ABSTRACT

Introduction It is important to assess compatibility of the chosen formulation with the dosing apparatus since any incompatibility of the formulation with these materials may lead to reduced drug delivery. The consequences would be a decrease in the therapeutic response and/or plasma kinetics (Cmax, AUC), thus adversely affecting toxicological safety evaluation. Consideration should also be given to the stability of the formulation with the vessel used to store the formulation and any filtration steps performed. Other considerations should include compatibility of the formulation with any maintenance flush, such as saline, to prevent precipitation of the formulation and serious pathological sequelae. Published literature offers many sources of information on incompatibility and stability problems that may be encountered.