Pharmaceutical dosage form of amorphous nelfinavir mesylate

A - Human Necessities – 61 – K

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Details

A61K 31/472 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61P 31/18 (2006.01)

Patent

CA 2444116

A solid unit oral pharmaceutical dosage form of amorphous nelfinavir mesylate is provided comprising amorphous nelfinavir mesylate, and a pharmaceutically acceptable, water soluble, non-ionic synthetic block copolymer of ethylene oxide and propylene oxide, said copolymer having a melting point of at least 40~C. A hot melt granulation process for making the dosage form is provided.

L'invention concerne une forme dosifiée pharmaceutique orale à unité solide de mésylate de nelfinavir amorphe, comprenant du mésylate de nelfinavir amorphe et un copolymère bloc synthétique non ionique, hydrosoluble, pharmaceutiquement acceptable d'oxyde d'éthylène et d'oxyde de propylène, ledit copolymère présentant un point de fusion d'au moins 40 ·C. L'invention concerne également un procédé de granulation par fusion permettant de fabriquer ladite forme dosifiée.

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