溶解测试的数学模型:面对实时释放测试的挑战和机遇
Kensaku Matsunami1, Alexander Ryckaert1, Valérie Vanhoorne2
1Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent, 9000, Oost-Vlaanderen, Belgium.
International journal of pharmaceutics
|December 2, 2024
概括
机械模型为制药制造业的实时释放测试 (RTRt) 提供了一个有希望的方法. 这些模型需要更少的数据,并且比数据驱动的方法更易于解释,可能降低RTRt开发成本.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 实时释放测试 (RTRt) 对于高效的制药制造至关重要,特别是连续制造.
- 当前的RTRt通常依赖于数据驱动的模型,这些模型可以在计算上快速,但缺乏可解释性.
- 机械模型为溶解测试提供了更广泛的适用性和解释性.
研究的目的:
- 探索应用机械模型对固体剂型的RTRt的潜在好处和挑战.
- 提供关于机械溶解模型和RTRt.的综合文献综述.
主要方法:
- 关于机械溶解模型和RTRt. 的综合文献综述.
- 与数据驱动模型相比,机械模型的好处和挑战的分析.
- 讨论机械模型实现的计算时间要求.
主要成果:
- 机械模型需要更少的实验数据,减少RTRt开发的时间和成本.
- 可解释性和更广泛的适用性是机械模型的关键优势.
- 计算效率是实施RTRt中的机械模型的关键因素.
结论:
- 机械模型为医药制造业中强大可靠的RTRt提供了机会.
- 通过简化模型或替代模型来解决计算时间对于实际的RTRt实现至关重要.
- 对机械模型的进一步研究可以在不进行破坏性测试的情况下提高产品质量保证.
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