Recent trends in stabilising peptides and proteins in pharmaceutical formulation - considerations in the choice of excipients.
In the area of peptide and protein pharmaceuticals, both the physical and chemical stability of biopharmaceuticals are critical and need to be optimised when formulating a drug product, in order to optimise the outcome after processing and storage. This review focuses on the effects on the stability from various types of excipient and the choices that have to be made during formulation of drug products containing peptides or proteins. It is illustrated, through examples, how the choice of one excipient over another can affect the stability of a protein drug formulation, along with other problems linked to this choice. The excipients used in pharmaceutical preparations are limited and from an academic point of view there is a clear requirement for new excipients.
Jorgensen
Lene
L
University of Copenhagen, Department of Pharmaceutics and Analytical Chemistry, Universitetsparken 2, DK-2100-Copenhagen, Denmark. lej@farma.ku.dk
Hostrup
Susanne
S
Moeller
Eva Horn
EH
Grohganz
Holger
H
D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D006801:Humans; D010455:Peptides / Q000737:chemistry / Q000627:therapeutic use*; D055550:Protein Stability; D011506:Proteins / Q000737:chemistry / Q000627:therapeutic use*
D005079:Excipients; D010455:Peptides; D011506:Proteins