Matsunami Kensaku, Ryckaert Alexander, Vanhoorne Valérie, Kumar Ashish
Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent, 9000, Oost-Vlaanderen, Belgium.
Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent, 9000, Oost-Vlaanderen, Belgium.
Int J Pharm. 2025 Jan 25;669:125002. doi: 10.1016/j.ijpharm.2024.125002. Epub 2024 Nov 30.
Real-time release testing (RTRt) of tablet dissolution can significantly improve manufacturing efficiency along with the adoption of continuous manufacturing in the pharmaceutical industry. To assure product quality without destructive testing, models for RTRt should be sufficiently reliable and robust. Whereas mechanistic models have merits of broader applicability and interpretability, data-driven models have been common approaches due to computational speed. This paper discusses challenges and opportunities in the application of mechanistic models for dissolution testing to enable RTRt of solid dosage. After a comprehensive literature review on mechanistic dissolution models and RTRt, the potential benefits and challenges of mechanistic models are presented. Compared to data-driven models, mechanistic models require less experimental data that can reduce time and cost for RTRt development. However, to enable the implementation of mechanistic models in RTRt, computational time should be short either by using a simple mechanistic model or by applying surrogate models.
片剂溶出度的实时释放测试（RTRt）能够显著提高制药行业的生产效率，并推动连续制造的采用。为了在不进行破坏性测试的情况下确保产品质量，用于RTRt的模型应具有足够的可靠性和稳健性。虽然机理模型具有更广泛的适用性和可解释性等优点，但由于计算速度的原因，数据驱动模型一直是常用方法。本文讨论了将机理模型应用于溶出度测试以实现固体剂型RTRt所面临的挑战和机遇。在对机理溶出模型和RTRt进行全面的文献综述后，介绍了机理模型的潜在益处和挑战。与数据驱动模型相比，机理模型所需的实验数据较少，这可以减少RTRt开发的时间和成本。然而，为了在RTRt中实现机理模型的应用，要么使用简单的机理模型，要么应用替代模型，以使计算时间缩短。
