FORMULATION AND DEVELOPMENT OF BILAYER FLOATING TABLET OF NEBIVOLOL HYDROCHLORIDE AND NIFEDIPINE

Pharmaceutical

This study focused on the development and evaluation of a bilayer tablet combining Nebivolol HCl as an immediate release (IR) layer and Nifedipine as a controlled release (CR) floating layer. Preformulation studies revealed that Nebivolol HCl, a sparingly soluble compound with moderate lipophilicity, required solubility enhancement, while Nifedipine, a BCS Class II drug with high lipophilicity but poor aqueous solubility, necessitated dissolution improvement. The CR layer was formulated using HPMC K4M as a release controlling polymer, with sodium bicarbonate and citric acid imparting buoyancy, while the IR layer employed sodium starch glycolate as a superdisintegrant to ensure rapid onset. Pre compression and post compression evaluations confirmed acceptable flow, compressibility, mechanical strength, and uniformity across formulations. Floating studies demonstrated rapid buoyancy initiation (13–16 minutes) and prolonged gastric retention (>12 hours) for optimized CR batches. In vitro dissolution revealed that CR 3 achieved nearly complete release (95.74% at 12 hours), following zero order kinetics with diffusion controlled release. The bilayer tablet (IR 4 + CR 3) exhibited satisfactory physical properties, rapid onset, and sustained therapeutic delivery. Stability studies confirmed consistent drug content, buoyancy, and release profiles under varied storage conditions, establishing the bilayer tablet as a promising dosage form for improved patient compliance and therapeutic efficacy.

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.