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Last Updated: October 29, 2020

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Claims for Patent: 8,883,838

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Summary for Patent: 8,883,838
Title:Pharmaceutical cream compositions and methods of use
Abstract: The present invention provides pharmaceutical cream compositions comprising oxymetazoline and methods for treating rosacea and other skin disorders as described herein using the above cream compositions.
Inventor(s): Shanler; Stuart D. (Pomona, NY), Powala; Christopher (Radnor, PA), Rios; Luis (Pembroke Pines, FL)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:13/309,403
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,883,838
Patent Claims: 1. A pharmaceutical composition comprising: about 0.0075% to about 2% by weight of oxymetazoline; about 1% to about 50% by weight of an emollient comprising medium chain triglycerides, diisopropyl adipate, oleyl alcohol and lanolin; about 8% to about 25% by weight of an emulsifier comprising: cetostearyl alcohol, about 7% to about 10% by weight of PEG-6 stearate/PEG-32 stearate/glycol stearate mixture, macrogol (6) cetostearyl ether, and macrogol (25) cetostearyl ether; wherein the composition is a cream.

2. The pharmaceutical composition of claim 1, having an emulsifier to emollient ratio of from about 0.7:1 to about 1.8:1.

3. The pharmaceutical composition of claim 1, further comprising an additive selected from the group consisting of preservatives, emulsion stabilizers, pH adjusters, chelating agents, viscosity modifiers, anti-oxidants, opacifying agents, skin conditioners, buffers, and combinations thereof.

4. The pharmaceutical composition of claim 1, wherein the composition further comprises a topically active pharmaceutical agent selected from the group consisting of an antimycobacterial agent, an anti-rosacea agent, and a mixture thereof.

5. The pharmaceutical composition of claim 1, wherein the composition has a pH from about 2.0 to about 7.0 at room temperature.

6. The pharmaceutical composition of claim 1, wherein the pH is unchanged after about 4 weeks storage at about 25.degree. C./60% RH, about 30.degree. C./75% RH or about 40.degree. C./75% RH.

7. The pharmaceutical composition of claim 1, wherein the pH is unchanged after about 1 week storage at about 60.degree. C.

8. The pharmaceutical composition of claim 1, further comprising a vasoconstrictor.

9. The pharmaceutical composition of claim 1, further comprising one or more components selected from: one or more preservatives in an amount of from about 0.01% to about 5% by weight of the pharmaceutical composition; one or more chelating agents in an amount of about 0.001% to about 2% by weight of the pharmaceutical composition; one or more viscosity modifiers in an amount of from about 0.5% to about 30% by weight of the pharmaceutical composition; one or more antioxidants in an amount of from about 0.01% to about 3% by weight of the pharmaceutical composition; one or more opacifying agents in an amount of from about 0.01% to about 20% by weight of the pharmaceutical composition; one or more skin conditioners in an amount of from about 1% to about 50% by weight of the pharmaceutical composition; one or more pH regulators in an amount sufficient to provide a pH of from about 2.5 to about 7.0 for the pharmaceutical composition; and combinations thereof.

10. The pharmaceutical composition of claim 1, which is physically and chemically stable.

11. The pharmaceutical composition of claim 1, wherein the emollient comprises about 7% by weight of medium chain triglycerides, about 7% by weight of diisopropyl adipate, about 7% by weight of oleyl alcohol and about 2% by weight of lanolin.

12. The pharmaceutical composition of claim 1, which comprises about 2% by weight of macrogol (6) cetostearyl ether and about 2% by weight of macrogol (25) cetostearyl ether.

13. The pharmaceutical composition of claim 1, which comprises about 7% to about 8% by weight of PEG-6 stearate/PEG-32 stearate/glycol stearate mixture.

14. The pharmaceutical composition of claim 1, which comprises about 4% to about 8% by weight of cetostearyl alcohol.

15. The pharmaceutical composition of claim 1, further comprising 0.01% to about 5% by weight of a preservative comprising methylparaben, propylparaben, and phenoxyethanol.

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