Table of Contents
ISRN Pharmacology
Volume 2013, Article ID 347457, 4 pages
Research Article

Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations

Medical Services Department, Akumentis Healthcare Ltd., 204 Second Floor, G-Corp Tech Park, Kasarvadavali, Near Hypercity, Ghodbunder Road, Thane (West), Maharashtra 400 615, India

Received 26 December 2012; Accepted 11 January 2013

Academic Editors: T. Irie and T. B. Vree

Copyright © 2013 Sandesh P. Kamdi and Prashant J. Palkar. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. P. W. Jungnickel, “Pantoprazole: a new proton pump inhibitor,” Clinical Therapeutics, vol. 22, no. 11, pp. 1268–1293, 2000. View at Google Scholar · View at Scopus
  2. D. L. Avner, “Clinical experience with pantoprazole in gastroesophageal reflux disease,” Clinical Therapeutics, vol. 22, no. 10, pp. 1169–1185, 2000. View at Publisher · View at Google Scholar · View at Scopus
  3. M. A. Pue, J. Laroche, I. Meineke, and C. de Mey, “Pharmacokinetics of pantoprazole following single intravenous and oral administration to healthy male subjects,” European Journal of Clinical Pharmacology, vol. 44, no. 6, pp. 575–578, 1993. View at Google Scholar · View at Scopus
  4. R. P. Raffin, L. M. Colomé, S. S. Guterres, and A. R. Pohlmann, “Enteric controlled-release pantoprazole-loaded microparticles prepared by using eudragit S100 and poly(ε-caprolactone) blend,” Pharmaceutical Development and Technology, vol. 12, no. 5, pp. 463–471, 2007. View at Publisher · View at Google Scholar · View at Scopus
  5. T. Jens. Carstensen and C. T. Rhodes, Drug Stability, Principles and Practices, Marcel Dekker, New York, NY, USA, 3rd edition, 2005.
  6. S. Yoshioka and S. J. Valentino, Stability of Drugs and Dosage Forms, Springer, Tokyo, Japan, 2002.
  7. J. Szejtli, “Molecular encapsulation by cyclodextrins,” in Encyclopedia of Nanoscience and Nanotechnology, vol. 2, pp. 283–384, 2003. View at Google Scholar
  8. R. Challa, A. Ahuja, J. Ali, and R. K. Khar, “Cyclodextrins in drug delivery: an updated review,” AAPS PharmSciTech, vol. 6, no. 2, pp. E329–E357, 2005. View at Publisher · View at Google Scholar
  9. The Unit States Pharmacopeial Convention, The United States of Pharmacopoeia—National Formulary, USP 27—NF 22, The Unit States Pharmacopeial Convention, Rockville, Md, USA, 2004.
  10. J. Szejtli, “Past, present, and future of cyclodextrin research,” Pure and Applied Chemistry, vol. 76, no. 10, pp. 1825–1845, 2004. View at Google Scholar · View at Scopus
  11. T. Irie and K. Uekama, “Pharmaceutical applications of cyclodextrins. III. Toxicological issues and safety evaluation,” Journal of Pharmaceutical Sciences, vol. 86, no. 2, pp. 147–162, 1997. View at Publisher · View at Google Scholar · View at Scopus
  12. S. Gould and R. C. Scott, “2-hydroxypropyl-β-cyclodextrin (HP-β-CD): a toxicology review,” Food and Chemical Toxicology, vol. 43, no. 10, pp. 1451–1459, 2005. View at Publisher · View at Google Scholar · View at Scopus
  13. “Pantoprazole cyclodextrin inclusion complexes,” International Publication Number, W 03/059393 A1, International Publication, Patent Cooperation Treaty (PCT), 2003.
  14. “FDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence,” US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), 2001,
  15. State Committee of Pharmacopoeia, Guidance for Evaluation of Bioavailability and Bioequivalence of Pharmaceutical Preparations in Human, chapter 193, Chemical Industry Press, Beijing, China, 2005.