从过期药物中回收有效药物成分盐酸二甲双胍和氯沙坦钾及一种新的氯沙坦多晶型的晶体结构。

IF 3.1 3区 医学 Q2 CHEMISTRY, ANALYTICAL
Laura Galindo-Leon, Juan D Galofre-Benitez, Julián Corredor-Gamba, Deissy N Jaramillo, Johan D Lozano, Mario A Macías, Elizabeth Jiménez-Díaz
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引用次数: 0

摘要

由于药物污染物在水生态系统中积累,过期药片的处置,特别是来自家庭的药片的处置日益成为一个环境问题。尽管FDA建议丢弃过期的药物,但研究表明,许多这些药物在过期后很长时间内仍能保持其原始效力的90% %。这为回收和再利用这些过期药片中含有的活性药物成分(api)提供了可能性。本研究提出了一种简单有效的从过期盐酸二甲双胍和氯沙坦钾片中提取原料药的方法。该方法对氯沙坦和二甲双胍的回收率分别为88 %和37 %。通过NMR, HPLC, IR, HRMS,粉末和单晶x射线衍射进行结构表征,与化学标准相比,证实了所回收原料药的完整性和高纯度。在L929细胞系中进行的生物实验表明,提取的原料药与化学标准的原料药具有相当的活性,这表明它们在生化分析中具有重复使用的潜力。在PDRX重结晶过程中,发现了氯沙坦钾的一种新的多晶形态,命名为“M型”。此外,一项为期12个月的稳定性研究表明,在储存条件下,这两种API都没有退化。这些结果表明,过期的原料药在化学和生物学上是可行的,可以作为化学研究和生物分析的合成前体。该议定书可扩展,适用于制药公司,并适用于工业和研究环境,为制药废物提供了可持续的解决方案。通过回收原料药用于教育和工业用途,这种方法促进了制药科学的环境管理和资源效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Recycling of active pharmaceutical ingredients Metformin hydrochloride and Losartan potassium from expired medications and crystal structure of a new Losartan polymorphic form.

The disposal of expired pharmaceutical tablets, particularly those from household sources, is a growing environmental concern due to the accumulation of pharmaceutical contaminants in water ecosystems. Despite FDA recommendations to discard expired medications, studies have shown that many of these pills retain up to 90 % of their original potency long after their expiration date. This opens up the possibility for recycling and reusing the Active Pharmaceutical Ingredients (APIs) contained in these expired pills. This study presents a simple yet effective extraction protocol for recovering APIs from expired tablets of Metformin hydrochloride and Losartan potassium. The method achieved recovery yields of 88 % for Losartan and 37 % for Metformin. Structural characterization via NMR, HPLC, IR, HRMS, and both powder, and single-crystal X-ray diffraction confirmed the integrity and high purity of the recovered APIs compared to chemical standards. Biological assays carried out in L929 cell line revealed that the extracted APIs retained comparable activity to their chemical-standard counterparts, suggesting their potential for reuse in biochemical assays. During the recrystallization process by using PDRX, a new polymorphic form of Losartan potassium was discovered and named "Form M". In addition, a twelve-month stability study showed no degradation for either API at storage conditions. These results suggest that expired APIs are chemically and biologically viable for repurposing, as synthetic precursors in chemical research and in biological assays. The protocol is scalable, adaptable to pharmaceutical companies, and applicable in both industrial and research settings, offering a sustainable solution to pharmaceutical waste. By recovering APIs for educational and industrial use, this approach promotes environmental stewardship and resource efficiency in pharmaceutical science.

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来源期刊
CiteScore
6.70
自引率
5.90%
发文量
588
审稿时长
37 days
期刊介绍: This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.
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