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PDF(1071 KB)
PDF(1071 KB)
药物创新制剂产业化及其综合优化技术
Commercial and Process Development of Pharmaceutical New Formulation and Optimization Technologies
为了让新药尽快获得批准和进入市场,创新制药公司通常会在开发新药的第一代产品时采用成熟且相对简单的剂形。这为以后这些药品创新制剂的开发预留了机会,因为更合理的剂型能改善其临床性能和安全性,同时为患者用药提供便利。创新剂型的开发不仅适用于专利到期的新药,也可能适用于较老的药物。但是在开发这些高技术含量的新药时,处方与工艺的开发会面临很多挑战。在本文中,作者根据自己的经验,就启动创新制剂开发项目要考虑的因素和大概流程进行了讨论,并基于质量源于设计的理念和科学文献,对在配方和工艺开发中使用实验设计,统计学和化学计量数据分析以及多元建模的趋势作了回顾。通过对文献中处方与工艺开发实例的分析,作者讨论了合理的实验设计和数据分析方法在创新制剂开发中的重要性。
In order to get fast approval and market access, innovator pharmaceutical companies usually adopt the most mature and relatively simple formulations for their first generation new drug products. This leaves the opportunities for these products to improve their clinical performance, safety profiles and/or patient adherenceby switching to more sophisticated new formulations, which usually happen around the time when the patents for the new drugs expire. This approach may also work for older drugs. On the other hand, the task of new formulation and process development are more challenging forhigh-technology drug products based on, for examples, various controlled release formulations. In this article, the authors give a discussion regarding the thinking behind initiating the endeavor of new-formulation based development project. Based on the principles of Quality-by-Design, the authors also give a review regarding the trend of using experimental design, statistical and chemometric data analysis and multivariate modeling in formulation and process development. By analyzing examples in the literature, the authors try to demonstrate the advantages of designed studies vs. the traditional univariate methods.
创新制剂 / 质量源于设计 / 处方 / 工艺过程 {{custom_keyword}} /
new formulation / quality by design / prescription / process development {{custom_keyword}} /
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