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WO2007110871A2 - Procedes et composition pour le traitement des maux de gorge - Google Patents

Procedes et composition pour le traitement des maux de gorge Download PDF

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Publication number
WO2007110871A2
WO2007110871A2 PCT/IL2007/000412 IL2007000412W WO2007110871A2 WO 2007110871 A2 WO2007110871 A2 WO 2007110871A2 IL 2007000412 W IL2007000412 W IL 2007000412W WO 2007110871 A2 WO2007110871 A2 WO 2007110871A2
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WO
WIPO (PCT)
Prior art keywords
oil
group
composition
mixtures
composition according
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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.)
Ceased
Application number
PCT/IL2007/000412
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English (en)
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WO2007110871A3 (fr
Inventor
Eran Eilat
Nitsan Primor
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NAVEH PHARMA (1996) Ltd
Original Assignee
NAVEH PHARMA (1996) Ltd
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Priority to EP07736152A priority Critical patent/EP2015761A4/fr
Publication of WO2007110871A2 publication Critical patent/WO2007110871A2/fr
Publication of WO2007110871A3 publication Critical patent/WO2007110871A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • 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
    • 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)
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy

Definitions

  • the present invention relates to pharmaceutical compositions and methods for treating, soothing or reducing the severity of a sore throat, e.g., during sleep, the compositions comprising an oily vehicle which provides an oily coating to the throat of a subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat for an extended period of time, preferably overnight.
  • the composition is preferably administered in the form of a throat spray.
  • Sore throat is an acute inflammation of the mucous membrane of the lower pharynx. Tonsils and the soft palate may also be inflamed. The main indication of a sore throat is pain when swallowing and, at times, a burning sensation and tightness in the throat. Secretions may be discharged from the mucous membrane or the throat may be very dry.
  • a sore throat can be caused by both a virus and bacterium.
  • a sore throat is most commonly caused by viral infections such as the common cold, but can also be brought on by anything that irritates the sensitive mucous membranes at the back of the mouth and throat.
  • the bacteria that causes the majority of throat infections such as strep throat and tonsillitis, are Group A streptococci (Group A strep). These infections can lead to other illnesses, and usually require medical attention.
  • a sore throat can also be related to other problems, such as allergies or even reflux, when stomach acids are regurgitated into the back of the throat. People who suffer from reflux, either on an occasional or chronic basis, will awaken some mornings with a sore throat due to the regurgitation of stomach acids into the back of throat overnight.
  • Treatment options include a) home remedies: i) drinking warm, clear liquids, such as hot tea or broth, ii) gargling several times a day with warm salt water, iii) drinking cold liquids or sucking popsicles, iv) humidifying the air where one sleeps, v) sucking on hard candies or throat lozenges can be very soothing, because it increases saliva production and vi) elevating the head slightly while sleeping so mucous can drain more efficiently; b) medication such over-the-counter pain medication and antibiotics in the case of bacterial infections; and c) surgery: at times, severe and recurring cases of tonsillitis, especially in children, will require the removal of the tonsils.
  • home remedies i) drinking warm, clear liquids, such as hot tea or broth, ii) gargling several times a day with warm salt water, iii) drinking cold liquids or sucking popsicles, iv) humidifying the air where one sleeps, v) sucking on hard candies or throat lozenges can
  • Chinese Patent Number CN 1238946 discloses a liquid spray for treating oral and throat diseases, which is prepared from blumea oil, bran oil, borneol, menthol, salt of glycyrrhizic acid, alcohol and distilled water.
  • US Patent Number 6,159,473 discloses a throat spray composition useful for topical application to sore throats.
  • the throat spray contains Piper methysticum (Kava Kava), an analgesic, as its main active ingredient. Additional ingredients include Echinacea angustifolia, Eucalyptus globulus, Thymus vulgaris, Lycopodium clavatum, Phytolacca decandra, Capsicum annum, Mentha piperita, and Phosphorus.
  • Piper methysticum Kava Kava
  • Additional ingredients include Echinacea angustifolia, Eucalyptus globulus, Thymus vulgaris, Lycopodium clavatum, Phytolacca decandra, Capsicum annum, Mentha piperita, and Phosphorus.
  • Anti-snoring sprays have been suggested as anti-snoring compositions. Anti-snoring sprays have largely been proven to be ineffective for hydrating mucus due to the short period of contact with the mucus unless repeatedly applied throughout the night.
  • MediSnoreTM is a commercially available throat spray comprising essential oils such as mineral oil (paraffin oil, liquid petrolatum, white mineral oil) glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil, that is capable of coating the throat with thin oily natural lubricants, thereby reducing or avoiding snoring for an extended period of time.
  • essential oils such as mineral oil (paraffin oil, liquid petrolatum, white mineral oil) glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil, that is capable of coating the throat with thin oily natural lubricants, thereby reducing or avoiding snoring for an extended period of time.
  • mineral oil paraffin oil, liquid petrolatum, white mineral oil
  • canola oil olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil
  • US Patent Number 6, 187,318 teaches a composition for preventing snoring, which includes various natural oils such as almond oil, olive oil, sunflower oil, and peppermint oil, which serve to lubricate the soft tissue including the uvula and soft palette during sleep and a magnesium-based compound.
  • the oils dampen the friction of the soft tissue and diminish the noise associated with snoring.
  • the magnesium-based compound helps the oils cling to the soft tissue.
  • US Patent Numbers 4,668,513 and 4,556,557 disclose methods and a processes for overcoming snoring using a composition comprising a surface active substance, a preserving agent and/or a substance acting bactericidally or fungicidally on the mucous membranes and optionally a substance for softening the mucous membranes in physiological common salt solution as well as optionally further additives which are compatible with the mucous membranes.
  • PCT Patent application Number WO 03/070178 describes an orally administered composition for relieving or eliminating snoring, in the form of a throat spray.
  • the composition includes a tissue-firming or astringent agent to firm up throat tissue, a soothing agent to soothe irritated or inflamed tissues, a lubricant to moisten dry or dehydrated tissues, and a mucous-thinning or expectorant agent to help remove any obstructive matter near the throat tissues.
  • US Patent Number 6,790,465 discloses an anti-snoring composition
  • an anti-snoring composition comprising at least one homopolysaccharide, which is administered to pharyngeal mucous membranes, e.g., soft palate and uvula.
  • the composition preferably includes oat beta-glucan and a suitable delivery agent that will hold the active ingredients in solution, and optionally may be combined with essential oil compounds, selected from the group consisting of peppermint oil, lemon oil, sunflower oil and eucalyptus oil, vitamins, and/or flavoring agents.
  • the solution is preferably administered in the form of a throat spray.
  • US Patent Number 6,491,954 discloses an anti-snoring composition in the form of a throat spray.
  • the composition comprises an aqueous ethanolic solution of seven homeopathic ingredients, (i) belladonna; (ii) ephedra vulgaris; (iii) histamine hydrochloride; (iv) hydrastis canadensis; (v) potassium dichromate; (vi) nux vomica; and (vii) teucrim marum.
  • compositions and methods that are safe and effective to treat, soothe or reduce the severity of a sore throat, especially during sleep.
  • Such a composition must work quickly and provide superior sore throat relief for an extended period of time.
  • the present invention relates to a pharmaceutical composition formulated for local administration to the mouth or throat of a subject for treating, soothing or reducing the severity of sore throat in the subject during sleep.
  • the composition comprises an oily vehicle which provides an oily coating to the throat of the subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat.
  • the present invention relates to a method for treating, soothing or reducing the severity of sore throat in a subject during sleep, by administering the composition of the present invention.
  • the advantage of this composition is that the oily vehicle coats the throat and the active ingredient provides relief, treats, and soothes the throat, thereby reducing the severity of sore throats for an extended period of time, preferably overnight, with a single application.
  • the activity of the compositions of the invention may be due to the ability of certain oils to coat the throat with a thin oily layer, thereby preventing adhesion of infectious agents to the walls of the throat and the subsequent colonization that leads to development of infection.
  • the water content of the oily vehicle of the invention is below that required to support growth of infectious agents.
  • One aspect of the present invention relates to a pharmaceutical composition formulated for local administration to the mouth or throat of a subject for treating, soothing or reducing the severity of sore throat in the subject, the composition comprising an oily vehicle which provides an oily coating to the throat of the subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat, wherein the active ingredient is selected from the group consisting of an oil; a local anesthetic; an antiseptic agent, and mixtures thereof.
  • the oily vehicle is selected from the group consisting of mineral oil (paraffin oil, liquid petrolatum, white mineral oil), glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • mineral oil paraffin oil, liquid petrolatum, white mineral oil
  • canola oil olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • the pharmaceutical composition comprises an oily vehicle which is MediSnoreTM, a commercial preparation including mineral oil (paraffin oil, liquid petrolatum, white mineral oil), glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • mineral oil paraffin oil, liquid petrolatum, white mineral oil
  • canola oil olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • the oily vehicle consists of mineral oil (paraffin oil, liquid petrolatum, white mineral oil), glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • the active ingredient is an oil, examples of which include, but are not limited to angelica root oil, apricot kernel oil, arnica oil, benzoe siam oil, blood orange oil, blue chamomile oil, bulgarian rose oil, cajput oil, calendula oil, carrot seed oil, Clementine oil, cumin oil, cypress oil, douglas fir oil, fir grandis oil, frankincense arabian oil, galbanum oil, himalayan fir oil, ho-leaf oil, hyssop oil, immortelle oil, iris oil, jojoba oil, lavandin oil, marjoram oil, malaleuca oil, manuka oil, melissa oil, mimosa oil, mountain pine
  • the composition comprises at least one oil selected from the group consisting of almond oil, canola oil, cinnamon oil, chamomile oil, clove oil, geranium oil, glycerin, mineral oil, lemon oil, olive oil, sage oil, sesame oil, spearmint oil, tea-tree oil, thymol oil, turmeric oil, wintergreen oil, and mixtures thereof.
  • the composition is composed of only natural active ingredients.
  • the active ingredient is a local anesthetic selected from the group consisting of 2,4 dichlorobenzyl alcohol, benzocaine, benzyl benzoate, bupivacaine, calamine, chloroprocaine, chloroxylenol, cinchocaine, cocaine, dexivacaine, diamocaine, dibucaine, dyclonine, etidocaine, hexylcaine, ketamine, levobupivacaine, lidocaine, menthol, mepivacaine, oxethazaine, phenol, pramoxine, prilocaine, amethocaine, tetracaine, proparacaine, propoxycaine, pyrrocaine, resorcinol, risocaine, rodocaine, ropivacaine, tetracaine, troclosan, and mixtures thereof.
  • a local anesthetic selected from the group consisting of 2,4 dichlorobenzyl
  • the local anesthetic is present in an amount of about 0.1 % to about 5% (w/w).
  • the local anesthetic is benzocaine.
  • the active ingredient is an antiseptic agent selected from the group consisting of tyrothricin, amylmetacresol, dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2- methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3-one, and mixtures thereof.
  • the antiseptic agent is selected from the group consisting of tyrothricin, dequalinium chloride and boric acid. In another embodiment the antiseptic agent is present in an amount of about 0.1% to about 5% (w/w).
  • the pharmaceutical composition comprises an oily vehicle which is MediSnoreTM, and an active ingredient which is selected from an oil, a local anesthetic and an antiseptic agent, effective to treat sore throat, preferably overnight.
  • the oily vehicle is MediSnoreTM
  • the active ingredient is an oil selected from the group of oils known to possess calming and/or anti- inflammatory and/or anti-microbial and/or anti-viral actions, including but not limited to, turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil.
  • the pharmaceutical composition comprises an oily vehicle which is MediSnoreTM, an active ingredient which is selected from an oil, a local anesthetic and an antiseptic agent, and further comprises an oil selected from the group of oils known to possess calming and/or anti-inflammatory and/or anti-microbial and/or antiviral actions, including but not limited to, turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil.
  • an oily vehicle which is MediSnoreTM
  • an active ingredient which is selected from an oil, a local anesthetic and an antiseptic agent
  • an oil selected from the group of oils known to possess calming and/or anti-inflammatory and/or anti-microbial and/or antiviral actions including but not limited to, turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil.
  • the oily vehicle is MediSnoreTM and the active ingredient is a local anesthetic selected from the group consisting of 2,4 dichlorobenzyl alcohol, benzocaine, benzyl benzoate, bupivacaine, calamine, chloroprocaine, chloroxylenol, cinchocaine, cocaine, dexivacaine, diamocaine, dibucaine, dyclonine, etidocaine, hexylcaine, ketamine, levobupivacaine, lidocaine, menthol, mepivacaine, oxethazaine, phenol, pramoxine, prilocaine, amethocaine, tetracaine, proparacaine, propoxycaine, pyrrocaine, resorcinol, risocaine, rodocaine, ropivacaine, tetracaine, troclosan, and mixtures thereof.
  • the active ingredient is a local anes
  • the oily vehicle is MediSnoreTM and the active ingredient is an antiseptic agent selected from the group consisting of tyrothricin, amylmetacresol, benzalkinium chloride dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2- methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3-one, and mixtures thereof.
  • an antiseptic agent selected from the group consisting of tyrothricin, amylmetacresol, benzalkinium chloride dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2- methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3
  • the composition further comprises a magnesium-based compound which is capable of retaining the various oils on the soft tissue of the throat for an extended period of time, e.g., up to 10 hours.
  • the magnesium based compound is preferably provided in the form of carrageenan, magnesium aluminum silicate, or mixtures thereof.
  • the composition further comprises at least one agent selected from the group consisting of a tissue-firming agent, a tissue-soothing agent, a lubricant, and a mucous thinning agent or an expectorant.
  • the tissue-firming agent is preferably an astringent, including but not limited to alcohol, witch hazel, aluminum potassium sulfate, aluminum sodium sulfate, aluminum sulfate, zinc chloride, acacia tea, tannins, tincture of myrrh, and any combination thereof.
  • a tissue-soothing agent include but are not limited to essential oils, glycerin, chamomile flowers, alpha bisabolol, and any combination thereof.
  • Examples of a lubricant include but are not limited to glycerin, sorbitol, high fructose corn syrup, inulin, sucrose, phosphocholinamin, sodium alginate, and any combination thereof.
  • Examples of an expectorant include but are not limited to essential oils, alcohol, elecampane, cayenne, cineole, and any combination thereof.
  • the composition further comprises at least one homopolysaccharide, i.e., a polysaccharide having repeating units of one type of monosaccharide.
  • a preferred homopolysaccharide is a glucan consisting of glucose units, e.g., beta- 1,3/1, 6 glucan (referred to as "beta-glucan").
  • compositions of the present invention further comprise at least one homeopathic agent.
  • the homeopathic agent is selected from the group consisting of i) Belladonna; (ii) Ephedra vulgaris; (iii) Histamine hydrochloride; (iv) Hydrastis canadensis; (v) Potassium dichromate; (vi) Nux vomica; (vii) Teucrim marum, and any combination thereof.
  • a preferred homeopathic mixture is an ethanolic solution comprising one or more of the aforementioned seven homeopathic ingredients, more preferably an ethanolic solution comprising all seven homeopathic ingredients or a mixture of ethanolic solutions of each of the seven homeopathic ingredients.
  • the present invention provides a pharmaceutical composition for treating sore throat, the composition comprising dequalinium chloride, turmeric oil, clove oil, sage oil, cinnamon oil, tea-tree oil, wintergreen oil, chamomile oil, geranium oil, and olive oil.
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising turmeric oil, lemon oil, sage oil, mineral oil, glycerin, canola oil, chamomile oil, olive oil, spearmint oil, and sesame oil.
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising boric acid, turmeric oil, clove oil, thymol oil, mineral oil, glycerin, canola oil, olive oil, spearmint oil, and sesame oil.
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising benzocaine, tyrothricin, mineral oil, glycerin, canola oil, almond oil, olive oil, spearmint oil, and sesame oil.
  • the composition is administered to the subject prior to sleep.
  • the composition provides relief from sore throat for a period of at least about 2 hours after administration.
  • the composition provides overnight relief from sore throat.
  • the composition is administered in the form of a liquid, an oil, a spray, drops, aerosol, mouth wash, lozenge, syrup, foam, mousse or a gel.
  • the composition is administered in the form of a throat spray.
  • the composition is administered via a metered dose device.
  • a metered dose device comprises the composition.
  • a second aspect of the invention is the method of treating, soothing or reducing the severity of sore throat in a subject during sleep, comprising locally administering to the mouth or throat of a subject a pharmaceutical composition comprising an oily vehicle which provides an oily coating to the throat of the subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat, wherein the active ingredient is selected from the group consisting of an oil; a local anesthetic; an antiseptic agent, and mixtures thereof, as described above.
  • a third aspect of the invention is the use of a pharmaceutical composition as described above, for the preparation of a medicament for treating, soothing or reducing the severity of a sore throat.
  • the composition provides overnight relief from a sore throat.
  • the composition is in the form of a throat spray.
  • the present invention relates to a pharmaceutical composition formulated for local administration to the mouth or throat of a subject for treating, soothing or reducing the severity of sore throat in the subject during sleep, wherein the active ingredient is selected from the group consisting of an oil; a local anesthetic; an antiseptic agent, and mixtures thereof.
  • the composition comprises an oily vehicle which provides an oily coating to the throat of the subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat.
  • the present invention relates to a method for treating, soothing or reducing the severity of sore throat in the subject during sleep, by administering the composition of the present invention.
  • One aspect of the present invention relates to a pharmaceutical composition formulated for local administration to the mouth or throat of a subject for treating, soothing or reducing the severity of sore throat in the subject during sleep, the composition comprising an oily vehicle which provides an oily coating to the throat of the subject; and an active ingredient in an amount effective to treat, sooth or reduce the severity of sore throat, wherein the active ingredient is selected from the group consisting of an oil; a local anesthetic; an antiseptic agent, and mixtures thereof.
  • the term "soothing" means calming or placating.
  • oil includes any synthetic or naturally occurring oil, including but not limited to essential oils.
  • “Essential oils” are natural fragrance oils, including but not limited to wintergreen oil, menthol, peppermint oil, anise oil, clove oil, eucalyptus oil, spearmint oil, pine oil, chamomile oil, lemon oil, and orange oil.
  • purified or synthetic versions of the essential components can be used in place of the naturally occurring oils in the present invention.
  • the oils used in the compositions of the invention are active traditional treatment oils, vehicle (carrier) oils used to dilute the treatment oils, and mixtures thereof.
  • the active oil and the oily vehicle can each independently be selected from the group consisting of mineral oil (paraffin oil, liquid petrolatum, white mineral oil), nujol, almond oil, sunflower oil, angelica root oil, anise oil, aniseed oil, apricot kernel oil, arnica oil, basil oil, bay oil, benzoe siam oil, bergamot oil, black pepper oil, blood orange oil, blue chamomile oil, bulgarian rose oil, cajput oil, calendula oil, camphor oil, canola oil, cardamom oil, carrot seed oil, cedar wood oil, chamomile oil, chamomile wild oil, cinnamon oil, cimiamon bark oil, cinnamon leaf oil, citronella oil, clary sage oil, Clementine oil, clove oil, clove bud oil, clove leaf oil, coriander oil, cumin oil, cypress oil, douglas fir oil, eucalyptus oil, evening prime rose oil, fennel oil, fir grandis oil, frankin
  • the active oil is selected from angelica root oil, apricot kernel oil, arnica oil, benzoe siam oil, blood orange oil, blue chamomile oil, bulgarian rose oil, cajput oil, calendula oil, carrot seed oil, Clementine oil, cumin oil, cypress oil, douglas fir oil, fir grandis oil, frankincense arabian oil, galbanum oil, himalayan fir oil, ho-leaf oil, hyssop oil, immortelle oil, iris oil, jojoba oil, lavandin oil, marjoram oil, malaleuca oil, manuka oil, melissa oil, mimosa oil, mountain pine oil, musk mallow oil, myrrh oil, nettle oil, niauli oil, oak moss oil, oregano oil, oud oil, peru myrtle oil, ravintsara oil, rock rose oil, rosa alba oil, rosewood oil,
  • the oily vehicle is selected from the group mineral oil, (paraffin oil, liquid petrolatum, white mineral oil), glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil, eucalyptus oil and mixtures thereof.
  • Exemplary preferred active oils are traditional treatment oils that are known to possess calming, anti-inflammatory, anti-microbial and anti-viral action. Such oils include in preferred, but non-limiting examples, turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil. Other possible effects of active oils are to reduce stress and emotional excitability. Some examples of the effects of traditional treatment oils include but are not limited to: A) Peppermint oil eliminates bad breath with its pleasant mint flavor and helps clear nasal passages by expelling mucus and improving breathing. It also eliminates gas, bloating, abdominal cramps, relieves headaches and nausea and improves circulation and the production of digestive fluids.
  • Lemon oil when included, benefits the respiratory system by improving symptoms associated with catarrh, throat infections and asthma. It is also useful as an antiseptic and antispasmodic.
  • Eucalyptus oil is an ingredient used in decongestants and mouthwashes. Small amounts are used to relieve many respiratory problems including sinusitis, sinus headache, hay fever, colds, and head congestion. It soothes mucous membranes ensuring ease of breathing.
  • Turmeric's active ingredient is curcumin. It is thought to be an anti-inflammatory, as well as an antioxidant. Turmeric oil's aromatherapy properties include relaxing and stimulating, balancing.
  • the amount of each oil or oil combinations to be provided in the compositions of the invention can vary, and can be determined by a person of skill in the art.
  • the composition is a natural composition containing 100% oily components which include the active oil or mixtures of oils, and the carrier oil or mixtures of oils. In other embodiments, however, the composition can comprise less than 100% oil, with the balance being made up by any one or more of the active ingredients and/or additives described herein.
  • the composition can comprise from about 1% to about 99% (wt/wt) oil, from about 10% to about 90% (wt/wt) oil, from about 20% to about 80% (wt/wt) oil, and the like, based on the total weight of the composition.
  • the composition is composed of only natural active ingredients, and is therefore safe and effective for use in the general population.
  • the active ingredient is a local anesthetic.
  • local anesthetic is an anesthetic that causes loss of sensation only to the area to which it is applied.
  • Suitable anesthetics include but are not limited to 2,4 dichlorobenzyl alcohol, benzocaine, benzyl benzoate, bupivacaine, calamine, chloroprocaine, chloroxylenol, cinchocaine, cocaine, dexivacaine, diamocaine, dibucaine, dyclonine, etidocaine, hexylcaine, ketamine, levobupivacaine, lidocaine, menthol, mepivacaine, oxethazaine, phenol, pramoxine, prilocaine, amethocaine, tetracaine, proparacaine, propoxycaine, pyrrocaine, resorcinol, risocaine, rodocaine, ropivacaine, tetracaine, troclosan, and pharmaceutically acceptable derivatives thereof.
  • the local anesthetic is benzocaine.
  • the amount of local anesthetic to be included in the composition can be determined by a person of skill in the art. In one embodiment the local anesthetic is present in an amount of about 0.0001 % to about 50% (w/w), preferably about 0.01% to about 25% (w/w), more preferably about 0.1 % to about 5% (w/w), based on the total weight of the composition.
  • the active ingredient is an antiseptic agent.
  • antiseptic agent refers to an agent that is active against many micro-organisms, including bacteria, yeasts and fungi. It kills the micro-organisms that cause minor infections of the mouth and throat.
  • anesthetics include but are not limited to tyrothricin, amylmetacresol, benzalkinium chloride dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2-methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3- one, and mixtures thereof.
  • the antiseptic agent is selected from the group consisting of tyrotliricin, dequalinium chloride and boric acid.
  • the amount of local antiseptic to be included in the composition can be determined by a person of skill in the art.
  • the antiseptic agent is present in an amount of about 0.0001 % to about 50% (w/w), preferably about 0.01% to about 25% (w/w), more preferably about 0.1% to about 5% (w/w), based on the total weight of the composition.
  • the pharmaceutical composition comprises an oily vehicle which is MediSnoreTM, a commercial preparation including mineral oil (paraffin oil, liquid petrolatum, white mineral oil) glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • the oily vehicle consists of mineral oil (paraffin oil, liquid petrolatum, white mineral oil), glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.
  • the oily vehicle is MediSnoreTM and the active ingredient is selected from an oil and a pharmaceutical compound, selected from a local anesthetic and an antiseptic agent.
  • the composition is effective to treat sore throat overnight.
  • the oily vehicle is MediSnoreTM
  • the active ingredient is an oil selected from the group of oils known to possess calming and/or anti- inflammatory and/or anti-microbial and/or anti-viral actions, including but not limited to turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil.
  • the oily vehicle is MediSnoreTM
  • the active ingredient is selected from an oil, a local anesthetic and an antiseptic agent
  • the pharmaceutical composition further comprises an oil selected from the group of oils known to possess calming and/or anti-inflammatory and/or anti-microbial and/or anti-viral actions, including but not limited to turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil and eucalyptus oil.
  • the oily vehicle is MediSnoreTM and the active ingredient is local anesthetic selected from the group 2,4 dichlorobenzyl alcohol, benzocaine, benzyl benzoate, bupivacaine, calamine, chloroprocaine, chloroxylenol, cinchocaine, cocaine, dexivacaine, diamocaine, dibucaine, dyclonine, etidocaine, hexylcaine, ketamine, levobupivacaine, lidocaine, menthol, mepivacaine, oxethazaine, phenol, pramoxine, prilocaine, amethocaine, tetracaine, proparacaine, propoxycaine, pyrrocaine, resorcinol, risocaine, rodocaine, ropivacaine, tetracaine, troclosan, and mixtures thereof.
  • the active ingredient is local anesthetic selected from the group 2,4
  • the oily vehicle is MediSnoreTM and the active ingredient is an antiseptic agent selected from the group consisting of tyrothricin, amylmetacresol, benzalkinium chloride dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2- methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3-one, and mixtures thereof.
  • an antiseptic agent selected from the group consisting of tyrothricin, amylmetacresol, benzalkinium chloride dequalinium chloride, boric acid, hydrogen peroxide, triclosan, phenoxy isopropanol, chlorhexidine gluconate, povidone iodine, 2- methyl-4-iso-azophosphorus-3-one, 5-chloro-2-methyl-4-iso-azophosphorus-3
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising dequalinium chloride, turmeric oil, clove oil, sage oil, cinnamon oil, tea-tree oil, wintergreen oil, chamomile oil, geranium oil, and olive oil.
  • the composition further comprises at least one magnesium-based compound.
  • Magnesium is important to help retain the various oils on the soft tissue for up to ten hours.
  • magnesium is preferably provided in the form of carrageenan (chondrus crispus).
  • This compound is a plant material obtained from various members of the Gigarthineae of Solieriaceae families of red seaweed, Rodophyceae. It is marketed under various brand names of AquaronTM, GencarinTM, SeaspenTM and ViscarinTM.
  • Another preferred compound is magnesium aluminum silicate, which is a complex silicate refined from naturally occurring minerals. It is marketed under various brand names including Gel WhiteTM, MagnabriteTM and VeegumTM.
  • the magnesium compounds have an encapsulating effect that help retain the oils on the soft tissues in the throat for an extended period of time, preferably throughout the sleep period. If provided, the magnesium-based compound is typically present in an amount of about 0.1% to about 1% by weight, based on the total weight of the composition. Other suitable magnesium compounds are described in U.S. Patent Number 6,187,318, the contents of which are hereby incorporated by reference in their entirety.
  • the composition further comprises at least one agent selected from the group consisting of a tissue-firming agent, a tissue-soothing agent, a tissue lubricant, and a mucous thinning agent or an expectorant.
  • the tissue-firming agent or component can be any agent that can tighten or constrict body tissues.
  • the tissue-firming agent is an astringent or similar compound. If an astringent is used, it is preferably selected from the group comprising alcohol, witch hazel, aluminum potassium sulfate, aluminum sodium sulfate, aluminum sulfate, zinc chloride, acacia tea, tannins, tincture of myrrh, and a combination thereof.
  • the tissue-soothing agent or component can be any agent that can reduce irritation or inflammation of body tissues.
  • tissue- soothing agents include, but are not limited to, essential oils, glycerin, camomile (chamomile) flowers, alpha bisabolol (an extract derived from chamomile flowers), and a combination thereof.
  • the tissue lubricant component is any agent which provides moisture to body tissues, such as a humectant or a similar compound.
  • Preferred humectants include glycerin, sorbitol, inulin, high fructose corn syrup, sucrose, phosphocholinamin, sodium alginate, and a combination thereof.
  • the mucous-thinning or expectorant component includes any agent which thins thickened mucous and causes it to drain through nasopharyngeal passages.
  • Preferred expectorants include essential oils, alcohol, elecampane, cayenne, cineole, and a combination thereof.
  • the tissue-firming agent can be provided in an amount ranging from between about 2.0 wt% to about 15 wt%; the tissue-soothing agent can be provided in an amount ranging from between about 0.1 wt-% to about 15 wt%; the tissue lubricant can be provided in an amount ranging from between about 1.0 wt-% to about 15 wt%; and the thinning agent can be provided in an amount ranging from between about 0.1 wt% to about 15 wt%.
  • tissue-firming agents tissue-soothing agents
  • tissue lubricants tissue lubricants
  • mucous thinning agents or expectorants are further described in PCT International Publication Number WO 03/070178, the contents of which are hereby incorporated by reference in their entirety.
  • the composition further comprises at least one homopolysaccharide.
  • Homopolysaccharides are characterized by having repeating units of only one type of monosaccharide.
  • Examples of the repeating monosaccharide units in preferred homopolysaccharides suitable for use in accordance with the principles of the present invention include, without limitation, glucose, galactose, fructose, xylose, N- acetylglucosamine, etc.
  • a particularly preferred homopolysaccharide is glucan, e.g., beta 1,3/1,6-glucan (beta- glucan) which consists of glucose units. Beta-glucan can be extracted from animal or botanical sources.
  • beta-glucan derived from oats can be used.
  • Oat beta-glucan is available from commercial sources.
  • the homopolysaccharide can be present in the composition of the present invention in an approximate amount of from 0.01% to 50% by weight, more preferably from 0.01% to 25% by weight, and most preferably from 0.01% to 2.5% by weight. Examples of suitable homopolysaccharides are further described in U.S. Patent Number 6,790,465, the contents of which are hereby incorporated by reference in their entirety.
  • the composition further comprises at least one homeopathic agent.
  • the homeopathic agent selected from the group consisting of (i) Belladonna, (ii) Ephedra vulgaris, (iii) Histamine hydrochloride, (iv) Hydrastis canadensis, (v) Potassium dichromate, (vi) Nux vomica and (vii) Teucrim marum. Mixtures of the homeopathic agents are also contemplated, with mixtures containing all seven homeopathic agents being preferred.
  • the homeopathic agent or mixtures thereof is present in an ethanolic solution.
  • the composition can be prepared by combining ethanolic solutions of the aforementioned seven active homeopathic ingredients.
  • Each ingredient is diluted in accordance with conventional homeopathic formulation procedures using an aqueous solution containing 20 vol % of 95 vol % ethanol.
  • Active ingredients (iii) Hyistamine hydrochloride) and (v) (Potassium dichromate) are organic and inorganic chemicals, respectively, and are commercially available in 20 vol % aqueous ethanolic solutions from Boericke & Tafel, Inc. of Santa Rosa, Calif.
  • the remainder of the active ingredients are all derived from plants as follows: (i) Belladonna—an alkaloid extracted from the entire plant from roots to flower of Deadly Nightshade plant, commercially available in 20 vol % aqueous ethanolic solutions from Boericke & Tafel; (ii) Ephedra vulgaris ⁇ a decongestant extracted from the stems and branches of the Ma huang or While tea plant, commercially available in 20 vol % aqueous ethanolic solutions from Boericke & Tafel; (iv) Hydrastis canadensis ⁇ the active ingredient comprises three isoquinoline alkaloids extracted from the air-dried rhizome and roots of the herb Golden seal, commercially available in 20 vol % aqueous ethanolic solutions from Boericke & Tafel; (vi) Nux vomica ⁇ the active ingredient extracted from coarsely powdered seeds of the Poison nut or Quaker buttons plant, commercially available in 20 vol % aqueous ethanolic solutions from Bo
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising turmeric oil, lemon oil, sage oil, mineral oil, glycerin, canola oil, chamomile oil, olive oil, spearmint oil, and sesame oil.
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising boric acid as an antiseptic, turmeric oil, clove oil, thymol oil, mineral oil, glycerin, canola oil, olive oil, spearmint oil, and sesame oil.
  • the present invention provides a pharmaceutical composition for treating sore throat, the pharmaceutical composition comprising benzocaine as an anesthetic, tyrothricin as an antiseptic, mineral oil, glycerin, canola oil, almond oil, olive oil, spearmint oil, and sesame oil.
  • the composition is administered to a subject in the need thereof before retiring for sleep, which can be at night or during any portion of the day.
  • the composition is applied to the soft tissues of the back of the mouth and the throat, in particular to the soft palate at the rear of the mouth, to the uvula, the back of the tongue and the upper part of the pharynx.
  • the composition is preferably applied by spray to coat those tissues, after which the user goes to sleep without disturbing the coating by eating, drinking or smoking.
  • the composition provides relief from sore throat for a period of at least about 2 hours after administration, preferably for the entire duration of sleep.
  • the composition is administered in the form selected from the group consisting of a liquid, squirted liquid spray, liquid medicine administered in drops, aerosol, mouthwash lozenge, syrup, gel, foam, and mousse.
  • compositions are administered in the form of a throat spray.
  • composition is administered via a metered dose device.
  • a metered dose device comprises the composition.
  • a second aspect of the present invention is a method for treating soothing or reducing the severity of a sore throat during sleep the method comprising administering an effective amount of the anti sore throat composition of the present invention to an individual in need thereof.
  • the method encompasses use of a pharmaceutically acceptable composition in which each active ingredient is present in an amount substantially between about 0.0001 % to about 50% (w/w), preferably about 0.01% to about 25% (w/w), more preferably about 0.1% to about 5% (w/w), based on the total weight of the composition.
  • a third aspect of the invention is the use of the pharmaceutical composition of the present invention for the preparation of a medicament for treating, soothing or reducing the severity of a sore throat during sleep by administering to a subject in need thereof the composition comprising an active ingredient in an amount effective to treat, sooth or reduce the severity of a sore throat, and a carrier comprising at least one oil as describe above.
  • a "pharmaceutical composition” refers to a preparation of one or more of the compounds described herein, with other chemical components such as physiologically suitable carriers and excipients.
  • the purpose of a pharmaceutical composition is to facilitate administration of a compound to an organism.
  • compositions suitable for use in context of the present invention include compositions wherein the active ingredients are contained in an amount effective to achieve the intended purpose, i.e., treatment of sore throat. More specifically, a therapeutically effective amount means an amount of a compound effective to prevent, alleviate or ameliorate symptoms of throat soreness of the subject being treated.
  • active ingredient As used herein, the terms “active ingredient”, “active agent” or “agent”, are all broadly used to mean any chemical or material that is desired to be applied, administered or used to treat sore throats and can include, by way of illustration and not limitation any pharmacologic agents and drugs, including active oils, local anesthetic agents and antiseptic agents.
  • composition may be formulated into a wide variety of administration forms such as liquid, liquid medicine administered in drops, mouthwash lozenge, syrup gel, orally disintegrating tablets and capsules and chewing gum, foam or mousse
  • the currently preferred form is throat spray, as this form is most effective at quick adsorption into the bloodstream through the mucous membranes of the mouth and throat passageways.
  • inventive composition may be administered in any form and in any manner so long as the active ingredient makes contact with the back of the mouth and results in either reduction or substantial diminution of a sore throat through prolonged moisturization of the contact area.
  • Solid dosage forms can be prepared by methods which are well known in the art and may contain other ingredients known in such dosage forms such as acidity regulators, opaciflers, stabilizing agents, buffering agents, flavorings, sweeteners, coloring agents, and preservatives. Any additional ingredient that is added should not react with any other component of the pharmaceutical compositions of the present invention. If such interactions are possible the components concerned should be kept separate for example by encapsulating one or both of the possibly reacting components, by including one of the components in a coating applied to the lozenge after manufacture or by having the components in different layers of a multilayer product.
  • the solid dosage form may be a lozenge that is intended to be sucked by the patient or a masticable or suckable tablet, capsule, pastille or gum, for example chewing gum.
  • the term "lozenge” as used herein is intended to embrace all dosage forms where the product is formed by cooling a sugar-based or sugar alcohol based (e.g. isomalt) molten mass containing the active material.
  • the term "tablet” as used herein is intended to embrace unit dosage forms made from compressed powders or granules or compressed pastes.
  • Liquid and spray formulations can be prepared by dissolving or suspending the active ingredients in a liquid medium which may also contain other ingredients such as stabilizing agents, buffering agents, flavorings, sweeteners, coloring agents, and preservatives.
  • the formulation can then be packaged into an appropriate container.
  • a throat spray can be prepared by dissolving water-soluble components in water and non-water soluble ingredients in a co-solvent (e.g. alcohol).
  • the two phases are then mixed and the resulting mixture filtered and placed into dispensing containers.
  • the sprays can advantageously be fitted with a metered, manually operated spray mechanism or the dispenser can contain a pressurized propellant and be fitted with a suitable dispensing valve.
  • the composition is formulated for application via a metered dose device, e.g., a pressurized metered dose device.
  • a metered dose device e.g., a pressurized metered dose device.
  • Ingestion of the remainder of the liquid composition then means that the unabsorbed active ingredient can be absorbed in to the blood stream to provide systemic relief in addition to the relief that comes from the topical application of the active ingredient to the mucous membrane of the throat.
  • compositions of the present invention will, of course, vary depending upon several factors. In most cases, an individual in need of treatment or a physician or pharmacist can readily determine the effective amount of the inventive composition required to prevent, counter or arrest the progress of the condition.
  • ingredients such as flavor, appearance or fragrance enhancing agents
  • the components of the composition can be selected to impart a desirable flavor or fragrance to the composition.
  • Other ingredients such as preservatives, emulsifiers, stabilizers, and the like may be included in the composition of the present invention to enhance shelf life or use of the composition.
  • a throat spray composition is prepared using the following examples:
  • Example 1 Table 1 below shows a preferred formulation of the present invention. Table 1;
  • Example 2 shows another preferred formulation of the present invention Table 2:
  • Example 3 Table 3 shows another preferred formulation of the present invention
  • Example 4 shows another preferred formulation of the present invention Table 4:

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Abstract

La présente invention concerne un procédé destiné à traiter, calmer ou réduire la sévérité d'un mal de gorge ou d'autres irritations de la gorge pendant une durée prolongée, spécialement pendant le sommeil, par l'administration d'une composition pharmaceutique à l'arrière de la gorge. La composition comprend un véhicule huileux qui crée un enrobage huileux sur la gorge d'un sujet et une matière active dans une quantité efficace pour traiter, calmer ou réduire la sévérité d'un mal de gorge. La composition est administrée de préférence sous la forme d'une pulvérisation pour la gorge et elle soulage le mal de gorge pendant une durée prolongée, de préférence pendant toute la nuit.
PCT/IL2007/000412 2006-03-29 2007-03-29 Procedes et composition pour le traitement des maux de gorge Ceased WO2007110871A2 (fr)

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EP07736152A EP2015761A4 (fr) 2006-03-29 2007-03-29 Procedes et composition pour le traitement des maux de gorge

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WO2014053263A1 (fr) * 2012-10-04 2014-04-10 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pharmaceutique pour le traitement de l'enrouement ou de maux de gorge
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KR20100086998A (ko) * 2007-10-19 2010-08-02 레킷트 벵키저 헬스케어(유케이)리미티드 냉각제를 포함하는 경구용 조성물
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WO2009050490A1 (fr) * 2007-10-19 2009-04-23 Reckitt Benckiser Healthcare (Uk) Limited Composition orale comprenant un agent rafraîchissant
EP3093010A1 (fr) * 2007-10-19 2016-11-16 Reckitt Benckiser Healthcare (UK) Limited Composition orale comprenant un agent rafraîchissant
KR101580139B1 (ko) * 2007-10-19 2015-12-28 레킷트 벵키저 헬스케어(유케이)리미티드 냉각제를 포함하는 경구용 조성물
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EP2570123A1 (fr) * 2007-11-15 2013-03-20 Reckitt Benckiser Healthcare (UK) Limited Utilisation de l'alcool 2,4-dichlorobenzylique ayant un effet anesthésique
AU2008322739C1 (en) * 2007-11-15 2018-08-30 Reckitt Benckiser Healthcare (Uk) Limited Use of anti-bacterial compounds having an anaesthetic effect
WO2009063223A1 (fr) * 2007-11-15 2009-05-22 Reckitt Benckiser Healthcare (Uk) Limited Utilisation de composés antibactériens ayant un effet anesthésique
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EP3173069A1 (fr) 2011-04-29 2017-05-31 Moberg Pharma AB Compositions pharmaceutiques comprenant un anesthésique local comme la bupivacaïne pour l'administration locale dans la bouche ou la gorge
US9956211B2 (en) 2011-04-29 2018-05-01 Moberg Pharma Ab Pharmaceutical compositions comprising a local anaesthetic such as bupivacaine for local administration to the mouth or throat
WO2012146763A1 (fr) 2011-04-29 2012-11-01 Oracain Ii Aps Compositions pharmaceutiques comprenant un anesthésiant local tel que de la bupivacaïne pour administration dans la bouche ou la gorge
WO2014053263A1 (fr) * 2012-10-04 2014-04-10 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pharmaceutique pour le traitement de l'enrouement ou de maux de gorge
WO2016108233A1 (fr) * 2014-12-30 2016-07-07 Erez Zabari Formulation topique pour le traitement cosmétique de la peau et des cheveux
GB2541490A (en) * 2015-04-29 2017-02-22 Liam O'brien Sean Odontalgic preperation
GB2541490B (en) * 2015-04-29 2019-09-25 Sean Liam Obrien Odontalgic preparation
US10888620B2 (en) 2016-11-28 2021-01-12 Johnson & Johnson Consumer Inc. Liquid compositions for treating cough or cold symptoms
US11911478B2 (en) 2016-11-28 2024-02-27 Johnson & Johnson Consumer Inc. Liquid compositions
WO2018098470A1 (fr) 2016-11-28 2018-05-31 Johnson & Johnson Consumer Inc. Compositions liquides comprenant un agent mucoadhésif
BE1028842B1 (fr) * 2020-12-02 2022-07-05 Orionis Composition d'huiles essentielles
WO2023129120A3 (fr) * 2021-12-30 2023-08-17 Bezmi̇alem Vakif Üni̇versi̇tesi̇ Composition à base d'herbes à effet antiviral et son procédé de production
CN116531328A (zh) * 2023-05-11 2023-08-04 湖北凤凰白云山药业有限公司 一种聚维酮碘菊花喷雾剂的制备方法

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EP2015761A2 (fr) 2009-01-21
WO2007110871A3 (fr) 2007-12-06

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