30. July 2018
Injection site reactions (ISRs) and other adverse side-effects are commonly observed during therapy with biologics. These hypersensitivity related side-effects can vary from simple rash to life-threatening anaphylactic reaction, and may be linked to the immunogenicity of the drug including formation of antidrug antibodies. Reactions can also occur as a consequence of excipients in the product. We report the case of a patient who developed erythematous ISRs to both commercial PCSK9i formulations...
29. January 2016
The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The...