Systematic strategies for degradation kinetic study of pharmaceuticals: an issue of utmost importance concerning current stability analysis practices

Abstract

Degradation kinetic study ascertains the shelf life of drugs under different environmental conditions. It can facilitate the prediction of specific critical factors that can affect the quality of pharmaceuticals during storage. To date, general systematic strategies for performing degradation kinetics of drugs have not been discussed in any literature. Moreover, no regulatory guideline is available on the degradation kinetic study of pharmaceuticals. Owing to this, the kinetic behavior of drugs is not being analyzed uniformly. This article provides a detailed insight into degradation kinetic approaches including criticality in selecting different variables for the study. Factors that can affect the quality of degradation kinetic study data have been critically discussed. In addition, a systematic strategy to perform degradation kinetic study with advanced degradation models has been discussed. This article will be helpful for the researcher working in the field of stability analysis and guide to select a logical path for determining the kinetic behavior of drugs. High-quality degradation kinetic data through the properly designed study will help to establish accurate storage conditions of pharmaceuticals. This article is unique and novel of its kind and would have a significant contribution to the field of stability analysis.