用于儿科患者的循环德克斯基配方:制药前景和毒理学评估
Theingi Tun1, Hay Marn Hnin1, Vu Minh Triet1
1Faculty of Pharmaceutical Sciences, Chulalongkorn University, Pathumwan, Bangkok 10330, Thailand.
The Journal of pharmacy and pharmacology
|September 23, 2025
概括
环极素 (CD) 通过提高溶解度和味道来改善儿科药物配方. 虽然通常是安全的,但由于新生儿功能不成熟,建议对新生儿采取谨慎措施,需要进一步的安全数据和指导方针.
科学领域:
- 制药科学 制药科学
- 儿科药理学 儿科药理学
- 药物输送系统 药物输送系统
背景情况:
- 儿科药物开发面临年龄特定生理学的挑战,导致有限的批准配方.
- 对于儿童来说,口服是首选的,需要灵活和可口的剂量形式.
- 环极素 (CDs) 是辅助剂,可增强药物配方的溶解性,稳定性和口味掩饰性.
研究的目的:
- 审查循环德克斯林复杂化在儿科药物输送中的作用.
- 总结儿童群体中CDs的药理动力学和毒性数据.
- 举例介绍基于环氧德克斯的儿科配方.
主要方法:
- 对未成年动物的药理动力学研究和临床发现的文献综述.
- 对儿童使用环极素的安全性和耐受性数据的分析.
- 识别和综述使用环极的先进儿科剂型.
主要成果:
- 环极提升了儿科药物配方的可溶性,稳定性和可口性.
- 青少年动物研究表明,CDs的干净度取决于年龄,新生儿的排泄延迟.
- propyl-β-cyclodextrin和硫丁乙烯-β-cyclodextrin通常耐受良好,但由于潜在的积累,新生儿使用需要谨慎.
结论:
- 基于循环德克斯的系统改善了儿科配方,尽管监管部门的批准有限.
- 适合儿童的剂量形式,如口腔分散片和3D打印的迷你片,展示了CD的多功能性.
- 综合的安全数据和监管指南对于在儿科中更广泛的临床应用环极素至关重要.
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