Abstract

Abstract The effects of spheronization on the physico-chemical properties of uncoated and coated granules containing different kinds of fillers were investigated. The fillers used in the granules were water-soluble glucose and lactose, water-insoluble calcium hydrogen phosphate dihydrate, slightly swellable, hydrophilic microcrystalline cellulose and swellable maize starch. The ability of these fillers to spheronize varied depending on the structure of the crystals and the solubility of the material. Of the physical properties of the granules studied, only friability was affected by spheronization. The granules were coated with ethyl cellulose/hydroxypropylmethyl cellulose. Differences were seen in the behaviour of the fillers in the cores during the dissolution test when unspheronized and spheronized granules were compared. The differences were clearest when maize starch or microcrystalline cellulose was used in the cores of film-coated granules. They ruptured the coats of unspheronized and spheronized granules differently.

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