Formulation And Evaluation Of Floating Dexlansoprazole Systems Using Factorial Design
Abstract
Background: Dexlansoprazole (DLS), a proton pump inhibitor, is widely used for managing Gastroesophageal Reflux Disease (GERD). However, its short plasma half-life, pH-dependent solubility, and narrow absorption window in the upper gastrointestinal (GI) tract limit its bioavailability and therapeutic efficacy. To address these limitations, gastro retentive floating drug delivery systems (GRDDS) offer a promising strategy to prolong gastric residence time and enhance systemic absorption.
Objective: This study aimed to develop, optimize, and evaluate various GRDDS formulations of Dexlansoprazole using factorial design, focusing on in-vitro and in-vivo parameters to improve its bioavailability and therapeutic profile.
Methods: Three distinct GRDDS formulations—floating microspheres, bilayer tablets, and matrix tablets—were developed using gas-generating agents, swelling polymers, and mucoadhesive components. Factorial design and response surface methodology were employed to optimize formulation variables. Physicochemical properties, buoyancy, mucoadhesion, and in-vitro drug release were assessed under simulated gastric conditions (pH 1.2). In-vivo pharmacokinetic studies were conducted in albino rabbits to compare the bioavailability of optimized formulations with the marketed Dexilant®.
Results: The optimized floating microspheres (F17) showed high entrapment efficiency (92.33%), buoyancy over 12 hours, and controlled drug release over 12 hours. The bilayer tablet (FT3)…
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