科利科特® 智能密封100P用于开发神蛋白颗粒:探索儿童应用的味道掩盖潜力
Neeraja Komanduri1, Mashan Almutairi2, Rasha M Elkanayati1
1Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, USA.
Pharmaceutics
|April 26, 2025
概括
热挤出 (HME) 成功开发了口味掩盖的西奥菲林颗粒,使用Kollicoat® Smartseal 100P. 这种新的配方显著减少了苦味,并改善了药物释放,提高了患者的服药性.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 泰奥菲林的苦味对患者的遵守提出了挑战,特别是在儿科和老年人群中.
- 热挤出 (HME) 是开发口味掩饰药物配方的一个有前途的技术.
- 评估pH依赖的聚合物对于优化口味掩饰和药物释放概况至关重要.
研究的目的:
- 开发和评估使用HME技术口味掩饰的神素颗粒.
- 为了比较Kolicoat® Smartseal 100P,Eudragit® EPO和Kolicoat® MAE 100-55对于掩盖味道的西奥菲林的疗效.
- 为了优化药物加载和塑化剂度,以改善口味掩饰和释放特性.
主要方法:
- 使用HME制备的西奥菲林颗粒具有不同的药物负载 (10-30%) 和增塑剂 (PEG 1500) 度.
- 描述包括差异扫描热度计 (DSC),里埃变换红外光谱 (FTIR),苦门分析和体外释放测试.
- 稳定性研究在加快条件下 (40°C/75%RH) 进行了三个月.
主要成果:
- 优化的配方 (20% 铁奥菲林,20% PEG 1500,60% Kollicoat® Smartseal 100P) 在模拟的唾液液中显著减少了铁奥菲林的释放量 (1.1% 与纯药的 29.5% 相比).
- 味道掩盖的有效性得到证实,因为药物释放仍然低于苦味值.
- 科利卡特® Smartseal 100P和Eudragit® EPO在胃液中完全释放药物,而科利卡特® MAE 100-55的释放量有限. 在加速条件下,Kollicoat® Smartseal 100P配方保持稳定.
结论:
- Kollicoat® Smartseal 100P有效地与HME一起用于强大的神素味道掩饰.
- 开发的HME颗粒提供了一种有前途的方法,通过改善口感来提高患者的遵守性.
- 这项研究强调了Kollicoat® Smartseal 100P在口服药物递送的口味掩盖技术中的新应用.
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