A central composite design was applied to design a novel gastric floating drug delivery system
comprising propranolol HCl in Terminalia catappa gum and to evaluate the buoyancy, in vitro
drug release behavior, and pharmacokinetic parameters. All formulations exhibited good buoyancy
properties in vitro reflected by floating lag time of 1-110 sec, total floating time of 9-16 h and
prolonged release behaviour (upto 12 h). Statistically optimised formulation (PBGRso) was orally
administered to human volunteers under both fasted and fed conditions to evaluate gastric floating behavior
under different food conditions by X-ray evaluation. In vivo studies of optimised formulations
revealed that the gastric residence time of floating tablets was enhanced in the fed but not in the fasted state.
Pharmacokinetic studies of the optimised Terminalia catappa formulation and a commercial product (Ciplar LA 80)
carried out on healthy human volunteers showed a significant improvement in the bioavailability (132%) of propranolol
HCl released from from the experimental Terminalia catappa formulations compared with Ciplar LA 80.
Keywords: Buoyancy, central composite design, floating drug delivery, in vivo studies in humans, propranolol HCl, Terminalia
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