Characterization of the critical quality attributes for hydroxypropyl methylcellulose with different sources and analysis of the release of sustained-release tablets in vitro
10.16438/j.0513-4870.2021-0815
- VernacularTitle:来源差异羟丙甲纤维素关键质量属性的表征及对缓释片体外溶出的分析
- Author:
Shu-lin WAN
1
;
Hui-min SUN
2
;
Yu-ling BAI
1
;
Wen-ying XIE
1
;
Tian-bing GUAN
1
;
Bo-chu WANG
3
;
Chuan-yun DAI
1
Author Information
1. Chongqing Key Laboratory of Industrial Fermentation Microorganisms, School of Chemistry and Chemical Engineering, Chongqing University of Science and Technology, Chongqing 401331, China
2. NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients, National Institutes for Food and Drug Control, Beijing 100050, China
3. Key Laboratory of Biorheological Science and Technology Ministry of Education, College of Bioengineering, Chongqing University, Chongqing 400030, China
- Publication Type:Research Article
- Keywords:
excipient;
hydroxypropyl methylcellulose;
source difference;
critical quality attribute;
solid dosage form;
rug release
- From:
Acta Pharmaceutica Sinica
2022;57(2):484-491
- CountryChina
- Language:Chinese
-
Abstract:
The quality difference of pharmaceutical excipients from different sources affects the molding properties of the powder, resulting in changes in the properties of the final product. In this study, the critical quality attributes of hydroxypropyl methylcellulose (HPMC) with different specifications from two manufacturers (manufacturer A and manufacturer B) were characterized including particle size, physical morphology, viscosity and powder physical quality attributes. Aminophylline, diclofenac sodium, and metformin hydrochloride were utilized as model drugs with different solubility to prepare sustained-release tablets, and the effect of HPMC from different sources on drug release of sustained-release tablets in vitro was investigated. The results showed that HPMC with the same viscosity specification from different sources had outstanding differences in the physicochemical properties (including particle size, physical morphology, viscosity, dimension, compressibility and powder flow), which could change the hardness and friability of the sustained-release tablets. The differences in the physicochemical properties of HPMC had different effects on the dissolution of different sustained-release tablets in vitro. It had no significant effect on the release of easily soluble aminophylline and metformin hydrochloride, but had a greater impact on the release of poorly soluble diclofenac sodium. Compared with manufacturer A, the sustained-release effect of matrix tablets prepared by HPMC from manufacturer B was more excellent. The results of this study will provide a theoretical reference on selecting the appropriate excipients for formulation design.
