Granted Patent B2

US 8,722,021 · App. 13/786,902 · Granted May 13, 2014

Abstract

Claims (43)

1. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising:

i) about 0.1% to about 5% by weight of the carrier of a surface-active agent;

ii) about 2% to about 75% by weight of the carrier of an organic solvent selected from the group consisting of an emollient, a polar solvent, an oil, and mixtures thereof;

iii) about 0.01% to about 5% by weight of the carrier of at least one polymeric agent selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent, and a phase change agent; and

iv) water;

wherein upon release from a foam dispenser, a foam is produced; and

wherein the foam remains stable as a foam for at least 60 seconds at 37° C.

2. The foamable composition of claim 1 , wherein the carrier further comprises an active agent.

3. The foamable composition of claim 1 , wherein the liquefied or compressed gas propellant is present at about 3% to about 25% by weight of the carrier.

4. The foamable composition of claim 1 , wherein the organic solvent is selected from the group consisting of an emollient, a polar solvent, an essential oil, and mixtures of any two or more thereof.

5. The foamable composition of claim 1 , wherein the carrier comprises a micro-emulsion.

6. The foamable composition of claim 1 , wherein the carrier comprises nanoparticles.

7. The foamable composition of claim 1 , wherein the surface-active agent is present at less than about 2% by weight of the carrier.

8. The foamable composition of claim 1 , wherein the polymeric agent is present at less than about 1% by weight of the carrier.

9. The foamable composition of claim 1 , wherein the carrier does not include petrolatum.

10. The foamable composition of claim 2 , wherein the active agent is selected from the group consisting of an antibacterial agent, an antibiotic, an anti-parasitic agent, an antifungal agent, an antiviral agent, a corticosteroid, a steroidal anti-inflammatory agent, a non-steroidal immunomodulating agent, an immunosuppressant, an anti-allergic agent, an antihistamine, an anticancer agent, a hormone, an androgen, an estrogen, a progesterone, a contraceptive agent, a retinoid, vitamin A, vitamin B, vitamin D, an anesthetic, a lubricating agent, an immunizing agent, a cytotoxic drug, an antiproliferative drug, an anti-oxidant, a radical scavenger, and mixtures of any two or more thereof.

11. The foamable composition of claim 1 , wherein the carrier comprises less than about 2% by weight of the carrier of one or more lower alcohols having up to 5 carbon atoms in their carbon chain skeleton.

12. The foamable composition of claim 1 , wherein the polymeric 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, crosslinked copolymers of acrylic acid and C10-C30 alkyl acrylate (pemulen), carboxyvinyl polymers, a carbopol, and mixtures of any two or more thereof.

13. The foamable composition of claim 1 , wherein the foamable composition further comprises about 0.1% to about 5% by weight of the carrier of a foam adjuvant selected from the group consisting of a fatty alcohol having 15 or more carbons in its carbon chain; a fatty acid having 16 or more carbons in its 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 of any two or more thereof.

14. The foamable composition of claim 1 , wherein the surface-active agent is selected from the group consisting of a non ionic surface-active agent, a cationic surface-active agent, an amphoteric surface-active agent, an ionic surface-active agent, and mixtures of any two or more thereof.

15. The foamable composition of claim 1 , wherein the surface-active agent is a non ionic surface-active agent.

16. The foamable composition of claim 13 , wherein the combined amount of foam adjuvant, surface active agent, and gelling agent is less than about 8% by weight of the carrier.

17. The foamable composition of claim 14 , wherein the surface-active agent is selected from the group consisting of a polysorbate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, a polyoxyethylene fatty acid ester, polyoxyethylene (8) stearate, polyoxyethylene (20) stearate, polyoxyethylene (40) stearate, polyoxyethylene (100) stearate, a polyoxyethylene alkyl ether, polyoxyethylene cetyl ether, polyoxyethylene (23) cetyl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (10) cetyl ether, isoceteth-20, a sucrose ester, a partial ester of sorbitol, an anhydride of a partial ester of sorbitol, sorbitan monolaurate, sorbitan stearate, a monoglyceride, glyceryl monostearate, a diglyceride, lecithin, sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate, a betaine, cocamidopropyl betaine, and mixtures of any two or more thereof.

18. The foamable composition of claim 1 , wherein the carrier comprises more than about 50% by weight of the carrier of a potent solvent.

19. The foamable composition of claim 18 , wherein the potent solvent is selected from the group consisting of polyethylene glycol, propylene glycol, hexylene glycol, butane-diol and isomers thereof, glycerol, benzyl alcohol, dimethyl sulfoxide, ethyl oleate, ethyl caprylate, dimethylacetamide, N-methylpyrrolidone, N-hydroxyethylpyrrolidone, polyvinylpyrrolidone, isosorbide derivatives, dimethyl isosorbide, glycofurol, ethoxydiglycol, and mixtures of any two or more thereof.

20. The foamable composition of claim 10 , wherein the active agent is suitable for the treatment of a disorder of a body cavity or a mucosal surface, wherein the disorder is selected from the group consisting of a bacterial infection, a fungal infection, a viral infection, vaginal dryness, dyspareunia, HIV, a sexually transmitted disease, post-surgical adhesions, a hormonal deficiency, and a combination of any two or more thereof.

21. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising:

i) about 0.1% to about 5% by weight of the carrier of a surface-active agent;

ii) about 70% to about 99% by weight of the carrier of a hydrophobic organic solvent;

iii) a stabilizer selected from the group consisting of about 0.01% to about 5% by weight of the carrier of a polymeric agent and about 0.1% to about 5% by weight of the carrier of foam adjuvant;

wherein upon release from a foam dispenser, a foam is produced; and

wherein the foam remains stable as a foam for at least 60 seconds at 37° C.

22. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising:

i) about 0.2% to about 15% by weight of the carrier of a surface-active agent;

ii) about 70% to about 99% by weight of the carrier of a hydrophobic organic solvent;

iii) a stabilizer selected from the group consisting of about 0.01% to about 5% by weight of the carrier of a polymeric agent and about 0.1% to about 5% by weight of the carrier of foam adjuvant;

wherein upon release from a foam dispenser, a foam is produced; and

wherein the foam remains stable as a foam for at least 60 seconds at 37° C.

23. The foamable composition of claim 1 , wherein the foam remains stable as a foam for at least 2 or 3 minutes at 37° C.

24. The foamable composition of claim 22 , wherein the foam remains stable as a foam for at least 2 or 3 minutes at 37° C.

25. The foamable composition of claim 2 , wherein the active agent is an azole.

26. The foamable composition of claim 25 , wherein the azole is selected from the group consisting of azoles, diazoles, triazoles, pyrazoles, and mixtures of any two or more thereof.

27. The foamable composition of claim 26 , wherein the azole is selected from the group consisting of clotrimazole, econazole, fluconazole, ketoconazole, itraconazole, metronidazole, miconazole, phenylbutazone, oxyphenbutazone, feprazone, azapropazone, trimethazone, and mixtures of any two or more thereof.

Assignments (8)