Abstract

FORMULATION AND EVALUATION OF CYCLODEXTRIN COMPLEX ORALLY DISINTEGRATING TABLETS OF MEFENAMIC ACID

Prasad M. S.*, Somashekhar C. N.* and D. V. Gowda

Abstract

The aim of present study is to formulate and evaluate oral disintegrating tablets (ODTs) of Mefenamic acid and β-cyclodextrin complex based tablet prepared by freeze drying to attainment of improved solubility of Mefenamic acid and overcome the patient complaints. The inclusion complex (1:1 ratio) was formed by freeze drying. Direct compression method was used to prepare oral disintegrating tablets. Thirteen formulations were developed using Face centred composite design to optimize the concentration of crosscarmellose sodium (0/6/12) and microcrystalline cellulose (0/60/120) at different ratios. Prepared formulations were subjected to FTIR and DSC for the drug and for the Mefenamic acid + β- Cyclodextrin and they showed no change or interactions between the drug (Mefenamic acid) and excipients. XRD and 1HNMR were performed for compatibility with the drug and β-cyclodextrin. Then formulated tablets were subjected to post compression evaluation. Due to the freeze drying process, the rate of dissolution and efficiency of dissolution were increased by the complexation with β-cyclodextrin. Diluent and superdisintegrant concentrations played a major role, which affects the development of ODTs formulation. The solubility of the drug was increased due to inclusion with β-cyclodextrin. Higher the concentrations of MCC enhanced the disintegration and improved dissolution. Formulations with a higher concentration of mannitol increased the tablet hardness, compatibility and decreased the rates of dissolution the drug. Stability studies indicated no change in drug property.

Keywords: Mefenamic acid; ?-cyclodextrin; Freeze drying; Face centred CCD; ODTs; Patient compliance.