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Buffer-based method for preparing bivalirudin drug product
Buffer-based method for preparing bivalirudin drug product
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机译:一种基于缓冲剂的比伐卢定药品制备方法
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摘要
A method for preventing the formation of a bivalirudin precipitate during preparation of a pharmaceutical drug product comprising about 250 mg of bivalirudin, a dried bivalirudin drug product, and a concentrated liquid bivalirudin drug product. The method for preventing the formation of a bivalirudin precipitate comprises (i) preparing an aqueous solution comprising a buffer and a pH greater than the isoelectric point of bivalirudin; (ii) adding bivalirudin salt to the aqueous solution to form a bulk solution; (iii) transferring the bulk solution to one or more vessels; and (iv) drying the bulk solution. The buffer may have a pKa of about 4 to less than 7, and a pH greater than the isoelectric point of bivalirudin. The pH of the bulk solution may be maintained at a level greater than the isoelectric point of bivalirudin. Further, the bulk solution may have a final pH of about 4 to about 7.
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机译:一种防止在制备包含约250mg比伐卢定,干燥的比伐卢定药物产品和浓缩的液体比伐卢定药物产品的药物产品期间形成比伐卢定沉淀物的方法。防止比伐卢定沉淀形成的方法包括:(i)制备包含缓冲液且pH大于比伐卢定等电点的水溶液; (ii)在水溶液中加入比伐卢定盐以形成本体溶液; (iii)将散装溶液转移到一个或多个容器中; (iv)干燥本体溶液。缓冲液的pK a Sub>可以为约4至小于7,并且pH大于比伐卢定的等电点。本体溶液的pH可以维持在大于比伐卢定的等电点的水平。此外,本体溶液的最终pH可以为约4至约7。
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