Investigation into the Degree of Variability in the Solid-State Properties of Common Pharmaceutical Excipients—Anhydrous Lactose
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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 wordscompaction excipients lactose physical properties variability
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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