Abstract

RECENT STUDIES ON THE ANALYSIS OF PHARMACEUTICAL PREFORMULATION: AN OVERVIEW

Jegan Jayabalan,* and Rajagopal K

ABSTRACT

Estimation of drug-excipient interactions is a crucial step in preformulation studies of drug development to attain bioavailability, consistent stability and manufacturability of solid dosage forms. The acceptable stability of the drug formulations is one of the basic requirements for pharmaceutical development and commercialization. The arrival of thermoanalytical and spectroscopic methods like DSC, isothermal microcalorimetry, solid state NMR, HSM, SEM, FT-IR and PXRD into pre-formulation studies have contributed extensively to early prediction, and characterization of the active pharmaceutical ingredient incompatibility with pharmaceutical excipients to avoid expensive material wastage and considerably reduce the time required to arrive at an suitable formulation. Simultaneous use of numerous thermal and spectroscopic techniques allows an in-depth understanding of physical or chemical drug-excipient interactions and aids in selection of the most appropriate excipients in dosage form design. After a brief review of regulatory requirements and recent drug recalls due to physical instability, we discuss the various analytical techniques used for the drug-excipient interaction studies.

Keywords: Preformulation, Thermal methods, Analytical Techniques, DSC, X-Ray diffraction.