Xun Mingjin, Guo Hui, Cui Qingyan, Zhang Guimin, Feng Zhong, Gui Lei, Zhai Liying
National Engineering and Technology Research Center of Chirality Pharmaceutical, Lunan Pharmaceutical Group Co., Ltd, Linyi, China.
International Pharmaceutical Engineering Lab. in Shandong Province, Shandong New Time Pharmaceutical Co., Ltd, Linyi, China.
Drug Dev Ind Pharm. 2022 Apr;48(4):140-145. doi: 10.1080/03639045.2022.2101061. Epub 2022 Jul 22.
Establishing documented evidence that provides a high degree of assurance that a specific wet granulation process for manufacturing rosuvastatin calcium tablets 40 mg will consistently produce a product meeting its pre-determined specifications and quality attributes. It mainly involves the steps to be followed to evaluate and qualify the acceptability of the wet granulation manufacturing process of rosuvastatin calcium tablets 40 mg. The process is limited to the three batches manufactured of specific batch size with specified equipment and control parameters for rosuvastatin calcium tablets 40 mg. The results suggest providing documentary evidence that all the manufactured rosuvastatin calcium tablets were evaluated as per specifications. The steps involved such as Blend uniformity results between 90% and 110%, compression assay results between 90% and 110% were found within acceptable limits. Other tests related to compression such as hardness, thickness, disintegration, dissolution and for coatings such as weight gain, dissolution was found within acceptable limit. The design was chosen for fasting and fed study and showed bioequivalence with RLD (Codine®), with 90% CI values found to be between 80% and 125%.
建立书面证据，以高度保证用于生产40毫克瑞舒伐他汀钙片的特定湿法制粒工艺能够持续生产出符合其预定规格和质量属性的产品。它主要涉及评估和确认40毫克瑞舒伐他汀钙片湿法制粒生产工艺可接受性时应遵循的步骤。该工艺限于使用特定设备和控制参数生产的三批特定批量的40毫克瑞舒伐他汀钙片。结果表明提供了书面证据，证明所有生产的瑞舒伐他汀钙片均按规格进行了评估。所涉及的步骤，如混合均匀度结果在90%至110%之间，压片含量测定结果在90%至110%之间，均在可接受范围内。其他与压片相关的测试，如硬度、厚度、崩解、溶出度，以及与包衣相关的测试，如增重、溶出度，均在可接受范围内。该设计用于空腹和进食研究，与参比制剂（可定®）显示生物等效性，90%置信区间值在80%至125%之间。
