儿科口服分解片 (ODT) 具有增强的可口味性 基于普罗普兰诺洛尔HCl与基 propyl-β-Cyclodextrin并存
Marzia Cirri1, Paola A Mura1, Francesca Maestrelli1
1Department of Chemistry Ugo Schiff (DICUS), University of Florence, 50019 Sesto Fiorentino, Italy.
Pharmaceutics
|November 27, 2024
概括
新的口服分解片 (ODT) 掩盖了普拉诺洛尔的苦味,改善了儿科患者的剂量准确性和可口性. 这一发展为目前的液体制剂提供了更好的替代品,提高了药物合规性.
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
- 儿科配方 儿科配方 儿科配方
背景情况:
- 用于治疗儿童高血压和心律失常的普罗普拉诺洛,具有苦味和性后味.
- 目前的管理涉及粉碎片,导致不准确的剂量,糟糕的味道,和低患者遵守.
研究的目的:
- 开发使用循环德克斯特林复合的普罗兰的口服分解片 (ODT).
- 为了提高剂量准确性,口感,安全性和儿科患者的吞方便性.
主要方法:
- 通过联合研磨的循环德克斯特林复合被用来制造罗醇ODT.
- 优化了配方变量和过程参数.
- 进行了技术,形态和分解测试,包括使用电子舌头进行体外可口性评估.
主要成果:
- 一种最佳的ODT配方使用了Hydroxypropyl-β-cyclodextrin (HPβCD) 混土复合物与Pearlitol® Flash和Explotab®.
- 选择的配方在模拟的唾液中表现出药物的高溶解.
- 电子舌头评估证实HPβCD有效地掩盖了propranolol的味道.
结论:
- 开发的普拉诺洛尔ODT为即兴液体制剂提供了一个可行的替代方案.
- 这种新型剂型解决了在儿科医学中对固体普拉诺洛尔配方的需求.
- 预计改善口感和剂量准确性将提高儿科患者的服药性.
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