Saccharide foamable compositions

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.

1 . A foamable composition including:
 (i) water;   (ii) about 20% to about 80% by weight of a saccharide selected from the group consisting of a monosaccharide, a disaccharide, an oligosaccharide, a sugar alcohol and mixtures thereof; or honey, in an amount that provides about 20% to about 80% by weight of a mixture of saccharides in the composition;   (iii) about 0.2% to about 5% by weight of a non-ionic surface-active agent; and   (iv) a liquefied hydrocarbon propellant or compressed gas propellant at a concentration of about 3% to about 25% of the total composition;   and wherein the composition forms a breakable foam upon dispensing.   
   
   
       2 . The composition of  claim 1 , further comprising a polar solvent. 
   
   
       3 . The composition of  claim 2 , wherein the composition is hygroscopic. 
   
   
       4 . The composition of  claim 3 , wherein the composition has an Aw value of less than 0.9 or about 0.9. 
   
   
       5 . The composition of  claim 2 , wherein the polar solvent is selected from the group consisting of propylene glycol, butanediol, butanediol, butynediol, pentanediol, hexanediol, octanediol, neopentyl glycol, 2-methyl-1,3-propanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, dipropylene glycol, dibutylene glycol, glycerin, butane-1,2,3-triol, butane-1,2,4-triol and hexane-1,2,6-triol, dimethyl isosorbide, tetrahydrofurfuryl alcohol polyethyleneglycol ether, DMSO, a pyrrolidone, N-Methyl-2-pyrrolidone, 1-Methyl-2-pyrrolidinone, ethyl proxitol, dimethylacetamide, an alpha hydroxy acids, lactic acid, glycolic acid and polyethylene glycol. 
   
   
       6 . The composition of  claim 5 , wherein the polar solvent possesses skin penetration properties. 
   
   
       7 . The composition of  claim 2  further comprising a penetration enhancer. 
   
   
       8 . The composition of  claim 2 , further comprising:
 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 phase change agent; or   a foam adjuvant comprising a fatty alcohol or a fatty acid, or a mixture thereof.   
   
   
       9 . The composition of  claim 2 , further containing a hydrophobic solvent. 
   
   
       10 . The composition of  claim 9 , wherein the composition is in the form of an oil in water emulsion. 
   
   
       11 . The composition of  claim 9 , wherein the composition is in the form of a water in oil emulsion. 
   
   
       12 . The composition of  claim 1 , further comprising an ionic surface-active agent. 
   
   
       13 . The composition of  claim 12 , wherein the ratio of non-ionic to ionic surfactant is between 100:1 to 20:1. 
   
   
       14 . The composition of  claim 12 , wherein the ratio between the non-ionic surfactant and the ionic surfactant is in a in a range selected from (i) 1:1 to 20:1; and (ii) greater than 20:1. 
   
   
       15 . The composition of  claim 1 , further containing at least one active agent selected from the group of an active herbal extract, an acaricide, an age spot and keratose removing agent, an allergen, an analgesic agent, a local anesthetic, an antiacne agent, an antiallergic agent, an antiaging agent, an anti-infective agent, an antifungal agent, an agent that controls yeast, an antiparasitic agent, an antibacterial agent, an antibiotic agent, an antiburn agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic agent, an antihistamine, an antihyperkeratolyte agent, an antiinflammatory agent, an antiirritant, an antilipemic agent, an antimicrobial agent, an antimycotic agent, an antiproliferative agent, an antioxidant, an anti-wrinkle agent, an antipruritic agent, an antipsoriatic agent, an antirosacea agent, an antiseborrheic agent, an antiseptic agent, an antiswelling agent, an antiviral agent, an antiyeast 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 immunoregulating agent, an insecticide, an insect repellent, a keratolytic agent, a lactam, a metal, a metal oxide, a mitocide, a neuropeptide, a non-steroidal anti-inflammatory agent, an oxidizing agent, a pediculicide, a photodynamic therapy agent, a retinoid, a scabicide, 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. 
   
   
       16 . The composition of  claim 15 , wherein the antibiotic agent is selected from the group
 consisting of a beta-lactam antibiotic, an aminoglycoside, an ansa-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, an oxidizing agent, iodine, iodate, a periodate, a hypochlorite, a permanganate, a cationic antimicrobial agent, a quaternary ammonium compound, a biguanide, chlorohexidine, a triguanide, a bisbiguanide, a polymeric biguanide, a naturally occurring antibiotic compound and salts, ions and complexes thereof; or   wherein the antifungal agent is useful in the treatment of an infection of dermatophytosis, microsporum, trichophyton and epidermophyton infections, candidiasis, oral candidiasis (thrush), yeast and candida; or wherein the antifungal agent is selected from the group consisting of a polyene, natamycin, nystatin; an allylamine, naftifine, terbinafine; an imidazole, bifonazole, clotrimazole, econazole, fenticonazole, ketocanazole, miconazole, oxiconazole; a diazole, a triazoles, fluconazole, itraconazole, terconazole, tolnaftate, ciclopirox, undecylenic acid, sulbentine, griseofulvin, Amphotericin B, flucytosine (5FC), a morpholine compound, amorolfine, and the related morpholines and salts thereof, and any combination thereof at a therapeutically effective concentration; or   wherein 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 papain.   
   
   
       17 . A foamable composition including:
 (i) water;   (ii) about 20% to about 80% by weight of a saccharide selected from the group consisting of a monosaccharide, a disaccharide, an oligosaccharide, a sugar alcohol and mixtures thereof; or honey, in an amount that provides about 20% to about 80% by weight of a mixture of saccharides in the composition;   (iii) a polyol;   (iv) about 0.2% to about 5% by weight of a non ionic surface-active agent; and   (v) a liquefied hydrocarbon propellant or compressed gas propellant at a concentration of about 3% to about 25% of the total composition;   wherein the composition is hygroscopic; wherein the concentration of the saccharide and polyol is sufficient to provide an Aw value less than 0.9 or about 0.9;   and wherein the composition forms a breakable foam upon dispensing.   
   
   
       18 . The composition of  claim 17 , further containing at least one active agent selected from the group of an active herbal extract, an acaricide, an age spot and keratose removing agent, an allergen, an analgesic agent, a local anesthetic, an antiacne agent, an antiallergic agent, an antiaging agent, an anti-infective agent, an antifungal agent, an agent that controls yeast, an antiparasitic agent, an antibacterial agent, an antibiotic agent, an antiburn agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic agent, an antihistamine, an antihyperkeratolyte agent, an antiinflammatory agent, an antiirritant, an antilipemic agent, an antimicrobial agent, an antimycotic agent, an antiproliferative agent, an antioxidant, an anti-wrinkle agent, an antipruritic agent, an antipsoriatic agent, an antirosacea agent, an antiseborrheic agent, an antiseptic agent, an antiswelling agent, an antiviral agent, an antiyeast 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 immunoregulating agent, an insecticide, an insect repellent, a keratolytic agent, a lactam, a metal, a metal oxide, a mitocide, a neuropeptide, a non-steroidal anti-inflammatory agent, an oxidizing agent, a pediculicide, a photodynamic therapy agent, a retinoid, a scabicide, 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. 
   
   
       19 . A method of treatment of a disorder of a target site comprising:
 administering to a target site in need of treatment, said target site selected from the group consisting of the skin, a body surface, a body cavity or mucosal surface, the nasal cavity, the mouth, the eye, the ear canal, the vagina and the rectum;   a composition comprising:
 (i) water; 
 (ii) about 20% to about 80% by weight of a selected from the group consisting of a monosaccharide, a disaccharide, an oligosaccharide, a sugar alcohol and mixtures thereof; or honey, in an amount that provides about 20% to about 80% by weight of a mixture of saccharides in the composition; 
 (iii) optionally a polar solvent. 
 (iv) about 0.2% to about 5% by weight of a non ionic surface-active agent; and 
   a liquefied hydrocarbon propellant or compressed gas propellant at a concentration of about 3% to about 25% of the total composition;   wherein the composition is hygroscopic; wherein the concentration of the saccharide and any polar solvent is sufficient to provide an Aw value less than 0.9 or about 0.9; and wherein the composition forms a breakable foam upon administration.   
   
   
       20 . The method of  claim 19 , wherein the composition further comprises: 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 phase change agent; or a foam adjuvant comprising a fatty alcohol or a fatty acid, or a mixture thereof. 
   
   
       21 . The method of  claim 19 , wherein the disorder comprises an infection, wherein 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; and or wherein the disorder is selected from the group consisting of wound, ulcer, burn, 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, parasitic skin infections, skin neoplasia, skin neoplasms, pruritis, cellulitis, acute lymphangitis, lymphadenitis, erysipelas, cutaneous abscesses, necrotizing subcutaneous infections, scalded skin syndrome, folliculitis, furuncles, hidradenitis suppurativa, carbuncles, paronychial infections, rashes, erythrasma, impetigo, ecthyma, yeast skin infections, warts, molluscum contagiosum, trauma or injury to the skin, post-operative or post-surgical skin conditions, scabies, pediculosis, creeping eruption, eczemas, psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, edematous, erythema multiforme, erythema nodosum, granuloma annulare, epidermal necrolysis, sunburn, photosensitivity, pemphigus, bullous pemphigoid, dermatitis herpetiformis, keratosis pilaris, callouses, corns, ichthyosis, skin ulcers, ischemic necrosis, miliaria, hyperhidrosis, moles, Kaposi's sarcoma, melanoma, malignant melanoma, basal cell carcinoma, squamous cell carcinoma, poison ivy, poison oak, contact dermatitis, atopic dermatitis, rosacea, purpura, moniliasis, candidiasis, baldness, alopecia, Behcet's syndrome, cholesteatoma, Dercum disease, ectodermal dysplasia, gustatory sweating, nail patella syndrome, lupus, hives, hair loss, Hailey-Hailey disease, chemical or thermal skin burns, scleroderma, aging skin, wrinkles, sun spots, necrotizing fasciitis, necrotizing myositis, gangrene, scarring, vitiligo, chlamydia infection, gonorrhea infection, herpes, HIV/AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranuloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, nongonococcal 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 disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn's disease, hemorrhoids, anal itch, pruritus ani, fecal incontinence, constipation, polyps of the colon and rectum. 
   
   
       22 . A method for delivering a composition, comprising
 (a) charging a container with a composition comprising a foamable carrier and a liquefied or compressed gas hydrocarbon propellant, wherein the propellant is present at a concentration of about 3% to about 25% by weight of the total composition, and wherein the carrier comprises
 (i) water; 
 (ii) about 20% to about 80% by weight of a saccharide selected from the group consisting of a monosaccharide, a disaccharide, an oligosaccharide, a sugar alcohol and mixtures thereof; 
 (iii) optionally honey, in an amount that provides about about 20% to about 80% by weight of a mixture of saccharides in the composition; 
 (iv) optionally a polar solvent; 
 (v) about 0.2% to about 5% by weight of a non ionic surface-active agent; and 
   (b) dispensing the composition onto a body surface or in a body cavity, wherein the composition is hygroscopic; wherein the concentration of the saccharide and any polar solvent is sufficient to provide an Aw value less than 0.9 or about 0.9; and wherein the composition is dispensed as a breakable foam.   
   
   
       23 . The method of  claim 22 , wherein the carrier further comprises:
 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 phase change agent; or   a foam adjuvant comprising a fatty alcohol or a fatty acid, or a mixture thereof.   
   
   
       24 . The method of  claim 22 , wherein the breakable foam creates a semi-occlusive layer on the surface or body cavity. 
   
   
       25 . A foamable composition including:
 (i) water;   (ii) about 20% to about 80% by weight of a sugar alcohol;   (iii) optionally a polar solvent;   (iv) about 0.2% to about 5% by weight of a non ionic surface-active agent;   (v) about 0.01% to about 5% by weight of at least one foam adjuvant; and   (vi) a liquefied hydrocarbon propellant or compressed gas propellant at a concentration of about 3% to about 25% of the total composition, and wherein the composition is hygroscopic; wherein the concentration of the saccharide and any polar solvent is sufficient to provide an Aw value less than 0.9 or about 0.9; and and wherein the composition forms a breakable foam upon dispensing.   
   
   
       26 . The foamable composition of  claim 1 , further comprising:
 one or more additional components selected from the group consisting of anti perspirants, anti-static agents, buffering agents, bulking agents, chelating agents, cleansers, colorants, conditioners, deodorants, diluents, dyes, emollients, fragrances, hair conditioners, humectants, occlusive agents, oils, penetration enhancers, pearlescent aids, perfuming agents, permeation enhancers, pH-adjusting agents, preservatives, protectants, softeners, solubilizers, sunscreens, sun blocking agents, sunless tanning agents, viscosity modifiers and vitamins.   
   
   
       27 . The foamable composition of  claim 17  further comprising:
 one or more additional components selected from the group consisting of anti perspirants, anti-static agents, buffering agents, bulking agents, chelating agents, cleansers, colorants, conditioners, deodorants, diluents, dyes, emollients, fragrances, hair conditioners, humectants, occlusive agents, oils, penetration enhancers, pearlescent aids, perfuming agents, permeation enhancers, pH-adjusting agents, preservatives, protectants, softeners, solubilizers, sunscreens, sun blocking agents, sunless tanning agents, viscosity modifiers and vitamins.