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数学模型对从羟丙甲纤维素基质片剂获得的卡维地洛释放曲线的比较拟合

Comparative Fitting of Mathematical Models to Carvedilol Release Profiles Obtained from Hypromellose Matrix Tablets.

作者信息

Ojsteršek Tadej, Vrečer Franc, Hudovornik Grega

机构信息

KRKA, d. d., 8501 Novo Mesto, Slovenia.

Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia.

出版信息

Pharmaceutics. 2024 Apr 4;16(4):498. doi: 10.3390/pharmaceutics16040498.

DOI:10.3390/pharmaceutics16040498
PMID:38675159
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11053526/
Abstract

The mathematical models available in DDSolver were applied to experimental dissolution data obtained by analysing carvedilol release from hypromellose (HPMC)-based matrix tablets. Different carvedilol release profiles were generated by varying a comprehensive selection of fillers and carvedilol release modifiers in the formulation. Model fitting was conducted for the entire relevant dissolution data, as determined by using a paired -test, and independently for dissolution data up to approximately 60% of carvedilol released. The best models were selected based on the residual sum of squares (RSS) results used as a general measure of goodness of fit, along with the utilization of various criteria for visual assessment of model fit and determination of the acceptability of estimated model parameters indicating burst release or lag time concerning experimental dissolution results and previous research. In addition, a model-dependent analysis of carvedilol release mechanisms was carried out.

摘要

将DDSolver中可用的数学模型应用于通过分析卡维地洛从羟丙甲纤维素（HPMC）基骨架片中释放而获得的实验溶出数据。通过改变配方中多种填充剂和卡维地洛释放调节剂的选择，生成了不同的卡维地洛释放曲线。对整个相关溶出数据进行模型拟合，通过配对检验确定，并且独立地对卡维地洛释放量达到约60%之前的溶出数据进行模型拟合。基于作为拟合优度一般度量的残差平方和（RSS）结果，以及利用各种标准对模型拟合进行视觉评估，并确定估计的模型参数的可接受性，以表明与实验溶出结果和先前研究相关的突释或滞后时间，从而选择最佳模型。此外，还对卡维地洛的释放机制进行了模型依赖性分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/5fee5fe1f743/pharmaceutics-16-00498-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/f2bcafb6b1d5/pharmaceutics-16-00498-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/273e865eb05d/pharmaceutics-16-00498-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/550d34751e1e/pharmaceutics-16-00498-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/5fee5fe1f743/pharmaceutics-16-00498-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/f2bcafb6b1d5/pharmaceutics-16-00498-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/273e865eb05d/pharmaceutics-16-00498-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/550d34751e1e/pharmaceutics-16-00498-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71c7/11053526/5fee5fe1f743/pharmaceutics-16-00498-g001.jpg

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