IP Library Granted Patent US 12,133,859
Granted Patent B2
US 12,133,859 · App. 18/639,619 · Granted Nov 5, 2024

Topical compositions

Inventors: Varsha Bhatt (San Francisco, CA); Radhakrishnan Pillai (Santa Rosa, CA); Arturo Angel (Santa Rosa, CA)
Assignee: BAUSCH HEALTH IRELAND LIMITED
A61K31/7056A61K8/22A61K8/345A61K8/4913A61K8/731A61K9/0014A61K9/06A61K31/192A61K31/327A61K47/02A61K47/10A61K47/32A61P17/10A61Q19/005
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,133,859
App. No.
18/639,619
Granted
Nov 5, 2024
Kind
B2
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.

Claims (29)

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.

Assignments (6)
U.S. PATENT SECURITY AGREEMENT Recorded Nov 25, 2025
From: BAUSCH HEALTH IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 073715/0375 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 30, 2024
From: BHATT, VARSHA; PILLAI, RADHAKRISHNAN; ANGEL, ARTURO
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 069076/0260 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 3, 2024
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 068821/0550 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 3, 2024
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 068821/0559 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 3, 2024
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 068821/0568 →