Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization.


Many of the compounds considered for use in pharmaceutical formulations demonstrate incompatibilities with other components at high enough concentrations, including pairs of polymers, polymers and salts, or even proteins in combination with polymers, salts, or other proteins. Freeze concentration can force solutions into a region where incompatibilities… (More)


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