Forensic evaluation of solid dosage form using a thermoanalytical method

Abstract

In the present study, a generic dosage form of metformin hydrochloride was developed using deformulation of a marketed product. The excipients used in the marketed product were identified using thermospectral method such as differential scanning calorimetry (DSC). The marketed formulation contained metformin hydrochloride 850 mg. The ingredients present in the marketed dosage form after performing thermal analysis were identified as metformin hydrochloride, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl methyl cellulose, and magnesium stearate. DSC analyses of the individual ingredients indicated a melting endotherm in the temperature range of 100–290°C. The generic dosage form was prepared and characterized for physic-chemical parameters, the F2 similarity factor of percentmetformin release was found to be 56 and F1 dissimilarity factor was found to be 13.