ABSTRACT
Excipients provide an enhanced vehicle for the active pharmaceutical ingredient and are typically referred to as inactive or inert ingredients, where “inactive” or “inert” indicates the compound does not directly contribute to the intended therapeutic or diagnostic activity of the drug product. This chapter offers a comprehensive review of the excipients used in injectable products marketed in the United States, Europe and Japan. The presence of impurities in excipients can have a dramatic influence on the safety, efficacy or stability of the drug product. For parenteral products, non-exceptional excipients are ingredients other than preservatives, pH adjuster, antioxidant and buffers. Excipient selection during formulation development of parenteral dosage forms is focused on providing a safe, stable, efficacious and functional product. Progress in drug delivery systems and new proteins/peptides being developed for parenteral administration has created a need to expand the list of excipients that can be safely used.
