[HTML][HTML] Oxidation of drugs during drug product development: problems and solutions

A Gabrič, Ž Hodnik, S Pajk - Pharmaceutics, 2022 - mdpi.com
Oxidation is the second most common degradation pathway for pharmaceuticals, after
hydrolysis. However, in contrast to hydrolysis, oxidation is mechanistically more complex …

Reactive impurities in excipients: profiling, identification and mitigation of drug–excipient incompatibility

Y Wu, J Levons, AS Narang, K Raghavan, VM Rao - Aaps Pharmscitech, 2011 - Springer
Reactive impurities in pharmaceutical excipients could cause drug product instability,
leading to decreased product performance, loss in potency, and/or formation of potentially …

Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2

XM Lam, JY Yang, JL Cleland - Journal of pharmaceutical sciences, 1997 - Elsevier
Recombinant humanized monoclonal antibody HER2, rhuMAb HER2, in liquid formulations
undergoes oxidation when exposed to intense light and elevated temperatures (30 & 40° C) …

Kinetics and mechanism of the reaction of cysteine and hydrogen peroxide in aqueous solution

D Luo, SW Smith, BD Anderson - Journal of pharmaceutical sciences, 2005 - Elsevier
The oxidation of thiol-containing small molecules, peptides, and proteins in the presence of
peroxides is of increasing biological and pharmaceutical interest. Although such reactions …

Stabilization of pharmaceuticals to oxidative degradation

KC Waterman, RC Adami, KM Alsante… - Pharmaceutical …, 2002 - Taylor & Francis
A guide for stabilization of pharmaceuticals to oxidation is presented. Literature is presented
with an attempt to be a ready source for data and recommendations for formulators. Liquid …

Identification of a single tryptophan residue as critical for binding activity in a humanized monoclonal antibody against respiratory syncytial virus

Z Wei, J Feng, HY Lin, S Mullapudi, E Bishop… - Analytical …, 2007 - ACS Publications
We have identified a single tryptophan (Trp) residue responsible for loss of binding and
biological activity upon ultraviolet (UV) light irradiation in MEDI-493, a humanized …

Physicochemical and formulation developability assessment for therapeutic peptide delivery—a primer

A Bak, D Leung, SE Barrett, S Forster, EC Minnihan… - The AAPS journal, 2015 - Springer
Peptides are an important class of endogenous ligands that regulate key biological
cascades. As such, peptides represent a promising therapeutic class with the potential to …

Formulation development of protein dosage forms

MJ Akers, V Vasudevan, M Stickelmeyer - Development and manufacture …, 2002 - Springer
A formulation scientist assigned the task of developing a stable, elegant, and
manufacturable dosage form of a therapeutic protein drug has been given a significant …

[BOOK][B] Pharmaceutical formulation development of peptides and proteins

L Hovgaard, S Frokjaer, M van de Weert - 1999 - taylorfrancis.com
Pharmaceutical formulation of peptides and proteins has become an important part of
modern drug development. Many new drugs are based on peptide or protein recombinant …

Azobisisobutyronitrile loaded on mesoporous silica particles: A new stressor for solid-state oxidative forced degradation studies

J Petřík, D Zůza, J Heřt, P Řezanka, L Krejčík… - … of Pharmaceutical and …, 2023 - Elsevier
A new approach for testing drug sensitivity to autooxidative degradation in the solid state is
demonstrated in this work. A novel solid-state form of stressing agent for autooxidation has …