Patent ID: 8173173

Claim:
A process for preparing anhydrous lactose agglomerates, comprising: (i) subjecting essentially anhydrous lactose primary particles comprising at least 60 wt % crystalline β-lactose in a granulator to wet granulation at a temperature of 30°-100° C. using a binder solution, to obtain a granulation mass, (ii) drying the granulation mass during at least part of the granulation step (i), by blowing hot air having a relative humidity of 0-25% and a temperature of at least 50° C. at the inlet of the granulator and into the granulator, wherein during the wet granulation, free moisture content is maintained between 0.1 and 10 wt %, based on the total wet weight of the granulation mass, and (iii) after drying, obtaining said anhydrous lactose agglomerates which comprise at least 50 wt % β-lactose crystallites and a total water content in the range of 0-1.0 wt %, as determined by Karl Fischer titration.