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开发具有纤维酸和联合加工的半孔的固体分散的口腔可分散片,以改善溶解
Ana Baumgartner1, Odon Planinšek1
1Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia.
Pharmaceutics
|August 29, 2024
概括
这项研究开发了改进的口腔可分散片,使用纤维酸固体分散与中孔性二氧化和异. 优化的片剂增强了纤维酸的溶解,并符合可口溶解片剂标准,以方便患者的口服药物输送.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 诸如纤维酸盐之类的药物的水溶性较差,对口服固体剂型的开发构成了重大挑战.
- 开发适合患者的固体剂型需要克服药物溶解性差并确保有效的输送.
研究的目的:
- 用于制备含有丰纤维酸盐固体分散物的口腔可分散片.
- 为了提高药物溶解性和药片性能,使用共加工的中等和异的辅助剂.
- 为了达到与最终药片配方中未压缩的固体分散相比较的药物释放特征.
主要方法:
- 使用旋转蒸发以变化药物度的方法制备费诺纤维酸固体分散剂.
- 对准备好的固体分散物的固态特性和药物释放动力学的评估.
- 将优化的固体分散压缩成可口 dispersible 片,评估分解时间和药物释放.
主要成果:
- 含有30%药物的纤维酸固体分散物没有表现出晶体性,并且明显提高了溶解速度.
- 联合加工的辅助剂显示出改善的流量和压缩特性,同时保持高表面积.
- 配方的口腔可分散片符合分解时间要求,药物释放与未压缩的固体分散密切匹配.
结论:
- 费诺纤维酸盐与半孔二氧化和异的固体分散剂对于开发口腔 dispersible 片是有效的.
- 优化的配方增强了纤维酸的溶解率,并实现了可接受的口腔分解特性.
- 建议进行进一步的研究,以减少药片大小和分解时间,以改善患者的服药性.
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