Costa P
Serviço de Tecnologia Farmacêutica, Faculdade de Farmácia, Universidade do Porto, Rua Aníbal Cunha, 164, 4050-047, Porto, Portugal.
Int J Pharm. 2001 Jun 4;220(1-2):77-83. doi: 10.1016/s0378-5173(01)00651-2.
This paper addresses an alternative method to the evaluation of similarity factor f(2) as a criterion for assessment of similarity between two in-vitro dissolution profiles as proposed in the SUPAC-IR Guidance (1995). Diltiazem hydrochloride Sustained-Release (SR) tablets were tested and the following independent-model dissolution parameters were used: t10% dissolution time, t25% dissolution time, t50% dissolution time, mean dissolution time (MDT), dissolution efficiency (DE) at t(120), and at t(360). To compare the dissolution profiles, several release models were tested such as Higuchi, zero order, first order, Baker-Lonsdale, Hixson-Crowell, Weibull and Korsmeyer-Peppas. The similarities between two in-vitro dissolution profiles were assessed by pair-wise independent-model procedures such as difference factor (f1), similarity factor (f2) and Rescigno index (xi1 and xi2). The in vitro release kinetics of diltiazem hydrochloride sustained release tablets were evaluated using USP apparatus 2.
本文探讨了一种替代方法，用于评估相似性因子f(2)，作为如SUPAC-IR指南（1995年）中所提出的评估两种体外溶出曲线相似性的标准。对盐酸地尔硫卓缓释片进行了测试，并使用了以下独立模型溶出参数：10%溶出时间、25%溶出时间、50%溶出时间、平均溶出时间（MDT）、在t(120)和t(360)时的溶出效率（DE）。为了比较溶出曲线，测试了几种释放模型，如Higuchi模型、零级模型、一级模型、Baker-Lonsdale模型、Hixson-Crowell模型、Weibull模型和Korsmeyer-Peppas模型。通过成对独立模型程序，如差异因子（f1）、相似性因子（f2）和Rescigno指数（xi1和xi2），评估两种体外溶出曲线之间的相似性。使用美国药典装置2评估盐酸地尔硫卓缓释片的体外释放动力学。
