Formulation and characterization of controlled-release floating tablets of pregabalin

Abstract

Pharmaceutical research has increasingly focused on developing oral drug delivery systems with controlled-release capabilities to address challenges such as short gastric residence time and variable gastric emptying. This study designed and evaluated floating pregabalin tablets with controlled-release properties by experimenting with various blends of HPMC K4M and HPMC K100LV. The tablets are engineered to remain buoyant in the stomach, thereby enhancing gastric retention time and improving oral bioavailability. Using Design Expert Software, nine formulations (X1-X9) were developed and optimized. Among these, the X7 formulation demonstrated promising results: it exhibited a low initial swelling index but formed a substantial gel layer by the eighth hour, maintaining matrix integrity for approximately 6-7 hours. The optimized X7 formulation achieved a controlled drug release rate of 95.06% and maintained buoyancy for up to 12 hours, showcasing its potential for effective and sustained drug delivery. This research contributes to the advancement of oral controlled-release systems, offering a viable approach to improving pregabalin's therapeutic efficacy through enhanced gastric retention and consistent release rates.