Patent ID: 8173173
Filing Date: 2012-05-08
Classification: A61K,A61P,C13B,C13K

Abstract:
1. 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,  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.