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

  • Research Article
  • Theme: Advances in Pharmaceutical Excipients Research and Use: Novel Materials, Functionalities and Testing
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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.

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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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Authors and Affiliations

  1. Exploratory Biopharmaceutics R&D, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK

    John F. Gamble, Wing-Sin Chiu, Vivienne Gray, Helen Toale & Michael Tobyn

  2. Department of Pharmacy, University of Bath, Claverton Down, Bath, BA2 7AY, UK

    Wing-Sin Chiu

  3. Bristol-Myers Squibb, New Brunswick, New Jersey, USA

    Yongmei Wu

Authors
  1. John F. Gamble
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  2. Wing-Sin Chiu
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  3. Vivienne Gray
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  4. Helen Toale
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  5. Michael Tobyn
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  6. Yongmei Wu
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Corresponding author

Correspondence to John F. Gamble.

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Guest Editors: Otilia Koo, Thomas Farrell, Allison Radwick, and Sameer Late

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Gamble, J.F., Chiu, WS., Gray, V. et al. Investigation into the Degree of Variability in the Solid-State Properties of Common Pharmaceutical Excipients—Anhydrous Lactose. AAPS PharmSciTech 11, 1552–1557 (2010). https://doi.org/10.1208/s12249-010-9527-4

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  • DOI: https://doi.org/10.1208/s12249-010-9527-4

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