Low dose oral pharmaceutical composition of isotretinoin
AssigneeSun Pharmaceutical Industries Limited
InventorsHarish Kumar Madan, Rathinasabapathy Venkateshwaran, Sumit Madan, Ravi Kochhar
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Abstract
The present invention provides a low dose oral pharmaceutical composition of isotretinoin having reduced food effect, in particular no food effect. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.
Claims9
An oral pharmaceutical composition in the form of a capsule comprising isotretinoin and a pharmaceutically acceptable excipient, wherein the composition has a mean Cmax value in the range of about 9 ng/mL/mg to about 40 ng/mL/mg when administered in a dose of about 0.4 mg/kg to about 1.6 mg/kg of the body weight in a human subjects under fasting conditions.
Dependencies are inferred from the claim text.