PHARMACEUTICAL PARENTAL COMPOSITION COMPONENT CONTAINING SODIUM PARECOXIB, INJECTABLE SOLUTION AND SEALED VIAL UNDERSTANDING THE SAME

摘要

"reconstitutable parenteral composition containing a cox-2 inhibitor". A pharmaceutical composition comprises, in powder form, (a) at least one water-soluble therapeutic agent selected from selective cox-2 inhibitory drugs and prodrugs and salts thereof, for example parecoxib sodium, in an amount constitution. therapeutically effective total by about 30% to about 90% by weight, (b) a parenterally acceptable buffering agent in an amount from about 5% to about 60% by weight, and optionally (c) other parenterally excipient ingredients acceptable in a total amount not greater than about 10% by weight of the composition. The composition is reconstitutable in a parenterally acceptable solvent liquid to form a solution for injection. A lyophilization process is provided for the preparation of such a composition.