发达国家儿童用甲尼达悬浮剂:配方,质量和稳定性
Francesca Baratta1,2, Chiara Zingarelli1, Federica Fanton1
1Department of Drug Science and Technology, University of Turin, Via Pietro Giuria 9, 10125 Turin, Italy.
Pharmaceutics
|June 27, 2025
概括
为儿科患者开发了一种新的,低成本的甲尼达悬浮剂,以解决治疗孤儿的挑战. 这种稳定的配方可确保优质儿科药物的使用,即使在资源有限的热带环境中.
科学领域:
- 制药科学 制药科学
- 儿科药物开发 儿科药物开发
背景情况:
- 儿科人口仍然是一个治疗孤儿群体,药物配方短缺严重,特别是在低收入和中等收入国家.
- 现有的挑战需要开发可访问和有效的儿科药物.
研究的目的:
- 开发一种简单,低成本的儿科用甲尼达液体配方.
- 为了确保在各种存储条件下,儿科用美特罗尼达悬浮剂的质量和稳定性.
主要方法:
- 制备各种辅助剂混合物以达到250 mg/5 mL的甲尼达度.
- 质量控制测试包括含量统一性,pH值和分散性.
- 在室温,40°C和4°C下180天的稳定性评估.
主要成果:
- 开发的甲尼达配方表现出了出色的质量和稳定性.
- 在所有测试温度下,在180天后没有观察到甲尼达度或pH值的显著变化 (> 10%).
- 显微镜分析证实了研究期间的配方完整性.
结论:
- 甲尼达悬浮剂在各种环境条件下稳定,适合在热带地区使用,储存能力可变.
- 它的简单成分和制备方法允许在任何环境中保证质量的生产,提高了儿科医学的可访问性.
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