Effects of the Critical Quality Attribute (CQA) of Hypromellose on the Release of Diclofenac Sodium Sustained-release Tablets in Vitro
ZHANG Jing-zhen1,2, ZHANG Xue-mei3, DING Jia-xin3, ZHANG Xiao-na1,2, YANG Rui2, LIU Wan-hui1,3, SUN Hui-min2*, SUN Kao-xiang1,3*
1. School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai 264005, China; 2. National Institutes for Food and Drug Control, Beijing 100050, China; 3. State Key Laboratory of Long-Acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd, Yantai 264005, China
Abstract��OBJECTIVE To investigate the effect of the critical quality attributes of hypromellose (HPMC) on the release profile of diclofenac sodium sustained-release tablets in vitro. METHODS The characteristics including appearance, particle size, density, compression and specific surface area of HPMC K15M from three manufacturers (A, B and C) were studied and evaluated comprehensively. The compression data of HPMC K15M were non-linear fitted via the pressure-tensile strength curve method, Kawabe equation and Hasano equation. Sustained-release tablets were prepared by using diclofenac sodium as the active ingredient with different HPMC as gel matrix, and the in vitro release behavior of the tablets was determined in order to identify the critical quality attribute of HPMC that affect the in vitro release profile of diclofenac sodium sustained-release tablets. RESULTS The release rate of diclofenac sodium sustained-release tablets was correlated with the substitution type of HPMC, viscosity, density and specific surface area, but less affected by particle size. CONCLUSION Substitution, viscosity, density and specific surface area of HPMC are the CQAs factors influencing the release profile of diclofenac sodium sustained- release tablets.
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ZHANG Jing-zhen, ZHANG Xue-mei, DING Jia-xin, ZHANG Xiao-na, YANG Rui, LIU Wan-hui, SUN Hui-min, SUN Kao-xiang. Effects of the Critical Quality Attribute (CQA) of Hypromellose on the Release of Diclofenac Sodium Sustained-release Tablets in Vitro. Chinese Pharmaceutical Journal, 2019, 54(5): 382-389.
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2019, Vol. 54 
