Claims for Patent: 8,663,699

Summary for Patent: 8,663,699

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 (Sonoma, CA), Dow; Gordon J. (Santa Rosa, CA)
Assignee:	Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:	13/869,494
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,663,699
Patent Claims:	1. A method for treating acne comprising topically applying an effective amount of a stable pharmaceutically acceptable aqueous gel formulation comprising anti-acne active pharmaceutical ingredients consisting of 2.5% w/w benzoyl peroxide and 1.2% w/w clindamycin phosphate once daily to acne affected skin of a patient in need thereof, wherein the irritation potential of the once daily application is less than and the efficacy of the once daily application in terms of reduction of acne inflammatory and non-inflammatory lesions is similar to that obtained by twice daily application of a topic gel composition containing 5.0% benzoyl peroxide, 1% clindamycin, dicotyl sodium sulfosuccinate, and water. 2. The method of claim 1, wherein the benzoyl peroxide in the formulation is in suspension and has an average particle size of 2.5 to 30 microns. 3. The method of claim 2, wherein the aqueous formulation comprises a gelling agent selected from the group consisting of carbomer, hydroxyethyl cellulose, and hydroxypropyl cellulose gelling agents.