Patent ID: 9089534
Filing Date: 2015-07-28
Classification: A61K,A61P

Abstract:
1. An oral pharmaceutical composition of isotretinoin in the form of a capsule comprising about 16 mg of isotretinoin and one or more excipients in the form of a semi-solid paste contained within the capsule, the paste consisting essentially of an oil and a glyceroyl macrogolglyceride of HLB of at least 10 to improve the bioavailability of the isotretinoin, wherein the composition exhibits a total amount of isotretinoin absorbed that is bioequivalent to a commercially available capsule composition containing 20 mg of isotretinoin (Roaccutane) upon administration to a human subject, wherein the bioequivalence of the total amount of isotretinoin absorbed is established by a 90% confidence interval for AUC 0-∞ which is between 80% and 125% upon administration with food.