ABSTRACT:
Irbesartan is a poorly water soluble drug practically insoluble in water. The objective of the study is to improve the solubility of irbesartan by using solubility enhancer as ß-cyclodextrin and also to study the effect of water soluble polymer as PEG 400, Cremophore RH 40, PVP K 30, HPMC, soluplus on solubility of irb:ß-cyclodextrin binary system. The phase solubility study was carried out results reveals AL type of graph, which suggest 1:1 stochiometry of formed complex. The solubility study of irbesartan ß-cyclodextrin was carried out in presence of water soluble polymers. The study revealed that soluplus in 30% w/w proportion showed improved solubility as compared to irbesartan:ß-cyclodextrin (1:1 molar ratio) and plain irbesartan. Based on the study, binary and ternary inclusion complexes were prepared by grinding, microwave, ball mill and freeze drying techniques. The inclusion complexes were evaluated for in-vitro dissolution studies and characterized by Fourier transform infrared spectroscopy, Differential scanning calorimerty, Powder x ray diffraction study and 1H Nuclear Magnetic resonance spectroscopy study. The in-vitro dissolution study showed improved dissolution rate for irbesartan by ball milled and freeze dried binary and ternary complexes as compared to plain irbesartan, physical mixture and complexes prepared by grinding and microwave technique. The ternary freeze dried complex showed highest dissolution rate as that of binary and ternary complexes prepared by microwave, grinding, ball milling technique. This is confirmed by Fourier transform infrared spectroscopy, Differential scanning calorimerty, Powder x ray diffraction study and 1H Nuclear Magnetic resonance spectroscopy study. Thus, ternary inclusion complex containing irbesartan:ß-cyclodextrin:soluplus with improved solubility was successfully developed using freeze drying as novel technique.