Structural polymorphism research of alverine citrate

Acta Poloniae Pharmaceutica - Drug Research Pub Date : 2024-01-30 DOI:10.32383/appdr/175084

Magdalena Janczura, N. Rosiak, Marta Gromek, J. Cielecka‐Piontek

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Abstract

The study compares the active substance alverine citrate from three commercial sources in order to demonstrate polymorphic forms using the XRPD, SEM, and ATR-FTIR techniques. Based on the solubility tests of alverine citrate, a hard capsule was prepared with the highest possible dose of the active substance. The release profiles of alverine citrate and its stability were also investigated. XRPD and ATR-FTIR analysis shows that all alverine citrate samples (despite differences in the synthesis process) are in the same polymorphic Form I. Scanning electron micrographs of alverine citrate from each manufacturer show differences in morphology (texture). The solubility studies confirmed the complete solubility of the highest dose of alverine citrate in media with a pH of 1.2-6.8. The release studies show that the release of the active substance, regardless of the manufacturer type, meets the immediate release requirement. Accelerated stability studies confirm the stability of the alverine citrate from selected manufacturers. As a result, the manufacturer of the final medicinal product may allow their inter-changeability during production without compromising the safety or efficacy of the medicinal product.

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柠檬酸阿尔维林的结构多态性研究

本研究比较了三种商业来源的枸橼酸阿尔维林活性物质，以便利用 XRPD、SEM 和 ATR-FTIR 技术展示其多晶型。根据枸橼酸阿尔维林的溶解度测试结果，制备了含有最高剂量活性物质的硬胶囊。此外，还研究了枸橼酸阿尔维林的释放曲线及其稳定性。XRPD 和 ATR-FTIR 分析表明，所有枸橼酸阿尔维林样品（尽管合成工艺不同）都具有相同的多晶型 I。溶解度研究证实，最高剂量的枸橼酸阿尔维林在 pH 值为 1.2-6.8 的介质中完全溶解。释放研究表明，无论生产商是哪种类型，活性物质的释放都符合立即释放的要求。加速稳定性研究证实了选定制造商生产的枸橼酸阿尔维林的稳定性。因此，最终药品的生产商可以允许在生产过程中相互更换，而不会影响药品的安全性或有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Acta Poloniae Pharmaceutica - Drug Research

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