Correlation between critical material attributes of hydroxypropyl methyl cellulose type 2910 and film coating performance
10.11665/j.issn.1000-5048.2023121504
- VernacularTitle:2910型羟丙甲纤维素关键物料属性与薄膜包衣性能相关性研究
- Author:
Naicong CAI
1
;
Mengjuan SUN
;
Yumeng GUO
;
Yong BI
;
Jiasheng TU
;
Chunmeng SUN
Author Information
1. 中国药科大学药学院药剂系, 国家药品监督管理局药物制剂及辅料研究与评价重点实验室, 中国药科大学药用辅料及仿创药物研发评价中心, 南京210009
- Publication Type:Journal Article
- Keywords:
hydroxypropyl methylcellulose / film-forming properties / critical material attributes / principal component analysis / orthogonal partial least-squares discrimination analysis
- From:
Journal of China Pharmaceutical University
2024;55(6):758-766
- CountryChina
- Language:Chinese
-
Abstract:
To better promote the development of film-coated formulations and membrane agents, the present study was carried out to investigate the critical material attributes (CMAs) of different sources and models of HPMC in terms of film-coating performance and the correlation between each of the CMAs and the film-coating-related properties, using 2910 HPMC as the research target. Firstly, various analytical techniques were used to characterize the CMAs and film coating-related properties of HPMC. Secondly, the CMAs and film coating-related properties of HPMC were systematically evaluated by principal component analysis (PCA) and orthogonal partial least-squares discrimination analysis (OPLS-DA). The CMAs and film-coating-related properties of HPMC were systematically evaluated to elucidate the intrinsic relationship between the CMAs and film-coating-related properties of HPMC. The results showed that there were significant differences in viscosity, weight-average molecular weight, film tensile strength, elongation, elastic modulus, dissolution time, and flexibility of HPMCs from different manufacturers. The results of PCA and OPLS-DA analyses indicated that these 11 variables showed some correlations with each other. Both mathematical models showed better differentiation and classification of HPMC samples, and the OPLS-DA model had a better classification effect than the PCA model. Therefore, in this study, the physicochemical properties and the film-forming characteristic of HPMC were comprehensively evaluated, and the correlation between them was further established using PCA and OPLS-DA. The impact degree of different CMAs on the film coating performance of HPMC was clarified, which can be used as an important reference for the selection of excipient quality control programs in excipient production and formulation research and development.
