Oral pharmaceutical composition of isotretinoin

Abstract

The present invention provides an oral pharmaceutical composition of isotretinoin with reduced food effect. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

1 - 33 . (canceled) 
     
     
         34 . An oral pharmaceutical composition comprising a micronized isotretinoin having d90 value of not more than 30 microns, wherein said composition is in the form of dispersion in a liquid vehicle and exhibits a reduced food effect. 
     
     
         35 . The oral pharmaceutical composition according to  claim 34 , wherein said composition comprises a low dose isotretinoin in an amount of about 36 mg, about 32 mg, about 28 mg, about 24 mg, about 20 mg, about 16 mg, or about 8 mg. 
     
     
         36 . The oral pharmaceutical composition according to  claim 34 , wherein said composition is further filled into capsules. 
     
     
         37 . The oral pharmaceutical composition according to  claim 34 , wherein the micronized isotretinoin has D 90  less than 25 μm, less than 20 μm, less than 15 μm, or less than 10 μm. 
     
     
         38 . The oral pharmaceutical composition according to  claim 34 , wherein the micronized isotretinoin further has D 50  is less than 20 μm, less than 15 μm, less than 10 μm, or less than 5 μm. 
     
     
         39 . The oral pharmaceutical composition according to  claim 34 , wherein the micronized isotretinoin further has D 10  is less than 10 μm, less than 8 μm, less than 7 μm, less than 5 μm, or less than 2 μm. 
     
     
         40 . The oral pharmaceutical composition according to  claim 34 , wherein the composition releases more than 50% of isotretinoin in 15 minutes in a 900 ml of media with a pH of 7.8 rotating at a 100 rpm in USP Type I apparatus. 
     
     
         41 . An oral pharmaceutical composition according to  claim 34  wherein the composition has a mean fed/fasted ratio of C max  of about 1.10. 
     
     
         42 . An oral pharmaceutical composition according to  claim 34  wherein the has a mean fed/fasted ratio of AUC 0-t  of about 1.26.