Vol. 7, Issue 2, Part B (2025)

In this study, a bilayer tablet that features an immediate-release (IR) layer containing Baclofen and a sustained-release (SR) layer containing Pregabalin was developed and evaluated. Three superdisintegrants - Crospovidone, Croscarmellose sodium, and Sodium Starch Glycolate - were used in the formulation that formed the IR layer in different formulations and at different concentrations (1.5 mg, 3 mg, and 4.5 mg). However, three viscosity grades of Hydroxypropyl Methyl Methylcellulose (HPMC) - K4M, K15M, and K100M CR Premium - each tested at 30 mg, 60 mg, and 90 mg concentrations were all utilized to create the SR layer. Physical characteristics which include weight variation, friability, thickness, hardness, drug content (assay), and in-vitro dissolving performance were evaluated for the manufactured bilayer tablets. Formulation F9, which contained 4.5 mg of sodium starch glycolate in the Baclofen IR layer, was shown to achieve 99.25% drug release in 0.1M HCl in just one hour. Following an initial two-hour exposure to 0.1M HCl, the Pregabalin SR layer, which had been made with 90 mg of HPMC K100M CR Premium, demonstrated sustained drug release, reaching 98.97% over 12 hours in pH 6.8 phosphate buffer. When compared to the other tested modifications, this composition performed better. The sustained-release Pregabalin and immediate-release Baclofen were successfully combined in the optimized bilayer tablet. With 4.5mg of sodium starch glycolate, formulation F9 produced a 99.25% Baclofen release in just one hour. Pregabalin release (98.97% over 12 hours) was achieved by the sustained-release layer, which was made with 90mg of HPMC K100M CR Premium. The effectiveness of treatment for neuropathic illnesses is improved by this dual-drug delivery method.