Pharmaceutical cream compositions of oxymetazoline and methods of use

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.

What is claimed is: 
     
         1 . A method of treating 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 a pharmaceutically acceptable excipient. 
     
     
         2 . The method of  claim 1 , wherein the inflammatory lesions are selected from the group consisting of papules, pustules, cysts and phymas. 
     
     
         3 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of oxymetazoline is oxymetazoline hydrochloride. 
     
     
         4 . The method of  claim 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. 
     
     
         5 . The method of  claim 1 , wherein the composition further comprises a topically active pharmaceutical or cosmetic agent. 
     
     
         6 . The method of  claim 5 , wherein the topically active pharmaceutical or cosmetic agent is selected from a group consisting of an anti-rosacea agent, an antibacterial agent, an antimycobaterial 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. 
     
     
         7 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount of from about 0.0075% to about 5% by weight. 
     
     
         8 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount of from about 0.0075% to about 3% by weight. 
     
     
         9 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 2.5% by weight. 
     
     
         10 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 2% by weight. 
     
     
         11 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 1% by weight. 
     
     
         12 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.5% by weight. 
     
     
         13 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.25% by weight. 
     
     
         14 . The method of  claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.15% by weight. 
     
     
         15 . The method of  claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 30 days after final administration of the composition. 
     
     
         16 . The method of  claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 20 days after final administration of the composition. 
     
     
         17 . The method of  claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 10 days after final administration of the composition. 
     
     
         18 . The method of  claim 1 , wherein the composition further comprises an additional therapeutic for the treatment of non-inflammatory manifestations of rosacea such as telangiectasias, erythema, epidermal barrier dysfunction, or other manifestation of rosacea. 
     
     
         19 . The method of  claim 18 , wherein the additional therapeutic is selected from the group consisting of a selective alpha-1 adrenoreceptor agonist, a selective alpha-2 adrenoreceptor agonist, a non-selective alpha-1 adrenoreceptor agonist, a non-selective alpha-2 adrenoreceptor agonist, and a combination thereof. 
     
     
         20 . The method of  claim 1 , wherein administration of the composition is in combination with another therapy directed toward the treatment of inflammatory lesions.