Abstract

FORMULATION OPTIMIZATION AND EVALUATION OF RAPID DISINTEGRATING TABLET OF GLIBENCLAMIDE BY USING NATURAL SUPERDISINTEGRANT

M Sharique Ahmad*, Shashikant Barhate and Manoj Bari

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Abstract

The present study focuses on formulation, optimization, and evaluation of Rapid Disintegrating Tablets (RDTs) using a micronized drug, Glibenclamide, through the direct compression method, incorporating natural superdisintegrants. Glibenclamide, known for its hepatic metabolism and modest absorption rate of 40–45%, prompted the exploration of RDTs to enhance its bioavailability. Three concentrations (2%, 3.5%, and 5%) of natural superdisintegrants were employed to achieve the optimal formulation, balancing disintegration time and drug release. Formulation B5, comprising guar gum and microcrystalline cellulose, emerged as the preferred independent variable based on preliminary screening batches, exhibiting minimal disintegration time and maximal drug release. A 32-center composite design was implemented, with guar gum (GG) and microcrystalline cellulose (MCC) concentrations significantly influencing disintegration time (DT) and percentage drug release (%DR). The optimized formulation, GLB6, featuring GG (3.5%) and MCC (40%), demonstrated rapid disintegration (13.18 seconds) and increased drug release (92.72%) within 10 minutes. Comprehensive pre-compression and postcompression studies were conducted, ensuring adherence to pharmacopoeial standards. The outcomes affirm that GG and MCC possess excellent disintegration properties, as evidenced by GLB6's superior disintegration and dissolution profiles. In conclusion, GLB6, comprising (3.5%) GG and (40%) MCC, stands out for its enhanced disintegration and dissolution profiles, emphasizing its potential as a promising formulation for Glibenclamide RDTs.

Keywords: Rapid Disintegrating Tablet, Natural Superdisintegrant, Micronized Drug, Direct Compression, DOE, Glibenclamide.