Preformulation studies

The present investigation was undertaken to develop and assess a film-coated oral tablet of Epalrestat intended for the treatment of diabetes mellitus. Preformulation investigations, including solubility studies, melting point determination, Fourier-transform infrared (FTIR) spectroscopy, and UV spectrophotometric analysis, were carried out to evaluate the physicochemical characteristics of the drug and its compatibility with the selected excipients. Core tablets were formulated using the direct compression technique with appropriate pharmaceutical excipients. The prepared formulations were examined for key physicochemical parameters such as weight variation, hardness, thickness, friability, disintegration time, and drug content. Among the developed batches, formulation F6 demonstrated satisfactory evaluation results and was therefore selected as the optimized formulation for film coating. The coated tablets exhibited adequate mechanical strength, consistent drug content, and a controlled drug release profile. In-vitro dissolution studies indicated that more than 90% of the drug was released within 60 minutes. The findings suggest that the developed film-coated Epalrestat tablet possesses acceptable Preformulation and evaluation characteristics and may be suitable for oral drug delivery.