Invention Grant
- Patent Title: Anhdyrous lactose agglomerates and the preparation thereof
- Patent Title (中): 无糖乳糖聚集体及其制备
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Application No.: US11722968Application Date: 2005-12-21
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Publication No.: US08173173B2Publication Date: 2012-05-08
- Inventor: Klaas Daniël Kussendrager , Bouwe Walsma
- Applicant: Klaas Daniël Kussendrager , Bouwe Walsma
- Applicant Address: NL Zaltbommel
- Assignee: Campina Nederland Holding B.V.
- Current Assignee: Campina Nederland Holding B.V.
- Current Assignee Address: NL Zaltbommel
- Agency: Browdy and Neimark, PLLC
- Priority: EP04078479 20041222
- International Application: PCT/NL2005/050089 WO 20051221
- International Announcement: WO2006/068484 WO 20060629
- Main IPC: A61K9/50
- IPC: A61K9/50

Abstract:
The invention relates to a process for the preparation of anhydrous lactose agglomerates, said process comprising (i) subjecting essentially anhydrous lactose primary particles 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 solution, 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 agglomerates combine have excellent compactibility and flowability properties and are particularly useful as excipient in moisture-sensitive applications.
Public/Granted literature
- US20090081308A1 ANHDYROUS LACTOSE AGGLOMERATES AND THE PREPARATION THEREOF Public/Granted day:2009-03-26
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