Lek Pharmaceuticals, d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia.
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia.
Drug Dev Ind Pharm. 2020 Apr;46(4):566-575. doi: 10.1080/03639045.2020.1742140. Epub 2020 Apr 1.
The objective of this study is to present a practical example of a scale-independent design space development using a step-wise approach. A detailed description of the development process with a systematic outline of the main steps is provided. Design space is developed for film coating of tablets with moisture protective polyvinyl alcohol (PVA) based coating. The impact of scale-independent coating process parameters on the properties of film-coated tablets (FCT), i.e. water activity and film coating protection ability, and consequently on product long-term stability is explored. The main finding is that with model simplifications, a step-wise approach and rational development of scale-independent design space for the coating process, it is possible to efficiently predict, control, and optimize the long-term stability of a moisture sensitive product. However, the PVA moisture protective coating itself is recognized as having conflicting effects on product stability.
本研究旨在通过逐步方法展示一个实用的无因次设计空间开发实例。提供了详细的开发过程描述，并系统地概述了主要步骤。以具有防潮性的聚乙烯醇（PVA）包衣的片剂的薄膜包衣为例，开发无因次设计空间。考察了与无因次包衣工艺参数有关的、对薄膜包衣片剂（FCT）性能的影响，即水活度和薄膜包衣保护能力，以及对产品长期稳定性的影响。主要结论是，通过模型简化、逐步方法和无因次设计空间的合理开发，有可能高效地预测、控制和优化对湿度敏感产品的长期稳定性。但是，聚乙烯醇防潮性包衣本身被认为对产品稳定性具有矛盾的影响。
