IP Library Granted Patent US 11,648,256
Granted Patent B2
US 11,648,256 · App. 17/993,817 · Granted May 16, 2023

Topical compositions and methods for treating psoriasis

Inventors: Gordon J. Dow (Greenbrae, CA); Radhakrishnan Pillai (Santa Rosa, CA); Varsha D. Bhatt (San Francisco, CA)
Assignee: Bausch Health Ireland Limited
A61K31/573A61K9/0014A61K9/06A61K9/107A61K9/12A61K31/192A61K31/4436A61K45/06A61K47/14A61K47/26A61K47/44
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Quick Facts
Patent No.
US 11,648,256
App. No.
17/993,817
Granted
May 16, 2023
Kind
B2
Abstract

Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.

Claims (53)

1. A topical pharmaceutical composition for treating psoriasis, the composition comprising:

halobetasol propionate at a concentration of 0.01 percent by weight of the composition;

tazarotene at a concentration of 0.045 percent by weight of the composition;

a liquid oil component, wherein the liquid oil component comprises one or more materials that are practically insoluble or insoluble in water and which are liquid at room temperature of 22° C.; and

an aqueous component;

wherein the pharmaceutical composition is formulated as a lotion.

2. The pharmaceutical composition of claim 1 , wherein the halobetasol propionate is dissolved in the liquid oil component at room temperature.

3. The pharmaceutical composition of claim 1 , wherein the tazarotene is dissolved in the liquid oil component at room temperature.

4. The pharmaceutical composition of claim 1 , wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic ester, or a combination thereof.

5. The pharmaceutical composition of claim 4 , wherein the liquid oil component comprises a dicarboxylic acid ester.

6. The pharmaceutical composition of claim 4 , wherein the liquid oil component comprises a monocarboxylic acid ester.

7. The pharmaceutical composition of claim 4 , wherein the liquid oil component further comprises mineral oil or light mineral oil.

8. The pharmaceutical composition of claim 7 , wherein the liquid oil component further comprises light mineral oil.

9. The pharmaceutical composition of claim 1 , wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, and/or thickening agents.

10. The pharmaceutical composition of claim 9 , wherein the composition further comprises an emulsifying agent.

11. The pharmaceutical composition of claim 1 , wherein the composition further comprises a pH adjusting agent.

12. The pharmaceutical composition of claim 1 , wherein the composition is capable of providing a synergistic efficacy when the composition is used to treat psoriasis.

13. The pharmaceutical composition of claim 1 , wherein the composition is capable of providing a synergistic reduction is at least one adverse event when the composition is used to treat psoriasis, wherein the adverse event is selected from the group consisting of itching, burning, stinging, and combinations thereof.

14. A pharmaceutical composition for topical application to the skin of an individual, the composition comprising:

halobetasol propionate at a concentration of 0.01 percent by weight of the composition;

tazarotene at a concentration of 0.045 percent by weight of the composition;

a liquid oil component, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof; and

an aqueous component;

wherein the pharmaceutical composition is formulated as a lotion.

15. The topical pharmaceutical composition of claim 14 , wherein the composition further comprises a surfactant, an emulsifying agent, a thickening agent, a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent.

16. A topical pharmaceutical composition for treating psoriasis, the composition comprising:

halobetasol propionate at a concentration of 0.01 percent by weight of the composition;

tazarotene at a concentration of 0.045 percent by weight of the composition;

a liquid oil component, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof, and light mineral oil; and

an aqueous component, wherein the aqueous component comprises purified water;

a carbomer copolymer type B; and

a carbomer homopolymer type A;

wherein the pharmaceutical composition is formulated as a lotion.

17. The topical pharmaceutical composition of claim 16 , wherein the composition further comprises a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent.

18. A method for treating psoriasis, the method comprising topically applying a pharmaceutical composition to an affected area on a body of a subject suffering from psoriasis, wherein the composition comprises:

halobetasol propionate at a concentration of 0.01 percent by weight of the composition;

tazarotene at a concentration of 0.045 percent by weight of the composition;

a liquid oil component, wherein the liquid oil component comprises one or more materials that are practically insoluble or insoluble in water and which are liquid at room temperature of 22° C.; and

an aqueous component;

wherein the pharmaceutical composition is formulated as a lotion; and

wherein the composition is capable of providing synergistic efficacy.

19. The method of claim 18 , wherein said applying is carried out once daily for longer than two weeks.

20. The method of claim 19 , wherein the method continues to provide relief for a period of four weeks after eight weeks of applying the composition to the affected area on the body of the subject.

21. The method of claim 18 , wherein said applying is carried out once daily for twelve weeks.

22. The method of claim 18 , wherein the halobetasol propionate is dissolved in the liquid oil component at room temperature, wherein the tazarotene is dissolved in the liquid oil component at room temperature, or wherein both the halobetasol propionate and the tazarotene are dissolved in the liquid oil component at room temperature.

23. The method of claim 18 , wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic ester, or a combination thereof.

24. The method of claim 23 , wherein the liquid oil component comprises a dicarboxylic acid ester.

25. The method of claim 23 , wherein the liquid oil component comprises a monocarboxylic acid ester.

26. The method of claim 23 , wherein the liquid oil component further comprises mineral oil or light mineral oil.

27. The method of claim 23 , wherein the liquid oil component further comprises light mineral oil.

28. The method of claim 18 , wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, thickening agents, and/or a pH adjusting agent.

29. The method of claim 28 , wherein the composition further comprises an emulsifying agent.

30. The method of claim 18 , wherein the composition is capable of providing a synergistic reduction is at least one adverse event, wherein the adverse event is selected from the group consisting of itching, burning, stinging, and combinations thereof.

Assignments (8)
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 Mar 6, 2023
From: BAUSCH HEALTH US, LLC
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 062894/0410 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 6, 2023
From: DOW, GORDON J.; PILLAI, RADHAKRISHNAN; BHATT, VARSHA D.
To: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Reel/Frame 062894/0144 →
CHANGE OF NAME Recorded Mar 6, 2023
From: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
To: BAUSCH HEALTH US, LLC
Reel/Frame 062960/0900 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062853/0695 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062853/0729 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 062853/0655 →