优化和生产的aceclofenac-loaded微纤维固体分散通过离心旋转
Enikő Bitay1,2, Attila Levente Gergely1, Zoltán-István Szabó3,4
1Department of Mechanical Engineering, Faculty of Technical and Human Sciences, Sapientia Hungarian University of Transylvania, Calea Sighișoarei nr. 2., 540485 Târgu-Mureş, Romania.
Pharmaceutics
|September 28, 2023
概括
离心旋转成功地产生了阿塞克洛芬-聚乙烯-罗利胺纤维,增强了药物释放. 这种可扩展的方法产生了具有快速溶解的无形固体分散,性能优于晶体形式.
科学领域:
- 材料科学 材料科学 材料科学
- 制药技术 制药技术 制药技术
- 化学工程是化学工程的重要组成部分.
背景情况:
- 阿塞克洛芬雅是用于治疗疼痛和炎症的非类固醇抗炎药物 (NSAID).
- 开发先进的药物输送系统可以提高治疗疗效和患者的遵守性.
- 无形固体分散增强难溶性药物的可溶性和生物可用性.
研究的目的:
- 开发和优化一种可扩展的方法,使用离心旋转来生产载有阿塞克洛芬的聚烯 (PVP) 纤维的无形固体分散物.
- 描述生产的纤维的物理化学特性.
- 为了评估在体外溶解性能,阿塞克洛芬加载的纤维.
主要方法:
- 离心线被用来制造装有阿塞克洛芬的PVP纤维.
- 解决方案度和旋转速度被优化为纤维生产.
- 气相色谱被用来确定残留溶剂含量.
- 差异扫描热度计 (DSC) 和红外光谱 (IR) 用于物理化学表征.
- 进行了体外溶解研究,以评估药物释放特征.
主要成果:
- 平均直径为7.5 ± 2.5μm的无珠,光滑表面的纤维以每小时12.7g的速度产生.
- 其余乙醇含量低于监管限制 (0.5%).
- 物理化学分析表明,在纤维形成过程中,aceclofenac可能会从晶体转变为形态.
- 纤维化药物载体系统表现出瞬间的分解和快速的阿塞克洛芬雅克释放,显著优于晶体形式,特别是在早期的时间点.
结论:
- 离心旋转是一种可行的和可扩展的技术,用于生产载有阿塞克洛芬的PVP无形固体分散物.
- 与晶体aceclofenac相比,开发的基于纤维的系统显示了增强的溶解特性.
- 这项技术有望改善可溶性较差的药物的输送.
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