PREPARATION AND EVALUATION OF BILAYER TABLET OF PARACETAMOL AND THIOCOLCHICOSIDE: A DUAL APPROACH FOR PAIN MANAGEMENT

The traditional drug delivery system is not much effective when treating pain. Consequently, there is a gap in the market for a delivery system that can provide a treatment for this disorder. The present study is based on the objective to develop dual release bilayer tablet designed by BBD approach. The bilayer tablet contained an immediate release layer of paracetamol and a sustained release layer of thiocolchicoside. The optimization of the bilayer tablet was done using a three-level, three-factor Box-Behnken design. A total of thirteen formulations of paracetamol and thiocolchicoside were developed based on the design composition of paracetamol, sodium starch glycolate and sodium bicarbonate for the IR layer and thiocolchicoside, HPMC and magnesium stearate for the SR layer respectively. The developed dual release layers were compressed to form a bilayer tablet. The initial characterization and drug-excipient interaction studies were performed initially using infra-red (IR) spectroscopy and X-ray diffraction studies (XRD). Formulations showing good micrometric properties, disintegration and drug release, were selected for final compression of bilayer tablets. Formulation F13 showed the fastest drug release (91.34%) at 60 minutes and quick disintegration time (97 s). The sustained release thiocolchicoside tablet layer (F11-F13) had a hardness that varied from 4.05 to 4.90kg/cm2. Formulation F5 had the highest hardness, whereas F6 showed the lowest hardness. The sustained release layer showing 98.21% of drug release after 10 hours was selected for the compression to bilayer tablet. The developed dual layer tablets were investigated for quality parameters like hardness, percentage friability, weight variation, disintegration and dissolution. A high level of patient compliance is ensured through the current design as the patient does not need to get out of bed at night to take the medication.