Journal ArticleDOI
Lyophilization and development of solid protein pharmaceuticals
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TLDR
Four interrelated topics are discussed: lyophilization and its denaturation stresses, cryo- and lyo-protection of proteins by excipients, design of a robust lyophILization cycle, and with emphasis, instability, stabilization, and formulation of solid protein pharmaceuticals.About:
This article is published in International Journal of Pharmaceutics.The article was published on 2000-08-01. It has received 1373 citations till now.read more
Citations
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Freeze-drying of nanoparticles: formulation, process and storage considerations.
TL;DR: The most important parameters that influence the success of freeze-drying of these fragile systems are discussed, and an overview of nanoparticles freeze-Drying process and formulation strategies are provided with a focus on the impact of formulation and process on particle stability.
Journal ArticleDOI
Antibody structure, instability, and formulation
TL;DR: The structure and function of antibodies and the mechanisms of physical and chemical instabilities are reviewed and various aspects of formulation development have been examined to identify the critical attributes for the stabilization of antibodies.
Journal ArticleDOI
Protein drug stability: a formulation challenge
Sven Frokjaer,Daniel E. Otzen +1 more
TL;DR: The increasing use of recombinantly expressed therapeutic proteins in the pharmaceutical industry has highlighted issues such as their stability during long-term storage and means of efficacious delivery that avoid adverse immunogenic side effects as discussed by the authors.
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Stability of Protein Pharmaceuticals: An Update
TL;DR: This review summarizes the advances that have been made since then regarding protein stabilization and formulation and discusses the current understanding of chemical and physical instability.
Journal ArticleDOI
Protein aggregation and its inhibition in biopharmaceutics
TL;DR: This article intends to discuss protein aggregation and its related mechanisms, methods characterizingprotein aggregation, factors affecting protein aggregation, and possible venues in aggregation prevention/inhibition in various stages of protein drug development.
References
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Journal ArticleDOI
Formation of glasses from liquids and biopolymers.
TL;DR: The onset of a sharp change in ddT( is the Debye-Waller factor and T is temperature) in proteins, which is controversially indentified with the glass transition in liquids, is shown to be general for glass formers and observable in computer simulations of strong and fragile ionic liquids, where it proves to be close to the experimental glass transition temperature.
Journal ArticleDOI
Dominant forces in protein folding
TL;DR: The present review aims to provide a reassessment of the factors important for folding in light of current knowledge, including contributions to the free energy of folding arising from electrostatics, hydrogen-bonding and van der Waals interactions, intrinsic propensities, and hydrophobic interactions.
Journal ArticleDOI
Characteristics and Significance of the Amorphous State in Pharmaceutical Systems
Bruno C. Hancock,George Zografi +1 more
TL;DR: The amorphous state is critical in determining the solid-state physical and chemical properties of many pharmaceutical dosage forms and some of the most common methods that can be used to measure them are described.
Journal ArticleDOI
Instability, stabilization, and formulation of liquid protein pharmaceuticals.
TL;DR: The basic behavior of proteins, their instabilities, and stabilization in aqueous state in relation to the development of liquid protein pharmaceuticals is discussed.
Journal ArticleDOI
The role of vitrification in anhydrobiosis.
TL;DR: Evidence is presented here showing that trehalose has a remarkably high glass-transition temperature (Tg), which makes this sugar useful in stabilization of biomolecules of use in human welfare and may explain the stability and longevity of anhydrobiotes that contain it.
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