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WO2025114598A1 - Composition comprenant des extraits d'herbes pour atténuer le ronflement - Google Patents

Composition comprenant des extraits d'herbes pour atténuer le ronflement Download PDF

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Publication number
WO2025114598A1
WO2025114598A1 PCT/EP2024/084278 EP2024084278W WO2025114598A1 WO 2025114598 A1 WO2025114598 A1 WO 2025114598A1 EP 2024084278 W EP2024084278 W EP 2024084278W WO 2025114598 A1 WO2025114598 A1 WO 2025114598A1
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WO
WIPO (PCT)
Prior art keywords
composition
family
sodium hyaluronate
species
capsicum
Prior art date
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Pending
Application number
PCT/EP2024/084278
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English (en)
Inventor
Anders PERMIN
Jacob Boes
Tom HORNSHØJ-MØLLER
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Nyx Medico Aps
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Nyx Medico Aps
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Publication of WO2025114598A1 publication Critical patent/WO2025114598A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • Composition comprising herbal extracts to alleviate snoring
  • the present invention relates to a composition
  • a composition comprising the combination of two or more of extracts selected from the list of Centella asiatica or other members of the family Apiaceae, extract from the family Zingiberaceae, extract from the family Capsicum, extract from the family Valerianaceae, xylitol, hyaluronate, glycerine, vitamins and minerals for treating and/or alleviating snoring, chronic sinusitis, cold, and/or obstructive sleep apnea in humans and animals.
  • composition may be administered to the nose or oral cavity.
  • Snoring is a worldwide problem, not only for the snorer who has a disturbed sleeping rhythm or an increased risk of developing a serious illness, but also for the partner sleeping next to them.
  • Snoring is not defined a disease per se, but it is a symptom of restricted air passage in the upper airways that millions of people suffer from during their sleep. Most importantly, it is a symptom that most people are familiar with, and it is also extremely important to seek help for treatment. This is important as the snoring can cause more physiological diseases. In addition, it is often the first symptom of sleep apnea, which is a serious disease if untreated.
  • Chronic sinusitis is a nasal condition with constant production of mucus and may lead to snoring.
  • Sleep apnea also spelled sleep apnoea, is a sleeping disorder characterized by pauses in breathing or periods of shallow breathing during sleep. Each pause can last for a few seconds to a few minutes, and they happen many times a night. In the most common form, this follows loud snoring. There may be a choking or snorting sound as breathing resumes. As the disorder disrupts normal sleep, those affected may experience sleepiness or feel tired during the day. In children it may cause problems in school, or hyperactivity.
  • OSA obstructive
  • CSA central
  • mixed sleep apnea a combination of the two called mixed sleep apnea.
  • OSA is the most common form. Risk factors for OSA include being overweight, a family history of the condition, allergies, a small airway, and enlarged tonsils.
  • OSA breathing is interrupted by a blockage of airflow, while in CSA breathing stops due to a lack of effort to breathe.
  • People with sleep apnea may not be aware that they suffer from it. In many cases, it is first observed by a family member/bed partner. Sleep apnea is often diagnosed with an overnight sleep study. For a diagnosis of sleep apnea, more than five episodes an hour must occur.
  • sleep apnea may increase the risk of heart attack, stroke, diabetes, heart failure, irregular heartbeat, obesity, and traffic accidents.
  • an object of the present invention relates to compositions for treating, and/or alleviating snoring, chronic sinusitis, cold, and/or sleep apnea in a subject.
  • the present compositions are for use in combination with existing treatment.
  • compositions comprising a mixture of plant extracts for treating, and/or alleviating snoring, cold, chronic sinusitis, and/or sleep apnea in humans and animals that solves the above-mentioned problems of the prior art with snoring where lifestyle changes, mouthpieces, breathing devices, and/or surgery are the presently offered treatments.
  • the present invention provides compositions that may be used alone, or in combination with the existing treatments to provide a combined enhanced effect.
  • compositions are for reducing swelling and/ or stimulating contraction of tissues in the nasal and oral cavities.
  • a composition comprising the combination of:
  • the compositions are formulated as a spray such as a nasal or mouth spray, so that the invention provides a nasal or mouth spray comprising a composition according to the present invention.
  • a composition is useful for treating or alleviating swelling of nose or oral cavity tissues such as mucosa, and for treating or alleviating snoring, chronic sinusitis, cold, and/or sleep apnea in humans and animals.
  • the composition comprises the combination of: (i) an extract obtained from plant material selected from the family Apiaceae , preferably of the species Centella asiatica,
  • a sodium salt of the acid Sodium Hyaluronate - 40-60 kDa and a sodium salt of the acid : Sodium Hyaluronate 1000-2500 kDa.
  • a further aspect of the present invention relates to a composition for treating or alleviating swelling of nose or oral cavity tissues such as mucosa, and for avoiding the development of snoring, chronic sinusitis, cold, and/or sleep apnea in humans and animals, characterised in that the composition comprises the combination of:
  • sodium hyaluronate such as a sodium salt of the acid: Sodium Hyaluronate - 40-60 kDa and/or a sodium salt of the acid: Sodium Hyaluronate 1000- 2500 kDa and
  • compositions of the invention comprise a novel combination of extracts from various plants, shown in the present invention to be effective for preventing, and/or treating, and/or alleviating some of the fundamental causes of snoring, chronic sinusitis, cold, and/or sleep apnea in humans and animals.
  • the term "sleep apnea” is related only to obstructive sleep apnea (OSA).
  • OSA obstructive sleep apnea
  • Obstructive sleep apnea happens when the upper airway becomes blocked many times during sleep, reducing or completely stopping airflow. This is the most common type of sleep apnea. Anything that could narrow the airways such as obesity, large tonsils, or changes in hormone levels can increase the risk for obstructive sleep apnea.
  • compositions comprise a lubricant.
  • the composition comprises glycerine as a lubricant.
  • extract relates to a substance made by subjecting plant material to a solvent resulting in concentrating one or more analytes from the plant material into the solvent.
  • an extract obtained from a plant material selected from the family Zingiberaceae or "an extract obtained from a plant material selected from the family Apiaceae” or “an extract obtained from a plant material selected from the family Valerianaceae” or “an extract obtained from a plant material selected from the family Capsicum” relates to the process of subjecting the plant materials (one selected from the family Zingiberaceae; one selected from the family Apiaceae; one selected from the family Valerianaceae, or herb or combination of herbs containing valerenic acid; and one selected from the family Capsicum containing capsaicin) to a solvent extracting the analytes of interest and providing the extracts.
  • the composition comprises plant extract from Apiaceae selected from the Centella family.
  • the plant extract is from the species Centella asiatica.
  • the composition comprises extract from plant material selected from the family Valerianaceae.
  • the composition further comprises valerian root extract from Valeriana officinalis.
  • the plant material is selected from the family Apiaceae comprises a plant material extracted from the species Centella asiatica.
  • composition according to the invention comprises plant material from the family Zingiberaceae such as from the species Zingiber officinale, such as root extracts from Zingiber officinale.
  • the Zingiber extract is a root extract.
  • the composition according to the invention comprises plant extract from Capsicum in the form of a fruit extract from the species Capsicum annuum or Capsicum frutescens.
  • composition according to the present invention comprises the combination of:
  • the composition according to invention further comprises one or more of vitamins A, D, E, K, B and C and minerals Ca, Mg, Se and Zn and a lubricant such as glycerine.
  • Centella contains pentacyclic triterpenoids, including madecassic acid (brahmic acid), asiaticoside, and asiatic acid.
  • Centella asiaticaCentella asiatica C. asiatica
  • Centella asiatica has been used to treat various disorders and minor wounds and to encourage lactation.
  • the composition comprises madegassic acid, and/or asiatic acid; and/or asiaticoside.
  • the composition comprises zingiber extract and madegassic acid; and/or asiaticoside; and/or asiatic acid.
  • the content of the extract obtained from a plant material selected from the family Zingiberaceae; preferably Zingiberaceae present in the composition may be standardizing from the flavonoid content, preferably from the content of zingiber.
  • the compositions according to the invention comprises valerian root extract (Valeriana Officinalis') containing valerenic acid.
  • Valerian can be added to give a calming, sedative and anxiolytic effect.
  • the root extract of Valeriana officinalis contains several active compounds, including valerenic acid, valerenal, and volatile oils, which contribute to its observed effects.
  • the composition comprises xylitol.
  • Xylitol is a prebiotic moisturizer that supports the microbiome profile of skin. Highly purified xylitol prebiotic provides moisturizing benefit and improves microbiome diversity. Xylitol is included in many oral hygiene products because it works against bacteria and other microorganisms that can cause challenges in the oral cavity.
  • the composition according to the invention comprises extracts of the herbs: Centella asiatica, Zingiber officinale, and from the family Capsicum selected from the species Capsicum annuum or Capsicum frutescens, as well as Sodium Hyaluronate - 40-60 kDa and Sodium Hyaluronate 1000-2500 kDa.
  • the compositions according to the invention further comprise a lubricant.
  • the lubricant is glycerine.
  • the composition according to the invention comprises extracts of the herbs: Centella asiatica, Zingiber officinale, and from the family Capsicum selected from the species Capsicum annuum or Capsicum frutescens, as well as Sodium Hyaluronate - 40-60 kDa and Sodium Hyaluronate 1000-2500 kDa, and glycerine.
  • the composition has a pH value in the range of pH 4-7,5, such as in the range of pH 4, 5-6, 5, e.g., in the range of pH 5-6, such as in the range of pH 5, 5-5,8, such as about pH 5.
  • the composition comprises less than 3% extraction liquid; such as less than 2%; such as less than 1,5%; e.g. less than 1%; such as less than 0,5%; e.g. less than 0,3%; such as less than 0,1%.
  • the content of the extract obtained from a plant material selected from the family Apiaceae present in the composition may be standardizing from the content of asiatic acid.
  • the composition comprises the range of 0, 1-0,4 w/w% asiatic acid.
  • the composition according to the invention comprises within the range of 0, 1-0,4 w/w% asiatic acid, such as in the range of 0,1-0, 2 w/w% asiatic acid, e.g., in the range of 0,2-0, 4 w/w% asiatic acid, such as in the range of 0,2-0, 3 w/w% asiatic acid.
  • the composition may comprise flavonoids, preferably glycosidic bound flavonoids (such as zingiber, asiatic acid; asiaticoside; and/or madegassic acid).
  • flavonoids preferably glycosidic bound flavonoids (such as zingiber, asiatic acid; asiaticoside; and/or madegassic acid).
  • composition comprises in the range of 0-
  • 1.5 w/w% zingiber extract such as in the range of 0,01 - 1,5 w/w%.
  • the capsaicin extract is based on chili, red pepper or other plants of the Capsicum family containing the capsaicin compound.
  • the composition according to the invention comprises in the range of 0-5,0 w/w% capsaicin, such as in the range of 0,5-
  • the composition according to the invention comprises in the range of 0-0,5 w/w% valerenic acid, such as in the range of 0,1-0, 5 w/w% valerenic acid, e.g., in the range of 0,2-0, 4 w/w% valerenic acid, such as in the range of 0,2-0, 3 w/w% valerenic acid.
  • the composition comprises a higher content of madecassoside than asiatic acid and/or than asiaticoside.
  • the composition comprises a content of madecassoside which between 1,5-10 times higher than the content of asiatic acid on a weight-by-weight basis, such as between
  • the composition comprises a content of madecassoside which between 2-10 times higher than the content of asiaticoside on a weight-by-weight basis, such as between
  • the composition according to the invention comprises a content of asiatic acid which is between 1,25-5 times higher than the content of asiaticoside on a weight-by-weight basis, such as between 1,5-2, 5 times higher, e.g. about 2 times higher.
  • the composition according to the invention comprises a preservation agent. Suitable preservation agents may routinely be chosen by the skilled person.
  • the composition according to the invention comprises a sorbate compound, such as potassium sorbate as a preservation agent.
  • composition comprises xylitol in the range of 0-10 w/w%.
  • composition comprises in the range of 0, 1-0,4 w/w% asiatic acid and 0-1,5 w/w% zingiber.
  • the composition comprises in the range of 0, 1-0,4 w/w% asiatic acid; 0-1,5 w/w% zingiber; and 0-5,0 w/w% capsaicin.
  • the composition comprises in the range of 0, 1-0,4 w/w% asiatic acid; 0-1,5 w/w% zingiber; 0-5,0 w/w% capsaicin; and 0-0,5 w/w% valerenic acid.
  • the composition comprises in the range of 0, 1-0,4 w/w% asiatic acid; 0-1,5 w/w% zingiber; 0-5,0 w/w% capsaicin; and 0-25 w/w% lubricant, such as glycerine.
  • the solvents used for providing the extracts according to the present invention may be an aqueous solvent, such as water, or an alcoholic solvent.
  • the alcoholic solvent may be selected from methanol, ethanol, isopropanol, or a mixture hereof.
  • the composition comprises less than 2% alcoholic solvent; such as less than 1,5% alcoholic solvent; e.g., less than 1% alcoholic solvent; such as less than 0,5% alcoholic solvent; e.g., less than 0,3% alcoholic solvent; such as less than 0,1% alcoholic solvent, e.g., no alcoholic solvent.
  • a further embodiment according to the present invention comprises an extract obtained from plant material selected from the family Apiaceae in an aqueous solvent.
  • the term "powder” relates to a composition having a moisture content of 15% (w/w) or less, such as a moisture content of 10% (w/w) or less, e.g. a moisture content of 7,5% (w/w) or less, such as a moisture content of 5% or less.
  • the composition according to the invention comprises sodium levulinate as a preservation agent in a concentration in the range of 0,1-0, 5% (w/w) on a dry-matter basis, such as about 0,2% (w/w) on a dry-matter basis.
  • the composition according to the invention is for use as a medicament.
  • the unique combination of extracts in the compositions of the invention are useful in a variety of treatments of medical conditions, in non-limiting example including those of for use in the prevention, treatment or alleviation of inflammation or swelling in the nose or oral cavity, or for use in the prevention, treatment or alleviation of snoring, obstructive sleep apnea, chronic sinusitis and/or cold in mammals such as in humans.
  • composition according to the invention is for administration to the nose or to the oral cavity or throat.
  • the composition according to the invention is for administration to the oral cavity or throat, such as to the mucosa in the oral cavity or throat in the form of anyone of an oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule.
  • the composition according to the invention is for administration to the nose, such as to the mucosa in the nose, in the form of anyone of a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants.
  • the composition according to the invention is an oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule.
  • the composition according to the invention is a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants.
  • the composition according to the invention is a nasal and oral cavity composition or formulation for relief of congestion in the nose or oral cavity.
  • the composition according to the invention is a nasal or oral cavity or throat composition or formulation in the form of a spray.
  • a preferred embodiment of the present invention relates to a nasal spray comprising a composition according to the present invention.
  • the nasal spray may be a decongestant nasal spray.
  • the nasal spray may comprise a capacity in the range of 5-100 ml, such as in the range of 10-75 ml, e.g., in the range of 20-50 ml, such as 30 ml.
  • the nasal spray may be adjusted to provide 25-300 pl/unit dose; such as 50-200 pl/unit dose; e.g., 75-150 pl/unit dose, such as 100 pl/unit dose.
  • composition according to the present invention has shown a contractive effect on the structure of the connective tissue in the soft part of the palate and throat, creating a more open passage in the upper respiratory tract.
  • composition according to the invention further comprises an extract from plant material selected from the family Valerianaceae. In some embodiments, the composition according to the invention further comprises xylitol.
  • composition according to the invention is for oral and/or nasal administration.
  • the composition is for use as a medicament, such as in non-limiting example for preventing, treating, or alleviating swelling of tissues in the nose or oral cavity, or for treating or alleviating snoring, chronic sinusitis, cold, and/or sleep apnea in mammals such as in humans.
  • the compositions are for administration in two-unit doses, each in the range of 25-300 pl of the composition.
  • the composition is for administration in an effective dosage to the nose or oral cavity.
  • the composition according to the invention is for administration to a mammal such as a human, with a frequency at least 1-2 times a day.
  • the composition is administered as two-unit doses, each in the range of 50-200 pl such as two unit doses, each in the range of 75-150 pl, such as two unit doses, each of 100 pl.
  • the composition is for use in treating or alleviating swelling of tissue in the nose or oral cavity, or for treating or alleviating snoring, cold, chronic sinusitis and/or sleep apnea in mammals such as in humans.
  • the composition may be administered as two-unit doses nasally such as to each nostril and two-unit doses may be orally administered to humans and animals, preferably by administration at least 1-2 times a day.
  • the compositions are for use in treating or alleviating swelling of tissues in the nose or oral cavity of subjects using a CPAP machine when sleeping.
  • the compositions of the invention is for administration in an effective dosage before sleeping, such as once or twice a day, or with such time interval before sleeping to allow the composition to be effective.
  • Subjects suffering from snoring, chronic sinusitis, cold, and/or sleep apnea may use an increased dosage such as an effective dosage of the composition according to the present invention, to treat and/or alleviate the snoring, chronic sinusitis, cold, and/or sleep apnea as described above.
  • the composition according to the present invention is preferably an aqueous solution such as an aqueous buffer solution.
  • the aqueous solution comprises extract obtained from a plant material selected from the family Zingiberaceae.
  • the composition of the invention further comprises extract obtained from a plant material selected from the family Apiaceae.
  • the compositions of the invention further comprises extract obtained from a plant from the family Capsicum, and in some embodiments additionally extract obtained from a plant from the family Valerianaceae.
  • the dry matter content provided in step (i) and/or (ii) during the extraction process may be in the range of 40-70% (w/w); such as in the range of 50-65% (w/w); e.g. about 60% (w/w).
  • the extract obtained from plant material selected from the family Zingiberaceae comprises the flavonoids, kaempferol and quercetin.
  • the extract obtained from plant material selected from the family Apiaceae comprises madegassic acid, asiaticoside, and/or asiatic acid.
  • the extract obtained from plant or fruit material selected from the family Capsicum, preferably Capsicum annuum or Capsicum frutescens, comprises capsaicin.
  • the extract obtained from plant material selected from the family Valerianaceae comprises valerenic acid.
  • the method according to the present invention further comprises the step of adding a preservation agent to the mixed composition.
  • the preservation agent is a sorbate compound, such as potassium sorbate.
  • the sorbate compound is in the composition to reach a content within the range of 0,1-0, 5% (w/w) on a dry-matter basis, such as about 0,2% (w/w) on a dry-matter basis.
  • the extract obtained from a plant material from the family Zingiberaceae is obtained from rhizoma.
  • the extract of Zingiberaceae is in the form of a liquid, a juice, a paste or in the form of a syrup, preferably in the form of a syrup.
  • the extract obtained from a plant material selected from the family Apiaceae may be in the form of a dry powder.
  • Such dry powder comprising the Apiaceae extract may subsequently be dissolved in water or in the liquid extract of plant material selected the family Zingiberaceae.
  • the Apiaceae powder is dissolved in Zingiberaceae extract provided in the form of a liquid, a juice, a paste or a syrup.
  • the extract obtained from plant material selected from the family Capsicum may in some embodiments be in the form of a liquid, a juice or a syrup.
  • the extract obtained from a plant material selected from the family Valerianaceae may in some embodiments be in the form of a liquid, a juice or a syrup.
  • water may be added to the extract obtained from plant material selected from the family Zingiberaceae.
  • Zingiberaceae Preferably Zingiberaceae (step 1)
  • step (b) or to the mixture provided in step (c), where the extract obtained from a plant material selected from the family Zingiberaceae.
  • Zingiberaceae obtained in step (a) are mixed with the extract obtained from plant material from one or more of the plant materials selected from the family Apiaceae, Valerianaceae and/or Capsicum as obtained in step (b), to provide the desired concentration of ingredients.
  • results from fibroblast cell culture experiments described in the examples section of this application indicate that the compositions of the invention affect cell morphology leading to less swelling of the fibroblast cells in the cultures. This indicate that the compositions may cause less swelling of fibroblastic tissues in conditions of the nose or oral cavity where such swelling is part of the pathology. Further, experiments wherein the compositions are administered to patients showed improved breathing during sleep due to less swelling of nasal and oral cavity tissues, and further much improvement in sleep quality. Snoring was reduced significantly in the patients receiving daily doses of the composition of the invention.
  • This cell line established a less classical fibroblast cellular morphology compared to MRC5.
  • compositions of the invention affect cell morphology leading to less swelling of the fibroblast cells in the cultures. This indicate that the compositions may cause less swelling of fibroblastic tissues in conditions of the nose or oral cavity where such swelling is part of the pathology.
  • Test batch 000 was delivered as a Nasal Spray
  • Test-Batch 000 produced by Persano.
  • Test batch 000 comprised extracts of Centella asiatica, Zingiber officinale, Capsicum and sodium hyaluronate, as well as glycerine as lubricant.
  • Table 1 Results from the two-week intervention period based on self-assessment.
  • Test versions of sprays with variable amounts of each compound and combinations of compounds were created. Sodium was added to create an isotonic solution, and an appropriate compound to adjust pH to a range of 4-7,5 included, as was a preservative to ensure an appropriate shelf-life for the spray.
  • composition comprising the combination of:
  • composition according to embodiment 1, wherein the lubricant is glycerine.
  • composition according to embodiment 1 or 2 wherein the composition further comprises sodium hyaluronate.
  • composition according to any of embodiments 1 - 3, wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000- 2500 kDa.
  • the composition comprises the combination of:
  • composition according to anyone of the preceding embodiments, wherein the composition comprises the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa
  • composition according to anyone of the preceding embodiments, wherein the composition comprises the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa and
  • composition according to anyone of the preceding embodiments, wherein the composition comprises the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa and
  • composition according to any one of the previous embodiments for use as a medicament.
  • composition according to any one of the previous embodiments, wherein the composition is for use in the prevention, treatment or alleviation of inflammation or swelling in the nose or oral cavity.
  • composition according to any one of the previous embodiments wherein the composition is for use in the prevention, treatment or alleviation of snoring, obstructive sleep apnea, chronic sinusitis and/or cold in mammals such as in humans. 18. The composition according to any one of the previous embodiments, wherein the composition is for administration to the nose or to the oral cavity or throat.
  • composition according to embodiment 18, wherein the composition is for administration to the oral cavity or throat, such as to the mucosa in the oral cavity or throat in the form of anyone of an oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule.
  • composition according to embodiment 18, wherein the composition is for administration to the nose such as to the mucosa in the nose, in the form of anyone of a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants comprising the composition according to anyone of embodiments 1-18.
  • An oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule comprising a composition according to anyone of embodiments 1-18.
  • a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants comprising the composition according to anyone of embodiments 1-18.
  • composition or formulation according to anyone of embodiments 18-21, wherein the composition or formulation is a spray.
  • composition formulated as a nasal spray comprising the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa and
  • composition formulated as a nasal spray comprising the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa and
  • composition formulated as a nasal spray comprising the combination of:
  • sodium hyaluronate wherein the sodium hyaluronate comprise Sodium Hyaluronate - 40-60 kDa and/or Sodium Hyaluronate 1000-2500 kDa and
  • composition for use in the prevention, treatment or alleviation of snoring, obstructive sleep apnea, chronic sinusitis and/or cold in mammals such as in humans.
  • composition further comprises vitamins A, D, E, K, B and C and minerals Ca, Mg, Se and Zn and glycerine.
  • composition according to anyone of the preceding embodiments wherein the composition has a pH value in the range of pH 4-7,5, such as in the range of pH 4, 5-6, 5, e.g., in the range of pH 5-6, such as in the range of pH 5, 5-5,8.
  • composition according to anyone of the preceding embodiments wherein the composition comprises less than 3% extraction liquid; such as less than 2%; such as less than 1,5%; e.g. less than 1%; such as less than 0,5%; e.g. less than 0,3%; such as less than 0,1%.
  • composition according to anyone of the preceding embodiments wherein the composition comprises within the range of 0, 1-0,4 w/w% asiatic acid, such as in the range of 0, 1-0,2 w/w% asiatic acid, e.g., in the range of 0,2-0, 4 w/w% asiatic acid, such as in the range of 0.2-0, 3 w/w% asiatic acid.
  • composition according to anyone of the preceding embodiments wherein the composition comprises within the range of 0-1,5 w/w% zingiber extract, such as in the range of 0,01-1,5 w/w% zingiber extract or powder.
  • composition according to anyone of the preceding embodiments wherein the composition comprises in the range of 0-5,0 w/w% capsaicin, such as in the range of 0,01- 5 w/w%, such as in the range of 0,5-4, 5 w/w% capsaicin, e.g., in the range of 1,0-3, 5 w/w% capsaicin, such as in the range of 1,5-2, 5 w/w% capsaicin.
  • composition according to anyone of the preceding embodiments wherein the composition comprises in the range of 0-0,5 w/w% valerenic acid, such as in the range of 0,1-0, 5 w/w% valerenic acid, e.g., in the range of 0,2-0, 4 w/w% valerenic acid, such as in the range of 0,2-0, 3 w/w% valerenic acid.
  • composition according to anyone of the preceding embodiments wherein the composition comprises a content of asiatic acid which is between 1,25-5 times higher than the content of asiaticoside on a weight-by-weight basis, such as between 1,5-2, 5 times higher, e.g. 2 times higher.
  • composition according to anyone of the preceding embodiments wherein the composition comprises a preservation agent.
  • the preservation agent is a sorbate compound, such as potassium sorbate.
  • composition according to embodiment 35 wherein the sorbate compound is added in a concentration in the range of 0,1-0, 5% (w/w) on a dry-matter basis, such as about 0,2% (w/w) on a dry-matter basis.
  • composition according to embodiment 34 wherein the preservation agent is sodium levulinate in a concentration in the range of 0,1-0, 5% (w/w) on a dry-matter basis, such as about 0,2% (w/w) on a dry-matter basis.
  • composition according to any one of the preceding embodiments wherein the composition is for use in the treatment or alleviation of snoring, obstructive sleep apnea, chronic sinusitis and/or cold in mammals such as in humans.
  • composition according to anyone of the preceding embodiments, wherein the composition is for administration to the nose or to the oral cavity or throat.
  • composition according to the preceding embodiment wherein the composition is for administration to the oral cavity or throat, such as to the mucosa in the oral cavity or throat in the form of anyone of an oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule.
  • composition according to embodiment 40 wherein the composition is for administration to the nose, such as to the mucosa in the nose, in the form of anyone of a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants comprising the composition according to anyone of embodiments 1-23.
  • An oral solution, a suspension, an emulsion, a lozenge or troche, a spray, a gel, a mouthwash or gargle, or a tablet or capsule comprising a composition according to anyone of the preceding embodiments.
  • a nasal spray, nasal drops, nasal gels, nasal powders, nasal aerosols, nasal patches or films, or nasal implants comprising the composition according to anyone of the preceding embodiments.
  • composition or formulation according to anyone of embodiments 40-45, wherein the composition or formulation is a spray.

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Abstract

La présente invention concerne une composition comprenant la combinaison d'extraits de Centella asiatica ou d'autres membres de la famille Apiaceae, un extrait de la famille Zingiberaceae , un extrait de la famille Valerianaceae, un extrait de la famille Capsicum, du xylitol, de l'hyaluronate de sodium, de la glycérine, des vitamines et des minéraux pour traiter et/ou atténuer le ronflement, la sinusite chronique, le rhume et/ou l'apnée obstructive du sommeil chez l'homme et l'animal.
PCT/EP2024/084278 2023-11-30 2024-12-02 Composition comprenant des extraits d'herbes pour atténuer le ronflement Pending WO2025114598A1 (fr)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5804211A (en) * 1996-06-05 1998-09-08 Health Pharm Usa, Inc. Composition and method for suppressing or eliminating snoring
WO2003080036A2 (fr) * 2002-03-25 2003-10-02 Lmd Utilisation d'un vanilloide comme anti-ronflement
US20090226550A1 (en) * 2008-03-07 2009-09-10 Smith Marlene M Organic compositions and methods of use
US7955627B1 (en) * 2008-03-07 2011-06-07 Smith Marlene M Organic compositions and methods of use
WO2019209229A2 (fr) * 2017-12-29 2019-10-31 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Formulations topiques comprenant des extraits d'herbes
CN112426510A (zh) * 2020-12-04 2021-03-02 广西冠硕科技有限公司 一种治疗关节炎的组方及其制备方法
WO2022185242A1 (fr) * 2021-03-04 2022-09-09 Ape8 S.R.L. Composition médicale destinée à être inhalée
WO2022258722A1 (fr) * 2021-06-11 2022-12-15 Noz Aps Composition comprenant un extrait de centella et un extrait d'hippophae

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5804211A (en) * 1996-06-05 1998-09-08 Health Pharm Usa, Inc. Composition and method for suppressing or eliminating snoring
WO2003080036A2 (fr) * 2002-03-25 2003-10-02 Lmd Utilisation d'un vanilloide comme anti-ronflement
US20090226550A1 (en) * 2008-03-07 2009-09-10 Smith Marlene M Organic compositions and methods of use
US7955627B1 (en) * 2008-03-07 2011-06-07 Smith Marlene M Organic compositions and methods of use
WO2019209229A2 (fr) * 2017-12-29 2019-10-31 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Formulations topiques comprenant des extraits d'herbes
CN112426510A (zh) * 2020-12-04 2021-03-02 广西冠硕科技有限公司 一种治疗关节炎的组方及其制备方法
WO2022185242A1 (fr) * 2021-03-04 2022-09-09 Ape8 S.R.L. Composition médicale destinée à être inhalée
WO2022258722A1 (fr) * 2021-06-11 2022-12-15 Noz Aps Composition comprenant un extrait de centella et un extrait d'hippophae

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