通过预测建模评估中,共和聚合物系统对Cefdinir溶解和稳定性的影响
Raghad Al Nuss1, Mohamad Anas Al Tahan2, Hind El-Zein3
1Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Arab International University, Daraa, Syria.
British journal of biomedical science
|March 2, 2026
概括
使用无形化策略来配制可溶性较差的药物,如cefdinir,可显著提高溶解和口服生物可用性. 半孔二氧化分散为生物制药分类系统IV类化合物提供优越的长期稳定性.
科学领域:
- 制药科学 制药科学
- 药物运输 药物运输 药物运输
- 材料科学 材料科学 材料科学
背景情况:
- 生物制药分类系统 (BCS) 第四类药物具有较差的溶解性和透性,限制了口服生物可用性.
- 提高药物溶解对于提高难溶性化合物的生物可用性和治疗疗效至关重要.
- 形态化策略为克服药物配方中的可溶性挑战提供了潜在的解决方案.
研究的目的:
- 用三种形态化策略来制备BCS IV类药物 - - 塞夫丁尼尔,即固体分散,中孔散和同形态系统.
- 评估这些配方对药物稳定性和溶解概况的影响.
- 评估各种存储条件下的无形系统的长期物理稳定性.
主要方法:
- 使用喷雾干燥和溶剂浸泡技术制备Cefdinir.
- 使用差分扫描热度计 (DSC),偏光显微镜 (PLM) 和粉末X射线衍射 (PXRD) 进行无形系统的表征.
- 在不同存储条件下 (温度和湿度) 进行溶解研究和物理稳定性评估.
主要成果:
- 所有模态化配方显示,与晶体 cefdinir 相比, cefdinir 的释放显著增强.
- 固体分散和共同形态系统显示了溶解速率的最大改善,并保持了超和.
- 半孔二氧化分散体表现出优越的长期稳定性,在测试条件下保持超过95%的药物含量和无形结构6个月.
结论:
- 形态化策略有效地提高BCS IV类药物的溶解和生物可用性.
- 半孔二氧化分散剂由于孔隙封闭,为无形药物提供了卓越的物理稳定性.
- 平衡溶解增强与固态稳定性是不易溶解药物的合理配方设计的关键.
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