WO2007110871A2

WO2007110871A2 - Methods and composition for treating sore throat

Info

Publication number: WO2007110871A2
Application number: PCT/IL2007/000412
Authority: WO
Inventors: Eran Eilat; Nitsan Primor
Original assignee: Naveh Pharma (1996) Ltd.
Priority date: 2006-03-29
Filing date: 2007-03-29
Publication date: 2007-10-04
Also published as: EP2015761A2; EP2015761A4; WO2007110871A3

Abstract

The present invention relates to a method for treating, soothing or reducing the severity of a sore throat or other irritations of the throat for an extended period of time, especially during sleep, by administering a pharmaceutical composition into the back of the throat. The composition comprises an oily vehicle that 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 a sore throat. The composition is preferably administered in the form of a throat spray, and provides relief from sore throat for an extended period of time, preferably overnight.

Description

METHODS AND COMPOSITION FOR TREATING SORE THROAT

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION

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. Some are simply caused by irritants in our environment or by the use of our voice. During cold weather, the dry heat indoors can cause a sore throat, especially in the morning. Also, being around smoke, drinking alcoholic beverages and eating spicy foods can cause a sore throat. Straining or misusing your voice (as in yelling at a ball game) can also cause a sore throat. Soreness is typically most pronounced after sleep and may even cause sleep apnea.

Symptoms generally improve as the day progresses. 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.

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.

Throat 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.

Prichard (Prichard A. J., The Use of Essential Oils to Treat Snoring. Phytother Res. 2004; 18(9):696-9) teaches the use of essential oils to reduce snoring in individuals. MediSnore™ 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. Other compositions for treating snoring are described in several patents and patent applications. 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 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.

There remains a need for 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.

SUMMARY OF THE INVENTION

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. In addition, 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.

Without wishing to be bound by any particular theory or mechanism of action, 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. Furthermore, 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.

In one embodiment, 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.

In another currently preferred embodiment the pharmaceutical composition comprises an oily vehicle which is MediSnore™, 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.

In another embodiment, 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. In one embodiment, 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 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, Siberian fir oil, silver fir oil, tonka bean oil, vetivere oil, violet leaf oil, walnut oil, wheat germ oil, yarrow oil, ylang-ylang oil and mixtures thereof.

In one embodiment, 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. In one embodiment, the composition is composed of only natural active ingredients.

In another embodiment 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. In another embodiment the local anesthetic is present in an amount of about 0.1 % to about 5% (w/w). In a currently preferred embodiment the local anesthetic is benzocaine. In another embodiment 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. In a currently preferred embodiment 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). In a preferred embodiment the pharmaceutical composition comprises an oily vehicle which is MediSnore™, and an active ingredient which is selected from an oil, a local anesthetic and an antiseptic agent, effective to treat sore throat, preferably overnight.

In another preferred embodiment, the oily vehicle is MediSnore™, and 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.

In another preferred embodiment, the pharmaceutical composition comprises an oily vehicle which is MediSnore™, 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. In another preferred embodiment the oily vehicle is MediSnore™ 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.

In another preferred embodiment the oily vehicle is MediSnore™ 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.

In one embodiment, 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.

In another embodiment, 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. Examples of 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.

In another embodiment, 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").

In yet another embodiment, the compositions of the present invention further comprise at least one homeopathic agent. Preferably, 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.

In a currently preferred embodiment, 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. In another currently preferred embodiment, 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.

In another currently preferred embodiment, 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.

In another currently preferred embodiment, 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.

In one embodiment, the composition is administered to the subject prior to sleep. In another embodiment, the composition provides relief from sore throat for a period of at least about 2 hours after administration. In a preferred embodiment the composition provides overnight relief from sore throat. In one embodiment 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.

In a currently preferred embodiment, the composition is administered in the form of a throat spray. In another currently preferred embodiment, the composition is administered via a metered dose device. In another embodiment, 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. In one embodiment the composition provides overnight relief from a sore throat. In another embodiment the composition is in the form of a throat spray. Further embodiments and the full scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

DETAILED DESCRIPTION OF THE INVENTION

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. In addition, 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. As used herein, the term "soothing" means calming or placating.

As used herein, the term "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. In addition, 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, frankincense arabian oil, galbanum oil, geranium oil, ginger oil, glycerin, grapefruit oil, green pepper oil, himalayan fir oil, ho-leaf oil, hyssop oil, immortelle oil, iris oil, jasmine oil, juniper oil, jojoba oil, lavender oil, lavandin oil, lemon oil, lemon grass oil, lime oil, linaloe wood oil, litsea oil, marjoram oil, malaleuca oil, mandarine oil, manuka oil, melissa oil, menthol, mimosa oil, mint oil, mountain pine oil, musk mallow oil, myrrh oil, neroli oil, nettle oil, niauli oil, oak moss oil, olive oil, orange oil, oregano oil, oud oil, palmarosa oil, patchouli oil, peppermint oil, peru myrtle oil, petit grain oil, pine needle oil, ravintsara oil, rock rose oil, rosa alba oil, rosemary oil, rosewood oil, sage oil, sandalwood oil, sesame oil, Siberian fir oil, silver fir oil, soybean oil, spearmint oil, tea-tree oil, thyme oil, tonka bean oil, turmeric oil, vanilla oil, vetivere oil, violet leaf oil, walnut oil, wheat germ oil, wintergreen oil, yarrow oil, ylang-ylang oil and mixtures thereof.

In one embodiment, 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, Siberian fir oil, silver fir oil, tonka bean oil, vetivere oil, violet leaf oil, walnut oil, wheat germ oil, yarrow oil, ylang-ylang oil and mixtures thereof. In a currently preferred embodiment 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.

B) 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.

C) 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.

D) 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. In one embodiment, 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. For example, 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.

In one embodiment, the composition is composed of only natural active ingredients, and is therefore safe and effective for use in the general population. In another embodiment the active ingredient is a local anesthetic. As used herein, the term "local anesthetic" is an anesthetic that causes loss of sensation only to the area to which it is applied. Examples of 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. In a currently preferred embodiment 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.

In another embodiment the active ingredient is an antiseptic agent. As used herein, the term "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. Examples of suitable 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. In a currently preferred embodiment 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. In one embodiment 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. In a preferred embodiment the pharmaceutical composition comprises an oily vehicle which is MediSnore™, 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. In another embodiment, 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.

In another currently preferred embodiment, the oily vehicle is MediSnore™ and the active ingredient is selected from an oil and a pharmaceutical compound, selected from a local anesthetic and an antiseptic agent. Preferably, the composition is effective to treat sore throat overnight.

In another preferred embodiment, the oily vehicle is MediSnore™, and 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.

In another preferred embodiment, the oily vehicle is MediSnore™, the active ingredient is selected from an oil, a local anesthetic and an antiseptic agent, and 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. In another preferred embodiment the oily vehicle is MediSnore™ 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. In another preferred embodiment the oily vehicle is MediSnore™ 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. In a currently preferred embodiment 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.

In one embodiment, 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. In the present invention 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 Aquaron™, Gencarin™, Seaspen™ and Viscarin™. 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 White™, Magnabrite™ and Veegum™. 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.

In another embodiment, 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. Preferably, 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. Examples of 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 amounts of the aforementioned optional agents can vary, with representative examples being provided below for the purpose of illustration and not for limitation. For example, 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%. Other examples of suitable tissue-firming agents, tissue-soothing agents, tissue lubricants, and 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.

In another embodiment, 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. Alternatively, beta-glucan derived from oats ("oat beta-glucan") can be used. Oat beta-glucan is available from commercial sources. If provided, 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.

In yet another embodiment, the composition further comprises at least one homeopathic agent. In one embodiment, 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. In one embodiment, the homeopathic agent or mixtures thereof is present in an ethanolic solution. For example, 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) (Histamine 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 Mormon 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 Boericke & Tafel; and (vii) Teucrim marum~the active ingredient extracted from the entire plant Cat thyme, commercially available in 20 vol % aqueous ethanolic solutions from Boericke & Tafel. These homeopathic agents are further described in U.S.

Patent Number 6,491,954, the contents of which are hereby incorporated by reference in their entirety. In a currently preferred embodiment 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.

In another currently preferred embodiment 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.

In another currently preferred embodiment 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.

In another embodiment 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. In one embodiment 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.

In a currently preferred embodiment the composition is administered in the form of a throat spray. In another currently preferred embodiment the composition is administered via a metered dose device. In another embodiment, 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.

As used herein 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.

Pharmaceutical 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.

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.

While the 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. It is also understood that the 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. For example, 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. In one preferred embodiment, the composition is formulated for application via a metered dose device, e.g., a pressurized metered dose device. Sprays that are administered so that the liquid composition is brought into contact with the mucus membrane of the throat so that some of the active components of the composition are absorbed thereby providing topical relief from sore throat. 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.

The dosage regimen for the 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.

In another embodiment, other ingredients, such as flavor, appearance or fragrance enhancing agents, can optionally be used as long as they do not interfere with the operation of the composition on the oral tissues. In some cases, such as with essential oils, 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.

The present invention will be further illustrated in the following, non-limiting examples. The examples are illustrative only and do not limit the claimed invention regarding the materials, conditions, process parameters and the like recited herein.

EXAMPLES

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: Table 2 shows another preferred formulation of the present invention Table 2:

Example 3: Table 3 shows another preferred formulation of the present invention

Table 3:

Example 4: Table 4 shows another preferred formulation of the present invention Table 4:

While the present invention has been particularly described, persons skilled in the art will appreciate that many variations and modifications can be made. Therefore, the invention is not to be construed as restricted to the particularly described embodiments, rather the scope, spirit and concept of the invention will be more readily understood by reference to the claims which follow.

Claims

What is claimed is:

1. 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.

2. The composition according to claim 1, wherein the active ingredient is an oil, said oil selected from the group consisting of 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, Siberian fir oil, silver fir oil, tonka bean oil, vetivere oil, violet leaf oil, walnut oil, wheat germ oil, yarrow oil, ylang-ylang oil and mixtures thereof.

3. The composition according to claim 1 or 2, wherein the oily vehicle is selected from the group consisting of mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil, eucalyptus oil and mixtures thereof.

4. The composition according to claim 1 or 2, wherein 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.

5. The composition according to claim 4, wherein the local anesthetic is present in an amount of about 0.1 % to about 5% (w/w).

6. The composition according to claim 4, wherein the local anesthetic is benzocaine.

7. The composition according to claim 1 or 2, wherein 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.

8. The composition according to claim 7, wherein the antiseptic agent is present in an amount of about 0.1% to about 5% (w/w).

9. The composition according to claim 7, wherein the antiseptic agent is selected from the group consisting of tyrothricin, dequalinium chloride and boric acid.

10. The composition according to claim 1 or 2, wherein the oily vehicle comprises mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.

11. The composition according to claim 10, wherein 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.

12. The composition according to claim 11, further comprising an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof.

13. The composition according to claim 10, wherein 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.

14. The composition according to claim 13, further comprising an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof.

15. The composition according to claim 1 or 2, further comprising a magnesium-based compound effective to maintain the composition on the throat of the subject.

16. The composition according to claim 15, wherein the magnesium based compound is selected from the group consisting of carrageenan, magnesium aluminum silicate, and mixtures thereof.

17. The composition according to claim 1 or 2, further comprising at least one agent selected from the group consisting of a tissue-firming agent, a tissue-soothing agent, a lubricant, and an expectorant.

18. The composition according to claim 17, wherein the tissue-firming agent is an astringent.

19. The composition according to claim 18, wherein the astringent is 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 any combination thereof.

20. The composition according to claim 17, wherein the tissue-soothing agent is selected from the group comprising essential oils, glycerin, chamomile flowers, alpha bisabolol, and any combination thereof.

21. The composition according to claim 17, wherein the lubricant is selected from the group comprising glycerin, sorbitol, high fructose corn syrup, inulin, sucrose, phosphocholinamin, sodium alginate, and any combination thereof.

22. The composition according to claim 17, wherein the expectorant is selected from the group comprising essential oils, alcohol, elecampane, cayenne, cineole, and any combination thereof.

23. The composition according to claim 1 or 2, further comprising at least one homopoly saccharide .

24. The composition according to claim 23, wherein the homopolysaccharide is beta- glucan.

25. The composition according to claim 1 or 2, further comprising at least one homeopathic agent.

26. The composition according to claim 25, wherein 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.

27. The composition according to claim 1, comprising dequalinium chloride, turmeric oil, clove oil, sage oil, cinnamon oil, tea-tree oil, wintergreen oil, chamomile oil, geranium oil, and olive oil.

28. The composition according to claim 1, comprising turmeric oil, lemon oil, sage oil, mineral oil, glycerin, canola oil, chamomile oil, olive oil, spearmint oil, and sesame oil.

29. The composition according to claim 1, comprising boric acid, turmeric oil, clove oil, thymol oil, mineral oil, glycerin, canola oil, olive oil, spearmint oil, and sesame oil.

30. The composition according to claim 1, comprising benzocaine, tyrothricin, mineral oil, glycerin, canola oil, almond oil, olive oil, spearmint oil, and sesame oil.

31. The composition according to claim 1, wherein the composition is in the form of a liquid, an oil, a spray, drops, aerosol, mouth wash, lozenge, syrup, foam, mousse and a gel.

32. The composition according to claim 1, wherein the composition is in the form of a throat spray.

33. A metered dose device comprising the composition according to claim 1.

34. A 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 the subject a pharmaceutical composition according to claim 1 or 2, in an amount effective to treat, sooth or reduce the severity of sore throat.

35. The method according to claim 34, wherein the oily vehicle in said pharmaceutical composition is selected from the group consisting of mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and mixtures thereof

36. The method according to claim 34, wherein the composition is administered to the subject prior to sleep.

37. The method according to claim 36, wherein the composition provides overnight relief from sore throat.

38. The method according to claim 34, wherein the composition is in the form a throat spray.

39. The method according to claim 34, wherein the composition is administered via a metered dose device.

40. The method according to claim 34, wherein the active ingredient in said pharmaceutical composition 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.

41. The method according to claim 40, wherein the local anesthetic is present in an amount of about 0.1 % to about 5% (w/w).

42. The method according to claim 40, wherein the local anesthetic is benzocaine.

43. The method according to claim 34, wherein the active ingredient in said pharmaceutical composition 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.

44. The method according to claim 43, wherein the antiseptic agent is present in an amount of about 0.1% to about 5% (w/w).

45. The method according to claim 43, wherein the antiseptic agent is selected from the group consisting of tyrothricin, dequalinium chloride and boric acid.

46. The method according to claim 34, wherein the oily vehicle in said pharmaceutical composition comprises mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.

47. The method according to claim 46, wherein the active ingredient in said pharmaceutical composition 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.

48. The method according to claim 47, wherein the pharmaceutical composition further comprises an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof.

49. The method according to claim 46, wherein the active ingredient in said pharmaceutical composition 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.

50. The method according to claim 49, wherein the pharmaceutical composition further comprises an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof

51. Use of a pharmaceutical composition according to claim 1 or 2 for the preparation of a medicament for treating, soothing or reducing the severity of a sore throat.

52. Use according to claim 51, wherein the oily vehicle in said pharmaceutical composition is selected from the group consisting of mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil, eucalyptus oil and mixtures thereof.

53. Use according to claim 51, wherein the composition is administered to the subject prior to sleep.

54. Use according to claim 51, wherein the composition provides overnight relief from sore throat.

55. Use according to claim 51, wherein the composition is in the form a throat spray.

56. Use according to claim 51, wherein the composition is administered via a metered dose device.

57. Use according to claim 51, wherein the active ingredient in said pharmaceutical composition 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.

58. Use according to claim 57, wherein the local anesthetic is present in an amount of about 0.1 % to about 5% (w/w).

59. Use according to claim 57, wherein the local anesthetic is benzocaine.

60. Use according to claim 51, wherein the active ingredient in said pharmaceutical composition 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.

61. Use according to claim 60, wherein the antiseptic agent is present in an amount of about 0.1% to about 5% (w/w).

62. Use according to claim 60, wherein the antiseptic agent is selected from the group consisting of tyrothricin, dequalinium chloride and boric acid.

63. Use according to claim 51, wherein the oily vehicle in said pharmaceutical composition comprises mineral oil, glycerin, canola oil, olive oil, sesame oil, almond oil, spearmint oil and eucalyptus oil.

64. Use according to claim 63, wherein the active ingredient in said pharmaceutical composition 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.

65. Use according to claim 64, wherein the pharmaceutical composition further comprises an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof.

66. Use according to claim 63, wherein the active ingredient in said pharmaceutical composition 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.

67. Use according to claim 66, wherein the pharmaceutical composition further comprises an oil selected from the group consisting of turmeric oil, chamomile oil, sage oil, thymol oil, clove oil, lemon oil, peppermint oil, eucalyptus oil, and mixtures thereof.