Abstract

The purpose of this study was to investigate the influence of amorphous content in spray-dried lactose on tableting characteristics. To obtain different amorphous contents, spray-dried lactoses were prepared at various lactose concentrations in distilled water. Plain spray-dried lactose and hydrochlorothiazide-lactose based tablets were compressed on an instrumented tablet press. Heckel analysis indicated that relative density (D B ) and yield pressure (P y ) correlated with both the degree of crystallinity and particle size and shape. The compactibility of the tablets was found to increase with amorphous content up to 20 % and then decreased and leveled off as the amorphous content was greater than 30 %. At 30 % amorphous and higher the spray-dried lactose tablets exhibited dissolution and erosion rather than disintegration in distilled water which was observed with lower amorphous lactose. The results indicated that tablet disintegration was influenced by compaction pressure and amorphous level (p

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