Design, Development, and Evaluation of Gelucire-Based Gastric Floating Beads of Pregabalin

Abstract

Abstract: The objective of this research is to design, develop, and evaluate Gelucire-based gastric floating beads of Pregabalin. These beads are intended to provide a sustained release profile, enhance bioavailability, and improve patient compliance. The beads were prepared using the ionotropic gelation technique and characterized for their physicochemical properties, buoyancy, drug entrapment efficiency, and in vitro release profile. The results demonstrated that the optimized formulation exhibited a prolonged release of Pregabalin, enhanced floating ability, and improved bioavailability compared to conventional formulations.

An attempt is made to prepare bead of 210nm using various grades of gelucire such as Gelucire 50/13, Gelucire 48/01, Gelucire 43/01. Among which gelucire 43/01 gave spherical bead. The method of preparation of beads was found to be simple and reproducible. Percentage yield was found in a range of 70±1.5 to 89.25±0.28. Percentage drug entrapment of drug was obtained in all formulations in a range of 47.79±1.90 to 87.95±0.75. Due to higher Drug-lipid ratio beads the size of bead slightly increased produce. The average size of bead range was between 2.42±0.13 to 3.24±0.05µm. The in vitro data indicated that pure drug was 99% release with in 3hrs. The drug release from the bead prepared in formulation F8 achieved 60.93±0.56% in 6hrs and 80.06±0.28% in 12hrs.

Keywords: Pregabalin, Gelucire, Gastric floating beads, Sustained release, Bioavailability, Ionotropic gelation.