Study on formulation screening of chloral hydrate oral solution
10.16438/j.0513-4870.2023-0869
- VernacularTitle:水合氯醛口服溶液的处方筛选研究
- Author:
Shu-ye QI
1
;
Wen-hui LIU
2
;
Hui-dan TU
1
;
Shang-chen YAO
1
;
Bao-ming NING
1
Author Information
1. National Institutes for Food and Drug Control, Beijing 102629, China
2. Beijing Hongsheng Medical Technology Co., Ltd., Beijing 100076, China
- Publication Type:Research Article
- Keywords:
chloral hydrate;
oral solution;
stability;
palatability;
formulation screening
- From:
Acta Pharmaceutica Sinica
2023;57(11):3210-3215
- CountryChina
- Language:Chinese
-
Abstract:
Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.
