DRUG SUBSTANCE PREPARATIONS, PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS COMPRISING S-(+)-FLURBIPROFEN

摘要

PROBLEM TO BE SOLVED: To provide (S)-(+)-2-(2-fluoro-4-biphenylyl) propionic acid (flurbiprofen), or a salt or ester thereof, substantially having a prescribed limited amount of specific impurities associated with the synthesis and purification.SOLUTION: An embodiment comprises: reacting racemic flurbiprofen with a solution of (S)-(-)-α-alkylbenzylamine; isolating formed (S)-(+)-flurbiprofen-(S)-(-)-α-alkylbenzylamine; and then recovering and recrystallizing (S)-(+)-flurbiprofen for purification.