Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom.
Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom.
Int J Pharm. 2015;486(1-2):136-43. doi: 10.1016/j.ijpharm.2015.03.023. Epub 2015 Mar 16.
Tablet disintegration characterisation is used in pharmaceutical research, development, and quality control. Standard methods used to characterise tablet disintegration are often dependent on visual observation in measurement of disintegration times. This presents a challenge for disintegration studies of tablets in opaque, physiologically relevant media that could be useful for tablet formulation optimisation. This study has explored an application of texture analysis disintegration testing, a non-visual, quantitative means of determining tablet disintegration end point, by analysing the disintegration behaviour of two tablet formulations in opaque media. In this study, the disintegration behaviour of one tablet formulation manufactured in-house, and Sybedia Flashtab placebo tablets in water, bovine, and human milk were characterised. A novel method is presented to characterise the disintegration process and to quantify the disintegration end points of the tablets in various media using load data generated by a texture analyser probe. The disintegration times in the different media were found to be statistically different (P<0.0001) from one another for both tablet formulations using one-way ANOVA. Using the Tukey post-hoc test, the Sybedia Flashtab placebo tablets were found not to have statistically significant disintegration times from each other in human versus bovine milk (adjusted P value 0.1685).
片剂崩解特性在药物研究、开发和质量控制中得到了广泛应用。用于描述片剂崩解的标准方法通常依赖于视觉观察测量崩解时间。然而，对于在不透明的、生理相关的介质中进行片剂崩解研究，这种方法存在挑战，因为这些介质可能对片剂配方优化有用。本研究探讨了一种纹理分析崩解测试的应用，这是一种非视觉、定量的方法，用于确定片剂崩解终点，通过分析两种片剂配方在不透明介质中的崩解行为来实现。在这项研究中，对一种内部制造的片剂配方和 Sybedia Flashtab 安慰剂片剂在水中、牛和人乳中的崩解行为进行了特征描述。提出了一种新的方法，使用质地分析仪探头产生的负载数据来描述片剂在不同介质中的崩解过程，并量化片剂的崩解终点。结果发现，对于两种片剂配方，不同介质中的崩解时间彼此之间存在统计学差异（P<0.0001），这表明使用单因素方差分析。使用 Tukey 事后检验，发现 Sybedia Flashtab 安慰剂片剂在人乳和牛乳中的崩解时间没有统计学上的显著差异（调整后的 P 值为 0.1685）。
