Pharmaceutical cream compositions of oxymetazoline and methods of use
AssigneeAclaris Therapeutics, Inc.
InventorsStuart D. SHANLER, Christopher POWALA
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Abstract
The present invention is directed to: a) a method of treating telangiectasia; b) a method of treating inflammatory lesions; and c) a method of treating two or more symptoms of rosacea selected from erythema, telangiectasia, or inflammatory lesions comprising topical administration of a pharmaceutical composition comprising oxymetazoline and a pharmaceutically acceptable excipient.
Claims34
-20. (canceled)
A method of treating erythema, telangiectasia or inflammatory lesions associated with rosacea comprising topically administering a pharmaceutical composition comprising a therapeutically effective amount of oxymetazoline or a pharmaceutically acceptable salt thereof, and about 1% to about 50% by weight of an emollient comprising medium chain triglycerides, diisopropyl adipate, oleyl alcohol, and lanolin.
The method of claim 2 1, wherein the pharmaceutically acceptable salt of oxymetazoline is oxymetazoline hydrochloride.
The method of claim 2 1 , wherein the composition further comprises an additive selected from the group consisting of emulsifiers, preservatives, emulsion stabilizers, pH adjusters, chelating agents, viscosity modifiers, anti-oxidants, surfactants, emollients, opacifying agents, skin conditioners, buffers, and combinations thereof.
The method of claim 2 5, wherein the topically active pharmaceutical or cosmetic agent is selected from a group consisting of an anti-rosacea agent, an antibacterial agent, an antimycobacterial agent, an anti-acne agent, an anti-parasitic agent, an antifungal agent, an steroidal anti-inflammatory agent, an non-steroidal anti-inflammatory agent, an anesthetic agent, an anti-pruriginous agent, an anti-free radical agent, an anti-seborrheic agent, an antipsoriatic agent, a tricyclic anti-depressant, an antihistamine, and a chemotherapeutic agent.
A method of treating erythema, telangiectasia or inflammatory lesions associated with rosacea comprising topically administering a pharmaceutical composition comprising
- about 1.0% by weight oxymetazoline HCl;
- about 20% by weight of an emulsifier, wherein the emulsifier comprises polyethylene glycol stearate (PEG-6 stearate), polyethylene glycol 32 stearate (PEG-32 stearate), glycol stearate, cetostearyl alcohol, ceteareth-6, and ceteareth-25;
- and
- about 23% of an emollient comprising anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, and oleyl alcohol;
- about 4% of a solvent;
- about 0.05% of butylated hydroxytoluene;
- about 0.01% of a disodium edetate;
- about 0.52% of a buffer comprising sodium citrate dihyrate and anhydrous citric acid;
- about 1.05% of a preservative comprising methylparaben, propylparaben, and phenoxyethanol;
- wherein the composition is a cream;
- wherein the ratio of the PEG-6 stearate, PEG-32 stearate and glycol stearate to the cetostearyl alcohol is about 1:1;
- wherein the ratio of the emulsifier to the emollient is about 0.87:1;
- and
- wherein the pH of the composition is about 4.5.
Dependencies are inferred from the claim text.