Abstract: In the pharmaceutical sector, forced degradation studies are an important part of drug product development to assess the stability of drug formulations under stressed conditions that approximate what drugs will encounter in practice. These studies subject drugs to heat, light, humidity, and oxidative environments, increasing degradation rates in order to determine possible degradation byproducts and reaction pathways. The purpose of these studies is to determine the mechanisms by which drugs degrade and how their efficacy and safety depend on these mechanisms. The various processes that are often employed to impose different environmental stresses include thermal stress, oxidative stress, hydrolytic stress, and photolytic stress. The effects of each type of stress on the drugs vary: thermal stress enhances molecular degradation, oxidative stress leads to loss of electrons and the formation of undesired by-products, and hydrolytic stress requires the drug to be exposed to moisture, whereas photolytic stress requires it to be exposed to light. These degradation pathway findings will assist pharmaceutical companies in developing stable formulations and navigating regulatory drug approval processes. By better understanding degradation processes, it becomes possible to create more capable products, thereby ensuring marketplace quality and safety.
Paul et al. (Tue,) studied this question.