Functionality enhancement of sorbitol and anhydrous calcium diphosphate composites for direct compression applications

Abstract

Sorbitol and calcium diphosphate have been used as diluents for making solid dosage forms. However, due to their intrinsic properties these two materials cannot be used for direct compression applications. In order to improve their functional properties, coprocessing of sorbitol with anhydrous calcium diphosphate was conducted by spray drying, agglomeration, hot melt granulation and cocrystallization. The resulting powder and tableting properties and the selection of the best technology were evaluated by the principal component analysis. Bulk and tap densities increased with increasing calcium diphosphate levels. Spray drying rendered highly porous materials with the lowest yield, whereas agglomeration rendered a product yield of ~90%. Hot melt rendered materials with the best compactibility. The bulk and tap densities, product yield and porosity of the composites depended on the technology employed. On the contrary, properties such as true density, compact tensile strength and tablet disintegration times were more dependent on the level of calcium diphosphate rather than on the technology used. Further, processing time was independent of the technology and level of calcium diphosphate. Coprocessing proved to be useful tool to modify the powder properties of sorbitol. The agglomeration was selected as the most practical technology for the production of sorbitol:calcium diphosphate composites for direct compression applications.