A Novel Bending Point Criterion for Dissolution Profile Interpretation
A Novel Bending Point Criterion for Dissolution Profile Interpretation
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DOI：
10.1081/ddc-100107254
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发表时间：
2001-01
影响因子：
3.4
通讯作者：
L. Van Vooren;G. Krikilion;J. Rosier;B. de Spiegeleer
中科院分区：
文献类型：
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作者：
L. Van Vooren;G. Krikilion;J. Rosier;B. de Spiegeleer
开发了一种新的弯曲点标准，并将其与用于解释某些溶出曲线的许多现有标准进行了比较;这些比较标准为固定时间点的溶出百分比、拟合的Weibull参数和溶出曲线下面积（AUC）。将统计弯曲点模型应用于显示线性溶出的溶出曲线。弯曲点模型基于一般线性模型，其置信度信息使用参数估计值的方差-协方差矩阵获得。实际上，线性部分中的三个时间点和平台水平上的两个时间点用于可靠的弯曲点估计。对3批3种贮存条件的口腔粘膜粘附缓释片进行了比较研究。弯曲点的相对标准偏差（RSD）值通常在1%和5%之间，这大大低于其他标准的相应值（通常在3%和15%之间）。认为弯曲点标准对于某些溶出曲线的表征具有耐用性和稳定性。此外，弯曲点具有特定的物理解释，其有助于该口含片的缓释应用的框架。
A novel bending point criterion was developed and compared with a number of existing criteria for the interpretation of certain dissolution profiles; these comparison criteria were the percentage dissolved at a fixed time point, the fitted Weibull parameters, and the area under the dissolution curve (AUC). The statistical bending point model was applied to dissolution curves that showed linear dissolution. The bending point model is based on a general linear model, and its confidence information is obtained using the variance-covariance matrix of the parameter estimates. Practically, three time points in the linear part and two time points on the plateau level are used for a reliable bending point estimation. A comparative study with three batches and three storage conditions of slow-release mucoadhesive buccal tablets was performed. The relative standard deviation (RSD) values of the bending point were typically between 1% and 5%, which are considerably lower than the corresponding values of the other criteria (typically between 3% and 15%). The bending point criterion is considered robust and stable for the characterization of certain dissolution profiles. Moreover, the bending point has a particular physical interpretation that is helpful in the framework of the slow-release application of this buccal tablet.