Development and Optimization of Immediate Release Imipramine Hydrochloride Tablets Using Superdisintegrants by Direct Compression Technique

Abstract

The present study aimed to develop and optimize immediate-release tablets of Imipramine Hydrochloride using Croscarmellose Sodium (CCS) as a superdisintegrant by the direct compression technique. Preformulation studies and Fourier-transform infrared spectroscopy (FTIR) analysis were performed to evaluate the physicochemical properties of the drug and its compatibility with the selected excipients. Nine formulations (F1–F9) containing varying concentrations of CCS were prepared and evaluated for pre-compression and post-compression parameters, including flow properties, weight variation, hardness, friability, drug content, disintegration time, and in-vitro drug release. All formulations exhibited satisfactory pharmaceutical characteristics. Among them, formulation F9 demonstrated the most desirable performance, with a drug content of 99.83 ± 0.42%, friability of 0.526%, disintegration time of 2 min, and 96.23% drug release within 30 min. The optimized formulation was further evaluated using drug-release kinetic models and accelerated stability studies. The stability study showed no significant changes in the evaluated parameters during the study period. The findings demonstrate that direct compression is a suitable technique for the preparation of immediate-release Imipramine Hydrochloride tablets, while the concentration of CCS significantly influences tablet disintegration and drug-release performance. The optimized formulation exhibited rapid disintegration, satisfactory drug content, and efficient drug release, indicating its potential as an immediate-release tablet formulation.