IP Library Granted Patent US 11,679,115
Granted Patent B2
US 11,679,115 · App. 17/154,591 · Granted Jun 20, 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 11,679,115
App. No.
17/154,591
Granted
Jun 20, 2023
Kind
B2
Abstract

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

Claims (43)

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

(a) halobetasol propionate at a concentration of about 0.01% by weight of the composition;

(b) tazarotene at a concentration of about 0.045% by weight of the composition; and

(c) a dermatologically acceptable carrier comprising:

diethyl sebacate at a concentration of about 2.5% to 3.5% by weight of the composition, a mineral oil at a concentration of about 7.5% to 8.5% by weight of the composition, carbomer copolymer type B at a concentration of about 0.3% to 0.5% by weight of the composition,

carbomer homopolymer type A at a concentration of about 0.5% to about 0.7% by weight of the composition, and

purified water.

2. The topical pharmaceutical composition of claim 1 , further comprising one or more components selected from the group consisting of a surfactant, a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent.

3. The topical pharmaceutical composition of claim 2 , wherein the surfactant is sorbitan monooleate, which is present at a concentration of about 0.05% to 0.2% by weight of the composition.

4. The topical pharmaceutical composition of claim 2 , wherein the humectant is sorbitol solution (70%), which is present at a concentration of about 10% to about 11% by weight of the composition.

5. The topical pharmaceutical composition of claim 2 , wherein the antimicrobial preservatives consist of methyl paraben, which is present at a concentration of about 0.1% to about 0.2% by weight of the composition, and propyl paraben, which is present at a concentration of about 0.02% to about 0.04% by weight of the composition.

6. The topical pharmaceutical composition of claim 2 , wherein the chelating agent is edetate disodium dihydrate, which is present at a concentration of about 0.03% to about 0.06% by weight of the composition.

7. The topical pharmaceutical composition of claim 2 , wherein the pH adjusting agent is sodium hydroxide, which is present in an amount to provide a pH of 5.5±0.5.

8. The topical pharmaceutical composition of claim 1 , further comprising a surfactant, a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent.

9. The topical pharmaceutical composition of claim 8 , wherein the surfactant is sorbitan monooleate, which is present at a concentration of about 0.05% to 0.2% by weight of the composition.

10. The topical pharmaceutical composition of claim 9 , wherein the humectant is sorbitol solution (70%), which is present at a concentration of about 10% to about 11% by weight of the composition.

11. The topical pharmaceutical composition of claim 10 , wherein the antimicrobial preservatives consist of methyl paraben, which is present at a concentration of about 0.1% to about 0.2% by weight of the composition, and propyl paraben, which is present at a concentration of about 0.02% to about 0.04% by weight of the composition.

12. The topical pharmaceutical composition of claim 11 , wherein the chelating agent is edetate disodium dihydrate, which is present at a concentration of about 0.03% to about 0.06% by weight of the composition.

13. The topical pharmaceutical composition of claim 12 , wherein the pH adjusting agent is sodium hydroxide, which is present in an amount to provide a pH of 5.5±0.5.

14. The topical pharmaceutical composition of claim 8 , wherein:

the diethyl sebacate is present at a concentration of about 2.97% by weight of the composition,

the mineral oil is light mineral oil, which is present at a concentration of about 8.03% by weight of the composition,

the carbomer copolymer type B is present at a concentration of about 0.4% by weight of the composition,

the carbomer homopolymer type A is present at a concentration of about 0.6% by weight of the composition,

the surfactant is sorbitan monooleate, which is present at a concentration of about 0.1% by weight of the composition,

the humectant is sorbitol solution (70%), which is present at a concentration of about 10.7% by weight of the composition,

the antimicrobial preservatives consist of methyl paraben, which is present at a concentration of about 0.17% by weight of the composition, and propyl paraben, which is present at a concentration of about 0.03% by weight of the composition,

the chelating agent is edetate disodium dihydrate, which is present at a concentration of about 0.05% by weight of the composition, and

the pH adjusting agent is sodium hydroxide, which is present in an amount to provide a pH of 5.5±0.5.

15. A method of treating psoriasis, the method comprising topically applying a pharmaceutical composition according to claim 1 to an affected area of a body of a subject suffering from psoriasis, wherein the applying is carried out one or more times per day for a period of time sufficient to treat the psoriasis.

16. The method of claim 15 , wherein the applying is carried out once per day for eight weeks.

17. The method of claim 15 , wherein:

the diethyl sebacate is present at a concentration of about 2.97% by weight of the composition,

the mineral oil is light mineral oil, which is present at a concentration of about 8.03% by weight of the composition,

the carbomer copolymer type B is present at a concentration of about 0.4% by weight of the composition,

the carbomer homopolymer type A is present at a concentration of about 0.6% by weight of the composition,

and wherein the composition further comprises:

sorbitan monooleate at a concentration of about 0.1% by weight of the composition,

sorbitol solution (70%), at a concentration of about 10.7% by weight of the composition,

methyl paraben at a concentration of about 0.17% by weight of the composition,

propyl paraben at a concentration of about 0.03% by weight of the composition,

edetate disodium dihydrate at a concentration of about 0.05% by weight of the composition, and

sodium hydroxide in an amount to provide a pH of 5.5±0.5.

Assignments (18)
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 Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
Reel/Frame 073654/0242 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
Reel/Frame 073654/0300 →
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 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062078/0276 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061882/0708 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY INTEREST Recorded Jun 13, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 060346/0705 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2022
From: BAUSCH HEALTH US, LLC
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 060038/0057 →
SECURITY AGREEMENT Recorded Feb 10, 2022
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 059121/0001 →
SECURITY INTEREST Recorded Aug 25, 2021
From: BAUSCH HEALTH IRELAND LIMITED; BAUSCH+LOMB IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 057287/0160 →
SECURITY INTEREST Recorded Aug 25, 2021
From: BAUSCH HEALTH IRELAND LIMITED; BAUSCH+LOMB IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 057287/0140 →
CHANGE OF NAME Recorded Jul 13, 2021
From: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
To: BAUSCH HEALTH US, LLC
Reel/Frame 056849/0553 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: DOW, GORDON J.; PILLAI, RADHAKRISHNAN; BHATT, VARSHA D.
To: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Reel/Frame 056837/0351 →
SECURITY INTEREST Recorded Jun 8, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056811/0814 →
SECURITY INTEREST Recorded May 20, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH + LOMB IRELAND LIMITED; BAUSCH HEALTH US, LLC; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056304/0581 →
SECURITY INTEREST Recorded May 20, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH + LOMB IRELAND LIMITED; BAUSCH HEALTH US, LLC; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 056304/0556 →