IP Library › Granted Patent US 8,784,780

Granted Patent B2

US 8,784,780 · App. 13/046,088 · Granted Jul 22, 2014

High oil-content emollient aerosol foam compositions

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Patent No.: US 8,784,780
App. No.: 13/046,088
Granted: Jul 22, 2014
Kind: B2

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Abstract

Described herein are high oil-content emulsions and compositions for the treatment of inflammatory skin disorders. The emulsions may be formulated as aerosol compositions. The aerosol propellant may be a hydrofluoroalkane propellant. The emulsions or compositions may comprise active agents, such as corticosteroids. Also described are methods of treating inflammatory skin disorders, 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 (172)

1. A method of treating an inflammatory skin disorder, comprising the step of applying to an affected area of a subject in need thereof a therapeutically-effective amount of a composition comprising:

an emulsion, wherein the emulsion comprises

Ceteth-20, from about 1% to about 5% by weight of the emulsion;

cetostearyl alcohol, from about 3% to about 9% by weight of the emulsion;

mineral oil, from about 1% to about 18% by weight of the emulsion;

petrolatum, from about 3% to about 11% by weight of the emulsion;

dimethicone, from about 0.5% to about 2.0% by weight of the emulsion;

butylated hydroxytoluene, from about 0.01% to about 0.05% by weight of the emulsion;

water, from about 27% to about 82% by weight of the emulsion;

glycerin, from about 2.5% to about 7.5% by weight of the emulsion;

urea, from about 0.3% to about 0.9% by weight of the emulsion;

citric acid, from about 0.2% to about 0.6% by weight of the emulsion;

sodium citrate, from about 0.1% to about 0.5% 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 0.20% by weight of the emulsion; and

an active agent, from about 0.002% to about 0.20% by weight of the emulsion;

a propellant; and

a purge gas.

2. The method of claim 1 , wherein the inflammatory skin disorder is selected from the group consisting of psoriasis, atopic dermatitis, contact dermatitis, xerotic eczema, seborrheic dermatitis, discoid eczema, venous eczema, acne, rosacea, poison ivy, hives, and occupational dermatitis.

3. The method of claim 2 , wherein the subject is human.

4. The method of claim 3 , wherein the affected area of the subject is the face, earlobes, neck, scalp, genitals, eyelids, palms, fingers, feet, exural surfaces of joints, or extensor aspects of joints.

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

6. The method of claim 1 , wherein the active agent is selected from the group consisting of corticosteroids, vitamin D analogues, retinoids, immunomodulators, antifungals, and combinations/mixtures thereof.

7. The method of claim 1 , wherein the active agent is selected from the group consisting of hydrocortisone, hydroxyl-triamcinolone, alpha-methyl dexamethasone, dexamethasone-phosphate, beclomethasone dipropionates, clobetasol valerate, desonide, desoxymethasone, desoxycorticosterone acetate, dexamethasone, dichlorisone, diflorasone diacetate, diflucortolone valerate, fluadrenolone, fluclorolone acetonide, fludrocortisone, flumethasone pivalate, fluosinolone acetonide, fluocinonide, flucortine butylesters, fluocortolone, fluprednidene acetate, flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone, triamcinolone acetonide, cortisone, cortodoxone, flucetonide, fludrocortisone, difluorosone diacetate, fluradrenolone, fludrocortisone, difluorosone diacetate, fluradrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone dipropionate, chloroprednisone, chlorprednisone acetate, clocortelone, clescinolone, dichlorisone, diflurprednate, flucloronide, flunisolide, fluoromethalone, fluperolone, fluprednisolone, hydrocortisone valerate, hydrocortisone cyclopentylpropionate, hydrocortamate, meprednisone, paramethasone, prednisolone, prednisone, beclomethasone dipropionate, triamcinolone, and combinations/mixtures thereof.

8. The method of claim 1 , wherein the active agent is selected from the group consisting of hydrocortisone butyrate, betamethasone dipropionate, and combinations/mixtures thereof.

9. The method of claim 1 , wherein the active agent is selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin K, vitamin D analogue calcipotriene, vitamin D analogue calcipotriol, and combinations/mixtures thereof.

10. The method of claim 1 , wherein the active agent is selected from the group consisting of retinoids, retinoic acid, tretinoin, and combinations/mixtures thereof.

11. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 54.46% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

hydrocortisone butyrate, in about 0.10% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

12. The method of claim 1 , wherein

the emulsion comprises

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 55.46% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

hydrocortisone butyrate, in about 0.10% by weight of the emulsion; and

the emulsion further comprises

safflower oil, in about 6.75% by weight of the emulsion;

oleic acid, in about 0.50% by weight of the emulsion; and

stearic acid, in about 0.50% by weight of the emulsion.

13. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.51% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

betamethasone dipropionate, in about 0.05% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

14. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 2.38% by weight of the emulsion;

petrolatum, in about 6.85% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.51% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

betamethasone dipropionate, in about 0.05% by weight of the emulsion; and

the emulsion further comprises

oleic acid, in about 7.40% by weight of the emulsion; and

oleyl alcohol, in about 10.00% by weight of the emulsion.

15. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.54% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

tretinoin, in about 0.02% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

16. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.555% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion; and

calcipotriene, in about 0.005% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

17. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.505% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion;

betamethasone dipropionate, in about 0.05% by weight of the emulsion; and

calcipotriene, in about 0.005% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

18. The method of claim 1 , wherein

the emulsion comprises:

Ceteth-20, in about 3.00% by weight of the emulsion;

cetostearyl alcohol, in about 6.00% by weight of the emulsion;

mineral oil, in about 12.38% by weight of the emulsion;

petrolatum, in about 7.50% by weight of the emulsion;

dimethicone, in about 1.00% by weight of the emulsion;

butylated hydroxytoluene, in about 0.03% by weight of the emulsion;

water, in about 56.49% by weight of the emulsion;

glycerin, in about 5.00% by weight of the emulsion;

urea, in about 0.64% by weight of the emulsion;

citric acid, in about 0.42% by weight of the emulsion;

sodium citrate, in about 0.32% by weight of the emulsion;

methylparaben, in about 0.30% by weight of the emulsion;

propylparaben, in about 0.10% by weight of the emulsion;

betamethasone dipropionate, in about 0.05% by weight of the emulsion; and

tretinoin, in about 0.02% by weight of the emulsion; and

the emulsion further comprises safflower oil, in about 6.75% by weight of the emulsion.

19. 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.

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

Assignments (22)

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 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 & 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 →

U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025

From: MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC); PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; BAUSCH HEALTH AMERICAS, INC.; SOLTA MEDICAL, INC.

To: JPMORGAN CHASE BANK, N.A.

Reel/Frame 071566/0200 →

U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025

To: THE BANK OF NEW YORK MELLON

Reel/Frame 071564/0463 →

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 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

To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT

Reel/Frame 061595/0066 →

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

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

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