Investigation into the degree of variability in the solid-state properties of common pharmaceutical excipients-anhydrous lactose.
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.
Exploratory Biopharmaceutics R&D, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK. john.gamble@bms.com
John F
JF
Gamble
Wing-Sin
WS
Chiu
Vivienne
V
Gray
Helen
H
Toale
Michael
M
Tobyn
Yongmei
Y
Wu
D004339:Drug Compounding; D005079:Excipients; D005557:Formaldehyde; D006245:Hardness Tests; D007785:Lactose / Q000737:chemistry*; D010316:Particle Size; D013499:Surface Properties; D013607:Tablets
D005079:Excipients; D013607:Tablets; D005557:Formaldehyde; D007785:Lactose