双反应性离子交换树脂封装的阿托莫克胺化物用于口味掩饰和双相释放
Tao Xiao1, Quanzhu Yang2, Lusi Chen1
1College of Pharmacy, Jiangxi University of Chinese Medicine, Nanchang, 330004, China.
AAPS PharmSciTech
|April 29, 2025
概括
阿托莫克西丁化口服分解片 (ATH ODT) 掩盖了苦味,并为ADHD治疗提供了双相释放. 这种新型配方改善了与现有治疗相比的血药物度稳定性和患者服药性.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 药理动力学 药理动力学
背景情况:
- 阿托莫克西丁化 (ATH) 是一种关键的ADHD药物,面临着苦味和剂量遵守的挑战.
- 目前的ATH剂量策略在药物暴露和患者遵守之间存在权衡,特别是在儿童中.
研究的目的:
- 开发一种新的ATH口服分解片 (ODT) 配方,以克服口味掩饰和改善药理学特征.
- 使用离子交换树脂 (IER) 和涂层IER创建ATH的双相释放系统,以实现更好的药物度稳定性.
主要方法:
- ATH被封装在离子交换树脂 (ATH@IER) 中,以适应pH的,口味掩饰的释放.
- 一个双相释放系统 (ATH@MC) 是通过涂层ATH@IER与Eudragit® RS100.
- 通过将ATH@IER和ATH@MC (40:60比) 与其他辅助剂结合起来制造ATH ODT.
主要成果:
- 该ATH@IER配方有效地掩盖了ATH的苦味,电子舌头分析证实了这一点.
- 药理动力学研究表明,ATH ODT产生双模式血度,使峰值度 (Cmax) 降低两倍,同时保持AUC.
- 与商业ATH口服溶液相比,ATH ODT表现出更稳定的血药物度,每天服用两次.
结论:
- 开发的ATH ODT配方成功地掩盖了阿托莫丁化的苦味.
- ATH ODT的双相释放系统提供了更稳定的血药物度概况,增强了ADHD的治疗潜力.
- ATH ODT为ADHD治疗提供了一个有前途的替代方案,改善了当前阿托莫克赛丁配方的局限性.
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