Claims for Patent: 12,133,859

Summary for Patent: 12,133,859

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:	US18/639,619
Patent Claims:	1. A topical gel formulation comprising: 1-1.5 wt. % clindamycin phosphate; 2.5-3.5 wt. % benzoyl peroxide comprising a plurality of benzoyl peroxide particles; 0.15-0.2 wt. % adapalene comprising a plurality of adapalene particles; a gelling agent; an additional agent as a polyhydric alcohol; and water. 2. The topical gel formulation of claim 1, wherein the concentration of clindamycin phosphate is about 1.2 wt. %, the concentration of benzoyl peroxide is about 3.1 wt. %, and the concentration of adapalene is 0.15 wt. %. 3. The topical gel formulation of claim 2, wherein the polyhydric alcohol is propylene glycol in a concentration of about 5 wt. %, the gelling agent is carbomer homopolymer Type C in a concentration of about 1.75 wt. %, the formulation further comprising potassium hydroxide in an amount to provide a pH of 5-6. 4. The topical gel formulation of claim 1, wherein the formulation is stable at room temperature for at least six weeks. 5. The topical gel formulation of claim 1, wherein the formulation is stable at room temperature for at least ten weeks. 6. The topical gel formulation of claim 1, wherein the formulation is stable at 36° F. to 46° F., then stable at or below 77° F. for at least six weeks. 7. The topical gel formulation of claim 1, wherein the formulation is stable at 36° F. to 46° F. prior to dispensing to a patient, then stable at or below 77° F. for at least 10 weeks. 8. The topical gel formulation of claim 1, wherein the gelling agent is selected from the group consisting of hydroxypropylcellulose, hydroxyethylcellulose, carboxyvinyl polymers, carboxyvinyl polymers crosslinked with allyl ethers of polyalcohols, carboxyvinyl copolymers, polyacrylates, acrylate copolymers, acrylamide/sodium acryloyldimethyltaurate copolymers, polyvinyl alcohols, polyethylene oxides, propylene glycol alginates, methylcellulose, hydroxypropylmethylcellulose, xanthan gum, carrageenan gum, and combinations thereof. 9. The topical gel formulation of claim 1, wherein the gelling agent comprises carbomer homopolymer Type C. 10. The topical gel formulation of claim 1, wherein the gelling agent is a crosslinked polymer comprising carboxy moieties and wherein the formulation further comprises a base selected from the group consisting of potassium hydroxide, sodium hydroxide and combinations thereof in an amount sufficient to deprotonate the carboxy moieties sufficiently to cause the gelling agent to thicken. 11. The topical gel formulation of claim 1, wherein the amount of gelling agent is 1.5 wt. % to 2 wt. %. 12. The topical gel formulation of claim 1, wherein the plurality of benzoyl peroxide particles is homogeneously dispersed in the formulation. 13. The topical gel formulation of claim 1, wherein the plurality of benzoyl peroxide particles has a mean particle size between 1 and 50 microns. 14. The topical gel formulation of claim 11, wherein the plurality of adapalene particles is homogeneously dispersed in the formulation. 15. The topical gel formulation of claim 1, wherein the adapalene and the benzoyl peroxide do not undergo any detrimental interaction with one another. 16. The topical gel formulation of claim 1, wherein the polyhydric alcohol is selected from the group consisting of propylene glycol, ethoxydiglycol, polyethylene glycol, and glycerol. 17. The topical gel formulation of claim 1, wherein the formulation is free of additional agents as organic solvents other than the polyhydric alcohol. 18. The topical gel formulation of claim 1, wherein the amount of polyhydric alcohol is 3 wt. % to 7 wt. %. 19. The topical gel formulation of claim 1, wherein the formulation is free of ionic surfactants. 20. The topical gel formulation of claim 1, wherein the formulation is free of preservatives other than the polyhydric alcohol.