IP Library Granted Patent US 10,653,656
Granted Patent B2
US 10,653,656 · App. 16/108,942 · Granted May 19, 2020

Topical pharmaceutical compositions for treating skin conditions

Inventors: Varsha Bhatt (San Francisco, CA); Radhakrishnan Pillai (Santa Rosa, CA)
Assignee: Bausch Health Ireland Limited
A61K31/203A61K9/06A61K47/10A61K47/14A61K47/18A61K47/32A61K47/36A61K47/44A61P17/10
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Quick Facts
Patent No.
US 10,653,656
App. No.
16/108,942
Granted
May 19, 2020
Kind
B2
Abstract

In one aspect, topical pharmaceutical compositions for treating a skin condition or disorder are provided. In some embodiments, the topical pharmaceutical composition is formulated as a lotion and comprises a therapeutically effective amount of an active agent; a viscosity increasing agent; a polymeric emulsifier; and an oil component. In some embodiments, the topical pharmaceutical composition comprises tretinoin.

Claims (45)

1. A topical pharmaceutical composition for treating a skin condition or disorder, comprising:

an active agent in an amount from 0.01% to 1% by weight of the composition, wherein the active agent consists of tretinoin;

a polymeric emulsifier, wherein the polymeric emulsifier comprises a cross-linked copolymer of acrylic acid and C10-C30 alkyl acrylate, and wherein the polymeric emulsifier is present in an amount from 0.02% to 0.08% by weight of the composition;

a viscosity increasing agent, wherein the viscosity increasing agent comprises a cross-linked homopolymer of an acrylic acid, and wherein the viscosity increasing agent is present in an amount from 0.1% to 2% by weight of the composition;

a moisturizing agent, wherein the moisturizing agent comprises soluble collagen and sodium hyaluronate, and wherein the moisturizing agent is present in an amount from 5% to 10% by weight of the composition;

an oil component comprising one or more oils, wherein the oil component is present in an amount from 1% to 3.5% by weight of the composition, and wherein each oil in the oil component is independently selected from the group consisting of mineral oil, light mineral oil, petrolatum, fatty alcohols, monocarboxylic acid esters, dicarboxylic acid esters, medium-chain triglycerides, and long-chain triglycerides; and

water;

wherein the composition is formulated as a lotion.

2. The topical pharmaceutical composition of claim 1 , comprising the tretinoin in an amount of 0.05% by weight of the composition.

3. The topical pharmaceutical composition of claim 1 , wherein the polymeric emulsifier is a carbomer copolymer type B.

4. The topical pharmaceutical composition of claim 1 , wherein the oil component consists of mineral oil, light mineral oil, petrolatum, or a combination thereof.

5. The topical pharmaceutical composition of claim 1 , wherein the oil component consists of mineral oil.

6. The topical pharmaceutical composition of claim 1 , wherein the viscosity increasing agent is a carbomer homopolymer type A.

7. The topical pharmaceutical composition of claim 1 , wherein the viscosity increasing agent is present in an amount from 0.1% to 2% by weight of the composition.

8. The topical pharmaceutical composition of claim 7 , wherein the viscosity increasing agent is present in an amount from 0.6% to 1% by weight of the composition.

9. The topical pharmaceutical composition of claim 1 , wherein the composition has a viscosity from 2,500 cP to 18,000 cP.

10. The topical pharmaceutical composition of claim 9 , wherein the composition has a viscosity from 8,000 cP to 12,000 cP.

11. The topical pharmaceutical composition of claim 1 , further comprising one or more preservatives, antioxidants, and/or humectants.

12. The topical pharmaceutical composition of claim 1 , further comprising a neutralizing agent that maintains the pH of the composition at a pH from 5 to 6.

13. The topical pharmaceutical composition of claim 1 , comprising:

the tretinoin in an amount of 0.05% by weight of the composition;

the polymeric emulsifier in an amount of 0.05% by weight of the composition, wherein the polymeric emulsifier is a carbomer copolymer type B;

the viscosity increasing agent in an amount from 0.6% to 1% by weight of the composition; wherein the viscosity increasing agent is carbomer homopolymer type A;

the oil component in an amount up to 3% by weight of the composition, wherein the oil component consists of mineral oil;

the moisturizing agent in an amount from 5% to 10% by weight of the composition;

a humectant in an amount from 5% to 20% by weight of the composition, wherein the humectant is glycerin;

an antioxidant in an amount from 0.1% to 2% by weight of the composition, wherein the antioxidant is butylated hydroxytoluene;

a wetting agent in an amount from 0.05% to 0.5% by weight of the composition, wherein the wetting agent is octoxynol-9;

optionally, one or more preservatives in an amount from 0.25% to 5% by weight of the composition, wherein the preservatives are benzyl alcohol, methyl paraben, or a combination thereof; and

optionally, a neutralizing agent, wherein the neutralizing agent is trolamine.

14. The topical pharmaceutical composition of claim 1 , wherein the composition has a viscosity of less than 15,000 cP.

15. The topical pharmaceutical composition of claim 14 , wherein the composition has a viscosity from 8,000 cP to 12,000 cP.

16. A kit comprising the topical pharmaceutical composition of claim 1 .

17. A method for treating a skin condition or disorder, comprising administering the topical pharmaceutical composition of claim 1 to a subject in need thereof.

18. The method of claim 17 , wherein the skin condition or disorder is acne vulgaris.

19. The method of claim 17 , wherein the topical pharmaceutical composition is applied once daily to an affected area of skin.

20. A topical pharmaceutical composition for treating a skin condition or disorder, wherein the topical pharmaceutical composition is formulated as a lotion and comprises:

an active agent an amount of 0.05% by weight of the composition wherein the active agent consists of tretinoin;

a carbomer copolymer type B in an amount from 0.04% to 0.06% by weight of the composition;

a carbomer homopolymer type A in an amount from 0.2% to 1% by weight of the composition;

soluble collagen and sodium hyaluronate in an amount from 5% to 10% by weight of the composition;

an oil component in an amount up to 3.5% by weight of the composition, wherein the oil component consists of mineral oil;

one or more preservatives, antioxidants, humectants, wetting agents, and/or neutralizing agents; and

water.

21. A method for treating acne vulgaris, the method comprising applying to the skin of a subject having acne vulgaris the topical pharmaceutical composition of claim 20 .

Assignments (17)
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 HEALTH IRELAND LIMITED; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMA POLAND SPOLKA Z ORGANICZONA ODPOWIEDZIALNOSCIA; VALEANT SP. Z.O.O.
Reel/Frame 073637/0222 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH AMERICAS, INC.; 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.
Reel/Frame 073637/0126 →
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 →
SECURITY INTEREST Recorded Oct 5, 2021
From: BAUSCH & LOMB IRELAND LIMITED; BAUSCH HEALTH COMPANIES INC.; DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH; TECHNOLAS PERFECT VISION GMBH
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 057821/0800 →
SECURITY INTEREST Recorded Jan 21, 2021
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 054984/0345 →
SECURITY INTEREST Recorded Jan 21, 2021
From: BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, INC.; BAUSCH & LOMB INCORPORATED; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 054984/0324 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 3, 2019
From: BAUSCH HEALTH IRELAND LIMITED; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT PHARMACEUTICALS LUXEMBOURG S.À R.L.; VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA; VALEANT SP. Z O. O.
To: THE BANK OF NEW YORK MELLON, AS COLLATERAL AGENT
Reel/Frame 049672/0652 →
SECURITY INTEREST Recorded Mar 11, 2019
From: BAUSCH HEALTH AMERICAS, INC.; 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.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 048556/0758 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2019
From: DOW PHARMACEUTICAL SCIENCES, INC.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 048508/0880 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2018
From: BHATT, VARSHA; PILLAI, RADHAKRISHNAN
To: DOW PHARMACEUTICAL SCIENCES, INC.
Reel/Frame 046698/0245 →