ANHDYROUS LACTOSE AGGLOMERATES AND THE PREPARATION THEREOF

摘要

The invention relates to a process for the preparation of anhydrous lactose agglomerates, said process comprising (i) subjecting essentially anhydrous lactose primary part icles comprising at least 60 wt% crystalline -lactose in a granulator to a wet granulation step at a temperature in the range of 30 - 100 °C using a binder solut ion, wherein the granulation mass is subjected to drying for at least part of the granulation step, and (ii) after-drying the granulation mass. The anhydrous lactose agglomerates thus produced comprise at least 50 wt% -lactose crystallites and have a total water content in the range of 0 - 1.0 wt%, which is required according to the standards laid down by the Pharmacopoeia for anhydrous lactose excipients. These agglo merates combine have excellent compactibility and flowability properties and are particularly useful as excipient in moisture-sensitive applications.