Evaluation of effect of the primary particle size on compactibility of spray-dried lactoses

Spray-dried lactose is one of the most used filler-binders in direct compaction of tablets. Spray-dried lactose is produced by spray-drying a suspension of α-lactose monohydrate crystals in a saturated aqueous solution of lactoses. The resulting product is composed of spherical particles, containing 80-85% crystals of α-lactose monohydrate (primary particles) and 15-20% amorphous lactose The compactibility of two commercial spray-dried lactoses, Pharmatose® DCL 11 (DCL11), prepared from α-lactose monohydrate with a median primary particle size of 34 µm and a new product, Pharmatose® DCL 14 (DCL14), prepared from 20 µm primary particles, were investigated.