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Preparation, physicochemical characterization, dissolution and formulation studies of telmisartan cyclodextrin inclusion complexes

Keywords: β-cyclodextrin , dissolution studies , hydroxypropyl-β-cyclodextrin , inclusion complexes , telmisartan

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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 effect of complexation on aqueous solubility and rate of dissolution in dissolution media. The phase solubility curve was classified as an A P type for both the CDs, which indicated formation of the 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. 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 a complex prepared with HPβ-CD using the kneading method. Mean dissolution time (MDT) and similarity factor (f2) indicated a 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 HP-β-CD by kneading method. Improvement in solubility and in-vitro drug release of telmisartan was more with HP-β-CD as compared to β-CD

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