Pharmaceutical composition, injectable solution and vial comprising parecoxib or salt thereof and process for preparing reconstitutable selective COX-2 inhibitory composition

摘要

The pharmaceutical composition comprising, in powder form, (a) parecoxib or salt thereof in a therapeutically effective total amount constituting 30 % to 90 % by weight of the composition; (b) parenterally acceptable buffering agent in an amount 10 % to 60 % by weight of the composition; (c) optionally other parenterally acceptable excipient ingredients in a total amount of up to 10 % by weight of the composition, said composition being reconstitutable in a parenterally acceptable solvent liquid to form an injectable solution. Disclosed are also process for preparing the composition by lyophilisation, an injectable solution prepared by reconstituting the composition and a sealed vial containing a unit dosage amount of the composition.