Dorożyński Przemysław, Kulinowski Piotr, Jamróz Witold, Juszczyk Ewelina
Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, Kraków 30-688, Poland.
Department of Magnetic Resonance Imaging, Institute of Nuclear Physics PAN, ul. Radzikowskiego 152, Kraków 31-342, Poland; Institute of Technology, The Pedagogical University of Cracow, ul. Podchorążych 2, Kraków 30-084, Poland.
Int J Pharm. 2014 Dec 30;477(1-2):57-63. doi: 10.1016/j.ijpharm.2014.10.016. Epub 2014 Oct 12.
The objectives of the work included: presentation of magnetic resonance imaging (MRI) and fractal analysis based approach to comparison of dosage forms of different composition, structure, and assessment of the influence of the compositional factors i.e., matrix type, excipients etc., on properties and performance of the dosage form during drug dissolution. The work presents the first attempt to compare MRI data obtained for tablet formulations of different composition and characterized by distinct differences in hydration and drug dissolution mechanisms. The main difficulty, in such a case stems from differences in hydration behavior and tablet's geometry i.e., swelling, cracking, capping etc. A novel approach to characterization of matrix systems i.e., quantification of changes of geometrical complexity of the matrix shape during drug dissolution has been developed. Using three chosen commercial modified release tablet formulations with diclofenac sodium we present the method of parameterization of their geometrical complexity on the base of fractal analysis. The main result of the study is the correlation between the hydrating tablet behavior and drug dissolution - the increase of geometrical complexity expressed as fractal dimension relates to the increased variability of drug dissolution results.
展示基于磁共振成像（MRI）和分形分析的方法，用于比较不同组成、结构的剂型，并评估组成因素（即基质类型、辅料等）对药物溶解过程中剂型性质和性能的影响。这项工作首次尝试比较不同组成且在水化和药物溶解机制上存在明显差异的片剂配方所获得的MRI数据。在这种情况下，主要困难源于水化行为和片剂几何形状的差异，即膨胀、开裂、盖帽等。已开发出一种表征基质系统的新方法，即在药物溶解过程中对基质形状几何复杂性变化进行量化。使用三种选定的含双氯芬酸钠的商业缓释片剂配方，我们展示了基于分形分析对其几何复杂性进行参数化的方法。该研究的主要结果是水化片剂行为与药物溶解之间的相关性——以分形维数表示的几何复杂性增加与药物溶解结果的变异性增加相关。
