Antimicrobial Preservatives Part One: Choosing a Preservative System

摘要

Excipients are essential ingredients in medicinal products, facilitating manufacture, stability, absorption, administration and, in some cases, drug targeting. They can also, enhance aesthetic appearance, facilitate product differentiation and improve compliance. They are no longer generally considered to be pharmacologically inert. Indeed, antimicrobial preservatives by their very definition need to show antimicrobial activity to facilitate meaningful product shelf-lives. Their presence is specifically mandated for multidose semi-solid and liquid products. Additionally, these requirements also apply to devices for transdermal delivery where the delivery system is aqueous-based and enhanced by application of a mild electric current, i.e. electrophoretic. Performance standards for antimicrobial efficacy are defined within the various pharmacopoeias and involve challenging the formulation with a range of different microbial species, i.e. bacteria (three types), a yeast (Candida) and a mold (Aspergillus). Viruses are not included. Test organisms are common to all product types, but individual requirements can vary with product type.