“质量源于设计”在拉考沙胺注射液处方工艺研究中的应用

Application of “Quality by Design” in the Formulation and Process Research of Lacosamide Injection

基于“质量源于设计”(quality by design,QbD)理念,对拉考沙胺注射液的质量概况(QTPP)、关键质量属性(CQA)进行研究、基于关键物料属性(CMA)等方面对处方工艺变量进行了风险评估,制定了溶液 pH 值的控制策略。

Based on the concept of“quality by design (QbD)”,the sources of quality risks in Lacosamide injection were analyzed;“quality target product profile (QTPP)”and the“critical quality attributes (CQA)”of injections were discussed.The risks of injection formulation and process variables were analyzed,Developed a strategy to control the pH of the solution.