TOPICAL COMPOSITIONS
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.
1 - 10 . (canceled)
11 . A topical gel formulation consisting essentially of:
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 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;
potassium hydroxide; and
water.
12 . The topical gel formulation of claim 11 , wherein the concentration of clindamycin phosphate is about 1.2 wt. %.
13 . The topical gel formulation of claim 11 , wherein the concentration of benzoyl peroxide is about 3.1 wt. %.
14 . The topical gel formulation of claim 11 , the concentration of adapalene is 0.15 wt. %.
15 . The topical gel formulation of claim 11 , wherein the polyhydric alcohol is propylene glycol.
16 . The topical gel formulation of claim 11 , wherein the polyhydric alcohol is in a concentration of about 5 wt. %.
17 . The topical gel formulation of claim 11 , wherein the gelling agent comprises carbomer homopolymer Type C.
18 . The topical gel formulation of claim 11 , wherein the gelling agent comprises Carbopol 980.
19 . The topical gel formulation of claim 11 , wherein the gelling agent is in a concentration of about 1.75 wt. %.
20 . The topical gel formulation of claim 11 , wherein the potassium hydroxide is in an amount to provide a pH of 5-6.
21 . The topical gel formulation of claim 11 , wherein the formulation is stable at room temperature for at least six weeks.
22 . The topical gel formulation of claim 11 , wherein the formulation is stable at room temperature for at least ten weeks.
23 . The topical gel formulation of claim 11 , wherein the formulation is stable at 36° F. to 46° F.
24 . The topical gel formulation of claim 11 , wherein the formulation is stable at or below 77° F. for at least 10 weeks.
25 . The topical gel formulation of claim 11 , wherein the plurality of benzoyl peroxide particles is homogeneously dispersed in the formulation.
26 . The topical gel formulation of claim 11 , wherein the plurality of benzoyl peroxide particles has a mean particle size between 1 and 50 microns.
27 . The topical gel formulation of claim 11 , wherein the plurality of adapalene particles is homogeneously dispersed in the formulation.
28 . The topical gel formulation of claim 11 , wherein the adapalene and the benzoyl peroxide do not undergo any detrimental interaction with one another.
29 . The topical gel formulation of claim 11 , wherein the formulation is free of additional agents as organic solvents other than the gelling agent or polyhydric alcohol.
30 . A topical gel formulation consisting essentially of:
1.2 wt. % clindamycin phosphate;
3.1 wt. % benzoyl peroxide comprising a plurality of benzoyl peroxide particles;
0.15% adapalene comprising a plurality of adapalene particles;
5% propylene glycol;
1.75% Carbopol 980;
potassium hydroxide in an amount to provide a pH of 5-6; and
water.