薄膜包衣放大生产过程中关键因素的考量

Consideration of key factors during film coating scale up process

目的:介绍薄膜包衣放大生产过程中一些关键因素与包衣产品质量的关系。方法:分述了包衣过程中片剂混合均匀度的影响因素、设备干燥能力的构成及喷液速度的影响因素。结果:在薄膜包衣放大生产过程中,载药量、片芯的质量与设计、挡板的类型、锅体转速、设备的干燥能力及喷液速度等是影响包衣产品质量的关键因素。结论:通过对上述关键因素的调节,可以实现产品质量的稳定性与重现性。

Objective：To review the relationship between some key factors and quality of the film coated products during scale up process. Methods：The factors that related to mixing effect of tablets during scale up coating,drying capability of the coater and fluid delivering rate were analyzed. Results：The key factors during film coating included pan load, quality and design of the core, baffle style, pan speed, drying capability of the coater and fluid delivering rate. Conclusion：Stable and reproducible quality of film coated products can be available by optimizing the key factors mentioned above during film coating scale up process.