MX2007014106A - Saccharide foamable compositions - Google Patents

Abstract

A foamable composition, containing a saccharide for use in the treatment of various disorders including:water, a saccharide, about 0.2%to about 5%by weight of a surface- active agent, about 0.01%to about 5%by weight of at least one polymeric agent selected from a bio-adhesive agent, a gelling agent, a film forming agent and a phase change agent, and a liquefied or compressed gas propellant at a concentration of about 3%to about 25%by weight of the total composition.

Description

FOAMISH COMPOSITIONS OF SACRED BACKGROUND OF THE INVENTION This invention relates to foamable cosmetic and pharmaceutical compositions. Topical external administration is an important route for the administration of drugs in the treatment of diseases. Many groups of drugs, including, for example, antibiotics, antifungals, antiinflammatories, anesthetics, analgesics, antiallergics, corticosteroids, retinoids and antiproliferative drugs are generally administered in semisolid preparations. Although semi-solid compositions, such as creams and ointments are commonly used by consumers, new forms are desirable to achieve better control of the application, while maintaining or improving the beneficial properties to the skin of those products. There are still unmet needs for improved, easy-to-use, stable and non-irritating foamed formulations that are intended to treat dermal and mucosal tissues with unique therapeutic properties.

SUMMARY OF THE INVENTION The present invention is directed to provide an external topical administration tool. According to the present invention, a foamable saccharide composition is provided which includes: (i) water, (ii) a saccharide, (iii) from about 0.2% to about 5% by weight of a surfactant, (iv) about 0.1% to about 5% by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film-forming agent and a phase-change agent and (v) a gaseous propellant liquefied or compressed in a concentration from about 3% to about 25% by weight of the total composition. According to further embodiments of the present invention, the saccharide is selected from the group consisting of a saccharide, a monosaccharide, a disaccharide, an oligosaccharide and a sugar alcohol, and mixtures of natural saccharides, such as honey. According to still further embodiments of the present invention, the saccharide composition further includes a foam adjuvant, selected from the group of a long chain fatty alcohol and a long chain fatty acid. According to yet another embodiment of the present invention, the saccharide composition further includes a hydrophobic solvent. According to a further embodiment of the present invention, the composition is in the form of a water-in-oil emulsion; and wherein the HLB of the surfactant is between about 9 and about 14. According to a further embodiment of the present invention, the saccharide composition further includes at least one component, selected from the group consisting of a keratolytic agent, and a polar solvent. According to an even more embodiment of the present invention, the saccharide composition further contains at least one active agent, selected from the group of: an active herbal extract, an acaricide, an age spots removing agent and keratosis, an allergen , an analgesic agent, a local anesthetic, an anti-acne agent, an anti-allergic agent, an anti-aging agent, an antibacterial agent, an antibiotic agent, an anti-scald agent, an anti-cancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an agent antiedemic, an antihistamine, an antihyperkeratolytic agent, an anti-inflammatory agent, an anti-irritant, an anti-lipemic agent, an antimicrobial agent, an antifungal agent, an antiproliferative agent, an anti-oxidant, an anti-wrinkle agent, an antipruritic agent, an anti-psoriatic agent, an antiparasitic agent , an antiseborrhoeic agent, an antiseptic, an anti-inflammatory agent, an antiviral agent, an age Anti-lavender, an astringent, a topical cardiovascular agent, a chemotherapeutic agent, a corticosteroid, a dicarboxylic acid, a disinfectant, a fungicide, a hair growth regulator, hormone, a hydroxy acid, an immunosuppressant, an immunoregulatory agent, an insecticide, an insect repellent, a keratolytic agent, a lactam, a metal, a metal oxides, a mitocid, a neuropeptide, a non-steroidal anti-inflammatory agent, an agent oxidant, a pediculicide, a photodynamic therapy agent, a retinoid, a healing agent, scabicide, a self-tanning agent, a skin bleaching agent, a vasoconstrictor, a vasodilator, a vitamin, a vitamin D derivative, a wound healing agent and a wart remover. According to yet another embodiment of the present invention, the saccharide composition is hygroscopic. According to an even further embodiment of the present invention, the concentration of saccharide is adjusted to provide a value of Aw of the foamable composition selected from the ranges of (1) about 0.8 and about 0.9.; (2) about 0.7 and about 0.8; and (3) less than about 0.7. According to further embodiments of the present invention, the hygroscopic pharmaceutical composition further includes a therapeutically effective concentration of an anti-infective agent. According to still further embodiments of the present invention, the anti-infective agent, selected from a group of an antibiotic agent, an antibacterial agent, an antifungal agent, an agent controlling yeast, an antiviral agent and an antiparasitic agent. According to still further embodiments of the present invention, the antibiotic agent is selected from the group consisting of a beta-lactam antibiotic, an aminoglycoside, an ampho-type antibiotic, an anthraquinone, an azole, metronidazole, an antibiotic glycopeptide, a macrolide , erythromycin, clindamycin, an antibiotic nucleoside, an antibiotic peptide, polymyxin B, an antibiotic polyene, an antibiotic polyether, an antibiotic quinolone, an antibiotic steroid, fucidic acid, mupirocin, chloramphenicol, a sulfonamide, tetracycline, an antibiotic metal, silver, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium, and an oxidizing agent, iodine, iodate, a periodate, a hypochlorite, a permanganate, a substance that releases free radicals and / or active oxygen, a cationic antimicrobial agent , a quaternary ammonium compound, biguanide, chlorhexidine, a triguanide, a bisbiguanide, a polymeric bisguanide, an antibiotic compound tural and analogs, derivatives, salts, ions and complexes thereof. According to still further embodiments of the present invention, the antifungal agent is useful in the treatment of an infection of dermatophytosis, microsporum, trichophyton and infections by epidermophyton, candidiasis, oral candidiasis (twig), yeast and candida. According to still further embodiments of the present invention, the antifungal agent is selected from the group consisting of polyene, natamycin, nystatin; an arylamine, naftifine, terbinafine; an imidazole, bifonazole, clotrimazole, econazole, fenticonazole, ketoconazole, miconazole, oxiconazole; a diazole, triazoles, fluconazole, itraconazole, terconazole, tolnaftate, cyclopirox, undecylenic acid, sulbentin, griseofulvin, amphotericin B, flucytosine (5FC), morpholine compounds, amorolfine, and the related morpholines and the like, derivatives and salts thereof, and any combination thereof at a therapeutically effective concentration. According to a second embodiment of the present invention, there is provided a method of treating a skin disorder, a body surface, a body cavity or mucosal surface, the nasal cavity, the mouth, the eyes, the optic canal, the vagina and rectum, which consists of administering the saccharide compositions to a target treatment site.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a foamable composition, which contains a saccharide for use in the treatment of various disorders. According to one or more embodiments of the present invention, the foamable saccharide composition includes: a. an aqueous solution of saccharide; b. from about 0.2% to about 5% by weight of a surfactant; c. from about 0.01% to about 5% by weight of at least one polymeric agent; and d. a propellant of liquefied or compressed gas at a concentration of about 3% to about 25% by weight of the total composition. All% values were provided on a weight basis (w / w). Water and optional ingredients were added to complete the total mass up to 100%. Upon release of an aerosol container, the foamable composition forms a liquefied expanded foam for the treatment of an infected surface and for topical administration to the skin, a body surface, a body cavity or a mucosal surface.

Saccharide Saccharides vary from simple sugars containing three to seven carbon atoms to very complex polymers. Exemplary saccharides include but are not limited to monosaccharides, disaccharides, oligosaccharides and sugar alcohols, which possess hygroscopic properties. A monosaccharide is a simple sugar that can not be hydrolyzed to smaller units. The empirical formula is (CH20) n in a range in size of triose (n = 3) to heptoses (n = 7). Exemplary monosaccharide compounds are ribose, glucose, fructose and galactose. The disaccharides are made up of two monosaccharides joined together, such as sucrose, maltose and lactose. A sugar alcohol (also known as a polyol, polyhydric alcohol, or polyalcohol) is a hydrogenated form of a saccharide, whose carbonyl group (aldehyde or ketone, reducing sugar) has been reduced to a primary or secondary hydroxyl group. They are commonly used to replace sucrose in food products, often in combination with high-intensity artificial sweeteners to counteract low sweetness. Some exemplary sugar alcohols which are suitable for use according to the present invention are mannitol, sorbitol, xylitol, maltitol, lactitol. (Maltitol and lactitol are not completely hydrogenated compounds and they are a monosaccharide combined with a polyhydric alcohol). In one embodiment of the present invention, the concentration of a saccharide in the foamable composition of the present invention is between about 20% and about 80%. In certain embodiments, the concentration of the saccharide is between about 50% and about 80%. An exemplary saccharide solution, suitable according to the present invention, contains 70% sorbitol in water. Another example is honey, which is composed mainly of sugars and water. The average honey contains about 80% saccharides and about 17% water, and the primary saccharides are fructose and glucose.

Polymeric Agen-B The composition of the present invention contains a polymeric agent. It has been documented that the presence of a polymeric agent is desirable for the creation of foam, which has a fine bubble structure, which does not easily collapse upon release of the pressurized aerosol can. The polymeric agent serves to stabilize the foam composition and to control the residence of the drug in a target organ. Preferably, the polymeric agent is selected from the group consisting of a bioadhesive agent, a gelling agent, a film-forming agent and a phase-change agent. Exemplary polymeric agents include, in a non-limiting form, natural polymeric materials, such as robin gum, sodium alginate, sodium caseinate, egg albumin, gelatin agar, carrageenan gum, sodium alginate, xanthan gum, extract of quince seed, tragacanth gum, guar gum, cationic guames, hydroxypropyl guar gum, starch, polymers containing amine such as chitosan, acid polymers obtainable from natural sources, such as alginic acid and hyaluronic acid; chemically modified starches and the like, carboxyvinyl polymers, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylic acid polymers, polymetracrylic acid polymers, polyvinyl acetate polymers, polyvinyl chloride polymers, polyvinylidene chloride polymers, and the like. Additional exemplary gelling agents include the copolymers of acrylic acid / ethyl acrylate, and the carboxy vinyl polymers. These resins consist essentially of a crosslinked polymer of water-soluble polyalkenyl polyether, colloidal of acrylic acid crosslinked with a crosslinking agent such as polyallyl sucrose or polyallyl pentaerythritol. Examples include Carbopol® 934, Carbopol® 940, Carbopol® 950, Carbopol® 980, Carbopol® 951, Carbopol® 981. Carbopol® 934 is a water-soluble polymer of acrylic acid cross-linked with a polyallyl ether of sucrose. Additional exemplary polymeric agents include semi-synthetic polymeric materials such as cellulose ethers, such as methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethyl carboxymethylcellulose, carboxymethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose and cellulose. cationic Polyethylene glycol, which has a molecular weight of 1000 or more (eg, PEG 1, 000, PEG 4,000, PEG 6,000 and PEG 10,000) also has gelling capacity, although they are considered as "additional polar solvents" as detailed herein , they are also considered polymeric agents. Mixtures of the above polymeric agents were contemplated. The concentration of the polymeric agent should be selected so that the composition, after being filled in aerosol cans, is fluid, and can be stirred in the can. In one or more embodiments, the concentration of the polymeric agent is selected such that the viscosity of the composition, prior to filling the composition in the aerosol can, is less than 12,000 CPs, and more preferably, less than 10,000. CPs.

Surfactant The composition of the present invention also contains a surfactant. Surfactants (also called "surfactants") include any agent that binds to oil and water in the composition, in the form of an emulsion. A hydrophilic / lipophilic balance (HLB) of surfactant describes the affinity of the emulsifier to water or oil. HLB is defined by nonionic surfactants. The HLB scale ranges from 1 (totally lipophilic) to 20 (totally hydrophilic), with 10 representing an equal balance or balance of both characteristics. The lipophilic emulsifiers form water-in-oil (w / o) emulsions; the hydrophilic surfactants form oil-in-water (o / w) emulsions. The HLB of a mixture of two emulsifiers is equal to the weight fraction of the emulsifier. Sometimes its HLB value plus the weight fraction of the emulsifier B times its HLB value (weighted average). According to one or more embodiments of the present invention the surfactant has a lipophilic hydrophilic balance (HLB) between about 9 and about 14, which is the HLB (the HLB required to stabilize an o / w emulsion of a given oil) of most oils and hydrophobic solvents. Thus, in one or more embodiments, the composition contains a single surfactant having an HLB value between about 9 and 14, and in one or more embodiments, the composition contains more than one surfactant and the weighted average of its HLB values is between about 9 and about 14. In addition, in other embodiments, when a water-in-oil emulsion is desirable, the composition contains one or more surfactants, having an HLB value of between about 2 and about 9. Preferably, the composition of the present invention contains a nonionic surfactant. Non-limiting examples of possible nonionic surfactants include polysorbates, such as polyoxyethylene (20) sorbitan monostearate (Tween 60) and poly (oxyethylene) (20) sorbitan monooleate (Tween 80); poly (oxyethylene) fatty acid esters (POE), such as Myrj 45, Myrj 49, Myrj 52 and Myrj 59; poly (oxyethylene) alkyl ethers such as poly (oxyethylene) cetyl ether, poly (oxyethylene) -palmityl ether, hexadecyl ether of polyethylene oxide, polyethylene glycol cetyl ether, brij 38, brij 52, brij 56 and brij Wl; sucrose esters, partial sorbitol esters and their anhydrides, such as sorbitan monolaurate and sorbitan monolaurate; mono or diglycerides, isoceteth-20, and mono-, di- and tris-esters of sucrose with fatty acids (sucrose esters). In certain cases, the surfactant is selected from the group of cationic, zwitterionic, amphoteric and ampholytic surfactants, such as sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate and betaines. In one or more embodiments of the present invention, the surfactant includes at least one nonionic surfactant. Ionic surfactants are known to be irritants. Therefore, nonionic surfactants are preferred in applications that include sensitive tissues such as that found in most mucosal tissues, especially when they are infected or inflamed. We have surprisingly found that nonionic surfactants alone provide foams of excellent quality, ie an "E" score according to the graduation scale discussed hereinafter. Thus, in a preferred embodiment, the surfactant, the composition contains a nonionic surfactant, or a mixture of nonionic surfactants as the sole surfactant. In addition, in additional embodiments, the foamable composition includes a mixture of at least one nonionic surfactant and at least one ionic surfactant in a ratio in the range of about 100: 1 to 6: 1. In additional embodiments, the surfactant comprises a combination of nonionic surfactant and an ionic surfactant, in a ratio of between 1: 1 and 20: 1. The concentration of the surfactant is between about 0.1% and about 5%.

Hydrophobic Solvent Optionally, the foamable support also contains at least one hydrophobic solvent. The identification of a "hydrophobic solvent", as used herein, is not intended to characterize the solubilization capabilities of the solvent by any specific active agent or any other component of the foamable composition. Rather, that information is provided to assist in the identification of suitable materials to be used as part of the foamable compositions described herein. A "hydrophobic solvent", as used herein refers to a material having solubility in distilled water at room temperature of less than about 1 gm per 100 mL, more preferably less than about 0.5 gm per 100 mL, and so more preferably less than about 0.1 gm per 100 mL. In one or more embodiments, the organic hydrophobic carrier is an oil, such as mineral oil, isopropyl palmitate, isopropyl isostearate, diisopropyl adipate, diisopropyl dimerate, maleated soybean oil, octyl palmitate, cetyl lactate, cetyl ricinoleate , tocopheryl acetate, acetylated lanolin alcohol, cetyl acetate, phenyl trimethicone, glyceryl oleate, tocopheryl linoleate, wheat germ glycerides, arachidyl propionate, myristyl lactate, decyl oleate, propylene glycol ricinoleate, lanolate isopropyl, pentaerythritol tetrastearate, neopentyl glycol dicaprylate / dicaprate, isononyl isononanoate, isotridecyl isononanoate, myristyl myristate, triisocetyl citrate, octyl dodecanol, unsaturated or polyunsaturated oils, such as olive oil, corn oil, soybean oil, oil of canola, cottonseed oil, coconut oil, sesame oil, sunflower oil, seed oil borage, syzigium aromaticum oil, hemp oil, herring oil, cod liver oil, salmon oil, flaxseed oil, wheat germ oil, nighttime spring oils; essential oils; and silicon oils, such as dimethicone, cyclomethicone, polyalkyl siloxanes, polyaryl siloxanes, polyalkylaryl siloxanes and polyether siloxane copolymers, polydimethylsiloxanes (dimethicones) and copolymers of poly (dimethylsiloxane) - (diphenylsiloxane).

Foaming Adjuvant Optionally, a foam adjuvant is included in the foamable supports of the present invention to increase the foaming ability of the surfactants and / or to stabilize the foam. In one or more embodiments of the present invention, the foam adjuvant includes fatty alcohols having 15 or more carbons in its carbon chain, such as cetyl alcohol and stearyl alcohol (or mixtures thereof). Other examples of fatty alcohols are arachidyl alcohol (C20), behenyl alcohol (C22), 1-triacontanol (C30), and alcohols with longer carbon chains (up to C50). Fatty alcohols, beeswax derivatives and including a mixture of alcohols in the majority of which have at least 20 carbon atoms in their carbon chain, are especially well suited as foam adjuvants. The amount of fatty alcohol required to support the foam system is inversely related to the length of its carbon chains. Foam adjuvants, as defined herein, are also useful in facilitating better dispersion and absorption capacity of the composition. In one or more embodiments of the present invention, the foam adjuvant agent includes fatty acids having 16 or more carbons in its carbon chain, such as hexadecanoic acid (C16), stearic acid (C18), arachidic acid (C20), behenic acid (C22), octacosanoic acid (C28), as well as fatty acids with longer carbon chains (up to C50), or mixtures thereof. As for fatty alcohols, the amount of fatty acids required to support the foam system is inversely related to the length of its carbon chain. Optionally, the carbon atom chain of the fatty alcohol or the fatty acid may have at least one double bond. One more class of foam adjuvant agent includes a fatty alcohol or branched fatty acid. The carbon chain of the fatty acid or fatty alcohol may also be substituted with a hydroxyl group, such as 12-hydroxy stearic acid.

Keratolytic Agent In one embodiment of the present invention, the saccharide composition contains a keratolytic agent. The term "keratolytic agent" is used herein to mean a compound which loosens and removes the stratum corneum from the skin, or alters the structure of the keratin layers of the skin. Keratolytic agents are used in the treatment of many dermatological disorders, which involve dry skin, hyperkeratinization (such as psoriasis), itching of the skin (such as serosis), acne and rosacea. Suitable keratolytic agents include but are not limited to N-acetylcysteine, azelaic acid, cresols, dihydroxybenzene compounds, such as resorcinol and hydroquinone, alpha-hydroxy acids, such as lactic acid and glycolic acid, phenol, pyruvic acid, resorcinol, sulfur, salicylic acid, retinoic acid, isoretinoic acid, retinol, retinal, urea and derivatives, esters, salts and mixtures thereof.

Polar Solvent / Penetration Enhancer In one embodiment of the present invention, the saccharide composition contains polar solvent. In one or more embodiments, the polar solvent is a polyol, ie an organic substance that contains at least two hydroxy groups in its molecular structure. Examples of polyols include propylene glycol (for example 1,2-propylene glycol and 1,3-propylene glycol), butanediol (for example, 1,2-butanediol, 1,3-butanediol, 2,3-butanediol and 1, 4-butanediol), butanediol (for example, 1,3-butanediol and 1,4-butenediol), butindiol, pentanediol (for example, pentan-1,2-diol, pentan-1,3-diol, pentan-1, 4-diol, pentan-1,5-diol, pentan-2,3-diol and pentan-2, -diol), hexanediol (for example, hexane-1,6-diol, hexan-2, 3-diol and hexan -2, 5, 6-diol), octandiol (for example, 1,8-octanediol), neopentyl glycol, 2-methyl-l, 3-propanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, dipropylene glycol, dibutylene glycol, glycerin, butan-1, 2, 3-triol, butan-1,2,4-triol and hexan-1,2,6-triol.

Additional polar solvents that may be contained in the composition of the present invention include dimethyl isosorbide, tetrahydrofurfuryl alcohol polyethylene glycol ether (glycofurol), DMSO, pyrrolidones, (such as N-Methyl-2-pyrrolidone and l-Methyl-2-pyrrolidinone) , ethyl proxitol, dimethylacetamide (DMAc) and alpha hydroxy acids, such as lactic acid, glycolic acid and polyethylene glycol. Notably, polar solvents, as exemplified above, generally have improved skin penetration properties.

Additional components In one embodiment of the present invention, a composition of the present invention includes one or more additional components. These additional components include but are not limited to antiperspirants, antistatic agents, buffering agents, leavening agents, chelating agents, cleansers, colorants, conditioners, deodorants, diluents, dyes, emollients, fragrances, hair conditioners, humectants, occlusive agents, oils, penetration enhancers, opalescent adjuvants, perfuming agents, permeation enhancers, pH adjusting agents, preservatives, protectants, skin penetration enhancers, softeners, solubilizers, sunscreens, sunscreens, tanning agents, modifiers the viscosity and vitamins. As is known to those skilled in the art, in some cases, the specific additional component may have more than one activity, function or effect. In one embodiment of the present invention, the additional component is a pH adjusting agent or a buffering agent. Suitable buffering agents include but are not limited to acetic acid, adipic acid, calcium hydroxide, citric acid, glycine, hydrochloric acid, lactic acid, magnesium aluminometasilicates, phosphoric acid, sodium carbonate, sodium citrate, sodium hydroxide, sorbic acid, succinic acid, tartaric acid and derivatives, salts and mixtures thereof. In one embodiment of the present invention, the additional component is an emollient. Suitable emollients include but are not limited to mineral oil, lanolin oil, coconut oil, cocoa butter, olive oil, aloe vera extract, jojoba oil, castor oil, fatty oils, fatty alcohols, diisopropoyl adipate , hydroxybenzoate esters, benzoic acid esters of C9 to C15 alcohols, isononyl iso-nonanoate, silicon oils, polyethers, alkyl benzoates of C12 to cl5, oleic acid, fatty acid stearic, cetyl alcohols, hexadecyl alcohol, dimethyl polysiloxane, polyoxypropylene cetyl ether, polyoxypropylene butyl ether, and derivatives, esters, salts and mixtures thereof. In one embodiment of the present invention, the additional component is a humectant. Suitable humectants include but are not limited to guanidine, urea, glycolic acid, glycolate salts, ammonium glycolate, quaternary alkyl ammonium glycolate, lactic acid, lactate salts, ammonium lactate, quaternary alkyl ammonium lactate, aloe vera, aloe vera gel, allantoin, urazole, polyhydroxy alcohol, sorbitol, glycerol, hexantriol, propylene glycol, butylene glycol, hexylene glycol, a derivative of hexylene glycol, polyethylene glycol, a sugar, a starch, a sugar derivative, a derivative of starch, alkoxylated glucose, hyaluronic acid, lactamide monoethanolamine, acetamide monoethanolamine and derivatives, esters, salts and mixtures thereof. In one embodiment of the present invention, the additional component is a condom. Suitable preservatives include but are not limited to C12 to C15 alkyl benzoates, alkyl p-hydroxybenzoates, aloe vera extracts, ascorbic acid, benzalkonium chloride, benzoic acid, benzoic acid esters, C9 to C15 alcohols, hydroxytoluene butylated, castor oil, cetyl alcohols, chlorocresol, citric acid, cocoa butter, coconut oil, diazolidinyl urea, diisopropyl adipate, dimethyl polysiloxane, DM DMhymoglobin, ethanol, fatty acids, fatty alcohols, hexadecyl alcohol, hydroxybenzoate esters , iodopropynyl butylcarbamate, isononyl iso-nonanoate, jojoba oil, lanolin oil, methyl paraben, mineral oil, oleic acid, olive oil, polyethers, polyoxypropylene butyl ether, polyoxypropylene cetyl ether, potassium sorbate, silicon oils, propionate sodium, sodium benzoate, sodium bisulfite, ascorbic acid, stearic fatty acid, vitamin E, vitamin E acetate and derivatives, esters, ales and mixtures thereof. In one embodiment of the present invention the additional component is ameliorating the penetration of the skin. Suitable skin penetration enhancers include but are not limited to acetone, acyl lactylates, acyl peptides, acyl sarcosinates, alkanolamine salts of fatty acids, alkyl benzene sulphonates, alkyl ether sulphates, alkyl sulfates, anionic surfactants , benzyl benzoates, benzyl salicylate, butan-1, -diol, butyl benzoate, butyl laurate, butyl myristate, butyl stearate, cationic surfactants, citric acid, cocoamidopropylbetaine, decyl methyl sulfoxide, decyl oleate, azelate of dibutyl, dibutyl phthalate, dibenzyl sebacate, dibutyl sebacate, dibutyl suberate, dibutyl succinate, dicapryl adipate, dodecyl phthalate, diethylene glycol, diethyl sebacate, diethyl-m-toluamide, di (2-hydroxypropyl) ether, diisopropyl adipate, diisopropyl sebacate, N, N-dimethyl acetamide, dimethyl azelate, N, N-dimethyl formamide, 1,5-dimethyl-2-pyrrolidone, dimethyl sebacate, dimethyl sulphoxide, dioctyl adipate, dioctyl azelate, dioctyl sebacate, 1,4 dioxane, 1-dodecylazacycloheptan-2-one, dodecyl dimethyl amine oxides, ethyl caprate, ethyl caproate, ethyl caprylate, 2-ethyl pelargonate -hexyl, ethyl-2-hydroxy-propanoate, ethyl laurate, ethyl myristate, 1-ethyl-2-pyrrolidone, ethyl salicylate, hexyl laurate, 2-hydroxyoctanoic acid, 2-hydroxypropanoic acid, 2-hydroxypropionic acid, isethionates, isopropyl isostearate, isopropyl palmitate, guar chloride hydroxypropyltrimonium, hexan-2, 5-diol, chelating agent, lamellanes, lauryl alcohol, maipones, metal salts of fatty acids, methyl nicotinate, 2-methyl propan-2-ol, l-methyl-2-pyrrolidone, 5-methyl-2-pyrrolidone, methyl taurides, miranol, nonionic surfactants, octyl alcohol, octylphenoxy polyethoxyethanol, oleic ethanolamide, pleial alcohol, pentan-2, -diol, phenoxyethanol, phosphatidyl choline, phosphine oxides, polyalkoxyalkylated ether glycollates , poly (diallylpiperidino chloride), poly (dipropyldiallylammonium chloride), polyglycerol esters, polyoxyethylene lauryl ether, polyoxy stearate: polyoxyethylene, polyoxypropylene 15 stearyl ether, poly (vinyl pyridinium chloride), propan-1-ol, propan-2 -or l, propylene glycol dipelargonate, pyroglutamic acids, 2-pyrrolidone, pyruvic acids, Quaternium 5, Quaternium 18, Quaternium 19, Quaternium 23, Quaternium 31, Quaternium 40, Quaternium 57, quaternary amine salts, poly (dimethylaminoethyl methacrylate) ), quaternized, poly (quaternized vinyl alcohol, sapamine hydrochloride, sodium cocoamino-propionate, sodium dioctyl sulfosuccinate, sodium laurate, sodium lauryl ether sulfate, sodium lauryl sulfate, sugar-coated esters, sulfosuccinate, tetrahydrofuran, tetrahydrofurfural alcohol, transcutol, triethanolamine dodecyl benzene sulfonate, triethanolamine oleate, urea, water and derivatives, esters, salts or mixtures thereof.

Propellants Examples of suitable propellants include volatile hydrocarbons such as butane, propane, isobutane and fluorocarbon gases, or mixtures thereof. In certain embodiments, the fluorohydrocarbon propellant, in addition to chlorofluorocarbons (CMC) which are propellants that do not damage the ozone layer, are particularly useful in the production of a nonflammable foamable composition. These propellants include, but are not limited to, hydrofluorocarbon propellants (HFCs), which do not contain chlorine atoms, and therefore fall completely out of the question of the destruction of stratospheric ozone by chlorofluorocarbons or other chlorinated hydrocarbons. Exemplary non-flammable propellants according to this aspect of the invention include propellants produced by DuPont under the registered Dymel trademark, such as 1,1,1,2-tetrafluoroethane (Dymel 134), and 1,1,1,2 , 3,3,3 heptafluropropane (Dyrael 227), 1,1, difluoro ethane (Dymel 152) and 1,1,1,3,3,3 hexafluropropane. HFCs have Ozone Depletion Potential of 0.00 and are thus allowed to be used as a propellant in aerosol products. The propellant constitutes approximately 5-25% by weight of the foamable composition. The aerosol propellants are used to generate and administer the foamable composition such as foam. The total composition including propellant, foamable compositions and optional ingredients is referred to as the foamable composition.

Composition and Physical Characteristics and Advantages of Foam The pharmaceutical or cosmetic composition made using the foamed support of the present invention is very easy to use. When applied on a body surface of affected mammals, ie, humans or animals, it is in a foamed state, allowing free application without leakage. Upon further application of a mechanical force, for example, by rubbing the composition on the surface of the body, the latter freely disperses on the surface and is rapidly absorbed.

The foamable composition of the present invention is stable, having an acceptable shelf life of at least one year, or preferably, at least two years at room temperature, as revealed in accelerated stability tests. The organic supports and propellants tend to impart stability to the emulsions and interfere with the formation of a stable foam upon release of a pressurized container. It has been observed, however, that the foamable compositions according to the present invention are surprisingly stable. By performing accelerated stability studies, they demonstrate the desirable texture; they form fine bubble structures that do not degrade immediately after contact with a surface, easy dispersion over the treated area and rapid absorption. The composition should also flow freely, to allow it to flow through the opening of the container, for example, an aerosol container, and create an acceptable foam. The quality of the foam can be graded as follows: Grade E (excellent): very rich and creamy in appearance, does not show any bubble structure or shows a very fine (small) bubble structure; it does not quickly become slow; after dispersing on the skin, the foam retains the creamy property and does not appear watery. Grade G (good): rich and creamy in appearance, very small bubble size, it "encourages" more quickly than an excellent foam, retains some creaminess after dispersing on the skin, and does not become watery. Grade FG (very good): a moderate amount of remarkable creaminess, the structure of the bubble is remarkable, after the dispersion on the skin the product is quickly encouraged and becomes a bit lower in the apparent viscosity. Grade F (bad): very little notable creaminess, bubble structure larger than that of a "very good" foam, after dispersing on the skin it becomes thin in appearance and watery. Grade P (poor): not remarkable creaminess, large bubble structure, and when dispersed on the skin it becomes very thin and watery in appearance. PV grade (very poor): dry foam, very large slow bubbles, difficult to disperse on the skin. Topically administrable foams are typically grade E or G grade, when released from an aerosol container. Smaller bubbles are indicative of a more stable foam, which does not spontaneously collapse immediately after being discharged from the container. The finer foam structure looks and feels smoother, thus increasing its usefulness and appearance. One more aspect of foam is its degradation capacity. The degradable foam is thermally stable, although it degrades under the shear force. The degradation capacity by the shearing force of the foam is clearly advantageous over the thermally induced degradation capacity. Thermally sensitive foams collapse immediately after exposure to skin temperature and, therefore, can not be applied by hand and then carried to the affected area. The foam of the present invention has several advantages when compared to hydroalcoholic foams compositions, as described in WO2004 / 071479; (1) Degradability. The foam of the present invention is thermally stable. Unlike the hydroalcoholic foam compositions of the prior art, the foam of the present invention is not "degraded" or breaks rapidly, ie it does not rapidly collapse upon exposure to the body temperature environment. The capacity of degradation or rupture of the shearing force of the foam is clearly advantageous over the thermally induced degradation or breaking capacity, since it allows a convenient application and a well targeted administration to the target area. (2) Skin drying and skin barrier function. Short chain alcohols are known to dry the skin and damage the integrity of the skin barrier. In contrast, the inclusion of a film-forming agent in the composition of the present invention does not cause undesirable damage to the skin barrier. (3) Irritability. Due to the absence of alcohol and improvement in the function of the skin barrier, irritability of the skin is eliminated. Another property of the foam is the specific gravity, as measured after the release of the aerosol can. Typically, the foams have a specific gravity of less than 0.12 g / mL; or less than 0.10 g / mL, or less than 0.08 g / mL, depending on its composition and propellant concentration.

Active Agents In one embodiment of the present invention, an active agent is incorporated into a foamable saccharide composition. Suitable active agents include but are not limited to active herbal extracts, acaricides, age spots and keratoses, allergens, analgesics, local anesthetics, anti-acne agents, antiallergic agents, anti-aging agents, antibacterials, antibiotics, anti-scald agents, agents anticancer, antidandruff agents, antidepressants, anti-dermatitis agents, anti-emetics, antihistamines, anthelmintics, antihyperkeratolytic agents, anti-inflammatory agents, antirrugants, anti-lipemic agents, antimicrobial agents, antipyretics, antiproliferative agents, antioxidants, anti-wrinkle agents, antipruritics, antipsoriatic agents, antirust agents, anti-seborrheic agents, antiseptics , anti-inflammatory agents, antiviral agents, antiselastic agents, astringents, topical cardiovascular agents, chemotherapeutic agents, corticosteroids, dicarboxylic acids, disinfectants, fungicides, growth regulators Hair, hormones, hydroxy acids, immunosuppressants, immunoregulatory agents, insecticides, insect repellents, keratolytic agents, lactams, metals, metal oxides, mitocides, neuropeptides, non-steroidal anti-inflammatory agents, oxidizing agents, pediculicides, photodynamic therapy agents, retinoids , healers, scabicides, self-tanning agents, skin whitening agents, vasoconstrictors, vasodilators, vitamins, vitamin D derivatives, wound healing agents and wart removers. As is known to one skilled in the art, in some cases a specific active agent may have more than one activity, function or effect.

Hygroscopic Property of Composition A hygroscopic substance is a substance that readily absorbs water from its surroundings. Microorganisms require water to grow and reproduce, and therefore the water requirements are best defined in terms of the water activity of the substrate. The water activity of a solution is expressed as Aw = P / Po, where P is the water vapor pressure of the solution and Po is the vapor pressure of the pure water at the same temperature. In addition, a hygroscopic substance to the aqueous solution in which a microorganism is growing will have the effect of decreasing Aw, with a consequent effect on cell growth. Each microorganism has a limiting Aw, below which it does not grow, for example, for streptococci, klebsiella ssp. , escherichia coli, clostridium perfringens, and pseudomonas ssp. the value of Aw is 0.95. Staphylococcus aureus is more resistant and can proliferate with an Aw as low as 0.86. The water activity of the product can be determined from the relative humidity of the air surrounding the sample when the air and sample are in equilibrium. The measurement is made by placing a sample in a closed space where this balance can take place. Once this occurs, the water activity of the sample and the relative humidity of the air are equal. The measurement taken at equilibrium is known as relative humidity in equilibrium or ERH. The relationship between the water activity and the ERH is according to the following formula: Aw = ERH / 100 Several types of water activity instruments are commercially available. An exemplary instrument uses cold mirror dewpoint technology, while other instruments measure relative humidity with detectors that change the resistance or electrical capacitance. The saccharides have a greater affinity for water, and therefore, exhibit hygroscopic properties; and the saccharide concentration determines the Aw of the support. Therefore, additions of saccharides to the composition can have a dramatic effect on Aw. In one or more embodiments, the saccharide is contained in the composition of the present invention at a concentration sufficient to provide an Aw value of the hygroscopic support of less than 0.9. In other embodiments, the concentration of the hygroscopic substance in the composition is selected to provide an Aw value selected from the ranges of (1) about 0.8 and about 0.9, (2) about 0.7 and about 0.8.; and (3) less than about 0.7. A saccharide composition having an aqueous activity that is less than that which can support microbial growth can be used as a topical treatment of surface infectious conditions. By providing a saccharide composition in a pressurized package presentation, this is isolated from the environment until before use, the Aw of the composition is maintained. In comparison, other dosage forms such as solutions, creams, lotions, ointments and the like involve repeated opening of the closure of the container, resulting in the absorption of water from the surrounding environment and a subsequent raising of the Aw (thereby decreasing the hygroscopicity of the product, and thereby diminishing its anti-infective potential). In contrast, a pressurized container does not allow any moisture to be absorbed by the preparation, and therefore, the hygroscopicity of the composition can not be damaged.

The saccharide composition as a support for an anti-infective agent In one or more embodiments, the saccharide composition of the present invention further contains an anti-infective agent, selected from the group of an antibiotic agent, an antibacterial agent, an antifungal agent, an agent that controls yeasts, an antiviral agent and an antiparasitic agent. The combination of the anti-infective effect of a saccharide composition, which acts through a dehydration mechanism, with an additional anti-infective agent acting through alternative mechanisms results in a synergistic effect and consequently a higher percentage of treatment success . The terms "antibacterial" and "antibiotic" as used herein include, but are not limited to, any substance that is destructive of or inhibits the growth of bacteria or any substance that has the ability to inhibit the growth of or destroy bacteria, and they are used in the treatment of infectious disorders. In one or more embodiments, the antibiotic agent is selected from the group consisting of a beta-lactam antibiotic, an aminoglycoside, an antibiotic of the ansa type, an anthraquinone, an azole, metronidazole, an antibiotic glycopeptide, a macrolide, erythromycin, clindamycin , an antibiotic nucleoside, an antibiotic peptide, poliraixin B, an antibiotic polyene, an antibiotic polyether, an antibiotic quinolone, an antibiotic steroid, fucidic acid, mupirocin, chloramphenicol, a sulfonamide, tetracycline, an antibiotic metal, silver, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium, an oxidizing agent, iodine, iodate, a periodate, a hypochlorite, a permanganate, a substance that releases free radicals and / or active oxygen, a cationic antimicrobial agent, an ammonium compound quaternary, a biguanide, chlorhexidine, a triguanide, a bisbiguanide, a polymeric biguanide, a natural antibiotic compound and the like, deri fords, salts, ions and complexes thereof. The term "antifungal" as used herein includes, but is not limited to, any substance that is destructive or that inhibits the growth of fungi and yeasts or any substance that has the ability to inhibit the growth of or destroy fungi and / or yeasts . In one or more embodiments, the antifungal agent is a useful agent in the treatment of a superficial skin infection by fungi, dermatophytosis, microsporum, trichophyton and infections of epidermophyton, candidiasis, oral candidiasis (thrush), candidiasis of the skin and membranes genital mucosa, candida paronychia, which injures the nails and the nail bed and genital and vaginal candida which attacks the genitals and the vagina. We have unexpectedly discovered that a saccharide composition contains a more effective antifungal drug than other compositions, comprising the same concentration of the antifungal agent, which is not hygroscopic. In addition, we have discovered that the antifungal agent, which is known to be effective against dermatophytes but not against candida, becomes effective against candida, when included in a saccharide composition, as described herein. There is no particular limitation on the antifungal agents used in the compositions of this invention. By way of example, preferred suitable antifungal agents are made of polyenes, for example, natamycin, nystatin; allylamines, for example naftifine, terbinafine; imidazoles, for example, bifonazole, clotrimazole, econazole, fenticonazole, ketoconazole, miconazole, oxiconazole; diazole, triazoles, for example, fluconazole, itraconazole, terconazole, tolnaftate, cyclopirox, undecylenic acid, sulbentin, griseofulvin, amphotericin B, flucytosine (5FC), and mordolines, for example amorolfine and related morpholines and the like, derivatives and salts thereof , and any combination thereof at a therapeutically effective concentration. Any known antiviral agent, at an effective therapeutic concentration, can be incorporated into the foamable composition according to one or more embodiments of the present invention. Thus, in the preferred embodiments of the present invention a pharmaceutical composition is provided, which includes: (i) an aqueous saccharide solution; (ii) from about 0.2% to about 5% by weight of a surfactant; (iii) from about 0.01% to about 5% by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film-forming agent and a phase-change agent; and (iv) a therapeutically effective concentration of an anti-infective agent; and (v) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

In one or more embodiments, the pharmaceutical composition also contains a penetration enhancer.

Fields of Applications The foamable support of the present invention is suitable for treating any suitable surface. In one or more embodiments, the foamable support is suitable for administration to the skin, a body surface, a body cavity or mucosal surface, for example, the cavity of the nose, eyes, mouth, ear canal, vagina and rectum (here called "white site" in a severe and interchangeable way). By selecting a suitable active agent, or a combination of at least two active agents, the foamable composition of the present invention is useful for treating an animal or human patient having any of a variety of dermatological disorders, including dermatological pain, dermatological inflammation, acne , common acne, inflammatory acne, non-inflammatory acne, acne fulminans, nodular papulopustular acne, acne conglobates, dermatitis, bacterial infections of the skin, fungal skin infections, viral skin infections, skin parasitic infections, skin neoplasia, cutaneous neoplasms, pruritus, cellulitis, acute lymphangitis, lymphadenitis, erysipelas, skin abscesses, necrotizing subcutaneous infections, exfoliated skin syndrome, folliculitis, boils, hidradenitis suppurativa, carbuncles, paronychial infections, rashes, erythrasma, impetigo, ecthyma, infections of the yeast skin, warts, molluscum contagi bear, trauma or skin lesion, postoperative or post-surgical skin conditions, scabies, pediculosis, progressive rash, eczema, psoriasis, pyrrhosis rosea, lichen planus, pityriasis rubra pilaris, edematous lesions, erythema multiforme, erythema nodosum, granuloma annulare, epidermal necrolysis , sunburn, photosensitivity, pemphigus, bullous pemphigoid, dermatitis herpetiformis, keratosis pilaris, callus, grains, ichthyosis, skin ulcers, ischemic necrosis, miliary, hyperhidrosis, moles, Kaposi's sarcoma, melanoma, malignant melanoma, basal cell carcinoma, carcinoma of squamous cells, poison ivy, poisonous beak, contact dermatitis, atopic dermatitis, rosacea, purpura, moniliasis, candidiasis, baldness, alopecia, Behcet's syndrome, cholesteatoma, Dercum's disease, ectodermal dysplasia, gustatory sweating, patellar nail syndrome, lupus, urticaria, hair loss, Hailey-Hailey disease, cutaneous burns chemical or thermal, scleroderma, aging of the skin, wrinkles, sunspots, necrotizing fasciitis, necrotizing myositis, gangrene, scars and vitiligo. Likewise, the foamable composition of the present invention is suitable for treating a disorder of a body cavity or mucosal surface, for example, the mucosa of the nose, mouth, eyes, ears, respiratory system, vagina or rectum. Non-limiting examples of these conditions include chlamydia infection, gonorrheal infection, hepatitis B, herpes, HIV / AIDS, human papilloma virus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, inguinal granuloma, lymphogranuloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, non-gonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, pelvic inflammation, endometritis, salpingitis, oophoritis , genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal diseases, abscesses / anal fistulas, anal cancer, anal fissures, anal warts, Crohn's disease, hemorrhoids, anal itching , anal itching, fecal incontinence, constipation, polyps of the colon and rectum. In one embodiment of the present invention, the composition is useful for the treatment of an infection. In one or more embodiments, the composition is suitable for the treatment of an infection, selected from the group of a bacterial infection, a fungal infection, a yeast infection, a viral infection and a parasitic infection. In one embodiment of the present invention, the composition is useful for the treatment of wounds, ulcers and burns. This use is particularly important since the composition of the present invention creates a thin, semi-cork layer, which coats the damaged tissue, while allowing the exudates to be released from the tissue. The composition of the present invention is also suitable for administering a hormone to the skin or to a mucous membrane or body cavity, to release the hormone to the tissue of the target organ, in any disorder that responds to treatment with a hormone. The invention is described with reference to the following examples. This invention is not limited to those examples and experiments. Many variations will suggest themselves and are within the intended scope of the appended claims.

Example 1 - Composition of foamable saccharide containing sorbitol and honey After the release of the aerosol can an excellent quality foam is formed (very small bubble size). The foam is stable when placed on the skin. After gentle rubbing, the foam easily disperses on the skin and thus absorbs quickly.

Example 2- Comparison of the foamable saccharide containing active agents The following active agents have been incorporated into the Formulations SOR1, SOR2 and HON1: 2% Terbinafine; 1% iconazole; 5% of Iodine-povidone; 0.1% Hydrocortisone Acetate; 0.05% Clobetasol dipropionate; and 1% Clindamycin.

Example 3 - Utility Study: comparison between a foam according to the present invention and a product in the form of ointment The objective of this study was to evaluate the useful properties of the foamed product "SORl", in comparison with a comparative ointment. Study panelists (n = 12) were asked to test the instability of two foamed products, compared to a comparator ointment, with respect to the following parameters: - Ease of application - Uniform dispersion - Accurate location - Absorption through the skin - Residue oily - Appearance of shiny residues - Thickness The panelists were instructed to evaluate a series of useful parameters and to grade each of the foamable products according to the following scale: Score - 3: The ointment is much better than the Foam (Ointment »> Foam) Score - 2: Ointment is better than foam (Ointment &> Foam) Score - 1: Ointment is slightly better than foam (Ointment &Foam) Score - 0 : Foam is superior as good as Ointment (Foam = Ointment) Score +1: Foam is slightly better than Ointment (Foam &Ointment) Score +2: Foam is superior better or better than Ointment (Foam > > Ointment) Score + 3: Foam is superior or much better than Ointment (Foam »&Ointment). The average result of the comparison indicates a high preference of the foam in all the parameters of utility, as shown in the following table.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (22)

1. CLAIMS Having described the invention as above, the content of the following claims is claimed as property: 1. A foamable saccharide composition, characterized in that it includes: (i) water; (ii) a saccharide; (iii) from about 0.2% to about 5% by weight of a surfactant; (iv) from about 0.01% to about 5% by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film-forming agent and a phase-change agent; and (v) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.
2. 2. The saccharide composition according to claim 1, characterized in that the saccharide is selected from a group consisting of a monosaccharide, a disaccharide, an oligosaccharide and a sugar alcohol.
3. 3. The saccharide composition according to claim 1, characterized in that the saccharide comprises honey.
4. 4. The saccharide composition according to claim 1, characterized in that it also contains a foam adjuvant, selected from the group of a long chain fatty alcohol and a long chain fatty acid.
5. 5. The saccharide composition according to claim 1, characterized in that it also contains a hydrophobic solvent.
6. 6. The saccharide composition according to claim 5, characterized in that the composition is in the form of an oil-in-water emulsion; and wherein the HLB for the surfactant is between about 9 and about 14. The saccharide composition according to claim 5, characterized in that the composition is in the form of a water-in-oil emulsion; and wherein the HLB of the surfactant is between about 2 and about 9. The saccharide composition according to claim 1, characterized in that it also contains an additive selected from the group of a keratolytic agent and a polar solvent. The saccharide composition according to claim 1, characterized in that it also contains at least one active agent selected from the group of an active herbal extract, an acaricide, a stain remover of age and keratosis, an allergen, an analgesic agent , a local anesthetic, an anti-acne agent, an anti-allergic agent, an anti-aging agent, an antibacterial agent, an antibiotic agent, an anti-sebum agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic agent, an antihistamine , an anti-hyperkeratolytic agent, an anti-inflammatory agent, an anti-irritant agent, an anti-lipemic agent, an antimicrobial agent, an antifungal agent, an antiproliferative agent, an antioxidant, an anti-wrinkle agent, an antipruritic agent, an anti-psoriatic agent, an anti-parasitic agent, an agent anti-seborrheic, an antiseptic agent, an anti-inflammatory agent, an antiviral agent, an anti-aging agent, an astringent, a topical cardiovascular agent, a chemotherapeutic agent, a corticosteroid, a dicarboxylic acid, a disinfectant, a fungicide, a hair growth regulator, a hormone, a hydroxy acid, an immunosuppressant, an immunoregulatory agent, a insecticide, an insect repellent, a keratolytic agent, a lactam, a metal, a metal oxide, a mitocid, a neuropeptide, a non-steroidal anti-inflammatory agent, an oxidizing agent, a pediculicide, a photodynamic therapy agent, a retinoid, an antisarna agent, a self-tanning agent, a skin whitening agent, a vasoconstrictor, a vasodilator, a vitamin, a vitamin D derivative, a wound healing agent and a wart remover. 10. The saccharide composition according to claim 1, characterized in that the composition is hygroscopic. The saccharide composition according to claim 10, characterized in that the concentration of saccharide is selected to provide a value of Aw selected from the ranges of (1) about 0.8 and about 0.9.; (2) about 0.7 and about 0.8; and (3) less than about 0.7. 12. The saccharide composition according to claim 10, characterized in that it also contains a therapeutically effective concentration of an anti-infective agent. The saccharide composition according to claim 12, characterized in that the anti-infective agent is selected from the group consisting of an antibiotic agent, an antibacterial agent, an antifungal agent, an agent controlling yeast, an antiviral agent and an antiparasitic agent. . 14. The saccharide composition according to claim 13, characterized in that the antibiotic agent is selected from the group consisting of a beta-lactam antibiotic, an aminoglycoside, an antibiotic of the ansa type, an anthraquinone, an azole, metronidazole, a antibiotic glycopeptide, a macrolide, erythromycin, clindamycin, an antibiotic nucleoside, an antibiotic peptide, polymyxin B, an antibiotic polyene, an antibiotic polyether, an antibiotic quinolone, an antibiotic steroid, fucidic acid, mupirocin, chloramphenicol, a sulfonamide, tetracycline, a metal antibiotic, silver, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium, an oxidizing agent, iodine, iodate, a periodate, a hypochlorite, a permanganate, a substance that releases free radicals and / or active oxygen, a cationic antimicrobial agent, a quaternary ammonium compound, a biguanide, chlorhexidine, a triguanide, a bisbiguanide, a biguanide limeric, a natural antibiotic compound and analogs, derivatives, salts, ions and complexes thereof. 15. The saccharide composition according to claim 13, characterized in that the antifungal agent is useful in the treatment of an infection of dermatophytosis, microsporum, trichophyton and infections of epidermophyton, candidiasis, oral candidiasis (thrush), yeast and candida. 16. The saccharide composition according to claim 13, characterized in that the antifungal agent is selected from the group consisting of a polyene, natamycin, nystatin; an allylamine, naftifine, terbinafine, an imidazole, bifonazole, clotrimazole, econazole, fenticonazole, ketoconazole, miconazole, oxiconazole; a diazole, a triazole, fluconazole, itraconazole, terconazole, tolnaftate, cyclopirox, undecylenic acid, sulbentin, griseofulvin, amphotericin B, flucytosine (5FC), a morpholine compound, amorolfine and related morpholines and the like, derivatives and salts thereof, and any combination thereof at a therapeutically effective concentration. The saccharide composition according to claim 8, characterized in that the keratolytic agent is selected from the group consisting of urea, an alpha-hydroxy acid, lactic acid, phenol, resorcinol, salicylic acid, a keratolytic enzyme, a proteolytic enzyme and papaina. 18. A method of treating a disorder of a target site, characterized in that it comprises: administering to a target site in need of treatment, the target site selected from the group consisting of the skin, a body surface, a body cavity or a surface mucosa, the nasal cavity, the mouth, the eyes, the ear canal, the vagina or the rectum, a saccharide composition comprising: (i) water; (ii) a saccharide; (iii) from about 0.2% to about 5% by weight of a surfactant; (iv) from about 0.01% to about 5% by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film-forming agent and a phase-change agent; and (v) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition. 19. The method according to claim 18, characterized in that the disorder comprises an infection. The method according to claim 19, characterized in that the infection is selected from the group consisting of a bacterial infection, a fungal infection, a yeast infection, a viral infection and a parasitic infection. 21. The method according to claim 18, characterized in that the disorder is selected from the group consisting of a wound, ulcer and burn. The method according to claim 18, characterized in that the disorder is selected from the group consisting of dermatological pain, dermatological inflammation, acne, acne vulgaris, inflammatory acne, non-inflammatory acne, acne fulminans, nodular papulopustular acne, acne conglobata, dermatitis, bacterial skin infections, fungal skin infections, viral skin infections, skin parasitic infections, skin neoplasms, cutaneous neoplasms, pruritus, cellulitis, acute lymphangitis, lymphadenitis, erysipelas, skin abscesses, necrotizing subcutaneous infections, exfoliated skin syndrome, folliculitis, boils, hidradenitis suppurativa, carbuncles, paronychial infections, rashes, erythrasma, impetigo, ecthyma, yeast skin infections, warts, molluscum contagiosum, trauma or skin lesion, post-operative or postoperative skin conditions , scabies, pediculosis, progressive rash, eczema, p psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, edematous lesions, erythema multiforme, erythema nodosum, granuloma annulare, epidermal necrolysis, sunburn, photosensitivity, pemphigus, bullous pemphigoid, dermatitis herpetiformis, keratosis pilaris, calluses, grains, ichthyosis, ulcers cutaneous, ischemic necrosis, miliary, hyperhidrosis, moles, Kaposi's sarcoma, melanoma, malignant melanoma, basal cell carcinoma, squamous cell carcinoma, poison ivy, poisonous peak, contact dermatitis, atopic dermatitis, rosacea, purpura, monialiasis, candidiasis baldness, alopecia, Behcet's syndrome, cholesteatoma, Dercum's disease, ectodermal dysplasia, gustatory sweating, patellar nail syndrome, lupus, urticaria, hair loss, Hailey-Hailey's disease, chemical or thermal skin burns, scleroderma, aging skin, wrinkles, sunspots, necrotizing fasciitis, necrotizing myositis, g angrena, scars and vitiligo, chlamydia infection, gonorrheal infection, hepatitis B, herpes, HIV / AIDS, human papilloma virus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, inguinal granuloma, lymphogranuloma venereum, mucopurulent cervicitis (PC ), molluscum contagiosum, non-gonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, pelvic inflammation, endometritis, salpingitis, oophoritis, cancer genital, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal diseases, abscesses / anal fistulas, anal cancer, anal fissures, anal warts, Crohn's disease, hemorrhoids, anal itching, pruritus anal, fecal incontinence, constipation, polyps of the colon and rectum.