Initial studies of water granulation of eight grades of hypromellose (HPMC)

Abstract

The purpose of this study is to investigate the water granulation mechanism of the hydrophilic matrix polymer HPMC in a high shear mixer and to relate the properties of the granules and tablets to the molecular weight and the degree of substitution for eight HPMC grades. Although the hydrophilic matrix system is a well known drug delivery one, there is a difficulty in that the desirable water granulation technique often causes problems in the presence of relatively large amounts of HPMC due to its hydrophilicity. The results of this study show that the properties of the granules and the tablets fall into two groups according to whether the molecular weight of the polymer is high or low. The granules of low molecular weight were smaller and more compact, with better flow properties but with less tensile strength of the compacts, whereas the opposite was valid for granules of high molecular weight. The explanation for these differences is linked to the proposed granulation mechanism of HPMC, in which the properties of the gel layer are important. The dominant factors governing the properties are the molecular weight and, to lesser extent, the degree of substitution.