Oral pharmaceutical composition of isotretinoin

Abstract

The present invention provides an oral pharmaceutical composition of isotretinoin having enhanced bioavailability. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

1 - 41 . (canceled) 
     
     
         42 . A process for preparing an oral pharmaceutical composition of isotretinoin having enhanced bioavailability comprising:
 (a) isotretinoin;   (b) meglumine;   (c) a surfactant;   (d) a surface stabilizer; and   (e) a carrier substrate;   
       wherein the process comprises:
 i. dissolving/dispersing meglumine, a surfactant, and a surface stabilizer in water; 
 ii. dispersing isotretinoin into the solution/dispersion of step i; 
 iii. milling the dispersion of step ii in a milling apparatus; 
 iv. adsorbing the milled dispersion of step iii onto a carrier substrate to obtain solid particles, powder, or granules; and 
 v. filling the solid particles, powder, or granules of step iv into capsules or processing the solid particles, powder, or granules of step iv with tablet adjuvants and compressing into tablets. 
 
     
     
         43 . The process according to  claim 42 , wherein in step i, an antioxidant is added. 
     
     
         44 . The process according to  claim 42 , wherein the pH of the dispersion obtained in step iii, or the solid particles, powder, or granules obtained in step iv, when dispersed in water, ranges from 3 to 11. 
     
     
         45 . The process according to  claim 42 , wherein the pH of the dispersion obtained in step iii, or the solid particles, powder, or granules obtained in step iv, when dispersed in water, ranges from 7 to 10.