创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

龚健, 徐彦, 赖鹏, 陈义生, 房杏春, 胡成松, ReddyCHINTA Srinivasa, 张国华. 高端口服固体仿制药的设计及其产品关键质量属性的控制——以FDA批准的琥珀酸美托洛尔缓释片为例[J]. 药学进展, 2018, 42(9): 644-654.
引用本文: 龚健, 徐彦, 赖鹏, 陈义生, 房杏春, 胡成松, ReddyCHINTA Srinivasa, 张国华. 高端口服固体仿制药的设计及其产品关键质量属性的控制——以FDA批准的琥珀酸美托洛尔缓释片为例[J]. 药学进展, 2018, 42(9): 644-654.
GONG Jian, XU Yan, LAI Peng, CHEN Yisheng, FANG Xingchun, HU Chengsong, Reddy CHINTA Srinivasa, ZHANG Guohua. Design of High-Barrier-to-Entry Oral Solid Generics and Control for the Critical Quality Attributes—A Case Study of FDA Approved Metoprolol Succinate ExtendedRelease Tablet[J]. Progress in Pharmaceutical Sciences, 2018, 42(9): 644-654.
Citation: GONG Jian, XU Yan, LAI Peng, CHEN Yisheng, FANG Xingchun, HU Chengsong, Reddy CHINTA Srinivasa, ZHANG Guohua. Design of High-Barrier-to-Entry Oral Solid Generics and Control for the Critical Quality Attributes—A Case Study of FDA Approved Metoprolol Succinate ExtendedRelease Tablet[J]. Progress in Pharmaceutical Sciences, 2018, 42(9): 644-654.

高端口服固体仿制药的设计及其产品关键质量属性的控制——以FDA批准的琥珀酸美托洛尔缓释片为例

Design of High-Barrier-to-Entry Oral Solid Generics and Control for the Critical Quality Attributes—A Case Study of FDA Approved Metoprolol Succinate ExtendedRelease Tablet

  • 摘要: 高端制剂难以仿制的主要原因是产品的设计要求比较复杂,如果对产品的理解和控制不足,产品质量和生物等效性则难以符合要求。目前,我国医药市场上高端制剂的可及性较低。国家鼓励创新的大环境为制药行业提高这类仿制药的可及性提供了一个好机会。琥珀酸美托洛尔缓释片是一个较难开发和生产的高端仿制药物制剂。以南通联亚药业被美国FDA批准的琥珀酸美托洛尔缓释片为例,对此产品的制剂特点、研发技术难点、审评要求及最终产品测试结果进行介绍,以期为国内高端仿制药物制剂的开发及审评提供参考。

     

    Abstract: High-barrier-to-entry generic drugs are difficult to make because of the relatively complex product design. Requirements of specification and bioequivalence are difficult to meet if the product is not fully understood and controlled. Currently, the accessibility of high-barrier-to-entry drug products in China's market is low. However, the country' s environment of encouraging innovation provides a good opportunity for the pharmaceutical industry to increase the accessibility of such generic products. Generic metoprolol succinate extended release (MPS ER) tablets are difficult to develop and manufacture. The formulation characteristics, technical challenges, regulatory requirements, and development results for Novast's FDA approved MPS ER tablet are summarized in this paper, serving as a case study for the development and review of high-barrier-to-entry generics in China.

     

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