Effects of Non-standard Storage Conditions on the Stability, Safety and Suitability of Drug Consumption

Abstract

Drugs are distinctive and sensitive products. It should pass specific tests and have specific criteria for human use. The disparity of any of the acceptance criteria will influence the product’s effectiveness, despite the product being still in validated expiry date. The stability study and manufacturing of many drugs were done at specific climatic zones, but marketed and sold at different climatic zones. In a hot poor country or country that suffers from a power supply shortage (like in Iraq), it is impossible to provide standard storage conditions as the manufacturer recommends. The research aims to study the effects of non-standard storage conditions on the official and non-official acceptance criteria for stored tablets compared to the same newly manufactured tablets. The results showed that the physical appearance, tablet hardness, friability, disintegration, uniformity of weight, assay was not affected. On the other hand, the dissolution profile of the stored products showed a change in the solubility behavior. From the results, we can conclude that storage conditions may not affect the content of the active substance. Still, it may affect other characteristics of the active substance, such as solubility. The research recommends the necessity of scrutiny of the storage conditions of drugs and not being lenient with them. Also recommends the necessity to study the dissolution profile and stability of excipients when conducting a drug stability study and determining the expiry date.