Anhdyrous Lactose Agglomerates And The Preparation Thereof

  • Published: Mar 26, 2009
  • Earliest Priority: Dec 22 2004
  • Family: 11
  • Cited Works: 0
  • Cited by: 5
  • Cites: 8
  • Additional Info: Full text
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.


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Document History
  • Publication: Mar 26, 2009
  • Application: Dec 21, 2005
    US US 72296805 A
  • Priority: Dec 21, 2005
    NL NL 2005050089 W
  • Priority: Dec 22, 2004
    EP EP 04078479 A

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