Impact of Critical Material Attributes of HPMC on the Release of Gliclazide from Hydrophilic Matrix Tablets

Abstract

The influence of HPMC viscosity and the degree of substitution hydroxypropyl level (DSHP) on the release rate of gliclazide was examined. The increase in the HPMC viscosity led to a significant decrease in the release rate. The second parameter, DSHP, showed a surprisingly high impact on the release rate with higher hydroxypropyl levels leading to a faster drug release. The results demonstrated the need for control on both parameters for formulators of gliclazide tablets in order to ensure a consistent drug release performance.

Keywords

• methocel™
• hpmc
• hydroxy propyl
• critical material attribute