Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 98, Issue 9, Pages 2886-2908Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.21825
Keywords
solid-state stability; freeze drying/lyophilization; physical characterization; protein formulation; relaxation time
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The solid state is preferred for many proteins due to their marginal stability in solution. However, even in the solid state, chemical and physical degradation can occur on the time scale of the drying process, distribution and use. This review summarizes the major degradation pathways of proteins in the solid state and the corresponding stabilization strategies. Specially, this review discusses the mechanisms of protein stabilization in the solid state. Understanding the mechanisms of protein stabilization is critical to efficient protein formulation development in the pharmaceutical industry. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2886-2908, 2009
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