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. 2010 Dec;11(4):1552-7.
doi: 10.1208/s12249-010-9527-4. Epub 2010 Oct 29.

Investigation into the degree of variability in the solid-state properties of common pharmaceutical excipients-anhydrous lactose

John F Gamble  1 , Wing-Sin Chiu, Vivienne Gray, Helen Toale, Michael Tobyn, Yongmei Wu
Affiliations

Investigation into the degree of variability in the solid-state properties of common pharmaceutical excipients-anhydrous lactose

John F Gamble et al. AAPS PharmSciTech. 2010 Dec.

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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Figures

Fig. 1
Fig. 1
Interval plot for specific surface area results for lactose anhydrous samples
Fig. 2
Fig. 2
Interval plot particle size results for lactose anhydrous samples
Fig. 3
Fig. 3
Interval plot for dispersive surface energy results for lactose anhydrous samples
Fig. 4
Fig. 4
Interval plot for yield pressure at 0.85 solid fraction results for lactose anhydrous samples
See this image and copyright information in PMC

References

    1. Doelker E, Mordier D, Iten H, Humbert-Droz P. Comparative tableting properties of sixteen microcrystalline celluloses. Drug Dev Ind Pharm. 1987;13(9):1847–1875. doi: 10.3109/03639048709068696. - DOI
    1. Landin M, Martinez-Pacheco R, Gómez-Amoza J, Souto C, Concheiro A, Rowe R. Influence of microcrystalline cellulose source and batch variation on the tabletting behaviour and stability of prednisone formulations. Int J Pharm. 1993;91(2):143–149. doi: 10.1016/0378-5173(93)90333-B. - DOI
    1. Moreton C. Functionality and performance of excipients in a quality-by-design world: obtaining information on excipient variability for formulation design space. Am Pharm Rev. 2009;12(5):28–33.
    1. Amidon, G.E. Physical and Mechanical Property Characterization of Powders, in: Physical Characterization of Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences, Volume 70) Eds: Brittain, H.G. 1995.
    1. Rios, M. Debating Excipient Functionality. Pharm Technol 2006.