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Mannitol hemihydrate in lyophilized protein formulations: Impact of its dehydration during storage o

Journal Article · · Int. J. Pharmaceut.

Research Organization:
Argonne National Laboratory (ANL), Argonne, IL (United States). Advanced Photon Source (APS)
Sponsoring Organization:
DOE - Office Of Science; DOE - BASIC ENERGY SCIENCES
OSTI ID:
1900922
Journal Information:
Int. J. Pharmaceut., Vol. 624
Country of Publication:
United States
Language:
ENGLISH

References (29)

The formation and effect of mannitol hemihydrate on the stability of monoclonal antibody in the lyophilized state journal June 2019
Differentiation and Quantitative Determination of Surface and Hydrate Water in Lyophilized Mannitol Using NIR Spectroscopy journal September 2006
Rational Design of Stable Lyophilized Protein Formulations: Theory and Practice book January 2002
Mechanisms of protein stabilization in the solid state journal September 2009
Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation journal January 2003
Lyophilization of Pharmaceuticals I journal April 1965
Impact of freezing procedure and annealing on the physico-chemical properties and the formation of mannitol hydrate in mannitol–sucrose–NaCl formulations journal November 2006
Mannitol–Sucrose Mixtures—Versatile Formulations for Protein Lyophilization journal April 2002
The Aggregation of Bovine Serum Albumin in Solution and in the Solid State journal April 2011
Investigation of Spatial Heterogeneity of Salt Disproportionation in Tablets by Synchrotron X-ray Diffractometry journal March 2017
Effects of Additives on the Stability of Recombinant Human Factor XIII during Freeze-Drying and Storage in the Dried Solid journal December 1998
Crystallization Rates for Amorphous Sucrose and Lactose Powders from Spray Drying: A Comparison journal March 2009
Influence of the Active Pharmaceutical Ingredient Concentration on the Physical State of Mannitol—Implications in Freeze-Drying journal August 2005
Influence of Processing Conditions on the Physical State of Mannitol—Implications in Freeze-Drying journal December 2006
Moisture-induced aggregation of lyophilized proteins in the solid state journal January 1991
Sugar Crystallization, Equilibrium Moisture Content and Crystallization of Amorphous Sucrose and Glucose journal January 1956
Controlling the physical form of mannitol in freeze-dried systems journal October 2013
Impact of bulking agents on the stability of a lyophilized monoclonal antibody journal August 2009
Protein Denaturation during Freezing and Thawing in Phosphate Buffer Systems: Monomeric and Tetrameric β-Galactosidase journal December 2000
Plasticizing Effect of Water on Thermal Behavior and Crystallization of Amorphous Food Models journal January 1991
Non-Isothermal and Isothermal Crystallization of Sucrose from the Amorphous State journal August 1994
Sucrose and Trehalose in Therapeutic Protein Formulations book January 2018
The Influence of Mannitol Hemihydrate on the Secondary Drying Dynamics of a Protein Formulation: A Case Study journal December 2017
Influence of Crystallizing and Non-crystallizing Cosolutes on Trehalose Crystallization During Freeze-Drying journal September 2010
Role of Sucrose-Ldh Hydrogen bond for Thermal Stabilizing Effect of Sucrose on Freeze-Dried ldh journal August 1999
Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations journal June 2021
Impact of sucrose level on storage stability of proteins in freeze-dried solids: I. correlation of protein–sugar interaction with native structure preservation journal September 2009
Existence of a mannitol hydrate during freeze‐drying and practical implications journal February 1999
Investigating the Moisture Sorption Behavior of Amorphous Sucrose Using a Dynamic Humidity Generating Instrument journal December 2007