期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 100, 期 1, 页码 294-310出版社
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.22261
关键词
wet granulation; binder; phase change; glassy state; rubbery/gel/solution state; granule strength; compactibility; entanglement; polymer adhesion; diffusion; mechanism
资金
- Management of Biopharmaceutics R&D and Analytical RD
The objective is to provide mechanistic understanding of a preferred wet granulation process that a binder is added in a dry state. Blends of CaCO3 and binders were prepared and used as model systems, and they were exposed to either 96% RH (rubbery/solution state) or 60% RH (glassy state) at room temperature to control the physical state of the binders, followed by high-shear granulation and particle size measurement. The blends of PVP K12, PVP K29/32, and HPC showed a significant increase in particle size after exposure to 96% RH. An increase of aspect ratio was also observed for the blend of HPC. In contrast, the blends being exposed to 60% RH did not exhibit any increase in particle size or aspect ratio. Regarding the effect of binder molecular weight on the mechanical strength of granules, granules of PVP K29/32 had higher strength than granules of PVP K12. This can be explained using polymer entanglement theory, in which the degree of polymerization (DP) of (N similar to 440-540) of PVP K29/32 is above the critical value (N-c similar to 300-600) for entanglement; while DP of PVP K12 (N similar to 20-30) is below it. Finally, a water sorption-phase transition-diffusion induced granule growth model for granulation has been suggested. (C) 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100: 294-310, 2011
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