Investigation of PEG crystallization in frozen and freeze-dried PEGylated recombinant human growth hormone-sucrose systems: Implications on storage stability

Journal of Pharmaceutical Sciences

Volumn 100, Issue 8, 2011, Pages 3062-3075

  Bhatnagar, Bakul S ^a,b   Martin, Susan W H ^c   Hodge, Tamara S ^c   Das, Tapan K ^c   Joseph, Liji ^c   Teagarden, Dirk L ^c   Shalaev, Evgenyi Y ^c   Suryanarayanan, Raj ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

^b Pfizer BioTherapeutics Pharmaceutical Sciences   (United States)

^c PFIZER INC   (United States)

Author keywords

Crystallization; Eutectic melting; Freeze drying; Low temperature XRD; Lyophilization; PEGylation; Phase separation; Recombinant human growth hormone; Stability; Sucrose

Indexed keywords

HUMAN GROWTH HORMONE; MACROGOL; SUCROSE;

AQUEOUS SOLUTION; ARTICLE; CHEMICAL COMPOSITION; CRYSTALLIZATION; DEAMINATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DECOMPOSITION; DRUG FORMULATION; DRUG PURITY; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; FREEZE THAWING; FREEZING; GEL PERMEATION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; OXIDATION; PHASE TRANSITION; PROTEIN STABILITY; TEMPERATURE SENSITIVITY;

EID: 79958819262     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22562     Document Type: Article

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