Preformulation Excipient Compatibility Testing. Application of a Differential Scanning Cal0Rimetric Method Versus a Wei Granulation Simulating, Isothermal Stress Method

Abstract

The application of a differential scanning calorimetric (DSC) method versus an isothermal stress (IS) method, which utilizes HPLC analysis of simulated wet granulations stored for two months at 60°, was investigated as an excipient compatibility predictor for fenretinide and as a determinant of the most excipient com patible of three mefenidil salts. Stability of the simulated wet granulations after two years at 25° was the reference criterion. The DSC method was determined to be an unreliable compatibility predictor for fenretinide and could not be used with one of the mefenidil salts. Conversely, the IS method was an accurate compatiblity predictor for both compounds.