Yuksel N, Kanik A E, Baykara T
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ankara, 06100 Tandoğan, Ankara, Turkey.
Int J Pharm. 2000 Nov 19;209(1-2):57-67. doi: 10.1016/s0378-5173(00)00554-8.
In this study, the aim was to apply different comparison methods to dissolution profiles of immediate release commercial film-coated tablets of naproxen sodium in order to (1) evaluate each method in terms of easy application and usefulness and (2) identify the advantages and disadvantages of each method. Dissolution testing was conducted using the USP monograph of naproxen sodium. The applied methods for the comparison of in vitro dissolution profiles are ANOVA-based methods, model-dependent methods, and model-independent methods including difference factor, f(1), and similarity factor, f(2). All the methods appear to be applicable and useful in comparing dissolution profiles. The results show that ANOVA-based methods and model-dependent methods are more discriminative than the f-factors. f-Factors seem to be easier to apply and interpret; only one value is obtained to describe the closeness of the two dissolution profiles. However, a last point for dissolution had to be determined, since the values of the f-factors depend on this point. The application and evaluation of model-dependent methods are more complicated; these methods present an acceptable model approach to the true relationship between percent dissolved and time variables, including statistical assumptions which could be checked. Dissolution profiles can be tested for differences in both level and shape by ANOVA-based methods and these methods provide detailed information about dissolution data which can be useful also in formulation development to match release to a reference product.
在本研究中，目的是将不同的比较方法应用于萘普生钠速释商业薄膜包衣片的溶出曲线，以便：（1）从易于应用和实用性方面评估每种方法；（2）确定每种方法的优缺点。使用萘普生钠的美国药典专论进行溶出度测试。用于比较体外溶出曲线的应用方法包括基于方差分析的方法、模型依赖型方法和模型非依赖型方法，后者包括差异因子f(1)和相似性因子f(2)。所有这些方法在比较溶出曲线方面似乎都是适用且有用的。结果表明，基于方差分析的方法和模型依赖型方法比f因子更具区分性。f因子似乎更易于应用和解释；只需获得一个值即可描述两条溶出曲线的接近程度。然而，由于f因子的值取决于这一点，所以必须确定溶出的最后一点。模型依赖型方法的应用和评估更为复杂；这些方法为溶解百分比与时间变量之间的真实关系提供了一种可接受的模型方法，包括可以检验的统计假设。基于方差分析的方法可以测试溶出曲线在水平和形状上的差异，并且这些方法提供了有关溶出数据的详细信息，这在制剂开发中也有助于使释放与参比产品相匹配。
