Apremilast pharmaceutical compositions and methods

Abstract

A topical pharmaceutical composition of apremilast used for the treatment of psoriasis and/or psoriatic arthritis is provided. It further relates to processes of preparation of the compositions and the method of use for these compositions.

1 . A method of treating inflammatory disease or disorder in a subject by topically administering a pharmaceutical composition comprising 0.5-10% of apremilast or its pharmaceutically acceptable salt by topically applying the composition to the affected skin of the subject for a period of time till the symptoms of psoriasis are abated. 
     
     
         2 . The method of  claim 1 , wherein the pharmaceutical composition further comprises a pharmaceutically acceptable carrier. 
     
     
         3 . The method of  claim 1 , wherein the inflammatory disease or disorder is psoriasis. 
     
     
         4 . The method of  claim 1 , wherein the inflammatory disease or disorder is psoriatic arthritis. 
     
     
         5 . The method of  claim 2 , wherein the pharmaceutically acceptable carrier is selected from the group comprising dimethyl sulfoxide (DMSO), glycerol, propylene glycol, petrolatum, water, or a mixture thereof. 
     
     
         6 . The method of  claim 2 , wherein the ratio of apremilast to pharmaceutically acceptable carrier is in the range of 1:100 to 100:1. 
     
     
         7 . The method of  claim 1 , wherein the pH of the pharmaceutical composition is maintained in the range from pH 3 to 8 using pH adjusting agents selected from hydrochloric acid, phosphoric acid, lactic acid, diethanolamine, triethanolamine, sodium hydroxide, monobasic sodium phosphate, dibasic sodium phosphate, or a mixture thereof. 
     
     
         8 . The method of  claim 1 , wherein the pharmaceutical composition comprises additional pharmaceutically acceptable excipients selected from the group comprising skin penetration enhancers, pharmaceutical surfactants, solubility enhancers, oil phase components, aqueous phase components, emulsifiers, anti-oxidants, vitamins, lubricants, preservatives, stabilizers, buffers and mixture thereof. 
     
     
         9 . The method of  claim 1 , wherein the subject is a human.