ABSTRACT:
The objective of this research was to prepare, characterize and to study dissolution properties of inclusion complexes of telmisartan (TLM), with β- cyclodextrin and hydroxypropyl- β- cyclodextrin and to study its effect on rate of dissolution. The phase solubility curve was classified as an AP type for both the CD’s, which indicated formation of inclusion complex of TLM in 1:2 stoichiometries with β-CD and HP-β-CD. The inclusion complexes in molar ratio of 1:2 were prepared by various methods such as kneading, co-evaporation and physical mixing. The molecular behavior of TLM in all samples were characterized by fourier- transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC) and powder x-ray diffraction studies. The result of studies showed inclusion of TLM molecule into cyclodextrin cavities. The highest improvement in in-vitro dissolution of TLM was observed in complex prepared with HPβ-CD using kneading method. Mean dissolution time (MDT) and similarity factor (f2) indicated significant difference between the release profile of TLM from complexes, physical mixture and pure TLM. The highest improvement in solubility and in-vitro drug release were observed in inclusion complex prepared with HPβ-CD by kneading method. Improvement in solubility and in-vitro drug release of Telmisartan were more with HPβ-CD as compared to β-CD