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Characterization of the critical quality attributes for hydroxypropyl methylcellulose with different sources and analysis of the release of sustained-release tablets in vitro
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Shu-lin WAN1, Hui-min SUN2, *, Yu-ling BAI1, Wen-ying XIE1, Tian-bing GUAN1, Bo-chu WANG3, Chuan-yun DAI1, *
Acta Pharmaceutica Sinica | 2022, 57(2) : 484 - 491
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Acta Pharmaceutica Sinica | 2022, 57(2): 484-491
• Original Articles •
Characterization of the critical quality attributes for hydroxypropyl methylcellulose with different sources and analysis of the release of sustained-release tablets in vitro
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Shu-lin WAN1, Hui-min SUN2, *, Yu-ling BAI1, Wen-ying XIE1, Tian-bing GUAN1, Bo-chu WANG3, Chuan-yun DAI1, *
Affiliations
  • 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
Published: 2022-02-12 doi: 10.16438/j.0513-4870.2021-0815
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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.

excipient  /  hydroxypropyl methylcellulose  /  source difference  /  critical quality attribute  /  solid dosage form  /  drug release
Shu-lin WAN, Hui-min SUN, Yu-ling BAI, Wen-ying XIE, Tian-bing GUAN, Bo-chu WANG, Chuan-yun DAI. Characterization of the critical quality attributes for hydroxypropyl methylcellulose with different sources and analysis of the release of sustained-release tablets in vitro[J]. Acta Pharmaceutica Sinica, 2022 , 57 (2) : 484 -491 . DOI: 10.16438/j.0513-4870.2021-0815
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Article Info
doi: 10.16438/j.0513-4870.2021-0815
  • Receive Date：2021-06-02
  • Online Date：2025-12-22
  • Published：2022-02-12
Article Data
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History
  • Received：2021-06-02
  • Revised：2021-07-14
Funding
Affiliations
    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
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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