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患者在使用中的稳定性测试FDA批准的美特福林组合产品的N-尼托拉胺不纯度

Sathish Dharani¹, Eman M Mohamed¹, Ziyaur Rahman¹

¹Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, 159 Reynolds Medical Sciences Building, College Station, Texas, 77843-1114, USA.

AAPS PharmSciTech

|January 24, 2024

概括

甲胺组合产品可以随着时间的推移而降解,使有害的N-二甲胺 (NDMA) 杂质超过安全限值. 这项研究强调了稳定性测试的必要性,以确保这些广泛使用的糖尿病药物的患者安全.

科学领域:

制药科学制药科学
药物的稳定性药物的稳定性
不洁净性分析 (Impurity Profiling) 是一种分析方法.

背景情况:

美国食品和药物管理局 (FDA) 在2020-2022年期间召回了281种甲福明延长释放产品,原因是N-二甲基胺 (NDMA) 超过了可接受的每日摄入量 (ADI).
之前的研究已经在即时释放和延长释放的甲福明产品中发现了NDMA.
在母药中检测到NDMA时,甲福明组合产品需要类似的杂质评估.

研究的目的:

评估用于NDMA的商业甲胺组合产品的使用时稳定性.
在典型的储存条件下评估NDMA形成的风险.

主要方法:

商用甲胺组合产品 (含甘胺,甘胺,皮奥格利塔,阿洛格利普丁,林格利普丁) 被重新包装到药房瓶中.
产品在30°C/75%的相对湿度下保存了3个月.
在3个月的储存期之前和之后,对NDMA水平进行了监测.

主要成果:

最初的NDMA水平从0到156.8 ng/片,在3个月后增加到25.4455.0 ng/片.
符合ADI限量的产品数量在储存后从18种减少到7种.
在几个甲福林组合配方中观察到NDMA的显著增加.

结论:

使用中的稳定性研究对于评估含有潜在酸盐杂质的药物产品的质量和安全性至关重要.
在可能的使用条件下,metformin组合产品可能会由于NDMA形成而构成安全风险.
持续监测和稳定性测试对于确保含有甲福林的药物的安全至关重要.

关键词:

这是一种N-二甲基胺 (nitrosodimethylamine).在使用中的稳定性.甲胺是一种甲胺.甲胺组合产品的产品酸氨基酸的含量是多少

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