Pharmaceutical cream compositions and methods of use
View Patent ↗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.
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° C./60% RH, about 30° C./75% RH or about 40° C./75% RH.
7. The pharmaceutical composition of claim 1 , wherein the pH is unchanged after about 1 week storage at about 60° 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.