High dose solid unit oral pharmaceutical dosage form of amorphous nelfinavir mesylate and process for making same

摘要

A solid unit oral pharmaceutical dosage form of amorphous nelfinavir mesylate is provided comprising amorphous nelfinavir mesylate in an amount of from about 400 mg to about 700 mg calculated as nelfinavir base, and a pharmaceutically acceptable water soluble, non-ionic synthetic block copolymer of ethylene oxide and propylene oxide, the copolymer having a melting point of at least about 45° C. and an HLB value at 25° C. of from about 18 to about 29, wherein the copolymer is present from about 40% to about 65% by weight of the nelfinavir mesylate. A hot melt granulation process for making the dosage form is provided.