Spray dried lactose and process for preparing the same

摘要

The invention relates to a spray dried lactose suitable for use as component of tablets and to a process for preparing same. The lactose is predominantly crystalline and contains at most 50% by weight of amorphous lactose. At least 50% by weight of the crystalline lactose consists of particles below 50 mu m. The preparation process comprises a step of suspending crystalline alpha-lactose hydrate at 0 DEG -90 DEG C. in a saturated lactose solution, and a spray drying step. The temperature of the suspension is kept substantially constant until the time of spray drying in order to minimize crystallization and dissolution events.