NDLI: Freeze-Concentration Separates Proteins and Polymer Excipients Into Different Amorphous Phases

Content Provider	Springer Nature Link
Author	Izutsu, Ken ichi Kojima, Shigeo
Copyright Year	2000
Abstract	Purpose. To study the miscibility of proteins and polymer excipients in frozen solutions and freeze-dried solids as protein formulation models. Methods. Thermal profiles of frozen solutions and freeze-dried solids containing various proteins (lysozyme, ovalbumin, BSA), nonionic polymers (Ficoll, polyvinylpyrrolidone [PVP]), and salts were analyzed by differential scanning calorimetry (DSC). The polymer miscibility was determined from the glass transition temperature of maximally freeze-concentrated solute (T$_{g}$′) and the glass transition temperature of freeze-dried solid (T$_{g}$). Results. Frozen Ficoll or PVP 40k solutions showed T$_{g}$′ at −22°C, while protein solutions did not show an apparent T$_{g}$′. All the protein and nonionic polymer combinations (5% w/w, each) were miscible in frozen solutions and presented single T$_{g}$′s that rose with increases in the protein ratio. Various salts concentration-dependently lowered the single T$_{g}$′s of the proteins and Ficoll combinations maintaining the mixed amorphous phase. In contrast, some salts induced the separation of the proteins and PVP combinations into protein-rich and PVP-rich phases among ice crystals. The T$_{g}$′s of these polymer combinations were jump-shifted to PVP's intrinsic T$_{g}$′ at certain salt concentrations. Freeze-dried solids showed varied polymer miscibilities identical to those in frozen solutions. Conclusions. Freeze-concentration separates some combinations of proteins and nonionic polymers into different amorphous phases in a frozen solution. Controlling the polymer miscibility is important in designing protein formulations.
Starting Page	1316
Ending Page	1322
Page Count	7
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	17
Issue Number	10
e-ISSN	1573904X
Language	English
Publisher	Kluwer Academic Publishers-Plenum Publishers
Publisher Date	2000-01-01
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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