为儿科使用开发卡维迪洛尔口服液体配方
Blanca Chiclana-Rodríguez1, Encarnacion Garcia-Montoya1,2, Khadija Rouaz-El Hajoui1,2
1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.
开发一个稳定的水溶液的卡维迪醇 (CARV) 用于儿科的使用是至关重要的. 这项研究使用酸提高了CARV的溶解性,创造了一个适合儿科的口服溶液,可保持长达12个月的稳定性.
科学领域:
- 制药科学 制药科学
- 儿科药理学 儿科药理学
- 药物的配方 药物的配方
背景情况:
- 卡维迪醇 (CARV) 是儿科心血管疾病的必不可少的β-阻断剂,但其水溶性较差限制了管理.
- 目前的做法涉及从固体片中提前制备液体CARV配方,这对儿童准确剂量提出了挑战.
研究的目的:
- 为了提高卡维迪醇 (CARV) 的水溶性,并开发一种稳定,适合儿科的口服溶液.
- 评估开发的CARV溶液的化学,物理和微生物稳定性.
- 使用实验设计 (DoE) 优化CARV解决方案的准备.
主要方法:
- 在各种pH介质中评估了CARV的可溶性和初步稳定性.
- 酸作为CARV.的可溶性增强剂被研究.
- 评估了1毫克/毫升CARV-酸溶液的化学,物理和微生物稳定性.
- 使用实验设计 (DoE) 来优化准备参数.
主要成果:
- 酸显著改善了CARV的水溶性,产生了令人满意的结果.
- 1毫克/毫升的CARV-酸溶液在25°C和30°C下稳定12个月,在40°C下稳定6个月.
- 美国能源部提供了一个方程式来关联酸和CARV度,并且发现甲基对短期稳定不必要.
结论:
- 成功开发了一种适合儿科使用的稳定水性carvedilol (CARV) 口服溶液.
- 卡尔维-酸溶液提供可靠和稳定的配方长达12个月,解决了儿科心血管护理的关键需求.
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