Claims for Patent: 12,616,710

Summary for Patent: 12,616,710

Title:	Topical compositions
Abstract:	The disclosure provides a topical gel formulation comprising 1-1.5 wt. % clindamycin phosphate, 2.5-3.5 wt. % benzoyl peroxide, and 0.1-0.2 wt. % adapalene, in combination with a gelling agent, a polyhydric alcohol, and water, useful in treating inflammatory skin conditions, including acne, together with methods of making and using the same.
Inventor(s):	Varsha Bhatt, Radhakrishnan Pillai, Arturo Angel
Assignee:	Bausch Health Ireland Ltd
Application Number:	US19/278,338
Patent Claims:	1. A topical gel formulation comprising: 1.2 wt. % clindamycin phosphate; 3.1 wt. % benzoyl peroxide comprising a plurality of benzoyl peroxide particles; 0.15 wt. % adapalene comprising a plurality of adapalene particles; a polyhydric alcohol selected from the group consisting of propylene glycol, ethoxydiglycol, glycerol, and combinations thereof; a gelling agent selected from the group consisting of hydroxypropylcellulose, hydroxyethylcellulose, carboxyvinyl polymers, carboxyvinyl copolymers, polyacrylates, acrylate copolymers, acrylamide/sodium acryloyldimethyltaurate copolymers, methylcellulose, hydroxypropylmethylcellulose, xanthan gum, carrageenan gum, and combinations thereof; and potassium hydroxide, wherein the plurality of benzoyl peroxide particles and the plurality of adapalene particles are uniformly dispersed in the formulation. 2. The topical gel formulation of claim 1, wherein the potassium hydroxide is present in an amount to provide a pH of 5-6. 3. The topical gel formulation of claim 1, wherein the formulation is stable at room temperature for at least six weeks. 4. The topical gel formulation of claim 1, wherein the polyhydric alcohol is propylene glycol.