Mannitol-sucrose mixtures - Versatile formulations for protein lyophilization

Journal of Pharmaceutical Sciences

Volumn 91, Issue 4, 2002, Pages 914-922

  Johnson, Robert E ^a   Kirchhoff, Carol F ^a   Gaud, Henry T ^a  

^a PFIZER INC   (United States)

Author keywords

Lyophilization; Mannitol; Protein; Sucrose

Indexed keywords

BULKING AGENT; EXCIPIENT; MANNITOL; RECOMBINANT PROTEIN; SUCROSE;

ARTICLE; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG STABILITY; ESCHERICHIA COLI; FREEZE DRYING; NONHUMAN; TEMPERATURE; THERMOGRAVIMETRY; X RAY POWDER DIFFRACTION;

EID: 0036285548     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.10094     Document Type: Article

References (17)

1. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase
2. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying
3. Formulations of sugars with amino acids or mannitol - Influence of concentration ratio on the properties of the freeze-concentrate and the lyophilizate
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5. Characterization of phase transitions during freeze-drying by in situ X-ray powder diffractometry
6. The physical state of mannitol after freeze-drying: Effects of mannitol concentration, freezing rate and a noncrystallizing cosolute
7. Polymorphic changes of mannitol during freeze-drying: Effect of surface-active agents
8. Vial Breakage by frozen mannitol solutions: Correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration
9. Energy/temperature diagram and compression behavior of the polymorphs of D-mannitol
10. Study of different crystalline forms of mannitol: Comparative behaviour under compression
11. The influence of lyophilization on the polymorphic behavior of mannitol
12. Collapse during freeze drying - Qualitative and quantitative aspects
13. Characterization of the formulation is the key to developing an optimal lyophilization cycle - A case study
14. The effects of formulation variables on the stability of freeze-dried human growth hormone
15. Lyophilized formulations of recombinant tumor necrosis factor
16. Freeze drying: From empiricism to predictability