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AAPS PharmSciTech

, Volume 11, Issue 4, pp 1552–1557 | Cite as

Investigation into the Degree of Variability in the Solid-State Properties of Common Pharmaceutical Excipients—Anhydrous Lactose

  • John F. Gamble
  • Wing-Sin Chiu
  • Vivienne Gray
  • Helen Toale
  • Michael Tobyn
  • Yongmei Wu
Research Article Theme: Advances in Pharmaceutical Excipients Research and Use: Novel Materials, Functionalities and Testing

Abstract

This paper reports the batch-to-batch and vendor-to-vendor variations in the solid-state characteristics of multiple batches of lactose anhydrous from each of three vendors and the subsequent impact of these differences on processability and/or functionality.

Key words

compaction excipients lactose physical properties variability 

Notes

Acknowledgements

The authors would like to thank Borculo Domo, DMV-Fonterra and Kerry Bioscience for the donation of the batches of lactose anhydrous used for this study. The authors would also like to thank Dr. Mridul Majumder (Pharmaterials Ltd.), Dr. Nancy Barbour, Dr. Peter Timmins and Dr. Michael Leane (all Bristol-Myers Squibb) for their support during this study.

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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • John F. Gamble
    • 1
  • Wing-Sin Chiu
    • 1
    • 2
  • Vivienne Gray
    • 1
  • Helen Toale
    • 1
  • Michael Tobyn
    • 1
  • Yongmei Wu
    • 3
  1. 1.Exploratory Biopharmaceutics R&D, Bristol-Myers SquibbMoretonUK
  2. 2.Department of PharmacyUniversity of BathBathUK
  3. 3.Bristol-Myers SquibbNew BrunswickUSA

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