Anderson N H, Bauer M, Boussac N, Khan-Malek R, Munden P, Sardaro M
Sanofi Research Centre, Northumberland, UK.
J Pharm Biomed Anal. 1998 Aug;17(4-5):811-22. doi: 10.1016/s0731-7085(98)00011-9.
Dissolution efficiency (D.E.), the area under a dissolution curve between defined time points, and the fit factors (f1 and f2) have been compared for the characterisation of dissolution profiles, using data from three batches of a product in nine different packs stored under two conditions. The factors f1 and f2 offer ease of calculation and a simple measure of similarity between pairs of dissolution profiles. This is well suited to the qualitative determination of 'similarity' as required by the FDA's SUPAC Guide. However, they do not provide information on individual batches, including their consistency. In contrast, D.E. does provide such information is well-suited to making quantitative comparisons amongst batches. Because D.E. has a simple physical meaning, it is easier to interpret D.E. data then corresponding f1 and f2 results. The confidence limits in D.E. values provide a useful measure of the variability in batch dissolution and allow the statistical significance of difference in D.E. between pairs of batches to be determined. Both of the above measures lead to the same conclusions regarding the similarity in protective power amongst the nine packs under test and to the value of added desiccant in maintaining the dissolution profile of the product when stored under high humidity conditions. It is concluded that D.E. offers a suitable alternative to the single point dissolution measurement for QC of immediate release products.
使用来自在两种条件下储存的九种不同包装中的三批产品的数据，比较了溶出效率（D.E.）、定义时间点之间的溶出曲线下面积以及拟合因子（f1和f2），以表征溶出曲线。f1和f2因子计算简便，是衡量成对溶出曲线之间相似性的简单指标。这非常适合美国食品药品监督管理局（FDA）的《SUPAC指南》所要求的“相似性”的定性测定。然而，它们并未提供关于各个批次的信息，包括批次的一致性。相比之下，D.E.确实提供了此类信息，非常适合在批次之间进行定量比较。由于D.E.具有简单的物理意义，因此相较于相应的f1和f2结果，D.E.数据更易于解释。D.E.值的置信限为批次溶出度的变异性提供了有用的度量，并允许确定成对批次之间D.E.差异的统计学显著性。上述两种方法对于测试的九种包装之间保护能力的相似性以及在高湿度条件下储存时添加干燥剂对维持产品溶出曲线的价值得出了相同的结论。得出的结论是，对于速释产品的质量控制，D.E.是单点溶出度测量的合适替代方法。
