There is a need for good quality stability studies for pharmaceuticals, especially with parenteral medicines that can degrade post formulation. Stability is an essential attribute of drug substances and their products and provides evidence on how the quality of a pharmaceutical formulation varies with time under the influence of a variety of environmental factors.
Chemical degradation can lead to a change in the concentration of the active ingredient, alteration in bioavailability as well as the formation of toxic breakdown products which can result in patients receiving sub-therapeutic doses and being exposed to harmful degradation products. Understanding the molecular stability of parenteral medicines will give insight into new treatment strategies based on alternative approaches to effectively treat patients.
The aim of this project is to study the physiochemical stability of parenteral medicines. Drug stability will be assessed regarding its formulation; the influence of its pharmaceutical ingredients; the influence of the container/ closure; storage conditions; temperature, light, and humidity; and the anticipated duration and conditions of pharmacy shelf-life and patient use.