Talc concentration effect on shelf life of acetaminophen tablets

Abstract

Excipients in pharmaceutical formulations are inactive ingredient from the biological point of view, but they have a key role in the preparation, and they can alter the stability of the active principle. In this work, we prepared acetaminophen tablets with different amounts of talc as excipient and the thermal stability was deeply investigated by thermogravimetric studies. Isoconversional analysis by Kissinger–Akahira–Sunose method and “Master plot” analysis have been successfully employed to describe the kinetics of degradation under inert atmosphere, and the shelf lives have been calculated as a function of the talc content. The shelf-life values as well as the activation energy, which is the dominant factor, evidenced that the inorganic filler enhances the drug degradation to a certain extend and that the composition dependence has a peculiar trend reflecting the particle cluster formation at a critical concentration value. An effort of physico-chemical explanation for this behaviour is put forward by a simple geometrical model from the microparticle-size analysis to predict the critical talc concentration.