The importance of binder moisture content in Metformin HCL high-dose formulations prepared by moist aqueous granulation (MAG)

Results in Pharma Sciences
Hiroshi TakasakiKatsuhide Terada

Abstract

The aim of this study was to evaluate binders to improve the flowability of granulates and compactibility of Metformin HCL (Met) using the moist aqueous granulation (MAG) process. The effect of the binder moisture content on granulate and tablet quality was also evaluated. Vinylpyrrolidone-vinyl acetate copolymer (Kollidon VA64 fine: VA64), polyvidone (Povidone K12: PVP), hydroxypropyl cellulose (HPC SSL SF: HPC) and hydroxypropyl methylcellulose (Methocel E5 LV: HPMC) were evaluated as binders. These granulates, except for HPMC, had a lower yield pressure than Met active pharmaceutical ingredient (API). HPMC Met was not sufficiently granulated with low water volume. No problems were observed with the VA64 Met granulates during the tableting process. However, HPC Met granulates had a bowl-forming tendency, and PVP Met granulates had the tendency to stick during the tableting process. These bowl-forming and sticking tendencies may have been due to the low moisture absorbency of HPC and the high volume of bound water of PVP, respectively. VA64 Met granulates had the highest ambient moisture content (bulk water, bound water) and moisture absorbency. It was concluded that the type of binder used for the Met MAG process has an impac...Continue Reading

References

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Sep 3, 2013·International Journal of Pharmaceutics·Hiroshi TakasakiKatsuhide Terada
Jan 11, 2014·International Journal of Pharmaceutics·David Cheng Thiam TanRajeev Gokhale

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Citations

Jun 23, 2016·International Journal of Pharmaceutics·Wongsakorn SuchaoinAndreas Bernkop-Schnürch
Apr 25, 2018·AAPS PharmSciTech·Oscar-Rupert Arndt, Peter Kleinebudde
Feb 13, 2021·Pharmaceutics·Claudia KösterPeter Kleinebudde
Jun 14, 2021·International Journal of Pharmaceutics·Jerome Hansen, Peter Kleinebudde

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Methods Mentioned

BETA
infrared spectroscopy
scraping

Software Mentioned

FlexiTab
MADG
MAG
Vision®

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