Details for Patent: 8,840,869

Title:	Body cavity foams
Abstract:	The invention relates to an alcohol-free cosmetic or therapeutic foam carrier comprising water, a hydrophobic organic carrier, a foam adjuvant agent, a surface-active agent and a gelling agent. The cosmetic or therapeutic foam carrier does not contain aliphatic alcohols, making it non-irritating and non-drying. The alcohol-free foam carrier is suitable for inclusion of both water-soluble and oil soluble therapeutic and cosmetic agents.
Inventor(s):	Friedman; Doron (Karmei Yosef, IL), Besonov; Alex (Rehovet, IL), Tamarkin; Dov (Maccabim, IL), Eini; Meir (Ness Ziona, IL)
Assignee:	Foamix Ltd. (Rehovot, IL)
Filing Date:	Apr 28, 2005
Application Number:	11/116,761
Claims:	1. A device for administration of a foamable composition into a body cavity, comprising an aerosol container, a valve, an insert applicator and a foamable composition for application into said body cavity, which upon release from said aerosol container provides an expanded foam suitable for topical administration; wherein the foamable composition comprises a propellant and a therapeutic composition being substantially free of lower alcohols wherein the therapeutic composition comprises: at least one organic carrier selected from a hydrophobic organic carrier, an emollient, a polar solvent, and mixtures thereof, at a concentration of about 70% to about 99% by weight of the therapeutic composition; at least one surface active agent at a concentration of about 0.2% to about 5% by weight of the therapeutic composition; at least one active agent; and at least one polymeric gelling agent at a concentration of about 0.01% to about 5% by weight of the therapeutic composition; wherein the propellant is a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the foamable composition; wherein the surface active agent is a non-ionic surface active agent or a mixture of at least one non ionic surface active agent and at least one ionic surface active agent in a ratio of about 20:1 or greater than 20:1. wherein upon release from the container the composition forms a breakable foam that collapses upon application of shear force; and wherein the breakable foam stays stable as a foam for at least about 3 minutes at about 37.degree. C. after being dispensed from the container. 2. The device of claim 1, wherein the valve is a metered dose valve and the metered dose is adjusted to afford a dose between about 10 .mu.L and about 1000 .mu.L. 3. The device of claim 1, wherein the valve is a metered dose valve and the metered dose is adjusted to afford a final volume of foam between about 0.17 mL and about 17 mL. 4. The device of claim 1, wherein the thickness of said insert applicator is selected from the group consisting of (1) between about 0.2 cm and about 0.4 cm; (2) between about 0.4 cm and about 0.8 cm; and (3) between about 0.8 cm and about 1 cm. 5. The device of claim 1, wherein the length of said insert applicator is between about 1 cm and about 20 cm. 6. The device of claim 1, wherein the thickness and length of said insert applicator are designed to match the dimensions of the target body cavity. 7. The device of claim 1, wherein the body cavity is selected from the group consisting of cranial cavity, the thoracic cavity, the abdominal cavity, the ventral cavity, the vagina, the rectum cavity, the penile cavity, the urinary tract, bladder, the cavity between the uterus and the fallopian tubes, the ovaries, the nasal cavity, the mouth, the eye, the ear, the peritoneum, the large and small bowel, the caecum, bladder, stomach, and other body cavities or spaces, which may accept topically-applied products. 8. The device of claim 1, wherein the gelling agent is selected from the group consisting of a locust bean gum, sodium alginate, sodium caseinate, egg albumin, a gelatin agar, a carrageenin gum, a xanthan gum, a quince seed extract, a tragacanth gum, a guar gum, a starch, a chemically modified starch, cellulose ethers, a hydroxyethyl cellulose, a methyl cellulose, a carboxymethyl cellulose, a hydroxy propylmethyl cellulose, a hydroxypropyl guar gum, a soluble starch, cationic celluloses, cationic guars, carboxyvinyl polymers, a polyvinylpyrrolidone, a polyvinyl alcohol, polyacrylic acid polymers, polymethacrylic acid polymers, polyvinyl acetate polymers, polyvinyl chloride polymers, polyvinylidene chloride polymers, acrylic acid/ethyl acrylate copolymers, carboxyvinyl polymers, a carbopol and mixtures thereof. 9. The device of claim 1, wherein the foamable composition further includes about 0.1% to about 5% by weight of a therapeutically active foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain; a fatty acid having 16 or more carbons in their carbon chain; fatty alcohols, derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain; a fatty alcohol having at least one double bond; a fatty acid having at least one double bond; a branched fatty alcohol; a branched fatty acid; a fatty acid substituted with a hydroxyl group; cetyl alcohol; stearyl alcohol; arachidyl alcohol; behenyl alcohol; 1-triacontanol; hexadecanoic acid; stearic acid; arachidic acid; behenic acid; octacosanoic acid; 12-hydroxy stearic acid and mixtures thereof. 10. The device of claim 1, wherein the organic carrier comprises a mixture of mineral oil and an emollient in a ratio between 1:4 and 4:1 on a weight basis. 11. The device of claim 1, wherein the surface active agent is selected from a non ionic surfactant, a cationic surfactant, an amphoteric surface active agent and an ionic surface active agent. 12. The device of claim 11, wherein the surface active agent is non-ionic. 13. The device of claim 1, wherein the surface active agent is a non-ionic surface active agent in a concentration of below 1% by weight of the therapeutic composition. 14. The device of claim 9, wherein the combined amount of foam adjuvant, surface active agent and gelling agent is less than about 8% by weight of the therapeutic composition. 15. The device of claim 9, wherein the combined amount of foam adjuvant, surface active agent and gelling agent is less than about 5% by weight of the therapeutic composition. 16. The device of claim 1, wherein the active agent is selected for the treatment of a disease or disorder, wherein the etiology of the disease is bacterial, fungal, viral, parasitic, inflammatory, autoimmune, allergic, hormonal, malignant, and combinations thereof or wherein the disorder is selected from of inflammation, bacterial infections, fungal infections, parasitic infections, viral infections, benign tumors, malignant tumors, pain, itch, allergy, dryness, wound, cut, a tissue adhesion abnormality, a hormonal abnormality, chlamydia infection, gonorrhea infection, hepatitis B, herpes, a neoplasm, a benign tumor, HIV/AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranloma 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, post-surgical adhesions, disorders that respond to hormone therapy and birth control. 17. The device of claim 1, wherein the active agent is selected for the treatment of a mucosal disorder, a vaginal disorder, a vulvar disorder, an anal disorder, the vagina, the rectum and penile cavities, the urinary tract, bladder, the cavity between the uterus and the fallopian tubes, the ovaries, a disorder of the respiratory system, or post- surgical adhesion. 18. The device of claim 1, wherein the active agent is selected from the group consisting of antibacterial agents, anti-parasitic agents, antifungal agents, antiviral agents, steroidal anti-inflammatory agents, non-steroidal immunomodulating agents, immunosuppressants, anti-allergic agents, anticancer agents, hormones, androgens, estrogens, progesterones, contraceptive agents, retinoids, vitamin A, vitamin B, vitamin D, local anesthetic agents, lubricating agents and immunizing agents. 19. The device of claim 1, wherein the composition further comprises an active agent selected from the group consisting of negatively charged sulfated polymers, hyaluronic acid, dextrin sulphate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, carrageenans, naphthalene sulfonate polymer, sodium alginate, a cationic polymer, and chitosan. 20. The device of claim 1, wherein the active agent is intended for trans-mucosal delivery. 21. The device of claim 20, wherein the active agent is intended for the treatment of a systemic disease, which responds to administration of the active agent. 22. The device of claim 1, wherein the oleaginous foamable composition contains more than 50% of a potent solvent. 23. The device of claim 22, wherein the potent solvent is selected from polyethylene glycol, propylene glycol, hexylene glycol, butane-diol and isomers thereof, glycerol, benzyl alcohol, DMSO, ethyl oleate, ethyl caprylate, dimethylacetamide, N-methylpyrrolidone, N-hydroxyethylpyrrolidone, polyvinylpyrrolidone, isosorbide derivatives, dimethyl isosorbide, glycofurol and ethoxydiglycol (transcutol). 24. The device of claim 1, wherein the body cavity is selected from the group consisting of cranial cavity, the thoracic cavity, the abdominal cavity, the ventral cavity, the vagina, the rectum cavity the penile cavity, the urinary tract, bladder, the cavity between the uterus and the fallopian tubes, the ovaries, the nasal cavity, the mouth, the eye, the ear, the peritoneum, the large and small bowel, the caecum, bladder, stomach, and other body cavities or spaces which may accept topically-applied products. 25. The device of claim 8, wherein the gelling agent comprises a bioadhesive agent. 26. The device of claim 16, wherein the etiology of the disease is selected from the group consisting of a viral infection, human papillomavirus (HPV), genital warts, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, anal cancer, anal fissure, and anal warts; and the active agent is selected from the group consisting of antiviral agents and non-steroidal immunomodulating agents. 27. The device of claim 1, wherein the foamable composition comprises less than about 2% of one or more lower alcohols by weight of the therapeutic composition. 28. The device of claim 1, wherein the foamable composition comprises less than about 1% of one or more lower alcohols by weight of the therapeutic composition. 29. The device of claim 1, wherein the gelling agent is a mucoadhesive agent. 30. The device of claim 1, further comprising a mucoadhesive agent selected from the group consisting of acidic synthetic polymers, a poly(acrylic)- and/or poly(methacrylic) acid, a poly(methylvinyl ether/maleic anhydride) copolymer, acidic synthetically modified natural polymers, a carboxymethylcellulose, neutral synthetically modified natural polymers, a hydroxypropylmethylcellulose, basic amine-bearing polymers, a chitosan, acidic polymers obtainable from natural sources, an alginic acid, a hyaluronic acid, pectin, a gum tragacanth, a karaya gum, neutral synthetic polymers, a polyvinyl alcohol, a cyclodextrin, a hydroxypropyl-.beta.-cyclodextrin, silicon dioxide and mixtures thereof. 31. The device of claim 1, wherein the foam is delivered into the body cavity with no or minimal overflow. 32. The device of claim 3, wherein the foam is delivered into the body cavity with no or minimal overflow. 33. The device of claim 1, wherein the device is adapted to provide a metered dose and the foam is delivered into the body cavity with no or minimal overflow. 34. The device of claim 1, wherein the device is adapted to provide a metered dose of a size suitable for the target body cavity and wherein the foam is deliverable into the body cavity with no or minimal overflow. 35. The device of claim 1, wherein the foam provides no or low irritation to the body cavity. 36. The device of claim 1, wherein the foam expands in the cavity. 37. The device of claim 1, wherein the foam provides no or low itching or itching potential to the body cavity surface. 38. The device of claim 1, wherein the foam can be retained in the body cavity for at least fifteen minutes after administration.