 , wherein the combination of B vitamins is as described in any of the embodiments, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :1 ; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 50:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 50:1 to about 25:1 , wherein the combination of B vitamins is as described in any of the embodiments , wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :1 ; wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 50:1 ; and optionally wherein the weight ratio of ginseng to total amount of vitamin B is from about 25:1 to about 5:1 , wherein the combination of B vitamins is as described in any of the embodiments , wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 250:1 to about 10:1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 50:1 to about 10:1 ; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 100:1 to about 10:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 25:1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 25:1 to about 1 :5; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 80:1 to about 15:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 50:1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :1 ; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 75:1 to about 25:1 , wherein the combination of B vitamins is as described in any of the embodiments, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of vitamin B is from about 200:1 to about 50:1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :1 ; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 75:1 to about 20:1 , wherein the combination of B vitamins is as described in any of the embodiments, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to total amount of
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 100:1 to about 10:1 ; wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 100:1 to about 10:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 100
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 50:1 to about 1 :1 ; wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 100:1 to about 10:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 75:1 to about 15:1 ; wherein the weight ratio of ginseng to passionflower is from about 5:1 to about 1 :5; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 80:1 to about 15:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 75
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 30:1 to about 2:1 ; wherein the weight ratio of ginseng to passionflower is from about 5:1 to about 1 :5; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 80:1 to about 15:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 30:1
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 50:1 to about 25:1 ; wherein the weight ratio of ginseng to passionflower is from about 3:1 to about 1 :3; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 75:1 to about 25:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 50:1
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 25:1 to about 5:1 ; wherein the weight ratio of ginseng to passionflower is from about 3:1 to about 1 :3; and optionally wherein the weight ratio of passionflower to total amount of vitamin B is from about 75:1 to about 20:1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of ginseng to total amount of vitamin B is from about 25:1
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 50:1 to about 1 :10; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 50:1 to about 1 :10; and optionally wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :10; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :10; and optionally wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 25: 1 to about 1 :5; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 25:1 to about 1 :5; and optionally wherein the weight ratio of ginseng to passionflower is from about 5:1 to about 1 :5, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :5; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 5:1 to about 1 :5; and optionally wherein the weight ratio of ginseng to passionflower is from about 5:1 to about 1 :5, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :1 ; and optionally wherein the weight ratio of ginseng to passionflower is from about 3:1 to about 1 :3, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from about 10:1 to about 1 :1 ; wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 5:1 to about 1 :1 ; and optionally wherein the weight ratio of ginseng to passionflower is from about 3:1 to about 1 :2, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passionflower, wherein the weight ratio of magnesium or a salt thereof to ginseng is from
  • the oral product may further comprise (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to L-theanine is from about 10:1 to about 1 :10, preferably from about 10:1 to about 1 :1.
  • the oral product may further comprise (vi) chamomile extract, and/or (vii) holy basil, wherein the weight ratio of magnesium or a salt thereof to chamomile extract is from about 50:1 to about 1 :10, and/or wherein the weight ratio of magnesium or a salt thereof to holy basil is from about 25:1 to about 1 :5.
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 50:1 to about 1 :10; wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is from about 10:1 to about 1 :10, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :10; wherein the weight ratio of ginseng to passionflower is from about 10:1 to about 1 :10; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is from about 10:1 to about 1 :10, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 25:1 to about 1 :5; wherein the weight ratio of ginseng to passionflower is from about 5:1 to about 1 :5; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is from about 10:1 to about 1 :5, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine,
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 5: 1 to about 1 :5; wherein the weight ratio of ginseng to passionflower is from about 5: 1 to about 1 :5; and wherein the weight ratio of magnesium or a salt thereof to L- theanine is from about 10:1 to about 1 :5, wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine,
  • the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passionflower is from about 10:1 to about 1 :1 ; wherein the weight ratio of ginseng to passionflower is from about 3:1 to about 1 :3; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is from about 10:1 to about 1 :1 , wherein the combination of B vitamins is as described in any of the embodiments hereinabove, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and wherein the oral product is free from melatonin.
  • active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passionflower, and (v) L-theanine
  • the oral product may further comprise (vi) chamomile extract, and/or (vii) holy basil, wherein the weight ratio of magnesium or a salt thereof to chamomile extract is from about 50:1 to about 1 :10, and/or wherein the weight ratio of magnesium or a salt thereof to holy basil is from about 25:1 to about 1 :5.
  • ginseng is preferably present as Panax ginseng (Korean ginseng).
  • the product may include one or more additional components in addition to the combination of active ingredients.
  • the oral product may further comprise an additive selected from the group consisting of a flavouring agent, sweetener, buffering agent, acidifying agent, thickener, filler, binder, humectant, preservative, salt, colouring agent, oral care additive, disintegration aid, antioxidant, water or mixtures thereof.
  • the oral product further comprises one or more additives selected from the group consisting of a flavouring agent, sweetener, acidifying agent, thickener, filler, binder, humectant, preservative, and mixtures thereof.
  • the oral product may comprise a filler.
  • Fillers for example, may fulfil multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like.
  • the filler is a porous particulate material and is cellulose-based.
  • the filler or bulking agent may be a non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources.
  • cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like), sugar beet (e.g., FIBREX® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof.
  • the filler is a cellulose material selected from the group consisting of maize fiber, oat fiber, barley fiber, rye fiber, buckwheat fiber, sugar beet fiber, bran fiber, bamboo fiber, wood pulp fiber, cotton fiber, citrus pulp fiber, grass fiber, willow fiber, poplar fiber, cocoa fiber, derivatives thereof, and combinations thereof.
  • the filler is a cellulose material selected from the group consisting of sugar beet fiber, wood pulp fiber, bamboo fiber, derivatives thereof, and combinations thereof.
  • the filler is derived from wood pulp fiber.
  • One particularly suitable filler for use in the products described herein is microcrystalline cellulose ("MCC").
  • MCC microcrystalline cellulose
  • the MCC may be synthetic or semi-synthetic, or it may be obtained entirely from natural celluloses.
  • the MCC may be selected from the group consisting of AVICEL® grades PH-100, PH-101 , PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-301 , PH-302, VIVACEL® grades 101 , 102, 12, 20 and EMOCEL® grades 50M and OOM, and the like, and mixtures thereof.
  • the filler is a non-tobacco plant material or a derivative thereof.
  • non-tobacco plant material include starches (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials.
  • additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of these fillers can also be used.
  • Starch as used herein may refer to pure starch from any source, modified starch, or starch derivatives. Starch is present, typically in granular form, in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starch from different sources has different chemical and physical characteristics. A specific starch can be selected for inclusion in the product based on the ability of the starch material to impart a specific organoleptic property to product. Starches derived from various sources can be used.
  • starch major sources include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava).
  • sources of starch include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams.
  • modified starches are modified starches.
  • a modified starch has undergone one or more structural modifications, often designed to alter its high heat properties. Some starches have been developed by genetic modifications, and are considered to be "modified” starches. Other starches are obtained and subsequently modified.
  • modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, enzyme treatment, acetylation, hydroxypropylation, and/or partial hydrolysis.
  • modified starches are modified by heat treatments, such as pregelatinization, dextrinization, and/or cold water swelling processes.
  • Certain modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, and starch sodium octenyl succinate.
  • the moisture content (e.g., water content) of the oral product, prior to use by a consumer of the product, may vary according to the desired properties.
  • the water content is less than about 50% by weight, and generally is from about 1 % to about 50% by weight, for example, from about 5% to about 45% by weight, about 10% to about 40% by weight, about 20% to about 35% by weight; including water amounts of at least about 5% by weight, at least about 10% by weight, at least about 15% by weight, and at least about 20% by weight of the oral product.
  • the water content may be higher and may be at least about 50%, such as at least about 60%, such as at least about 75% by weight of the oral product.
  • the water content of a liquid oral product may be at least about 90% by weight of the oral product.
  • the water content of a liquid oral product may be from about 60% to about 99.5% by weight, such as from about 75% to about 99% by weight, such as from about 80% to about 99% by weight of the oral product.
  • flavouring agent refers to materials which, where local regulations permit, may be used to create a desired taste, aroma or other somatosensorial sensation in a product for adult consumers.
  • sensory characteristics that can be modified by the flavoring agent include taste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma.
  • Flavouring agents may be natural or synthetic, and the character of the flavours imparted thereby may be described, without limitation, as fresh, sweet, herbal, confectionary, floral, fruity, or spicy.
  • the flavouring agent may be selected from the group consisting of naturally occurring flavour materials, botanicals, extracts of botanicals, synthetically obtained materials, or combinations thereof (e.g., tobacco, cannabis, licorice (liquorice), hydrangea, eugenol, Japanese white bark magnolia leaf, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, aniseed (anise), cinnamon, turmeric, Indian spices, Asian spices, herb, Wintergreen, cherry, berry, red berry, cranberry, raspberry, strawberry, peach, apple, orange, mango, pineapple, clementine, lemon, lime, tropical fruit, papaya, rhubarb, grape, durian, dragon fruit, cucumber, blueberry, mulberry, citrus fruits, Drambuie, bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe vera, cardamom, coconut,
  • the flavouring agent comprises a natural flavoring, such as berry (e.g. raspberry, blueberry or strawberry), honey, citrus (such as lemon, bergamot, orange or lime), or other botanical material.
  • berry e.g. raspberry, blueberry or strawberry
  • honey e.g. honey
  • citrus such as lemon, bergamot, orange or lime
  • the flavouring agent comprises menthol, spearmint and/or peppermint.
  • the flavouring agent comprises flavour components of cucumber, blueberry, citrus fruits and/or redberry.
  • the flavouring agent comprises eugenol.
  • the flavouring agent comprises flavour components extracted from tobacco.
  • the flavouring agent comprises flavour components extracted from cannabis.
  • the flavouring agent may comprise a sensate, which is intended to achieve a somatosensorial sensation which are usually chemically induced and perceived by the stimulation of the fifth cranial nerve (trigeminal nerve), in addition to or in place of aroma or taste nerves, and these may include agents providing heating, cooling, tingling, numbing effect.
  • a suitable heat effect agent may be, but is not limited to, van i I ly I ethyl ether and a suitable cooling agent may be, but not limited to eucalyptol, WS-3.
  • a flavouring agent may be included in the oral product in an amount up to about 10% by weight, such as up to about 5% by weight, such as up to about 1 % by weight of the oral product.
  • a flavouring agent is present in an amount of from about 0.01% to about 5% by weight, preferably in an amount of from about 0.1 % to about 2.5% by weight of the oral product, and more preferably in an amount of from about 0.25% to about 1 % by weight of the oral product.
  • the oral product may further comprise at least one binder.
  • a binder (or combination of binders) may be employed in the product in certain embodiments, in amounts sufficient to provide the desired physical attributes and physical integrity to the product.
  • Binders can be organic or inorganic, or a combination thereof.
  • Representative binders include cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof.
  • the amount of binder utilised in the product can vary, but may be up to about 30% by weight, and certain embodiments are characterised by a binder content of at least about 0.1 % by weight, such as from about 1 % to about 30% by weight, or about 1 % to about 10% by weight, based on the total weight of the oral product.
  • the binder comprises a cellulose derivative.
  • the cellulose derivative is a cellulose ether (including carboxyalkyl ethers), meaning a cellulose polymer with the hydrogen of one or more hydroxyl groups in the cellulose structure replaced with an alkyl, hydroxyalkyl, or aryl group.
  • Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose (“HPMC”), hydroxyethyl cellulose, and carboxymethylcellulose (“CMC”).
  • the cellulose derivative is or comprises HPC.
  • the cellulose derivative is a combination of HPC and HPMC.
  • the oral product comprises from about 1 % to about 10% of the cellulose derivative (such as HPC) by weight of the oral product, with certain embodiments comprising from about 1 % to about 5% by weight of cellulose derivative (such as HPC), based on the weight of the product.
  • the cellulose derivative such as HPC
  • the oral product comprises at least one humectant.
  • suitable humectants that may be included in the product include, but are not limited to, glycerin, 1 ,2-propanediol (propylene glycol), 1 ,3-propanediol, dipropylene glycol, sorbitol, xylitol, mannitol, and the like.
  • the humectant is or comprises glycerin.
  • the oral product comprises glycerin.
  • the humectant is or comprises propylene glycol.
  • the oral product comprises propylene glycol.
  • the amount of humectant utilised in the oral product can vary, but may be up to about 5% by weight, and certain embodiments can be characterised by a humectant content of at least about 1 % by weight, such as about 2 to about 5% by weight of the oral product.
  • the humectant (such as glycerin and/or propylene glycol) may be present in an amount of from about 0.01% to about 25% by weight of the oral product, such as from about 0.1 % to about 20% by weight of the oral product, such as from about 0.5% to about 15% by weight of the oral product, such as from about 1 % to about 10% by weight of the oral product, such as from about 5% to about 10% by weight of the oral product.
  • sweeteners In order to improve the sensory properties of the oral product, one or more sweeteners may be added.
  • the sweeteners can be any sweetener or combination of sweeteners, in natural or artificial form, or as a combination of natural and artificial sweeteners.
  • natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, and the like.
  • artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame and the like.
  • the sweetener comprises one or more sugar alcohols.
  • the sugar alcohol may include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, or combinations thereof.
  • the sweetener is selected from the group consisting of fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and mixtures thereof.
  • the sweetener is selected from the group consisting of sucralose, acesulfame K, aspartame, maltodextrin, mannitol, sucrose, and mixtures thereof.
  • the sweetener may be sucralose and/or acesulfame K.
  • the sweetener (such as sucralose and/or acesulfame K) may be present in an amount of from about 0.001 % to about 5% by weight, such as from about 0.01 % to about 3% by weight, preferably from about 0.01 % to about 1 % by weight of the oral product.
  • Non-limiting examples of suitable buffering agents that may be included in the oral product include alkali metals acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof.
  • the buffering agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, sodium phosphate, ammonium phosphate, dicalcium phosphate, tricalcium phosphate, and mixtures thereof.
  • the buffering agent is sodium bicarbonate and/or sodium carbonate. Where present, the buffering agent (e.g.
  • sodium bicarbonate and/or sodium carbonate may be included in an amount less than about 5% based on the weight of the oral product; for example, from about 0.5% to about 5%, such as, e.g., from about 0.75% to about 4%, from about 0.75% to about 3%, or from about 1 % to about 2% by weight, based on the total weight of the oral product.
  • Organic acid such as, e.g., from about 0.75% to about 4%, from about 0.75% to about 3%, or from about 1 % to about 2% by weight, based on the total weight of the oral product.
  • the product comprises an organic acid.
  • organic acid refers to an organic (i.e. , carbon-based) compound that is characterised by acidic properties.
  • organic acids are relatively weak acids (i.e., they do not dissociate completely in the presence of water), such as carboxylic acids (-CO 2 H) or sulfonic acids (- SO 2 OH).
  • reference to organic acid means an organic acid that is intentionally added.
  • an organic acid may be intentionally added as a specific mixture ingredient as opposed to merely being inherently present as a component of another mixture ingredient (e.g., the small amount of organic acid which may inherently be present in a mixture ingredient such as a tobacco material).
  • the one or more organic acids are added neat (i.e., in their free acid, native solid or liquid form) or as a solution in, e.g. water. In some embodiments, the one or more organic acids are added in the form of a salt.
  • the organic acid is a carboxylic acid or a sulfonic acid.
  • the carboxylic acid or sulfonic acid functional group may be attached to any alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl group having, for example, from one to twenty carbon atoms (C1-C20).
  • the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl carboxylic or sulfonic acid.
  • the organic acid is an alkyl carboxylic acid.
  • alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like.
  • the organic acid is an alkyl sulfonic acid.
  • alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid.
  • the alkyl carboxylic or sulfonic acid is substituted with one or more hydroxyl groups.
  • Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.
  • an organic acid may include more than one carboxylic acid group or more than one sulfonic acid group (e.g., two, three, or more carboxylic acid groups).
  • Nonlimiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid.
  • organic acids containing multiple carboxylic acids e.g., from two to four carboxylic acid groups
  • one or more of the carboxylic acid groups may be esterified.
  • Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl or dimethyl citrate, and the like.
  • the organic acid may include more than one carboxylic acid group and one or more hydroxyl groups.
  • Non-limiting examples of such acids include tartaric acid, citric acid, and the like.
  • the organic acid is citric acid, sodium citrate, calcium citrate, or a combination thereof.
  • the organic acid is an aryl carboxylic acid or an aryl sulfonic acid.
  • aryl carboxylic and sulfonic acids include benzoic acid, toluic acids, salicylic acid, benzenesulfonic acid, and p-toluenesulfonic acid.
  • suitable organic acids include 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4- aminosalicylic acid, acetic acid, adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+), camphor-10-sulfonic acid (+), capric acid, caproic acid, caprylic acid, cinnamic acid, cyclamic acid, decanoic acid, dodecylsulfuric acid, ethane-1 ,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, lactobionic acid, lauric
  • the organic acid is selected from the group consisting of citric acid, malic acid, lactic acid, benzoic acid, tartaric acid, and mixtures thereof.
  • the organic acid is or comprises citric acid or a salt thereof.
  • the organic acid is or comprises citric acid anhydrate.
  • the amount of organic acid present in the product may vary.
  • the oral product may comprise from about 0.01 % to about 10% by weight of organic acid (e.g. citric acid or a salt thereof), present as one or more organic acids, based on the total weight of the oral product.
  • the oral product comprises at least about 0.01 %, at least about 0.1 %, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1 %, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or at least about 10% organic acid by weight, based on the total weight of the oral product.
  • the oral product comprises from about 0.01 % to about 5% by weight of organic acid (e.g. citric acid or salt thereof) based on the weight of the oral product.
  • organic acid e.g. citric acid or salt thereof
  • the oral product comprises an organic acid in an amount of from about 0.1 % to about 2.5% by weight of the oral product.
  • a salt of an organic acid e.g., citric acid anhydrate
  • the percent by weight is calculated based on the weight of the free acid, not including any counter-ion which may be present.
  • the organic acid inclusion is sufficient to provide a product pH of from about 4.0 to about 9.0, such as from about 4.5 to about 7.0, or from about 5.5 to about 7.0, from about 4.0 to about 5.5, or from about 7.0 to about 9.0. In some embodiments, the organic acid inclusion is sufficient to provide a product pH of from about 4.5 to about 6.5, for example, from about 4.5, about 5.0, or about 5.5, to about 6.0, or about 6.5.
  • the organic acid is provided in a quantity sufficient to provide a pH of the product of from about 5.5 to about 6.5, for example, from about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0, to about 6.1 , about 6.2, about 6.3, about 6.4, or about 6.5.
  • a mineral acid e.g., hydrochloric acid, sulfuric acid, phosphoric acid, or the like
  • hydrochloric acid e.g., hydrochloric acid, sulfuric acid, phosphoric acid, or the like
  • Organic acids e.g., citric acid
  • the organic acid is added as a 50% aqueous solution.
  • the oral product may comprise a thickening agent in some embodiments.
  • suitable thickening agents may include a hydrocolloid, such as xanthan gum, guar gum, konjac gum, gum tragacanth and gum Arabic.
  • xanthan gum is understood to be a thickening agent that thickens compositions when added during cold processing (i.e. when heat is not applied).
  • a thickening agent e.g. xanthan gum
  • xanthan gum may be included in an amount of from about 0.001 % to about 5% by weight, and preferably from about 0.01 % to about 1 % by weight of the oral product.
  • a colouring agent may be employed in amounts sufficient to provide the desired physical attributes to the product.
  • examples of colouring agents include various dyes and pigments, such as caramel colouring and titanium dioxide.
  • Natural colouring agents such as curcumin, beet juice extract, spirulina; also a variety of synthetic pigments may also be used.
  • the amount of colorant utilised in the oral product can vary, but when present is typically up to about 3% by weight, such as from about 0.1 %, about 0.5%, or about 1 %, to about 3% by weight, based on the total weight of the oral product.
  • ingredients such as preservatives (e.g., potassium sorbate), disintegration aids (e.g., croscarmellose sodium, crospovidone, sodium starch glycolate, pregelatinized corn starch, and the like), and/or antioxidants can also be used.
  • preservatives e.g., potassium sorbate
  • disintegration aids e.g., croscarmellose sodium, crospovidone, sodium starch glycolate, pregelatinized corn starch, and the like
  • antioxidants e.g., antioxidants can also be used.
  • such ingredients, where used are used in amounts of up to about 10% by weight, for example at least about 0.1 % by weight, such as about 0.5 to about 10% by weight of the oral product.
  • a disintegration aid may be employed in an amount sufficient to provide control of desired physical attributes of the oral product such as, for example, by providing loss of physical integrity and dispersion of the various component materials upon contact of the formulation with water (e.g., by
  • Examples of further types of additives include zinc salts selected to be relatively water soluble for compositions with greater water solubility (e.g., zinc gluconate) or selected to be relatively water insoluble for compositions with reduced water solubility (e.g., zinc oxide), or combinations thereof. See, for example, those representative components, combination of components, relative amounts of those components, and manners and methods for employing those components, set forth in US Pat. No. 9,237,769 to Mua et al., US Pat. No. 7,861 ,728 to Holton, Jr. et al., US Pat. App. Pub. No. 2010/0291245 to Gao et al., and US Pat. App. Pub.
  • the oral product comprises zinc or zinc gluconate. In some embodiments, the oral product comprises zinc or zinc gluconate in an amount by weight from about 0.001 % to about 5%, or from about 0.01 to about 2%, preferably from about 0.01 to about 0.1 % based on the oral product.
  • the aforementioned additives can be employed together (e.g., as additive formulations) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final product). Furthermore, the aforementioned types of additives may be encapsulated as provided in the final product or composition. Exemplary encapsulated additives are described, for example, in WO 2010/132444 to Atchley, which has been previously incorporated by reference herein.
  • the products or compositions as described herein are configured for oral use.
  • the term "configured for oral use” as used herein means that the product is provided in a form such that during use, saliva in the mouth of the user causes one or more of the components of the product (e.g., active ingredients) to pass into the mouth of the user.
  • the product is adapted to deliver active ingredients and optionally flavouring agent to a user through mucous membranes in the user's mouth, the user's digestive system, or both.
  • the active ingredients and optionally flavouring agent can be absorbed through the mucous membranes in the mouth or absorbed through the digestive tract when the product is used.
  • the oral product comprises the combination of active ingredients in an amount of at least about 0.01% by weight, such as at least about 0.1 % by weight, or preferably at least about 0.5% by weight of the oral product.
  • the combination of active ingredients may be present in an amount of from about 0.01 % to about 20% by weight.
  • the combination of active ingredients may be present in an amount of from about 0.1% to about 10% by weight, preferably from about 0.5% to about 5% by weight of the oral product.
  • the oral product may take any form that is suitable for application to the oral cavity of a human or animal.
  • the oral product is an oral dosage form in the form of a solid, a gel or a liquid.
  • the oral product is a solid oral dosage form.
  • An oral product as described herein may take various forms, including gels, melts, tablets, lozenges, powders, pouches, and liquids (e.g. beverages).
  • the oral product is a liquid oral dosage form.
  • the oral product is in the form of a liquid dosage form.
  • the liquid dosage form is suitable for oral consumption, such that it may be referred to as a beverage as it can be ingested (i.e. drunk) by the user.
  • the liquid oral dosage form may be in the form of a shot; i.e. a drink that may be consumed quickly, e.g. in a single gulp or a couple of gulps.
  • Formulating the oral product in the form of a shot may be advantageous as it provides a convenient and easy-to-use mode of administration that does not take up much room during storage (e.g. in a fridge or cupboard) and is easily portable by the user so can be taken on the go.
  • Shots may also provide an efficient delivery vehicle for actives, whereby a level of active sufficient to provide good efficacy can be delivered to the user without the need to consume large volumes of liquid. Additionally, the shots may be formulated to have a pleasant taste. Drinking a shot may be considered to be more palatable and easier to a user than swallowing a tablet, for example.
  • the liquid oral dosage form may also be in the form of a larger beverage that is consumed more slowly over several gulps.
  • the liquid oral dosage form may have a volume of from about 1 mL to about 250 mL, such as from about 1 mL to about 200 mL.
  • the liquid oral dosage form may have a volume of from about 100 mL to about 250 mL and be provided in a package such as a carton, cup, can or bottle of liquid.
  • the liquid oral dosage form may have a volume of from about 10 mL to about 100 mL, such as from about 25 mL to about 75 mL. In such embodiments, the liquid oral dosage form may be considered to be a shot. For example, the volume of liquid may be about 60 mL or about 30 mL. Such form is preferred in the present disclosure.
  • the oral product may further comprise water in an amount of from about 50% to about 99.9% by weight of the oral product. In some embodiments, the oral product comprises water in an amount of from about 75% to about 99.9% by weight, preferably from about 80% to about 99.9% by weight.
  • the water may include tap water, rain water, mineralised water, or distilled water.
  • the liquid oral dosage form may comprise the combination of active ingredients in an amount of from about 0.1 % to about 15% by weight of the oral product, and water in an amount of from about 85% to about 99.9% by weight of the oral product.
  • the liquid oral dosage form may comprise the combination of active ingredients in an amount of from about 0.5% to about 12% by weight of the oral product, and water in an amount of from about 88% to about 99.5% by weight of the oral product.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form comprises (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; and optionally at least one of (v) L- theanine, (vi) chamomile extract and/or (vii) holy basil, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; and (v) L- theanine wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; and optionally chamomile extract; and/or holy basil wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; (v) L-theanine and optionally (vi) chamomile extract; and/or (vii) holy basil wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of B vitamins may consist of vitamin B2 and vitamin B6.
  • the liquid oral dosage form may further comprise valerian, optionally in an amount of from about 0.01 % to about 5% by weight of the oral product.
  • valerian may be present in an amount of from about 0.025% to about 2.5% by weight of the oral product, preferably in an amount of from about 0.05% to about 1 % by weight of the oral product.
  • the liquid oral dosage form may be free of valerian.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form may consist essentially of (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; (v) L-theanine, (vi) chamomile extract; and (vii) holy basil, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of B vitamins may consist of vitamin B2 and vitamin B6.
  • the combination of active ingredients in the melatonin-free liquid oral dosage form may consist of (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined hereinabove; (iii) ginseng; (iv) passionflower; (v) L-theanine, (vi) chamomile extract; and (vii) holy basil, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove.
  • the combination of B vitamins may consist of vitamin B2 and vitamin B6.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may comprise magnesium or a salt thereof in an amount of from about 50 mg to about 800 mg, such as from about 100 mg to about 600 mg, preferably from about 200 mg to about 500 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may comprise a total amount of B vitamins in an amount of from about 0.1 mg to about 10 mg, such as from about 0.5 mg to about 7.5 mg, preferably from about 1 mg to about 5 mg or from about 1 mg to about 7 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may comprise ginseng in an amount of from about 10 mg to about 500 mg, such as from about 25 mg to about 300 mg, preferably from about 50 mg to about 250 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may comprise passionflower in an amount of from about 10 mg to about 500 mg, such as from about 25 mg to about 300 mg, preferably from about 50 mg to about 250 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may include L-theanine in an amount of from about 5 mg to about 500 mg, such as from about 25 mg to about 400 mg, preferably from about 50 mg to about 300 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may include chamomile extract in an amount of from about 1 mg to about 500 mg, such as from about 5 mg to about 250 mg, preferably from about 10 mg to about 100 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may include holy basil in an amount of from about 5 mg to about 500 mg, such as from about 25 mg to about 400 mg, such as from about 50 mg to about 300 mg.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) from about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 10 mg to about 500 mg ginseng; (iv) from about 10 mg to about 500 mg passionflower; and optionally (v) from about 5 mg to about 500 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) from about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 25 mg to about 300 mg ginseng; (iv) from about 25 mg to about 300 mg passionflower; and optionally (v) from about 25 mg to about 400 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 200 mg to about 500 mg of magnesium or a salt thereof; (ii) from about 1 mg to about 5 mg or from about 1 mg to about 7 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 50 mg to about 250 mg ginseng; (iv) from about 50 mg to about 250 mg passionflower; and optionally (v) from about 50 mg to about 300 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) from about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 10 mg to about 500 mg ginseng; (iv) from about 10 mg to about 500 mg passionflower; and optionally (v) from about 5 mg to about 500 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) from about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 10 mg to about 500 mg ginseng; (iv) from about 10 mg to about 500 mg passionflower; and optionally (v) from about 5 mg to about 500 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) from about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 25 mg to about 300 mg ginseng; (iv) from about 10 mg to about 500 mg passionflower; and optionally (v) from about 5 mg to about 500 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) from about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 10 mg to about 500 mg ginseng; (iv) from about 25 mg to about 300 mg passionflower; and optionally (v) from about 5 mg to about 500 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 200 mg to about 500 mg of magnesium or a salt thereof; (ii) from about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 25 mg to about 300 mg ginseng; (iv) from about 25 mg to about 300 mg passionflower; and optionally (v) from about 25 mg to about 400 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) from about 1 mg to about 5 mg or from about 1 mg to about 7 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 25 mg to about 300 mg ginseng; (iv) from about 25 mg to about 300 mg passionflower; and optionally (v) from about 25 mg to about 400 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) from about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 50 mg to about 250 mg ginseng; (iv) from about 25 mg to about 300 mg passionflower; and optionally (v) from about 25 mg to about 400 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) comprises: (i) from about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) from about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins are as defined above; (iii) from about 25 mg to about 300 mg ginseng; (iv) from about 50 mg to about 250 mg passionflower; and optionally (v) from about 25 mg to about 400 mg of L-theanine, wherein the magnesium or salt thereof is described in any of the embodiments hereinabove, and the product is free of melatonin.
  • L-theanine may be a mandatory component in the combination of actives in the amount defined.
  • the liquid oral dosage form (e.g. in the form of a shot having a volume of 25 mL to 75 mL) may further comprise: (vi) from about 1 mg to about 500 mg, such as from about 5 mg to about 250 mg, preferably from about 10 mg to about 100 mg chamomile extract and/or (vii) from about 5 mg to about 500 mg, such as from about 25 mg to about 400 mg, preferably from about 50 mg to about 300 mg holy basil.
  • the amounts of the active ingredients as described above have been found by the inventors to promote sleep, including inducing sleep and/or maintaining sleep, while providing a safe product with reduced side effects.
  • the amounts may be tailored such that the product has high efficacy while also ensuring consumer safety and avoiding any overdose of actives.
  • ginseng is preferably present as Panax ginseng (Korean ginseng).
  • the liquid oral dosage form may include any further suitable additive. Suitable additives are described in greater detail above, and all of the additives described herein may be included in the liquid oral dosage form.
  • the liquid oral dosage form may further comprise an additive selected from the group consisting of a flavouring agent, sweetener, acidifying agent, thickener, humectant, preservative, and mixtures thereof. Examples of each of these forms of additives are described hereinabove.
  • the oral product is in the form of a solid.
  • solid means that the products can substantially sustain their physical shape when unsupported by external means, e.g. packaging etc. Thus, they are considered to be solid, solid-like, in solid form or in solid-like form at room temperature. For the avoidance of doubt the solid product remains substantially solid at up to 30°C.
  • the oral product is in solid form, such as in the form of loose moist snuff, loose dry snuff, pelletized pieces, extruded or formed strips, pieces, rods, or sticks, finely divided ground powders, finely divided or milled agglomerates of powdered pieces and components, flake-like pieces, molded processed pieces, films, readily water-dissolvable or water-dispersible films or strips, capsule-like materials, tablets, lozenges.
  • the oral product is a tablet or lozenge.
  • the oral product is in the form of moist snuff or snus, which may or may not contain tobacco.
  • the oral products as disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, ovoids, obloids, cylinders, beanshaped, sticks, or rods.
  • Cross-sectional shapes of the product can vary, and example cross- sectional shapes include circles, squares, ovals, rectangles, and the like.
  • Such shapes can be formed in a variety of manners using equipment such as moving belts, nips, extruders, granulation devices, compaction devices, and the like.
  • the solid oral product is in a form selected from the group consisting of a melt, a tablet or a lozenge.
  • the product can be meltable as discussed, for example, in US Patent App. Pub. No. 2012/0037175 to Cantrell et al., incorporated by reference herein in its entirety.
  • melt As used herein, “melt,” “melting,” and “meltable” refer to the ability of the product to change from a solid state to a liquid state. That is, melting occurs when a substance (e.g., a product as disclosed herein) changes from solid to liquid, usually by the application of heat.
  • a substance e.g., a product as disclosed herein
  • melttable refers to a product that is capable of liquefying in the mouth of the user as the product changes phase from solid to liquid, and is intended to distinguish products that merely disintegrate in the oral cavity through loss of cohesiveness within the product that merely dissolve in the oral cavity as aqueous-soluble components of the product interact with moisture.
  • meltable products comprise a lipid.
  • the composition comprises a lipid.
  • the lipid is typically a fat, oil, or wax substance derived from animal or plant material (e.g., plant-derived fats), and typically comprises mostly triglycerides along with lesser amounts of free fatty acids and mono- or diglycerides.
  • the lipid is a solid or semi-solid at room temperature (i.e. , 25°C) and capable of at least partially liquefying when subjected to the temperature of the oral cavity of the user (i.e., "melting").
  • Example plant-derived fats are comprised primarily of saturated or unsaturated fatty acid chains (most of which are bound within triglyceride structures) having a carbon length of about 10 to about 26 carbon atoms, or about 14 to about 20 carbon atoms, or about 14 to about 18 carbon atoms.
  • the lipid comprises an oil and, in particular, a food grade oil, including fractionated oils.
  • oils include, but are not limited to, vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter gourd oil, black seed oil, blackcurrant seed oil, borage seed oil, borneo tallow nut oil, bottle gourd oil, brazil nut oil, buffalo gourd oil, butternut squash seed oil, cape chestnut oil, canola oil, carob cashew oil, cocoa butter, cocklebur oil, coconut oil, corn oil, cothune oil, coriander seed oil, cottonseed oil, date seed oil, dika oil, egus seed oil, evening primrose oil, false flax oil, flaxseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok
  • vegetable oils e.
  • the plant-derived fats of the present disclosure include palm oil, (including fractionated palm oil) palm kernel oil, soybean oil, cottonseed oil, and mixtures thereof.
  • the lipid is a blend of palm oil and palm kernel oil.
  • the lipid can be, for example, hydrogenated, partially hydrogenated, or non-hydrogenated.
  • Example embodiments of lipids can be purchased under the brand names CEBES®, CISAO®, or CONF AO®, available from AarhusKarlshamn USA Inc.
  • the melting point of the lipid is typically about 29°C or above, such as about 29°C to about 49°C, or about 36°C to about 45°C, or about 38°C to about 41 °C. In some embodiments, use of lipids with a melting point of less than about 36°C is not advantageous due to possible melting during product storage or handling.
  • One test for determining the melting point of lipids is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Dropping Point of Waxes, ASTM International, West Conshohocken, PA, 2015, www.astm.org).
  • the amount of lipid within the composition may vary. In certain embodiments, the amount of lipid is at least about 10%, at least about 20%, or at least about 30%, on a dry weight basis of the composition. In certain embodiments, the amount of lipid is less than about 70%, less than about 60%, or less than about 50%, on a dry weight basis.
  • Example lipid weight ranges include about 10 to about 70% dry weight, such as about 35 to about 50% dry weight. In some embodiments, the amount of lipid is about 35, about 40, about 45, or about 50% by weight of the total oral product.
  • the oral product comprises a lipid.
  • the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated.
  • the lipid is a transhydrogenated filling fat of medium hardness such as Confao® 5, available from AarhusKarlshamn USA Inc., 131 Marsh Street, Port Newark, NJ 07114.
  • the product in meltable form comprises a lipid in an amount of from about 35 to about 50% by weight of the oral product, and a sugar alcohol in an amount of from about 35 to about 55% by weight of the oral product.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.
  • the sugar alcohol is or comprises isomalt.
  • a sugar substitute may be an alternative to the sugar alcohol, or used in combination with one or more sugar alcohols. Suitable sugar substitutes include allulose, soluble tapioca fiber, inulin, and combinations thereof.
  • the product is in the form of a compressed or molded tablet.
  • An exemplary tablet dosage form weighs from about 250 mg to about 1500 mg, such as about 250 mg to about 700 mg, or from about 700 mg to about 1500 mg.
  • the tablet can have any of a variety of shapes, including traditional pill or tablet shapes.
  • the product in tablet form comprises a glucose-polysaccharide blend and a sugar alcohol.
  • the glucose-polysaccharide blend is present in an amount of from about 35 to about 50% by weight, based on the total weight of the product; and the sugar alcohol is present in an amount of from about 30 to about 45% by weight, based on the total weight of the product.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.
  • the sugar alcohol is or comprises isomalt.
  • the product When in the form of a tablet, the product may be dissolvable.
  • the terms “dissolve,” “dissolving,” and “dissolvable” refer to products having aqueous-soluble components that interact with moisture in the oral cavity and enter into solution, thereby causing gradual consumption of the product.
  • the dissolvable product is capable of lasting in the user's mouth for a given period of time until it completely dissolves. Dissolution rates can vary over a wide range, from about 1 minute or less to about 60 minutes.
  • fast release products typically dissolve and/or release the desired component(s) (e.g., active ingredient, flavour, and the like) in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less).
  • Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of the interaction between the components of the product.
  • the products do not dissolve during the product's residence in the user's mouth.
  • the products disclosed herein may be in the form of a dissolvable lozenge product configured for oral use.
  • Example lozenge-type products of the invention have the form of a lozenge, tablet, microtab, or other tablet-type product. See, for example, the types of nicotine-containing lozenges, lozenge formulations, lozenge formats and configurations, lozenge characteristics and techniques for formulating or manufacturing lozenges set forth in US Pat. Nos. 4,967,773 to Shaw; 5,110,605 to Acharya; 5,733,574 to Dam; 6,280,761 to Santus; 6,676,959 to Andersson et al.; 6,248,760 to Wilhelmsen; and 7,374,779; US Pat.
  • Lozenge products are generally described as "hard”, and are distinguished in this manner from soft lozenges (i.e., pastilles).
  • Hard lozenges are mixtures of sugars and/or carbohydrates in an amorphous state. Although they are made from aqueous syrups, the water, which is initially present, evaporates as the syrup is boiled during processing so that the moisture content in the finished product is very low, such as 0.5% to 1.5% by weight.
  • the temperature of the melt generally must reach the hard crack stage, with an example temperature range of 149° to 154°C.
  • Lozenge-type products may exhibit translucence or transparency.
  • the desired transparency or translucency of the product can be quantified by any known method.
  • optical methods such as turbidimetry (or nephelometry) and colorimetry may be used to quantify the cloudiness (light scattering) and the color (light absorption), respectively, of the products.
  • Translucency can also be confirmed by visual inspection by simply holding the product up to a light source and determining if light travels through the material or product in a diffuse manner.
  • lozenge-type products of the present disclosure may incorporate various different additives in addition to the combination of active ingredients, and may be prepared according to a variety of different methods commonly known in the art for preparing lozenge-type products. Example compositions, products, and methods of preparing such products will be detailed herein below.
  • Lozenge products of the present disclosure typically include a composition comprising the combination of active ingredients in an amount of less than about 2% by weight, a sugar substitute in an amount of at least about 80% by weight, and a sugar alcohol syrup. Any active ingredient as discussed herein is suitable for use as an active ingredient in the lozenge products provided herein. In some embodiments, the active ingredient may be provided in liquid form or in a dry powder or particulate form.
  • the active ingredient typically is present in an amount from about 0.1 % to about 10% by weight, such as, e.g., from about 0.1 % to about 10% by weight, such as, e.g., from about 0.1 %, about 0.5%, about 1 %, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, or about 4.5% by weight, to about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, or about 10% by weight, based on the total weight of the product.
  • the active ingredient may be present in an amount of less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, or less than about 1 % by weight, based on the total weight of the product.
  • Sugar alcohols that may be useful according to the present invention include, but are not limited to, erythritol, threitol, arabitol, xylitol, ribotol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitol, and mixtures thereof.
  • the sugar alcohol is selected from the group consisting of erythritol, sorbitol, and isomalt.
  • the amount of sugar substitute in the lozenge products can vary, but is typically at least about 75%, at least about 80%, at least about 85%, or at least about 90%, or at least about 95% by weight of the product.
  • the sugar substitute is one or more of allulose, soluble tapioca fiber, and inulin.
  • Such sugar substitutes may be an alternative to sugar alcohols, or used in combination with one or more sugar alcohols.
  • the lozenge products of the present disclosure may comprise a syrup, e.g., a sugar syrup or a sugar alcohol syrup.
  • a syrup e.g., a sugar syrup or a sugar alcohol syrup.
  • Sud alcohol syrup as used herein is intended to refer to a thick solution of sugar alcohol in water, e.g., having greater than about 40% solids, preferably having greater than about 50% solids, greater than about 60% solids, greater than about 70% solids, or greater than about 80% solids.
  • the solid content of the sugar alcohol syrup primarily comprises the named sugar alcohol (i.e. , maltitol syrup typically comprises greater than about 80%, greater than about 85%, or greater than about 90% by weight maltitol on a dry basis).
  • Sugar alcohol syrups are generally prepared by heating a solution of the sugar alcohol in water and cooling the mixture to give a viscous composition.
  • the resulting syrup is typically characterized by a relatively high concentration of sugar alcohol and relatively high stability (i.e., the sugar alcohol typically does not crystallise from solution, e.g., at room temperature).
  • the syrup e.g., sugar alcohol syrup
  • sugar alcohol syrup desirably is capable of affecting the recrystallsation of a melted sugar substitute.
  • One example sugar alcohol syrup that is particularly useful according to the present disclosure is maltitol syrup.
  • Other sugar alcohol syrups can be used, including, but not limited to, com syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, lactitol, and polyglycitol syrups.
  • sugar alcohol syrups can be prepared or can be obtained from commercial sources.
  • maltitol syrups are commercially available from such suppliers as Corn Products Specialty Ingredients.
  • sugar alcohol syrups may be preferred, sugar syrups can, in certain embodiments, be used in place of or in combination with the sugar alcohol syrup.
  • corn syrup, golden syrup, and/or molasses can be used.
  • the amount of sugar alcohol syrup added to the lozenge composition mixture is typically that amount required to slow recrystallisation of the sugar substitute in melted form.
  • the amount of sugar alcohol syrup can vary, but typically ranges from about 0.1 % to about 2%, often from about 0.5% to about 1.5%, and more often about 1 % by weight of the lozenge product mixture. In certain embodiments, the amount of sugar alcohol syrup is higher, for example, up to about 2% by weight of the mixture, up to about 5% by weight of the mixture, up to about 10% by weight of the mixture, or up to about 20% by weight of the mixture.
  • Oral products of the present disclosure in the form of a lozenge may contain various amounts of water.
  • the water content of the lozenge described herein, prior to use by a consumer of the product, may vary within such ranges according to the desired properties and characteristics, in addition to dictating the final form of the product.
  • lozenge-type products typically possess a water content in the range of about 0.1 to about 5% by weight of the product.
  • the moisture content of a lozenge product, as present within a single unit of product prior to insertion into the mouth of the user is less than about 5%, less than about 3%, less than about 2%, or less than about 1 % by weight of the product.
  • the moisture content of a lozenge product as described herein may be within the range of about 0.1 % to about 5%, about 0.5 to about 3%, or about 1 to about 2 % by weight of the product.
  • compositions in the moisture-permeable pouch format are typically used by placing one pouch containing the composition in the mouth of a human subject/user.
  • the pouch is placed somewhere in the oral cavity of the user, for example under the lips, in the same way as moist snuff products are generally used.
  • the pouch preferably is not chewed or swallowed. Exposure to saliva then causes some of the components of the composition therein (e.g., the active ingredients and/or any flavours) to pass through e.g., the moisture-permeable pouch and provide the user with flavour and satisfaction, and the user is not required to spit out any portion of the composition. After about 10 minutes to about 60 minutes, typically about 15 minutes to about 45 minutes, of use/enjoyment, substantial amounts of the composition have been ingested by the human subject, and the pouch may be removed from the mouth of the human subject for disposal.
  • the pouch is saliva-permeable.
  • the pouch material used in oral pouched products is typically a dry-laid bonded nonwoven comprising viscose rayon fibres (i.e. regenerated cellulose) and an acrylic polymer that acts as binder in the nonwoven material and provides for heat-sealing of the pouches during manufacturing thereof.
  • the pouch material may also comprise synthetic fibres (e.g. polyester) in addition to viscose fibres.
  • the viscose nonwoven material normally used for smokeless tobacco pouches is similar to the fabric used in tea bags. Nonwovens are fabrics that are neither woven nor knitted.
  • the pouch material comprises a binder that provides for heat sealing of the pouches during manufacture.
  • the pouch material comprises an acrylic binder.
  • the pouch material comprises an acrylic binder in combination with viscose and/or polyester fibres.
  • Suitable packets, pouches or containers of the type used for the manufacture of smokeless tobacco products are available under the tradenames CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare.
  • the composition may be contained in pouches and packaged, in a manner and using the types of components used for the manufacture of conventional snus types of products.
  • the pouch provides a moisture-permeable container of a type that may be considered to be similar in character to the mesh-like type of material that is used for the construction of a tea bag.
  • Non-limiting examples of suitable types of pouches are set forth in, for example, US Pat. Nos. 5,167,244 to Kjerstad and 8,931 ,493 to Sebastian et al.; as well as US Patent App. Pub. Nos. 2016/0000140 to Sebastian et al.; 2016/0073689 to Sebastian et al.; 2016/0157515 to Chapman et al.; and 2016/0192703 to Sebastian et al., each of which is incorporated herein by reference.
  • Pouches can be provided as individual pouches, or a plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) can be connected or linked together (e.g., in an end-to-end manner) such that a single pouch or individual portion can be readily removed for use from a one-piece strand or matrix of pouches.
  • a plurality of pouches e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches
  • An example pouch may be manufactured from materials, and in such a manner, such that during use by the user, the pouch undergoes a controlled dispersion or dissolution.
  • Such pouch materials may have the form of a mesh, screen, perforated paper, permeable fabric, or the like.
  • pouch material manufactured from a mesh-like form of rice paper, or perforated rice paper may dissolve in the mouth of the user.
  • the pouch and composition each may undergo complete dispersion within the mouth of the user during normal conditions of use, and hence the pouch and composition both may be ingested by the user.
  • pouch materials may be manufactured using water dispersible film forming materials (e.g., binding agents such as alginates, carboxymethylcellulose, xanthan gum, pullulan, and the like), as well as those materials in combination with materials such as ground cellulosics (e.g., fine particle size wood pulp).
  • Preferred pouch materials though water dispersible or dissolvable, may be designed and manufactured such that under conditions of normal use, a significant amount of the composition contents permeate through the pouch material prior to the time that the pouch undergoes loss of its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired components, may be incorporated within, or applied to, the pouch material.
  • the amount of the oral product contained within each pouched product unit may vary.
  • the weight of the composition within each pouch is at least about 50 mg, for example, from about 50 mg to about 1 gram (1 ,000 mg), such as from about 100 mg to about 900 mg, such as from about 200 mg to about 800 mg, such as from about 500 mg to about 700 mg.
  • the weight of the composition within each pouch may be from about 100 mg to about 300 mg.
  • the weight of the composition within each pouch may be from about 300 mg to about 700 mg. If desired, other components can be contained within each pouch.
  • the moisture content of the composition (before insertion of the product into the user’s mouth) may be from about 20% to about 70% by weight, such as from about 30% to about 60% by weight, such as from about 40% to about 55% by weight of the oral product.
  • the oral product may be a snus-type or snuff-type product that is in ‘dry’ form.
  • the moisture content of the oral product may be no greater than about 10% by weight, such as no greater than about 5% by weight of the oral product.
  • the moisture content may be from about 0.1 % to about 10% by weight, such as from about 1 % to about 5% by weight of the oral product.
  • the oral product When in the form of a pouched oral product, the oral product typically comprises a filler.
  • the filler may preferably be a cellulose material selected from the suitable materials described hereinabove.
  • the filler is or comprises at least MCC.
  • the amount of filler can vary, but is typically at least about 5% to about 95% by weight of the oral product, based on the total weight of the oral product.
  • the filler (such as a cellulose material, such as MCC) may be present in the oral product in an amount of from about 5% to about 95% by weight, such as from about 10% to about 90% by weight, such as from about 15% to about 85% by weight, such as from about 20% to about 80% by weight, such as from about 25% to about 75% by weight, such as from about 30% to about 70% by weight, such as from about 35% to about 65% by weight, such as from about 40% to about 60% by weight of the oral product.
  • the filler (such as a cellulose material, such as MCC) may be present in an amount of from about 45% to about 55% by weight of the oral product.
  • the package may contain the oral product in powdered form.
  • the package may be in the form of a tin or plastic container.
  • the package may contain the oral product in the form of lozenge, tablet, or the like.
  • the package may be in the form of a blister pack, tin or plastic container containing such oral dosage forms.
  • a package containing at least one pouched oral product as described herein containing at least one pouched oral product as described herein.
  • a pouched product as described herein can be packaged within any suitable inner packaging material and/or outer container. See also, for example, the various types of containers for smokeless types of products that are set forth in US Pat. Nos. 7,014,039 to Henson et al.; 7,537,110 to Kutsch et al.; 7,584,843 to Kutsch et al.; 8,397,945 to Gelardi et al., D592.956 to Thiellier; D594.154 to Patel et al.; and D625.178 to Bailey et al.; US Pat. Pub. Nos.
  • the oral product is in the form of a liquid
  • a package in the form of a bottle or can that contains the liquid oral dosage form is provided.
  • the package may be a bottle containing the desired volume of liquid oral dosage form.
  • compositions e.g., active ingredients and any additives
  • the overall product with e.g., powdered composition components may be relatively uniform in nature (e.g., homogenous).
  • the components noted above, which may be in liquid or dry solid form, can be admixed in a pretreatment step prior to mixture with any remaining components of the product, or simply mixed together with all other liquid or dry ingredients.
  • the various components of the product may be contacted, combined, or mixed together using any mixing technique or equipment known in the art.
  • Any mixing method that brings the product ingredients into intimate contact can be used, such as a mixing apparatus featuring an impeller or other structure capable of agitation.
  • mixing equipment include casing drums, conditioning cylinders or drums, liquid spray apparatus, conical-type blenders, ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc., Plough Share types of mixer cylinders, Hobart mixers, and the like. See also, for example, the types of methodologies set forth in US Pat. Nos.
  • the components forming the product are prepared such that the mixture thereof may be used in a starch molding process for forming the product. Manners and methods for formulating products will be apparent to those skilled in the art. See, for example, the types of methodologies set forth in US Pat. No. 4,148,325 to Solomon et al.; US Pat. No. 6,510,855 to Korte et al.; and US Pat. No. 6,834,654 to Williams, US Pat. Nos. 4,725,440 to Ridgway et al., and 6,077,524 to Bolder et al., each of which is incorporated herein by reference.
  • the combination of active ingredients may be as described hereinabove.
  • the combination of actives may also be as described below in respect of “Further Broad Aspects”.
  • the active ingredients may be provided in the form of a liquid extract, a liquid oil or a powder.
  • step (c) may comprise mixing the active ingredients with water until said active ingredients have dissolved in the water.
  • Step (b) and/or step (c) may preferably be carried out at ambient or room temperature (20-25°C).
  • the temperature may be elevated in order to assist with dispersion or dissolution of the active ingredients in the water.
  • step (b) may comprise contacting the active ingredients with water at a temperature of from about 20-100°C, such as from about 30-90°C, or from about 40-80°C.
  • step (b) may comprise mixing the active ingredients with water at a temperature of from about 20-100°C, such as from about 30-90°C, or from about 40-80°C.
  • the process may comprise adding any additional additives at any stage.
  • any additives may be added to the active ingredients prior to combination with water and/or after the active ingredients have been combined with water.
  • the additives may also be added to the water prior to contacting the water with the combination of active ingredients.
  • Step (a) may comprise an optional step of combining any additives (e.g. acidifying agent) with the combination of active ingredients.
  • Step (b) may comprise an optional step of contacting the active ingredients with water and an additive.
  • Step (c) may comprise an optional step of adding additives to the mixture and mixing the additives with the combination of active ingredients and water.
  • the oral product further comprises one or more additives selected from a thickener, an organic acid, or mixtures thereof.
  • the one or more additives may be combined with water prior to addition of the active ingredients.
  • the step of combining the one or more additives with water may comprise heating the combination, e.g. to a temperature of from about 60°C to about 80°C, to achieve dissolution of the additive(s).
  • Further additives such as a sweetener, humectant, colouring agent or the like, may be added at this stage or may be added during and/or after the step of combining the active ingredients with the water.
  • the product is in the form of a compressed pellet or tablet.
  • the process for making the pellet or tablet involves first mixing the bulk filler (e.g., EMDEX®) and the active ingredients. The remaining composition ingredients (e.g., sugar alcohol and any other desired components, such as binders, colorants, sweeteners, flavors, and the like) are then added.
  • a colorant may be added to one of the composition components in a separate step prior to mixing with the remaining components of the composition.
  • the mixing of the composition can be accomplished using any mixing device.
  • the final composition is then compressed into pellet or tablet form using conventional tableting techniques and optionally coated.
  • Compressed composition pellets can be produced by compacting the composition, including any associated formulation components, in the form of a pellet, and optionally coating each pellet with an overcoat material.
  • Example compaction devices such as compaction presses, are available as Colton 2216 and Colton 2247 from Vector Corporation and as 1200i, 2200i, 3200, 2090, 3090 and 4090 from Fette Compacting.
  • Devices for providing outer coating layers to compacted pelletized compositions are available as CompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60 from Thomas Engineering.
  • a coating typically comprises a film-forming polymer, such as a cellulosic polymer, an optional plasticizer, and optional flavorants, colorants, salts, sweeteners or other additives of the types set forth herein.
  • the coating compositions are usually aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating.
  • Example film-forming polymers include cellulosic polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose, and carboxy methylcellulose.
  • Example plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food grade shellac, waxes such as carnuaba wax, and combinations thereof.
  • compositions can be prepared via any method commonly used for the preparation of hard boiled confections.
  • Example methods for the preparation of hard confections can be found, for example, in LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell, Ed., Leatherhead Food RA (Dec. 1996), pp. 21-44, which is incorporated herein by reference.
  • a first mixture of ingredients is prepared.
  • the composition of the first mixture of ingredients can vary; however, it typically comprises a sugar substitute and may contain various additional substances (e.g., the sugar alcohol syrup, NaCI, preservatives, further sweeteners, water, and/or flavourings). In certain embodiments, it comprises the sugar substitute, salt, and vanillin. In other embodiments, the first mixture comprises the sugar substitute and the sugar alcohol syrup.
  • the first mixture of ingredients does not contain the active ingredients; although, it some embodiments, the active ingredients may be incorporated into the first mixture of ingredients.
  • the first mixture of ingredients is heated until it melts; subsequently, the mixture is heated to or past the hard crack stage.
  • the hard crack stage is defined as the temperature at which threads of the heated mixture (obtained by pulling a sample of cooled syrup between the thumb and forefinger) are brittle or as the temperature at which trying to mold the syrup results in cracking.
  • the temperature at which the hard crack stage is achieved can vary, depending on the specific makeup of the product mixture but generally is between about 145°C and about 170°C.
  • the mixture is not heated above about 171 °C, which is the temperature at which caramelisation begins to occur.
  • the mixture is typically heated to the hard crack stage temperature or above and then allowed to cool.
  • the heating can be conducted at atmospheric pressure or under vacuum.
  • the method of the present invention is conducted at atmospheric pressure.
  • the first mixture of ingredients comprises a high percentage of isomalt and the mixture is heated to about 143°C. Once all components are dissolved, the temperature is raised past the hard crack stage (e.g., to about 166°C). The mixture is heated to this temperature and then removed from the heat to allow the mixture to cool.
  • the active ingredients and, optionally, additional components are separately combined in a second mixture.
  • the second mixture is added to the first mixture of ingredients, typically after the first mixture of ingredients has been removed from the heat.
  • the addition of the second mixture may, in some embodiments, occur only after the heated first mixture of ingredients has cooled to a predetermined temperature (e.g., in certain embodiments, to about 132 °C).
  • one or more flavouring agents are added to the second mixture immediately prior to adding the mixture to the first, heated mixture of ingredients. Certain flavouring agents are volatile and are thus preferably added after the mixture has cooled somewhat.
  • the combined mixture is then formed into the desired shape.
  • the mixture is poured directly into molds, formed (e.g., rolled or pressed) into the desired shape, or extruded. If desired, the mixture can be extruded or injection molded. In certain embodiments, the mixture is formed or extruded into a mold of desired shape in an enclosed system, which may require decreased temperature and which may limit evaporation of certain mixture components. For example, such a system may limit the evaporation of volatile components including, but not limited to, flavorants. Other methods of producing lozenges are also intended to be encompassed herein.
  • Typical conditions associated with manufacture of food-grade lozenge products such as described herein include control of heat and temperature (i.e. , the degree of heat to which the various ingredients are exposed during manufacture and the temperature of the manufacturing environment), moisture content (e.g., the degree of moisture present within individual ingredients and within the final composition), humidity within the manufacturing environment, atmospheric control (e.g., nitrogen atmosphere), airflow experienced by the various ingredients during the manufacturing process, and other similar types of factors.
  • various process steps involved in product manufacture can involve selection of certain solvents and processing aids, use of heat and radiation, refrigeration and cryogenic conditions, ingredient mixing rates, and the like.
  • the manufacturing conditions also can be controlled due to selection of the form of various ingredients (e.g., solid, liquid, or gas), particle size or crystalline nature of ingredients of solid form, concentration of ingredients in liquid form, or the like.
  • Ingredients can be processed into the desired composition by techniques such as extrusion, compression, spraying, and the like.
  • the lozenge product may be transparent or translucent.
  • "translucent” or “translucency” refers to materials allowing some level of light to travel therethrough diffusely.
  • lozenge products of the present disclosure can have such a high degree of clarity that the material can be classified as “transparent” or exhibiting "transparency,” which is defined as a material allowing light to pass freely through without significant diffusion. The clarity of the lozenge product is such that there is some level of translucency as opposed to opacity (which refers to materials that are impenetrable by light).
  • Transparency/translucency can be determined by any means commonly used in the art; however, it is commonly measured by spectrophotometric light transmission over a range of wavelengths (e.g., from about 400-700 nm). Alternatively, optical methods such as turbidimetry (or nephelometry) and colorimetry may be used to quantify the cloudiness (light scattering) and the color (light absorption), respectively, of the lozenge products provided herein. Translucency can also be confirmed by visual inspection by simply holding the material (e.g., extract) or product up to a light source and determining if light travels through the product in a diffuse manner.
  • turbidimetry or nephelometry
  • colorimetry may be used to quantify the cloudiness (light scattering) and the color (light absorption), respectively, of the lozenge products provided herein.
  • Translucency can also be confirmed by visual inspection by simply holding the material (e.g., extract) or product up to a light source and determining
  • the product is in meltable form.
  • the lipid is typically heated to slightly above the melting temperature such that the lipid is liquefied.
  • active ingredients, flavoring agents, and/or lecithin can be added to the liquefied lipid at this stage.
  • all or a portion of the liquefied lipid can be blended with the dry blend and mixed until the product reaches the desired level of homogeneity or until the desired textural properties are achieved.
  • the mixture is milled (e.g., in a dry roll mill) until the particle size is less than about 20 microns.
  • the milled isomalt-palm oil is combined with any remaining lipid, and the dry ingredients and flavor mixed in.
  • the base is generally warmed to a fluid consistency.
  • a sugar alcohol e.g., isomalt
  • a portion of the total lipid e.g., melted palm oil
  • salt and emulsifier e.g., sodium bicarbonate
  • Additional lipid is added with mixing until adhesive clumps form.
  • the clumped mixture is transferred portion-wise to a 3 roll mill and processed to a particle size of less than 50 microns, or about 20 microns.
  • the refined mixture is transferred to a mixer bowl, and the remaining lipid added with mixing. The mixture is warmed as necessary to maintain a fluid consistency.
  • Sweetener, flavour, and active ingredient(s) are added with mixing. Mixing is continued until a homogenous composition is obtained. The mixture is allowed to rest for a period of time, such as about 10 to 15 minutes.
  • the composition can be divided into discrete portions, such as by pouring the composition into a sheet-like structure, cooling, and then cutting the structure into individual portions, or by depositing the composition into molds and allowing to cool.
  • the molds may be starch molds or starchless molds. In particular embodiments, the molds are starchless.
  • the melt composition may be held in the mold (starch or starchless) for a predetermined duration of time such as, for example, from about 1 to about 15 minutes, to allow the melt composition to cool and solidify.
  • the molds containing the melt product may be cooled by refrigeration to accelerate solidification.
  • melt composition may be subjected to a co-extrusion process with another composition.
  • Example extrusion equipment suitable for use include food or gum extruders, or industrial pasta extruders such as Model TP 200/300 available from Emiliomiti, LLC of Italy.
  • a single machine may be capable of achieving multiple steps of the processes described herein, such as, for example, kneader systems available from Buss AG.
  • products can also be formed with multiple different formulations having different properties in the same product unit.
  • two different compositions can be deposited in a single mold to produce a layered product.
  • two different compositions could be co-extruded to form a product with different characteristics across its cross-section.
  • Such a process could be used to provide a product with two different compositions featuring different dissolution rates such that a first portion of the product dissolves at a first rate (e.g., a faster rate) and a second portion dissolves at a second, slower rate.
  • the process may comprise the steps of:
  • the combination of active ingredients may be as described hereinabove.
  • the combination of actives may also be as described below in respect of “Further Broad Aspects”.
  • the step (b) comprises mixing the at least one filler and the combination of active ingredients.
  • the combination of active ingredients is in solid form (e.g. in the form of a powder).
  • the combination of active ingredients may be mixed directly with the filler to provide the oral product.
  • the combination of active ingredients may be dissolved in a hydrophilic solvent (e.g. water and/or alcohol) prior to contacting the filler.
  • a hydrophilic solvent e.g. water and/or alcohol
  • the combination of active ingredients may be dissolved in water or alcohol (e.g. ethanol or propylene glycol) before being mixed with the filler.
  • the process may, in such embodiments, comprise the step of drying the product so as to remove the solvent.
  • the product may be dried via heating, freeze-drying, spray-drying, or simply leaving the product at room temperature for a certain period of time.
  • the drying step comprises leaving the product at room temperature for a period of 1 hour to 48 hours to remove the solvent.
  • the process may then further comprise the step of pouching the oral product using a pouch material as described hereinabove.
  • a combination of active ingredients to promote sleep preferably the combination of actives are present in an oral product, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower, wherein the combination of active ingredients (and oral product) is free from melatonin.
  • the use comprises promoting sleep by inducing and/or maintaining sleep of the subject to which the combination of active ingredients is administered.
  • the use may comprise increasing relaxation of the subject.
  • the combination of active ingredients is as defined hereinabove.
  • the combination may further comprise any of the additional active ingredients as described hereinabove.
  • the combination of active ingredients may further comprise at least one of (v) L-theanine; (vi) holy basil and/or (vii) chamomile extract.
  • the combination of active ingredients may in particular further comprise L-theanine.
  • the combination of active ingredients may provide an improved effect as compared with previously known products and/or a placebo.
  • the combination of active ingredients provides improved promotion of sleep compared with a placebo product, wherein the placebo product does not include the combination of active ingredients according to the present invention. In some embodiments the combination of active ingredients further improve relaxation compared with the placebo product.
  • Determination of sleep promotion and/or relaxation may be according to the methods described and employed in the Examples herein.
  • Sleep promotion may, for example, be determined using the PROMIS Sleep disturbance and/or PROMIS Sleep impairment questionnaires.
  • the PROMIS Sleep disturbance questionnaire provides a measurement of sleep quality
  • the PROMIS Sleep disturbance questionnaire provides a measurement of sleep satisfaction; improved sleep quality and sleep satisfaction fall within the scope of sleep promotion.
  • the combination of active ingredients may promote sleep by improving sleep quality and sleep satisfaction according to the PROMIS Sleep disturbance and PROMIS Sleep impairment questionnaires.
  • Sleep promotion may alternatively or additionally be determined using the Athens Insomnia Scale; this scale provides a measurement of the level of poor sleep; a reduced or lower level of poor sleep falls within the scope of sleep promotion.
  • the combination of active ingredients may further promote sleep by reducing the levels of poor sleep according to the Athens Insomnia Scale.
  • Relaxation may be determined using the STAI-S Scale (e.g. STAI-S-SF), Positive and Negative Affect Schedule (PANAS), the Profile of Mood States (preferably POMS-SF) and/or the Perceived Stress Questionnaire (PSQ).
  • the STAI-S Scale provides a measurement of state anxiety; the PANAS provides a measurement of positive affect; the POMS provides a measurement of mood disturbance; and the PSQ provides a measure of perceived stress. Lower state anxiety, increased positive affect, lower mood disturbance and/or reduced perceived stress is an indication of relaxation in the subject.
  • the combination of active ingredients further provides relaxation as measured by STAI-S, PANAS, POMS and/or PSQ.
  • a melatonin-free oral product comprising a combination of active ingredients, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof; (ii) ginseng and (iii) passionflower.
  • a melatonin-free oral product comprising a combination of active ingredients comprising (i) magnesium or a salt thereof, (ii) passionflower, and (iii) L-theanine.
  • a melatonin-free oral product comprising a combination of active ingredients comprising (i) magnesium or a salt thereof, (ii) ginseng, and (iii) passionflower, wherein the actives optionally further comprise L-theanine.
  • the combination of B vitamins is not an essential element.
  • a melatonin-free oral product comprising a combination of active ingredients comprising (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising vitamin B2, and vitamin B6; (iii) passionflower; and optionally (iv) L-theanine.
  • the combination of active ingredients may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising vitamin B2, and vitamin B6; and (iii) passionflower.
  • the combination of actives may include passionflower as an essential element but not ginseng.
  • Example 1 Liquid dosage form
  • the oral product has a volume of 30 or 60 mL per serving. All active ingredients are added to the water, and the resulting mixture stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, with each serving containing 30 or 60 mL of liquid.
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the oral product has a volume of 30 or 60 mL per serving.
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the oral product has a volume of 30 or 60 mL per serving.
  • Example 4 Liquid dosage form with a 100:1 weight ratio of magnesium salt to total B vitamins, and a 5:1 ratio of magnesium salt to ginseng
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the amount of magnesium or a salt thereof is about 400 mg and the amount of ginseng is about 80 mg per serving.
  • the amount of vitamin B6 is about 2 mg and the amount of vitamin B2 about 2 mg per serving.
  • the oral product has a volume of 60 mL per serving.
  • the oral product is prepared as set out in Examples 1 to 3.
  • the oral product may further have a weight ratio of magnesium salt to passionflower of 5:1 , meaning that passionflower is present at 80 mg.
  • the consequence is that the weight ratio of ginseng to passionflower is 1 : 1 , and the weight ratio of passionflower to total B vitamins is 20: 1.
  • Example 5 Liquid dosage form including L-theanine with a 1 :1 weight ratio of ginseng to passionflower and a weight ratio of 5:1 for magnesium salt to L-theanine
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the amount of magnesium salt is about 500 mg and the amount of L-theanine is about 100 mg per serving.
  • the amount of passionflower is about 200 mg per serving.
  • the amount of ginseng is about 200 mg.
  • the oral product has a volume of 30 mL per serving.
  • the oral product is prepared as set out in Examples 1 to 3.
  • the weight ratio of magnesium salt to passionflower is 5:2, and the weight ratio of magnesium salt to ginseng is similarly 5:2.
  • the total amount of B vitamins may be 3.5 mg.
  • Example 6 Liquid dosage form including chamomile extract
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the oral product has a volume of 60 mL per serving.
  • All active ingredients are added to the water, along with flavouring, colouring agent, thickener, acidifier, preservative and sweetener (in amounts to balance total wt% to 100 wt%), and the resulting mixture stirred until a homogeneous dispersion or clear solution is obtained.
  • the product is then packaged in bottles, with each serving containing 60 mL of liquid.
  • Example 7 Liquid dosage form including chamomile extract and holy basil
  • An oral product in the form of a liquid is prepared containing the following active ingredients:
  • the oral product has a volume of 60 mL per serving. All active ingredients are added to the water, along with flavouring, colouring agent, thickener, acidifier, preservative and sweetener (in amounts to balance total wt% to 100 wt%), and the resulting mixture stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, with each serving containing 60 mL of liquid.
  • Example 8 Liquid dosage form including chamomile extract, holy basil and L-theanine
  • An oral product in the form of a liquid is prepared containing the following ingredients:
  • the oral product has a volume of 60 mL per serving.
  • All active ingredients are added to the water, along with flavouring, colouring agent, thickener, acidifier, preservative and sweetener (in amounts to balance total wt% to 100 wt%), and the resulting mixture stirred until a homogeneous dispersion or clear solution is obtained.
  • the product is then packaged in bottles, with each serving containing 60 mL of liquid.
  • Example 8 A study was carried out to compare an oral product as prepared according to Example 8 with a placebo product (uniformly flavoured shot without the active ingredients of Example 8). Blind testing was carried out where one group of participants consumed the shot of Example 8, while a second group of participants were given the placebo product. The study investigated the effects of the liquid dosage forms for improving sleep.
  • the primary outcome of the study was sleep quality and satisfaction, and sleep disturbance and impairment; this outcome was measured via the PROMIS Sleep Questionnaire (Patient- Reported Outcomes Measurement Information System) after daily product consumption. This is a well-recognised measure in the art for sleep metrics. Secondary measures were restorative sleep score via a Restorative Sleep Questionnaire, insomnia severity score via the Athens Insomnia Scale, profile of mood state via POMS-SF, contentedness via State-Trait Anxiety Inventory (STAI), and perceived stress score via a Perceived Stress Questionnaire. The methods and endpoints are shown in the table below.
  • the daily consumption was one serving (one shot of 60 ml volume), 30 minutes before bedtime of the participant. All participants completed reflective weekly surveys. These measurements provided an assessment of the effect of the liquid dosage form on sleep.
  • the anticipated consumer benefits included reduced stress, relaxation, becoming “sleep ready”, providing a positive bedtime ritual, getting restorative and quality sleep, and falling asleep faster.
  • STAI-S the State-Trait Anxiety Inventory
  • STAI-S scale was used in the present Example; this consists of 20 statements and the instructions require participants to indicate how they feel at a particular moment in time.
  • the STAI-S scale can be used to determine the actual levels of anxiety intensity induced by stressful procedures.
  • the participants who consumed the Example 8 product reported lower levels of anxiety at day 14 and day 21 compared to the placebo. This indicates higher levels of contentedness or a relaxed state from the oral product of the invention compared to the placebo. The results are shown in Figure 1 .
  • Sleep quality - PROMIS Sleep disturbance - PROMIS or Patient-Reported Outcomes Measurement Information System is a set of person-centred measures that monitors physical, mental and social well-being.
  • PROMIS tools measure what participants are able to do and how they feel by asking a number of questions.
  • the “Sleep disturbance” instruments of PROMIS assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. All participants were asked to answer the questionnaire weekly. The 8-item short form questionnaire was used. The participants who consumed the Example 8 product reported overall lower levels of sleep disturbance at day 21 compared to the placebo. The results are shown in Figure 2.
  • AIS Poor Sleep - Athens Insomnia Scale
  • the AIS is an eight-item questionnaire that evaluates sleep onset, night and early-morning waking, sleep time, sleep quality, frequency and duration of complaints, distress caused by the experience of insomnia, and interference with daily functioning. All participants were asked to answer the questionnaire weekly. The participants who consumed the Example 8 product reported overall lower levels of poor sleep at day 14 and day 21 compared to the placebo. The results are shown in Figure 4.
  • POMS Total Mood Disturbance - Profile of Mood States
  • POMS is a psychological rating scale used to assess transient, distinct mood states.
  • POMS is a self-reporting instrument measuring six dimensions of fluctuating mood swings over time: Tension or Anxiety, Depression or Dejection, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Confusion or Bewilderment to give a combined average of total mood disturbance.
  • POMS-SF refers to the “Short Form” of the Profile of Mood States. All participants were asked to answer the questionnaire weekly. The participants who consumed the Example 8 product returned lower scores than the participants who consumed the placebo. This indicates lower mood disturbances as a result of the oral product of the invention compared to the placebo. The results are shown in Figure 5.
  • Oral products in the form of a liquid are prepared containing the following ingredients:
  • Each oral product has a volume of 60 mL per serving.
  • the active ingredients from Table A or Table B are added to water, along with flavouring, colouring agent, thickener, acidifier, preservative and sweetener (in amounts to balance total wt% to 100 wt%), and the resulting mixture stirred until a homogeneous dispersion or clear solution is obtained.
  • the product is then packaged in bottles, with each serving containing 60 mL of liquid.
  • the primary outcome of the study was sleep quality and satisfaction, and sleep disturbance and impairment; this outcome was measured via the PROMIS Sleep Questionnaire (Patient- Reported Outcomes Measurement Information System) after daily product consumption.
  • Secondary measures included e.g. self-reported sleep metrics via a daily sleep diary, restorative sleep score via a Restorative Sleep Questionnaire, insomnia severity score via the Athens Insomnia Scale, profile of mood state via Positive and Negative Affect Schedule (PANAS) and POMS-SF, contentedness via STAI-State-SF, and/or perceived stress score via a Perceived Stress Questionnaire.
  • PANAS Positive and Negative Affect Schedule
  • POMS-SF contentedness via STAI-State-SF
  • perceived stress score via a Perceived Stress Questionnaire.
  • the methods and endpoints are shown in the table below.
  • Example 9 A baseline was taken before the study (TO) and after 7 days (T7), followed by 21 days of daily product consumption.
  • the daily consumption was one serving (one shot of 60 ml volume), 30 minutes before bedtime of the participant. All participants completed sleep diaries, with entries being made daily in the morning post-sleep, and reflective weekly surveys. These measurements provided an assessment of the effect of the liquid dosage form on sleep.
  • the anticipated consumer benefits were the same as for Example 9.
  • the Positive and Negative Affect Schedule is one of the most widely used scales to measure mood and emotion.
  • the scale is comprised of 20 items, with 10 items measuring positive affect (e.g. excited, inspired) and 10 items measuring negative affect (e.g. upset, afraid). In this study, only positive affect was measured. Each item is rated on a five-point Likert Scale, ranging from 1 to 5, to measure the extent to which the affect has been experienced in a specified time frame.
  • the Perceived Stress Questionnaire includes 30 items and was developed as an instrument for assessing the stressful life events and circumstances that tend to trigger or exacerbate disease symptoms. With stress bearing significantly on the quality and consistency of the sleep cycle, the PSQ is a potentially valuable tool for evaluating the underlying causes of sleep disturbances.
  • AIS Athens Insomnia Scale
  • Day 7 was the true weekly reflection baseline since it ensured that the participants had had a week of taking no other products to promote sleep or relaxation.

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Abstract

La présente divulgation concerne un produit à administration par voie orale sans mélatonine comprenant une combinaison d'ingrédients actifs pour favoriser le sommeil et la relaxation. La divulgation concerne également l'utilisation d'une combinaison d'ingrédients actifs pour favoriser le sommeil d'un être humain ou d'un animal, la promotion du sommeil comprenant éventuellement au moins l'un parmi l'induction du sommeil et le maintien du sommeil.
PCT/GB2024/051260 2023-05-16 2024-05-15 Produit à administration par voie orale Pending WO2024236294A1 (fr)

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