在0.01 mg/mL时,稀释的德斯莫酸盐鼻内溶液的稳定性
Mihaela Friciu1, Priyanshu Bharadwaj1, Laurence Bertrand2
1Faculty of Pharmacy, Université de Montréal, Montreal, Quebec, Canada.
International journal of pharmaceutical compounding
|December 6, 2024
概括
在盐水中稀释到0.01毫克/毫升的儿科德斯莫普林酸盐溶液在5°C和25°C的玻璃瓶中稳定180天. 这一发现支持儿童准确的剂量.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 儿科配方 儿科配方 儿科配方
背景情况:
- 准确的小儿药物剂量是关键的,但基于体重的小剂量酸德斯莫酸鼻液 (0.1 mg/mL) 构成挑战.
- 将德斯莫酸盐稀释到0.01 mg/mL可能会提高剂量准确性,但其稳定性需要验证.
研究的目的:
- 为了评估0.01 mg/mL的德斯摩素酸盐溶液的180天物理化学稳定性.
- 评估在5°C和25°C的透明玻璃瓶中储存对药物稳定性的影响.
主要方法:
- 使用0.9%的化稀释至0.01毫克/毫升,并储存在透明玻璃瓶中.
- 样品在5°C和25°C进行了180天的化,定期分析器官质性,德斯摩酸盐度 (HPLC-UV),颗粒数量和微生物生长.
主要成果:
- 惠普LC-UV方法在量化德斯莫普林酸方面被证明是可靠的.
- 在180天内,没有观察到气味或颜色的显著变化.
- 测试结果,粒子计数 (符合USP<788>标准),以及微生物学测试表明稳定性.
结论:
- 德斯莫酸盐0.01 mg/mL,从商业鼻腔溶液中制备并储存在透明玻璃瓶中,在5°C和25°C两种温度下显示180天的稳定性.
- 这种经过验证的稳定性支持使用稀释溶液,以提高儿科剂量精度.
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