Comparison of In Vitro Dissolution Profiles of Oxcarbazepine-HP β-CD Tablet Formulations with Marketed Oxcarbazepine Tablets
Comparison of In Vitro Dissolution Profiles of Oxcarbazepine-HP β-CD Tablet Formulations with Marketed Oxcarbazepine Tablets
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DOI：
10.14227/dt150408p28
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发表时间：
2008-11-01
影响因子：
0.6
通讯作者：
Patel, Rajnikant
中科院分区：
文献类型：
--
作者：
Patel, Nirav;Chotai, Narendra;Patel, Rajnikant
本研究的目的是（1）比较奥卡西平-HP β-CD片剂与市售奥卡西平片剂的体外溶出曲线，（2）应用统计模型评价每种方法的易用性和有效性，（3）确定每种方法的优缺点。结果表明，含有羟丙基β-环糊精（HP β-CD）和羧甲基纤维素钠（NaCMC）的片剂比市售奥卡西平（OXO）片剂释放速度更快（1.93倍）。根据威布尔参数，OXC-HP β-CD与NaCMC片剂的Td是市售奥卡西平片剂的3倍。用几个数学方程研究了OXC与HP β-CD复合物从不同片剂中的释放动力学。采用模型非依赖性方法（包括差异因子f（1）和相似因子f（2））、模型依赖性方法和基于ANOVA的方法比较体外溶出曲线。结果表明，基于方差分析的方法和模型相关的方法比模型无关的方法更有区别。模型独立的方法似乎更容易应用和解释;仅获得一个值来描述两个溶出曲线的接近程度。模型依赖性方法的应用和评价更为复杂;这些方法为溶解百分比和时间变量之间的真实关系提供了可接受的模型方法，包括可以检查的统计假设。药物释放数据与Hixson-Crowell模型拟合良好。药物释放机制是药物未释放部分的立方根随时间的图形。威布尔模型更适用于比较释放曲线。Weibull参数对两个释放动力学数据集之间的差异更敏感。
The aims of this study were (1) to compare the in vitro dissolution profiles of oxcarbazepine-HP beta-CD tablet formulations with those of marketed oxcarbazepine tablets, (2) to apply statistical models to evaluate each method in terms of easy application and usefulness, and (3) to identify the advantages and disadvantages of each method. The results show that the tablets containing hydroxypropyl beta-cyclodextrin (HP beta-CD) with sodium carboxymethylcellulose (NaCMC) exhibit faster release (1.93-fold) than marketed oxcarbazepine (OXO) tablets. From Weibull parameters, it was shown that T-d is three times higher for OXC-HP beta-CD with NaCMC tablets than for marketed oxcarbazepine tablets. The release kinetics of OXC complexed with HP beta-CD from different tablets was investigated using several mathematical equations. Model-independent methods including difference factor, f(1), and similarity factor, f(2); model-dependent methods; and ANOVA-based methods were used for the comparison of in vitro dissolution profiles. The results show that ANOVA-based methods and model-dependent methods are more discriminative than model-independent methods. Model-independent methods seem to be easier to apply and interpret; only one value is obtained to describe the closeness of the two dissolution profiles. 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 that could be checked. Drug release data fit well to the Hixson-Crowell model. The drug release mechanism was a graphic of the cube root of the unreleased fraction of the drug with time. The Weibull model was more useful for comparing the release profiles. Weibull parameters were more sensitive to the differences between the two release kinetic data sets.