FORMULATION AND OPTIMIZATION OF MOUTH DISSOLVING TABLET CONTAINING INDOMETHACIN SOLID DISPERSION

Indomethacin is a non-steroidal anti-inflammatory drug mainly used for musculo skeletal & joint disorders including ankylosing, spondilitis, osteoarthritis, rhematiod arthiritis acute gout & in inflammation and pain. The major drawback of this drug is its very low water solubility and low erratic absorption from GIT. The purpose of the present investigation was to increase the solubility and dissolution rate of Indomethacin by the preparation of its solid dispersion with polyvinyl pyrrolidone k30, PEG-4000and PEG-6000 using solvent evaporation and physical mixture method and preparation of MDT of indomethacin with different superdisintegrant and sublimable material.Drug polymer interaction were investigated (XRD) and (FTIR). The DSC, XRD and FTIR results showed no drug-polymer chemical interaction in the solid dispersion. Indomethacin solid dispersion with PVP K-30 (1:5) by solvent evaporation was used for the preparation of mouth dissolving tablet with various superdisintegrant by direct compression and sublimation method. The formulated fast dissolving tablets were evaluated for hardness, friability, wetting time, disintegration and in vitro drug released. The hardness of the prepared tablets were found in the range of 2.4 kg/cm2 to 3.2 kg/cm2. The friability values were less than 1%. All the formulation had disintegration time less than 1 min. The formulation SBP3 containing 4% crosspovidone showed 99.93% drug released within 5 min. FT-IR spectra revealed no chemical incompatibility between the drug and PVP K-30. The stability studies were conducted as per ICH guidelines and the formulations were found to be stable with insignificant change in the hardness, disintegration and in vitro drug released pattern.

KEYWORDS: Indomethacin; Solid dispersion, polyvinyl pyrrolidone K-30; mouth dissolving tablet; superdisintigrants.