Literature DB >> 8415413

Decreased protein-stabilizing effects of cryoprotectants due to crystallization.

K Izutsu1, S Yoshioka, T Terao.   

Abstract

The stabilizing effects of various additives against inactivation of an enzyme (beta-galactosidase from Aspergillus oryzae) during freeze-drying were studied, with a focus on their crystallinity. The crystalline morphology of mannitol and inositol in freeze-dried cakes depended on the solute concentrations before freezing and the freeze-drying method used. The additives in their amorphous state showed concentration-dependent stabilization of the enzyme, whereas additive crystallization during freeze-drying decreased their effects. Heat treatment before freeze-drying also caused crystallization and diminished the stabilizing effects. Noncovalent soluble aggregates were observed in the inactivated enzyme solution. These results show the importance of maintaining the amorphous state of additives used as stabilizing agents during freeze-drying.

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Year:  1993        PMID： 8415413     DOI： 10.1023/a:1018988823116

Source DB:  PubMed          Journal:  Pharm Res        ISSN： 0724-8741            Impact factor:   4.200


  16 in total

1.  Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration.

Authors:  N A Williams; T Dean
Journal:  J Parenter Sci Technol       Date:  1991 Mar-Apr

2.  Formulation and stability of freeze-dried proteins: effects of moisture and oxygen on the stability of freeze-dried formulations of human growth hormone.

Authors:  M J Pikal; K Dellerman; M L Roy
Journal:  Dev Biol Stand       Date:  1992

3.  Lyophilized formulations of recombinant tumor necrosis factor.

Authors:  M S Hora; R K Rana; F W Smith
Journal:  Pharm Res       Date:  1992-01       Impact factor: 4.200

Review 4.  Protein--solvent interactions in pharmaceutical formulations.

Authors:  T Arakawa; Y Kita; J F Carpenter
Journal:  Pharm Res       Date:  1991-03       Impact factor: 4.200

5.  The mechanism of cryoprotection of proteins by solutes.

Authors:  J F Carpenter; J H Crowe
Journal:  Cryobiology       Date:  1988-06       Impact factor: 2.487

6.  Freeze-drying of haemoglobin in the presence of carbohydrates.

Authors:  P Labrude; B Chaillot; F Bonneaux; C Vigneron
Journal:  J Pharm Pharmacol       Date:  1980-08       Impact factor: 3.765

7.  Stabilization of protein structure by sugars.

Authors:  T Arakawa; S N Timasheff
Journal:  Biochemistry       Date:  1982-12-07       Impact factor: 3.162

8.  The influence of sucrose, dextran, and hydroxypropyl-beta-cyclodextrin as lyoprotectants for a freeze-dried mouse IgG2a monoclonal antibody (MN12).

Authors:  M E Ressing; W Jiskoot; H Talsma; C W van Ingen; E C Beuvery; D J Crommelin
Journal:  Pharm Res       Date:  1992-02       Impact factor: 4.200

9.  Freeze denaturation of enzymes and its prevention with additives.

Authors:  T Tamiya; N Okahashi; R Sakuma; T Aoyama; T Akahane; J J Matsumoto
Journal:  Cryobiology       Date:  1985-10       Impact factor: 2.487

10.  The effects of formulation variables on the stability of freeze-dried human growth hormone.

Authors:  M J Pikal; K M Dellerman; M L Roy; R M Riggin
Journal:  Pharm Res       Date:  1991-04       Impact factor: 4.200
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  36 in total

1.  The use of disaccharides in inhibiting enzymatic activity loss and secondary structure changes in freeze-dried β-galactosidase during storage.

Authors:  Ville Petteri Heljo; Kirsi Jouppila; Timo Hatanpää; Anne M Juppo
Journal:  Pharm Res       Date:  2010-10-22       Impact factor: 4.200

2.  Quantification of crystallinity in substantially amorphous materials by synchrotron X-ray powder diffractometry.

Authors:  Cletus Nunes; Arumugam Mahendrasingam; Raj Suryanarayanan
Journal:  Pharm Res       Date:  2005-08-31       Impact factor: 4.200

3.  Near-infrared imaging for studying homogeneity of protein-sugar mixtures.

Authors:  Natasa Jovanović; Ad Gerich; Andréanne Bouchard; Wim Jiskoot
Journal:  Pharm Res       Date:  2006-08-12       Impact factor: 4.200

4.  Storage stability of keratinocyte growth factor-2 in lyophilized formulations: effects of formulation physical properties and protein fraction at the solid-air interface.

Authors:  Dilip Devineni; Christoph Gonschorek; Marcus T Cicerone; Yemin Xu; John F Carpenter; Theodore W Randolph
Journal:  Eur J Pharm Biopharm       Date:  2014-05-21       Impact factor: 5.571

5.  Influence of processing conditions on the physical state of mannitol--implications in freeze-drying.

Authors:  Xiangmin Liao; Rajesh Krishnamurthy; Raj Suryanarayanan
Journal:  Pharm Res       Date:  2007-02       Impact factor: 4.200

6.  Mutual Influence of Mannitol and Trehalose on Crystallization Behavior in Frozen Solutions.

Authors:  Sampreeti Jena; Raj Suryanarayanan; Alptekin Aksan
Journal:  Pharm Res       Date:  2016-02-23       Impact factor: 4.200

Review 7.  Stability of protein pharmaceuticals: an update.

Authors:  Mark Cornell Manning; Danny K Chou; Brian M Murphy; Robert W Payne; Derrick S Katayama
Journal:  Pharm Res       Date:  2010-02-09       Impact factor: 4.200

Review 8.  Rational design of stable lyophilized protein formulations: some practical advice.

Authors:  J F Carpenter; M J Pikal; B S Chang; T W Randolph
Journal:  Pharm Res       Date:  1997-08       Impact factor: 4.200

9.  Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride.

Authors:  Chitra Telang; Lian Yu; Raj Suryanarayanan
Journal:  Pharm Res       Date:  2003-04       Impact factor: 4.200

10.  Influence of process conditions on the crystallization and transition of metastable mannitol forms in protein formulations during lyophilization.

Authors:  Wenjin Cao; Yong Xie; Sampathkumar Krishnan; Hong Lin; Margaret Ricci
Journal:  Pharm Res       Date:  2012-08-21       Impact factor: 4.200
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