PROTEIN SPRAY-FREEZE-DRYING: THE NEGATIVE INFLUENCE OF AMORPHOUS MANNITOL ON PROTEIN STABILITY

PROTEIN SPRAY-FREEZE-DRYING: THE NEGATIVE INFLUENCE OF AMORPHOUS MANNITOL ON PROTEIN STABILITY
Spring 2005
C. Rochelle1, G. Lee1, P. Laidler2, R. Prasad2, PH.D Thesis
1 Department of Pharmaceutics, Friedrich-Alexander University, Erlangen
2 Powderject Pharmaceuticals, Oxford
Department of Pharmaceutics, Friedrich-Alexander University, Erlangen
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Introduction
Mannitol is frequently used as carrier in freeze-dried formulations. The amorphous state recrystallises during primary drying. As a component of a formulation mannitol can be amorphous, however.
Maa showed that a mannitol portion = 30% is needed before crystallisation becomes evident on spray-drying. We have used mannitol as a 3rd component in a trehalose/dextran mixture for spray-freeze-drying to make particles for needlefree
injection. Mannitol was found to be amorphous and had disadvantageous properties for protein stability.