Reconstitutable parenteral composition containing COX-2 inhibitor

A pharmaceutical composition in a powder form is provided. The composition comprises (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 a therapeutically effective total amount constituting...

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Hauptverfasser: NEMA SANDEEP, KARARLI TUGRUL T, KARIM AZIZ
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:A pharmaceutical composition in a powder form is provided. The composition comprises (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 a therapeutically effective total amount constituting about 30% to about 90% by weight, (b) a parenterally acceptable buffering agent in an amount of about 5% to about 60% by weight, and optionally (c) other parenterally acceptable excipient ingredients 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 an injectable solution. A lyophilization process is provided for preparation of the composition. 本发明提供种粉剂形式的药用组合物,其包含:(a)治疗有效量的至少种水溶性治疗药物,所述治疗药物选自选择性COX-2抑制药物及其前体药物和盐,例如帕瑞考昔钠,所述水溶性治疗药物的总量占所述组合物的约30%至约90%(重量),(b)种胃肠外可接受的缓冲剂,所述缓冲剂量为所述组合物的约5%至约60%(重量),以及任选(c)其它胃肠外可接受的赋形剂成分,所述赋形剂成分的总量不超过所述组合物的约10%(重量)。所述组合物可以用胃肠外可接受的溶剂液体稀释配制成注射溶液。提供种用于制备所述组合物的冷冻干燥方法。