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固体分散体和药物递送系统中甲基丙烯酸铵共聚物（B型）与地尔硫䓬的相互作用

Ammonio Methacrylate Copolymer (Type B)-Diltiazem Interactions in Solid Dispersions and Drug-Delivery Systems.

作者信息

Kolev Iliyan, Ivanova Nadezhda, Topouzova-Hristova Tanya, Dimova Tanya, Koseva Pavlina, Vasileva Ivalina, Ivanova Sonya, Apostolov Anton, Alexieva Gergana, Tzonev Atanas, Strashilov Vesselin

机构信息

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Medical University "Prof. Dr. Paraskev Stoyanov"-Varna, 84 "Tzar Osvoboditel" Blvd., 9000 Varna, Bulgaria.

Department of Pharmaceutical Technologies, Faculty of Pharmacy, Medical University "Prof. Dr. Paraskev Stoyanov"-Varna, 84 "Tzar Osvoboditel" Blvd., 9000 Varna, Bulgaria.

出版信息

Polymers (Basel). 2022 May 23;14(10):2125. doi: 10.3390/polym14102125.

DOI:10.3390/polym14102125
PMID:35632008
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9144411/
Abstract

This paper presents a complex analytical study on the distribution, solubility, amorphization, and compatibility of diltiazem within the composition of Eudragit RS 100-based particles of microspongeous type. For this purpose, a methodology combining attenuated total reflectance Fourier transform infrared (ATR-FTIR) absorption spectroscopy, differential scanning calorimetry (DSC), scanning electron microscopy with energy-dispersive X-ray microanalysis (SEM-EDX), and in vitro dissolution study is proposed. The correct interpretation of the FTIR and drug-dissolution results was guaranteed by the implementation of two contrasting reference models: physical drug-polymer mixtures and casting-obtained, molecularly dispersed drug-polymer composites (solid dispersions). The spectral behavior of the drug-polymer composites in the carbonyl frequency (νCO) region was used as a quality marker for the degree of their interaction/mutual solubility. A spectral-pattern similarity between the particles and the solid dispersions indicated the molecular-type dispersion of the former. The comparative drug-desorption study and the qualitative observations over the DSC and SEM-EDX results confirmed the successful synthesis of a homogeneous coamorphous -type formulation with excellent drug-loading capacity and "controlled" dissolution profile. Among them, the drug-delivery particles with 25% diltiazem content (M-25) were recognized as the most promising, with the highest population of drug molecules in the polymer bulk and the most suitable desorption profile. Furthermore, an economical and effective analytical algorithm was developed for the comprehensive physicochemical characterization of complex delivery systems of this kind.

摘要

本文对微海绵型基于Eudragit RS 100的颗粒组合物中地尔硫卓的分布、溶解度、非晶化和相容性进行了复杂的分析研究。为此，提出了一种结合衰减全反射傅里叶变换红外（ATR-FTIR）吸收光谱、差示扫描量热法（DSC）、带能量色散X射线微分析的扫描电子显微镜（SEM-EDX）和体外溶出研究的方法。通过实施两种对比参考模型：物理药物-聚合物混合物和浇铸获得的分子分散药物-聚合物复合材料（固体分散体），确保了对FTIR和药物溶出结果的正确解释。药物-聚合物复合材料在羰基频率（νCO）区域的光谱行为被用作其相互作用/互溶性程度的质量标记。颗粒与固体分散体之间的光谱模式相似性表明前者为分子型分散。对比药物解吸研究以及对DSC和SEM-EDX结果的定性观察证实了成功合成了具有优异载药能力和“可控”溶出曲线的均匀共非晶型制剂。其中，地尔硫卓含量为25%的药物递送颗粒（M-25）被认为是最有前景的，聚合物主体中药物分子数量最多，解吸曲线最合适。此外，还开发了一种经济有效的分析算法，用于对这类复杂递送系统进行全面的物理化学表征。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/5871e7b5dff4/polymers-14-02125-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/e49ebbf9b129/polymers-14-02125-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/ea1bc62fce45/polymers-14-02125-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/013ee2aa6188/polymers-14-02125-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/ac35c89c12a3/polymers-14-02125-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/8c3e4edba651/polymers-14-02125-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/5871e7b5dff4/polymers-14-02125-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/e49ebbf9b129/polymers-14-02125-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/c30875380c86/polymers-14-02125-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/9105134b6873/polymers-14-02125-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/3cc4580a8053/polymers-14-02125-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/3e818d88b49d/polymers-14-02125-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/ea1bc62fce45/polymers-14-02125-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/013ee2aa6188/polymers-14-02125-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/ac35c89c12a3/polymers-14-02125-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/8c3e4edba651/polymers-14-02125-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa3/9144411/5871e7b5dff4/polymers-14-02125-g010.jpg

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