OPTIMIZATION OF GRANULE SIZE AND DISINTEGRANTS ON FORMULATION OF RAPID DISPERSIBLE TABLETS OF TOLFENAMIC ACID

Abstract

Optimization of formulation is the backbone of any robust formulation. Tolfenamic Acid is an orally and parenterally administered Non – steroidal anti-inflammatory drug belonging to the fenamate group. As per the British pharmacopoeia, uniformity of dispersion and fineness of dispersion is the basic requirement of Orodispersible tablets. Delay in dispersion times, variation in dispersion, poor wetting tendency of formulation is some of the measurable factors showing insufficient optimization in formulation of rapid dispersible tablets.  The size of granules plays a major role in disintegration and dispersion of rapid dispersible tablets. The present study was aimed to optimize the size of granules and selection of efficient disintegrants for rapid dispersible tablets of Tolfenamic acid. The present work studies effect of various size fractions of granules with superdisintegrants as Explotab, Ac di sol, Kyron T-314, Kollidon CL to determine the influence of disintegrant type and optimization of dispersion.  Tolfenamic acid was co-micronized with microcrystalline cellulose and surfactants as sodium Lauryl sulfate. The formulation was than evaluated for various physical and analytical properties of rapid dispersible tablets. Results obtained showed that there was a significant increase in dissolution rate of drug with ac di sol and in first 5 minutes of time interval. The size of granules fraction also having a clear impact on dispersion and fineness of dispersion, the dispersion time was increasing with increasing the granules size fractions.