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泰尔米沙坦片的通用开发的前进之路:整合关键材料属性和生物预测溶解,以实现目标产品配置

Megha Pillai¹, Ravi P Shah¹, Pinaki Sengupta¹

¹National Institute of Pharmaceutical Education and Research-Ahmedabad (NIPER-A), An Institute of National Importance, Government of India, Palaj, Gandhinagar 382355, Gujarat, India.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|February 5, 2026

概括

这项研究将关键物质属性 (CMA) 与使用特尔米沙坦配方的药物释放联系起来. 生物预测溶解方法有助于了解仿制药的性能,并支持监管文件.

科学领域:

制药科学制药科学
药物运输药物运输药物运输
制定发展制定发展

背景情况:

关键材料属性 (CMA) 显著影响药物释放概况.
了解这些属性对于开发强大的仿制药配方至关重要.
泰尔米沙坦是一种BCSII类药物,作为研究配方依赖药物释放的模型.

研究的目的:

系统地整合影响药物释放的CMA,包括颗粒大小,辅助剂成分和多态形式.
开发和评估Telmisartan配方的生物预测溶解方法.
建立一个框架,以了解通用特尔米萨坦配方之间的差异,并支持监管期望.

主要方法:

使用直角分析技术:色谱,热阶段显微镜,NMR光谱和溶解测试.
开发了一种模仿生理学pH条件 (酸性和中性) 的多阶段溶解策略.
采用去配方实验来根据API颗粒大小,辅助剂类型和微环境pH来对配方进行分类.

主要成果:

配方成功地根据API粒子大小 (例如,8 ± 2μm),辅助剂功能和微环境pH值进行了分类.
基于等级的方法为区分通用Telmisartan配方提供了一个强大的框架.
已确立的CMA和影响药物释放的关键质量属性 (CQA) 之间的相关性.

结论:

开发的方法使得通过将CMA与CQA联系起来,从而实现全面的配方开发.
生物预测溶解方法支持对体外试验的监管期望和对批准后变更的生物等价性豁免.
这种系统的方法提高了对仿制药品药物释放的理解和控制.

关键词:

生物预测性溶解方法关键材料属性关键材料属性在体外的药物释放.逆向工程是一种逆向工程.泰尔米沙坦 (Telmisartan) 是一种药物.

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