Kinetic analysis of solid-state degradation of pure pravastatin versus pharmaceutical formulation

In this paper, the kinetic behavior of decomposition of a well-known bioactive substance used for treating dyslipidemia and the prevention of cardiovascular disease drug from statin class, namely pravastatin, was described. The kinetic study was performed on the main decomposition process which occurs at nearly 200 °C, for both pure active substance and a generic commercial formulation that contain 40 mg pravastatin per tablet, using Kissinger, Friedman, Kissinger–Akahira–Sunose, Flynn–Wall–Ozawa and NPK methods. The stability of pravastatin as pure active substance and as tablet was compared by means of kinetic data, and the results suggested that in the solid pharmaceutical formulation, PRV has an increased stability compared to pure active substance.