The impact of storage conditions on the stability of clinical and experimental pharmaceuticals

To ensure a drug exhibits maximum efficacy and does not compromise patient acceptability or safety, it is essential to consider its physical, chemical, and biological stability outside of the body. Factors that can impact pharmaceutical stability include exposure to different environmental conditions (e.g. heat, light) and chemical processes (e.g. oxidation, hydrolysis) during transport, storage, and use. While pharmaceutical companies provide basic storage instructions, the impact of exposure to conditions that fluctuate from those recommended is not always evident. The aim of the investigations that form these doctoral studies was to determine the effect of different storage conditions, including solution pH and temperature, on the stability of a range of pharmaceuticals. These included clinically-used drugs, specifically remifentanil (an opioid analgesic), propofol (a short-acting anaesthetic), and tenecteplase (a thrombolytic agent), as well as an experimental plant extract still in development, EBC-46 (found to exhibit both anticancer and wound-healing properties). The findings of the studies demonstrate that even minor changes in the storage environment can have a substantial impact on the pharmaceutical stability of these diverse agents, therefore controlling this environment is crucial in ensuring full potency is retained long term.