DEVELOPMENT AND CHARACTERIZATION OF FLOATING SUSTAINED-RELEASE TABLETS OF AN ANTI-DIABETIC DRUG

Formulation and Evaluation of Floating SR Tablet

Abstract

ABSTRACT: The present work focuses on Prototype Formulation with regards to development and evaluation of a sustained release floating tablet of glibenclamide for improved management of type 2 diabetes mellitus. Glibenclamide is known for its poor solubility, short half-life, and narrow therapeutic index, which often cause fluctuations in blood drug levels when taken in standard forms. To overcome these issues, Developed The gastroretentive floating system using hydrophilic polymers (HPMC K4M and K15M) along with effervescent agents like sodium bicarbonate and citric acid. The tablets were made by direct compression and tested for key properties such as hardness, friability, weight consistency, swelling behavior, floating lag time, and total floating duration. Dissolution studies were performed in 0.1N HCl using USP II apparatus. A 3² factorial design was applied to optimize polymer and gas-generating agent concentrations. The best formulation showed quick buoyancy with minimal lag, remained afloat for up to 15 hours, and released about 78–85% of the drug over 8 hours. The release pattern followed a non-Fickian diffusion mechanism, involving both drug diffusion and polymer erosion. Risk assessment using FMEA emphasized the need for a precise balance between polymer and effervescent agent levels to achieve the desired floating and release characteristics. Overall, the developed floating tablet improved gastric retention, ensured sustained release, and enhanced the therapeutic effect of glibenclamide, offering a promising strategy for better glycemic control in type 2 diabetes.

KEYWORDS: Gastroretentive Floating drug delivery, HPMC K4M and K15M, Glibenclamide, Factorial Design, non-Fickian diffusion mechanism.