Improvement in Physicochemical Properties of Indomethacin by Melt Granulation Technique

Indomethacin (IM), most widely used non-steroidal anti-inflammatory drug widely used in developing countries, is classified in Class II in the Biopharmaceutics Classification Systems; this means that IM has very low water solubility and high permeability, thus the dissolution is the absorption rate-limiting factor. The aim of this work was to evaluate the suitability of melt granulation technique for enhancing the solubility, dissolution rate and other physicochemical properties of IM.Granules prepared by melt granulation using polyethylene glycol 4000 and poloxamer 188 as meltable binders and microcrystalline cellulose (MCC) and sodium starch glycolate (SSG) as filler and superdisintegrants respectively. The results showed that all the prepared melt granules shows higher solubility and improvement in dissolution rate comparative to pure IM and their physical mixture. The melt granules with MCC and SSG had a significant (** P<0.01) higher solubility dissolution rate in 15 minutes comparative to other granules and pure IM. The melt granule also shows improvement in flowability and wettability. In conclusion, melt granulation could be proposed as solvent free, rapid and low expensive manufacturing methods to increase the solubility and in vitro dissolution rate of IM.