Claims for Patent: 9,561,208

Summary for Patent: 9,561,208

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)
Assignee:	Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:	15/094,895
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,561,208
Patent Claims:	1. An aqueous suspension formulation for topical application to the skin, comprising 2.5% w/w to 4.5% w/w benzoyl peroxide, about 1.2% w/w clindamycin phosphate, propylene glycol, a carboxyvinyl polymer, and water; wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of benzoyl peroxide in a saturated solution of benzoyl peroxide, wherein the ratio of water to propylene glycol in the formulation ranges from 12:1 to 20:1, and wherein the concentration of the propylene glycol is one to four times the concentration of the benzoyl peroxide. 2. The formulation of claim 1, wherein the concentration of benzoyl peroxide ranges from 2.5% to 3.5% w/w. 3. The formulation of claim 1, wherein the concentration of benzoyl peroxide is about 3.5% w/w. 4. The formulation of claim 1, wherein the concentration of propylene glycol is about 5.0% w/w, the concentration of the carboxyvinyl polymer is about 1.75% w/w, and the ratio of water to propylene glycol in the formulation ranges from 12:1 to 18:1. 5. The formulation of claim 1, which is free of surfactant. 6. The formulation of claim 1, which contains a surfactant. 7. The formulation of claim 1, wherein the concentration of propylene glycol is about 5.0% w/w, the concentration of the carboxyvinyl polymer is about 1.75% w/w, and the ratio of water to propylene glycol in the formulation is about 18:1. 8. The formulation of claim 4, which is free of surfactant. 9. The formulation of claim 4, which contains a surfactant. 10. A method for treating acne, comprising applying to the skin of a patient in need thereof an aqueous suspension formulation comprising 2.5% w/w to 4.5% w/w benzoyl peroxide, about 1.2% w/w clindamycin phosphate, propylene glycol, a carboxyvinyl polymer, and water; wherein the combined concentration of water and propylene glycol is sufficient to provide a suspension of benzoyl peroxide in a saturated solution of benzoyl peroxide, wherein the ratio of water to propylene glycol in the formulation ranges from 12:1 to 20:1, wherein the concentration of the propylene glycol is one to four times the concentration of the benzoyl peroxide, and wherein the formulation is applied once a day for up to 12 weeks to the skin of the patient. 11. The method of claim 10, wherein the concentration of benzoyl peroxide in the formulation ranges from 2.5% to 3.5% w/w. 12. The method of claim 10, wherein the concentration of benzoyl peroxide in the formulation is about 3.5% w/w. 13. The method of claim 10, wherein the concentration of propylene glycol in the formulation is about 5.0% w/w, the concentration of the carboxyvinyl polymer in the formulation is about 1.75% w/w, and the ratio of water to propylene glycol in the formulation ranges from 12:1 to 18:1. 14. The method of claim 10, wherein the formulation is free of surfactant. 15. The method of claim 10, wherein the formulation contains a surfactant. 16. The method of claim 10, wherein the concentration of propylene glycol is about 5.0% w/w, the concentration of the carboxyvinyl polymer is about 1.75% w/w, and the ratio of water to propylene glycol in the formulation is about 18:1. 17. The method of claim 13, wherein the formulation is free of surfactant. 18. The method of claim 13, wherein the formulation contains a surfactant.