AAPS PharmSciTech

, Volume 10, Issue 1, pp 276–281 | Cite as

Preformulation Study of the Inclusion Complex Irbesartan-β-Cyclodextrin

Research Article


The aim of the present work was to improve the solubility and dissolution profile of Irbesartan (IRB), a poorly water-soluble drug by formation of inclusion complex with β-cyclodextrin (βCD). Phase solubility studies revealed increase in solubility of the drug upon cyclodextrin addition, showing AL—type of graph with slope less than one indicating formation of 1:1 stoichiometry inclusion complex. The stability constant (K s) was found to be 104.39 M−1. IRB–βCD binary systems were prepared by cogrinding, kneading using alcohol, kneading using aqueous alcohol, and coevaporation methods. Characterization of the binary systems were carried out by differential scanning calorimetry, Fourier transform infrared spectroscopy, scanning electron microscopy, X-ray diffraction, and proton nuclear magnetic resonance. The dissolution profiles of inclusion complexes were determined and compared with those of IRB alone and physical mixture. Among the various methods, coevaporation was the best in which the solubility was increased and dissolution rate of the drug was the highest. The study indicated the usefulness of cyclodextrin technology to overcome the solubility problem of IRB.

Key words

β-cyclodextrin dissolution inclusion complex Irbesartan solubility 









differential scanning calorimetry


Fourier transform infra-red spectroscopy


nuclear magnetic resonance


hydrochloric acid




apparent stability constant




physical mixture


scanning electron microscopy




X-ray diffraction



We would like to thank Dr. Vikram Jagtap, Aarti Drugs Ltd, India for kindly supplying the drug, Irbesartan, and Dr. M.R. Vora, Signet, India for kindly supplying β-cyclodextrin.


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Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  1. 1.Department of PharmaceuticsBharati Vidyapeeth’s College of PharmacyNavi MumbaiIndia

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