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低强度阿司匹林囊的随机组合用于脱敏化协议

Carly Messenger¹, Bailey Soper², Kara Cutaia³

¹Wegmans School of Pharmacy, St. John Fisher University, Rochester, New York. cm08859@sjf.edu.

International journal of pharmaceutical compounding

|February 2, 2024

概括

合成低强度阿司匹林囊用于过敏性脱敏是可行的,达到31天的过期使用日期. 然而,对于非常低强度 (1-3毫克) 的剂量均性和稳定性仍然存在挑战.

科学领域:

制药科学制药科学
药物复杂化药物复杂化
稳定性测试稳定性测试

背景情况:

阿司匹林过敏症需要使用低剂量阿司匹林的脱敏方案.
复合低强度阿司匹林 (<81毫克) 存在稳定性和剂量准确性的挑战.
现有的文献缺乏关于低强度阿司匹林囊稳定性和均性的全面数据.

研究的目的:

评估复合低强度阿司匹林囊 (1-40毫克) 的可行性,以消除敏感性.
评估复合低强度阿司匹林配方的稳定性和剂量统一性.
为了确定化合物低强度阿司匹林囊的适当的过期日期.

主要方法:

手动填充基基甲基纤维素囊与阿司匹林干粉 (纯药物或碎片).
配方包括40毫克,10毫克,3毫克和1毫克强度,具有简单的成分.
在室温下90天使用稳定性指示HPLC方法进行稳定性测试.

主要成果:

最初的强度在标签声明的100-105%以内,标准偏差<3% (除了7%的1mg强度).
与纯药物相比,粉碎的药片粉末改善了功效变异性.
40毫克和10毫克囊保留了90%的标签声明90天;3毫克和1毫克囊保留了90%的标签声明只有31天.

结论:

低强度阿司匹林囊可以在室温下添加至少31天的过期使用日期.
剂量均性和阿司匹林稳定性仍然是1毫克和3毫克强度的重大挑战.
复合药房应对低强度阿司匹林制剂进行试验批次的分析测试.

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