Drying Induced Variations in Physico-Chemical Properties of Amorphous Pharmaceuticals and Their Impact on Stability (I): Stability of aMonoclonal Antibody

Published

November 21, 2006

Author(s)

Ahmad Abdul-Fattah, Vu Truong-Le, Luisa Yee, Lauren Nguyen, Devendra Kalonia, Marcus T. Cicerone, Michael Pikal

Abstract

Both drying method and formulation had a significant impact on the properties of IgG1 powders, including storage stability. Among the drying methods, SSA was highest and perturbations in secondary structure were lowest with the spray dried preparations. Sucrose-rich foams had the lowest SSA and the lowest protein surface accumulation. Also, sucrose-rich foams had the lowest molecular mobility (both fast dynamics and global motions). Stability studies showed a log linear dependence of physical stability on composition. Preparations manufactured by Foam Drying were the most stable, regardless of the stabilizer level. In protein-rich formulations, freeze-dried powders showed the poorest storage stability and the stability differences were correlated to differences in secondary structure. In stabilizer-rich formulations, stability differences were best correlated to differences in molecular mobility (fast dynamics) and total protein surface accumulation.

Citation

Journal of Pharmaceutical Sciences

Volume

96

Issue

8

Pub Type

Journals

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Keywords

composition heterogeneity, glass dynamics, incoherent elastic neutron scattering, protein stabilization, structural relaxation

Citation

Abdul-Fattah, A. , Truong-Le, V. , Yee, L. , Nguyen, L. , Kalonia, D. , Cicerone, M. and Pikal, M. (2006), Drying Induced Variations in Physico-Chemical Properties of Amorphous Pharmaceuticals and Their Impact on Stability (I): Stability of aMonoclonal Antibody, Journal of Pharmaceutical Sciences, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=852691 (Accessed April 26, 2024)