当前位置： SCI文献检索 > ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS期刊下所有文献 > Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization.

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

Abstract：

: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 between solutes will manifest as the formation of multiple phases. Such phase separation complicates questions of the stability of the formulation as well as labile components, such as proteins. Yet, phase separation events are difficult to identify by common formulation screening methods. In this report, we use the osmotic virial expansion model of Edmond and Ogston (1) to describe phase-separating behavior of ternary aqueous polymer solutions. Second osmotic virial coefficients of polyethylene glycol 3350 (PEG) and dextran T500 were measured by light scattering. Assuming an equilibrium between ice and water in the freeze-concentrated solution, a degree of freeze concentration can be estimated, which, when combined with the phase separation spinodal, describes a "phase separation envelope" in which phase separation tendencies can be expected in the frozen solution. The phase separation envelope is bounded at low temperatures by the glass transition temperature of the freeze-concentrated solution. Scanning electron microscopic images and infrared spectroscopy of protein structure are provided as experimental evidence of the phase separation envelope in a freeze-dried system of PEG, dextran, and hemoglobin.

journal_name

Arch Biochem Biophys

journal_title

Archives of biochemistry and biophysics

authors

Heller MC,Carpenter JF,Randolph TW

doi

10.1006/abbi.1998.1078

subject

Has Abstract

pub_date

1999-03-15 00:00:00

pages

191-201

issue

2

eissn

0003-9861

issn

1096-0384

pii

S0003-9861(98)91078-5

journal_volume

363

pub_type

杂志文章

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