Claims for Patent: 9,504,704

Summary for Patent: 9,504,704

Title:	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Abstract:	An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.
Inventor(s):	Chang; Yunik (Clermont, FL), Dow; Gordon J. (Santa Rosa, CA), Pillai; Radhakrishnan (Santa Rosa, CA)
Assignee:	DOW PHARMACEUTICAL SCIENCES, INC. (Petaluma, CA)
Application Number:	14/260,211
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,504,704
Patent Claims:	1. A surfactant-free, aqueous 3.75% w/w benzoyl peroxide gel formulation for topical application to the skin comprising: water, propylene glycol, 3.75% w/w benzoyl peroxide, 1.2% w/w clindamycin phosphate, and a gelling agent, wherein the formulation comprises a stable suspension of benzoyl peroxide in a saturated solution of benzoyl peroxide, in which the concentration of the propylene glycol is between one and four times the concentration of the benzoyl peroxide, and in which the ratio of the water to the propylene glycol is at least 12:1. 2. The formulation of claim 1, in which the clindamycin phosphate is dissolved in the formulation. 3. The formulation of claim 1, in which the gelling agent is a carboxyvinyl polymer. 4. The formulation of claim 1, in which the benzoyl peroxide has a mean particle size of between 2.5 and 30 microns. 5. The formulation of claim 1, in which the ratio of the water to the propylene glycol is at least 17.5:1. 6. A surfactant-free, aqueous 3.75% w/w benzoyl peroxide gel for topical application to the skin comprising: 3.75% w/w benzoyl peroxide, 5.0% w/w propylene glycol, 1.2% w/w clindamycin phosphate, 1.75% w/w CARBOPOL 980.RTM. and 87.8% w/w water. 7. A method for treating acne comprising applying once a day for up to 12 weeks to the skin of a patient in need thereof a surfactant-free, aqueous 3.75% w/w benzoyl peroxide gel formulation according to claim 1. 8. The method of claim 7, wherein the formulation comprises 3.75% w/w benzoyl peroxide, 5.0% w/w propylene glycol, 1.2% w/w clindamycin phosphate, 1.75% w/w CARBOPOL 980.RTM. and 87.8% w/w water. 9. An aqueous formulation for topical application to the skin comprising water, propylene glycol, benzoyl peroxide, and clindamycin phosphate, wherein the concentration of propylene glycol is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of a benzoyl peroxide in a saturated solution of benzoyl peroxide, wherein the concentration of benzoyl peroxide in the formulation is 3.75% w/w, and wherein the concentration of clindamycin phosphate in the formulation is 1.2% w/w. 10. The aqueous formulation of claim 9, wherein the concentration of the propylene glycol is lower than that which will dissolve all of the benzoyl peroxide in the formulation following the removal of all of the water from the formulation. 11. The aqueous formulation of claim 9, wherein the concentration of the propylene glycol is 1 to 4 times the concentration of the benzoyl peroxide in the formulation. 12. The aqueous formulation of claim 9, wherein the ratio of water to propylene glycol in the formulation is at least 12:1. 13. The aqueous formulation of claim 12, wherein the ratio of water to propylene glycol is at least about 17.5:1. 14. The aqueous formulation of claim 9, wherein the aqueous formulation is free of surfactant. 15. The aqueous formulation of claim 9, wherein the aqueous formulation contains a surfactant. 16. A method for treating acne comprising applying once a day for up to 12 weeks to the skin of a patient in need thereof an aqueous formulation according to claim 9. 17. A method for treating acne comprising applying once a day for up to 12 weeks to the skin of a patient in need thereof an aqueous formulation according to claim 14. 18. A method for treating acne comprising applying once a day for up to 12 weeks to the skin of a patient in need thereof an aqueous formulation according to claim 15.