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味道掩饰的黄粉第一部分:利用混合物设计方法优化制造过程

Okhee Yoo¹, Sam Salman^2,3, Britta S von Ungern-Sternberg^3,4,5

¹Pharmacy, School of Allied Health, University of Western Australia, Perth, WA 6009, Australia.

Pharmaceuticals (Basel, Switzerland)

|August 26, 2023

概括

开发适合儿童年龄的富洛克萨林药物是很困难的,因为它的苦味和剂量需求. 这项研究提出了一种新的口味掩饰的三元微粒 (FTM) 配方,提供稳定和可重复的溶液.

科学领域:

制药科学制药科学
药物输送系统药物输送系统
儿科配方儿科配方儿科配方

背景情况:

黄 (FS) 对儿科使用提出了配方挑战,包括不佳的味道,快速溶解和大剂量要求.
对于儿科皮肤感染,有效提供FS需要克服食感性和稳定性问题.

研究的目的:

开发和优化适用于儿科的味道掩盖的三元微粒 (FTM) 配方.
调查Eudragit EPO (EE) 和棕酸 (PA) 在创建稳定和可复制的FTM中的使用.

主要方法:

在环境温度下采用非水性溶剂蒸发方法制造FS,EE和PA三元微粒.
使用混合物设计方法来优化制造过程,重点关注溶剂成分和比例.
最优化的方法涉及单个溶剂蒸发步骤,使用最小的ICH III类溶剂.

主要成果:

优化的制造工艺产生了稳定和可重复的FTM,其等分比为FS:EE:PA (1:0.8:0.6 w/w).
非水性环境温度方法成功地保持了可热性流西林的稳定性.
开发的FTM配方表现出强度和可扩展性的潜力.

结论:

一种有前途的口味掩饰的三元微粒配方 (FTM) 已经成功开发出来.
优化的制造工艺提供了一种稳定,可复制和可扩展的方法,用于生产适合儿科的流克洛西林药物.
这种FTM配方解决了儿科弗洛克萨林药物输送的关键挑战,改善了口感和稳定性.

关键词:

欧德拉吉特欧洲专利局 (EPO)流克洛沙林是一种流克洛沙林.混合物设计混合物设计儿科配方的儿童配方棕酸是一种棕酸.味道被掩盖的微粒.

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