Formulation and evaluation of Olmesartan Medoxomil solid dispersions to enhance its solubility and dissolution characteristics

Abstract

The objective of the present learns to improve solubility and dissolution of Olmesartan Medoxomil (OM) by improving water solubility by reliable dispersion methods using fusion method (FM) and solvent evaporation (SE) method via hydrophilic polymers PEG 6000 and PVP K30 in different ratios. Preformulation studies of OM: polymers were carried using DSC and FTIR proves that it is stable without any extra peaks, which implies no interaction among the drug and carrier. For OM in FM drug: polymer ratio was maintained in a range 1:1, 1:3, 1:5 and 1:7 w/w ratio of OM to PEG 6000 and coded as SDOM1, SDOM2, SDOM3 and SDOM4 whereas for SE method OM to PVP K30 ratio was maintained in a range of 1:1, 1:3, 1:5 and 1:7 w/w ratio and coded as SDOM5, SDOM6, SDOM7 and SDOM8. SDOM3 by FM and SDOM7 by SE method resulted in the highest production yield. The solubility studies have shown improved drug solubility compared with a pure drug in all medium. Percentage of drug content, flowability characters like the angle of repose and carr's index, bulk density, Hausner's, tapped density were within acceptable limits. In vitro drug release in the intestinal gastric medium of pH 1.2 was improved significantly when compared with pure drug. SDOM3 and SDOM7, selected for accelerated stability studies, had no significant change in physical parameters, drug content, with little changes in the in vitro drug release pattern. Hence solubility and dissolution rate of OM is increased by using the PEG 6000 and PVP K30 polymers.