FORMULATION AND EVALUATION OF BILAYER TABLETS OF TENOFOVIR AND SILYMARIN FOR HEPATITIS INDUCED LIVER CIRRHOSIS

Background: Chronic hepatitis B requires effective antiviral therapy combined with hepatoprotective support to manage liver function and prevent disease progression. Bilayer tablets provide a versatile platform to deliver drugs with distinct pattern of the drug release exhibited by a single dosage form. Objective: The study aimed to develop a bilayer tablet containing an immediate-release layer of Tenofovir and a sustained-release layer of Silymarin to provide rapid antiviral action with prolonged hepatoprotective effects in a single dosage form. Methods: Bilayer tablets were developed by direct compression and optimized through eight trial batches. FTIR confirmed drug–excipient compatibility. Post-compression tests evaluated physical properties and dissolution behavior. Drug-release kinetics were analyzed using zero-order, first-order, Higuchi, and Korsmeyer-Peppas models. Stability was assessed under ICH guidelines. Results: The optimized batch (F3: CCS in IR layer + HPMC K100M 10% in SR layer) demonstrated rapid Tenofovir release within 30 minutes and sustained Silymarin release over 12 hours. Kinetic modeling indicated Hixson-Crowell kinetics for Tenofovir (R² = 0.9855) and zero-order release with Super Case-II transport for Silymarin (R² = 0.9815, n = 1.36), confirming controlled and predictable release. FTIR spectra revealed no significant drug–excipient interactions. Stability studies showed no notable changes in physical, chemical, or dissolution properties during the study period. Conclusion: The developed bilayer tablet provides rapid antiviral action and sustained hepatoprotective effects, improving therapeutic outcomes, reducing dosing frequency, and enhancing patient compliance. This formulation is a promising strategy for managing chronic hepatitis B and warrants further in-vivo and clinical studies.