IP Library › Granted Patent US 8,592,380
Granted Patent B2
US 8,592,380 · App. 13/053,524 · Granted Nov 26, 2013

Aerosol foams comprising clindamycin phosphate

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Quick Facts
Patent No.
US 8,592,380
App. No.
13/053,524
Granted
Nov 26, 2013
Kind
B2
Abstract

Described herein are emulsions and compositions for the treatment of acne vulgaris. The emulsions may be formulated as aerosol compositions. The aerosol propellant may be a hydrofluoroalkane propellant. The emulsions or compositions may comprise clindamycin phosphate and a buffer salt, and may exhibit decreased rates of clindamycin phosphate hydrolysis. Also described are methods of treating acne vulgaris, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of an inventive emulsion or aerosol composition.

Claims (101)

1. A method of treating acne vulgaris, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of a composition, wherein the composition comprises

an emulsion, wherein the emulsion comprises:

cetostearyl alcohol, from about 1% to about 3% by weight of the emulsion;

emulsifying wax, from about 1% to about 3% by weight of the emulsion;

steareth-10, from about 0.3% to about 1.1% by weight of the emulsion;

dimethicone, from about 0.5% to about 1.5% by weight of the emulsion;

water, from about 65% to about 90% by weight of the emulsion;

clindamycin phosphate, from about 0.5% to about 1.8% by weight of the emulsion;

glycerol, from about 6% to about 18% by weight of the emulsion;

disodium EDTA, from about 0.05% to about 0.2% by weight of the emulsion;

methylparaben, from about 0.1% to about 0.5% by weight of the emulsion;

propylparaben, from about 0.05% to about 0.2% by weight of the emulsion;

sodium hydroxide, from about 0.005% to about 0.05% by weight of the emulsion; and

sodium phosphate monobasic, from about 0.1% to about 1.5% by weight of the emulsion;

a propellant; and

a purge gas.

2. The method of claim 1 , wherein the acne vulgaris is comedonal, papulo-pustular, or nodular.

3. The method of claim 1 , wherein the affected area is the face, chest, or back.

4. The method of claim 1 , wherein the emulsion or composition is applied once daily or twice daily.

5. The method of claim 1 , wherein the composition comprises:

an emulsion, wherein the emulsion comprises:

cetostearyl alcohol, in about 2.0% by weight of the emulsion;

emulsifying wax, in about 2.0% by weight of the emulsion;

steareth-10, in about 0.8% by weight of the emulsion;

dimethicone, in about 1.0% by weight of the emulsion;

water, in about 79.7% by weight of the emulsion;

clindamycin phosphate, in about 1.2% by weight of the emulsion;

glycerol, in about 12.5% by weight of the emulsion;

disodium EDTA, in about 0.1% by weight of the emulsion;

methylparaben, in about 0.3% by weight of the emulsion;

propylparaben, in about 0.1% by weight of the emulsion;

sodium hydroxide, in about 0.01% by weight of the emulsion; and

sodium phosphate monobasic, in about 0.3% by weight of the emulsion;

a propellant; and

a purge gas.

6. The method of claim 1 , wherein the composition comprises:

an emulsion, wherein the emulsion comprises:

cetostearyl alcohol, in about 2.0% by weight of the emulsion;

emulsifying wax, in about 2.0% by weight of the emulsion;

steareth-10, in about 0.8% by weight of the emulsion;

dimethicone, in about 1.0% by weight of the emulsion;

water, in about 79.0% by weight of the emulsion;

clindamycin phosphate, in about 1.2% by weight of the emulsion;

glycerol, in about 12.5% by weight of the emulsion;

disodium EDTA, in about 0.1% by weight of the emulsion;

methylparaben, in about 0.3% by weight of the emulsion;

propylparaben, in about 0.1% by weight of the emulsion;

sodium hydroxide, in about 0.03% by weight of the emulsion; and

sodium phosphate monobasic, in about 1.0% by weight of the emulsion;

a propellant; and

a purge gas.

7. The method of claim 1 , wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and combinations/mixtures thereof.

8. The method of claim 1 , wherein the purge gas is selected from the group consisting of nitrogen and argon.

9. The method of claim 1 , wherein the composition consists essentially of:

an emulsion, wherein the emulsion consists essentially of:

cetostearyl alcohol, from about 1% to about 3% by weight of the emulsion;

emulsifying wax, from about 1% to about 3% by weight of the emulsion;

steareth-10, from about 0.3% to about 1.1% by weight of the emulsion;

dimethicone, from about 0.5% to about 1.5% by weight of the emulsion;

water, from about 65% to about 90% by weight of the emulsion;

clindamycin phosphate, from about 0.5% to about 1.8% by weight of the emulsion;

glycerol, from about 6% to about 18% by weight of the emulsion;

disodium EDTA, from about 0.05% to about 0.2% by weight of the emulsion;

methylparaben, from about 0.1% to about 0.5% by weight of the emulsion;

propylparaben, from about 0.05% to about 0.2% by weight of the emulsion;

sodium hydroxide, from about 0.005% to about 0.05% by weight of the emulsion; and

sodium phosphate monobasic, from about 0.1% to about 1.5% by weight of the emulsion;

a propellant; and

a purge gas.

10. The method of claim 1 , wherein the composition consists essentially of:

an emulsion, wherein the emulsion consists essentially of:

cetostearyl alcohol, in about 2.0% by weight of the emulsion;

emulsifying wax, in about 2.0% by weight of the emulsion;

steareth-10, in about 0.8% by weight of the emulsion;

dimethicone, in about 1.0% by weight of the emulsion;

water, in about 79.7% by weight of the emulsion;

clindamycin phosphate, in about 1.2% by weight of the emulsion;

glycerol, in about 12.5% by weight of the emulsion;

disodium EDTA, in about 0.1% by weight of the emulsion;

methylparaben, in about 0.3% by weight of the emulsion;

propylparaben, in about 0.1% by weight of the emulsion;

sodium hydroxide, in about 0.01% by weight of the emulsion; and

sodium phosphate monobasic, in about 0.3% by weight of the emulsion;

a propellant; and

a purge gas.

11. The method of claim 1 , wherein the composition consists essentially of:

an emulsion, wherein the emulsion consists essentially of:

cetostearyl alcohol, in about 2.0% by weight of the emulsion;

emulsifying wax, in about 2.0% by weight of the emulsion;

steareth-10, in about 0.8% by weight of the emulsion;

dimethicone, in about 1.0% by weight of the emulsion;

water, in about 79.0% by weight of the emulsion;

clindamycin phosphate, in about 1.2% by weight of the emulsion;

glycerol, in about 12.5% by weight of the emulsion;

disodium EDTA, in about 0.1% by weight of the emulsion;

methylparaben, in about 0.3% by weight of the emulsion;

propylparaben, in about 0.1% by weight of the emulsion;

sodium hydroxide, in about 0.03% by weight of the emulsion; and

sodium phosphate monobasic, in about 1.0% by weight of the emulsion;

a propellant; and

a purge gas.

Assignments (16)
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: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 073637/0001 →
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 & 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 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 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 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 →
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 →
SECURITY INTEREST Recorded Feb 26, 2018
From: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 045444/0299 →
SECURITY INTEREST Recorded Feb 26, 2018
From: ATON PHARMA, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH & LOMB PHARMA HOLDINGS CORP.; COMMONWEALTH LABORATORIES, LLC; DOW PHARMACEUTICAL SCIENCES, INC.; ECR PHARMACEUTICALS CO., INC.; LABORATOIRE CHAUVIN S.A.S.; MEDICIS PHARMACEUTICAL CORPORATION; ONPHARMA INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; SOLTA MEDICAL, INC.; SYNERGETICS USA, INC.; TECHNOLAS PERFECT VISION GMBH; VALEANT CANADA LP; VALEANT PHARMACEUTICALS INTERNATIONAL; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS NORTH AMERICA LLC; WIRRA IP PTY LIMITED; VALEANT PHARMA POLAND SP. Z O.O.; VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L.; VALEANT PHARMACEUTICALS IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS COLLATERAL AGENT
Reel/Frame 045444/0634 →
SECURITY INTEREST Recorded Jul 19, 2017
From: PRECISION DERMATOLOGY, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 043041/0864 →
SECURITY AGREEMENT Recorded Jul 6, 2015
From: ECR PHARMACEUTICALS CO., INC.; PRECISION DERMATOLOGY, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 036091/0257 →
RELEASE OF SECURITY INTEREST Recorded Sep 27, 2013
From: MIDCAP FUNDING III, LLC
To: PRECISION DERMATOLOGY COMPANY, INC.; ONSET DERMATOLOGICS, LLC; PROSKIN, LLC; PRECISION MD, LLC; TP CREAM SUB, LLC; TP LOTION SUB, LLC
Reel/Frame 031296/0492 →
SECURITY AGREEMENT Recorded May 18, 2012
From: PRECISION DERMATOLOGY, INC.; ONSET DERMATOLOGICS, LLC; PROSKIN LLC; PRECISION MD LLC; TP CREAM SUB, LLC; TP LOTION SUB, LLC
To: MIDCAP FUNDING III, LLC
Reel/Frame 028234/0424 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2011
From: TRUMBORE, MARK W.; SCHILLING, WENDY; VARANASI, RAVI K.
To: PRECISION DERMATOLOGY, INC.
Reel/Frame 026230/0241 →