Medicated chewing gums represent an orally administered dosage form with promising potential for local and systemic drug delivery. However, compared to other solid oral dosage forms, formulation development and release mechanism of medicated chewing gums are extremely complex, and thus only few products reached the approval for the market so far. Therefore, Quality by Design (QbD) approaches for rational formulation development of medicated chewing gums are needed to utilize their full potential. For chewing gum tablets, which are manufactured by direct compression, QbD approaches derived from tableting processes might be exerted. In this context, the SeDeM-Diagram-Expert-System implements the QbD approach while indicating whether a blend is suitable for direct compression and comprises powder properties, which need to be improved to facilitate the formulation development. Here, we present the successful application of the SeDeM-Diagram-Expert-System to the formulation development of medicated chewing gum tablets manufactured by direct compression. Furthermore, limitations of the SeDeM-System for medicated chewing gum tablets are evaluated and potential modifications of the system are suggested and discussed for future use.

药用口香糖代表口服剂型，具有潜在的局部和全身性药物递送潜力。但是，与其他固体口服剂型相比，药用口香糖的配方开发和释放机理极其复杂，因此，迄今为止只有很少的产品获得市场认可。因此，需要用于药物咀嚼型胶基糖的合理配方开发的质量设计（QbD）方法，以充分利用其潜力。对于通过直接压制制造的口香糖片，可采用源自压片过程的QbD方法。在这种情况下，SeDeM-Diagram-Expert-System会实施QbD方法，同时指出混合物是否适合直接压缩并具有粉末性质，需要改进以促进配方开发。在这里，我们介绍了SeDeM-Diagram-Expert-System在将药物直接压制制成的口香糖片的配方开发中的成功应用。此外，还评估了SeDeM-System对药用口香糖片的局限性，并建议和讨论了该系统的潜在改进方案，以供将来使用。