Timmins Peter, Desai Divyakant, Chen Wei, Wray Patrick, Brown Jonathan, Hanley Sarah
Drug Product Science & Technology, Bristol-Myers Squibb, Merseyside, UK.
Department of Pharmacy, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK.
Ther Deliv. 2016 Aug;7(8):553-72. doi: 10.4155/tde-2016-0026.
Approaches to characterizing and developing understanding around the mechanisms that control the release of drugs from hydrophilic matrix tablets are reviewed. While historical context is provided and direct physical characterization methods are described, recent advances including the role of percolation thresholds, the application on magnetic resonance and other spectroscopic imaging techniques are considered. The influence of polymer and dosage form characteristics are reviewed. The utility of mathematical modeling is described. Finally, how all the information derived from applying the developed mechanistic understanding from all of these tools can be brought together to develop a robust and reliable hydrophilic matrix extended-release tablet formulation is proposed.
本文综述了围绕控制亲水性基质片剂药物释放机制的表征方法及相关认识的发展。文中不仅提供了历史背景并描述了直接的物理表征方法,还探讨了包括逾渗阈值的作用、磁共振及其他光谱成像技术应用等近期进展。同时回顾了聚合物和剂型特性的影响,并阐述了数学建模的实用性。最后,提出了如何整合运用所有这些工具所获得的深入机理认识得出的全部信息,来开发一种稳健可靠的亲水性基质缓释片剂配方。