Table of Contents
ISRN Toxicology
Volume 2012, Article ID 813836, 14 pages
http://dx.doi.org/10.5402/2012/813836
Research Article

In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets

Environmental and Analytical Chemistry Division, School of Advanced Sciences, VIT University, Vellore 632014, India

Received 1 September 2012; Accepted 3 October 2012

Academic Editors: A. I. Haza, Y. C. Hseu, and J. V. Rogers

Copyright © 2012 Utpal Kumar Sanki and Badal Kumar Mandal. 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. Abrams, “New words for old: lower urinary tract symptoms for 'prostatism',” British Medical Journal, vol. 308, no. 6934, pp. 929–930, 1994. View at Google Scholar · View at Scopus
  2. W. J. G. Hellstrom, R. A. Schmidt, T. F. Lue, and E. A. Tanagho, “Neuromuscular dysfunction in nonbacterial prostatitis,” Urology, vol. 30, no. 2, pp. 183–188, 1987. View at Google Scholar · View at Scopus
  3. L. Denis, J. D. McConnell, O. Yoshida et al., “The evaluation and treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction,” in Proceedings of the 4th International Consultation on Benign Prostatic Hyerplasia (BPH), L. Denis, K. Griffiths, and S. Khoury, Eds., pp. 669–684, Health Publication, Plymouth, UK, 1997.
  4. R. Bruskewitz, “Management of symptomatic BPH in the US: who is treated and how?” European Urology, vol. 36, no. 3, pp. 7–13, 1999. View at Google Scholar · View at Scopus
  5. P. Narayan and A. Tewari, “Overview of α-blocker therapy for benign prostatic hyperplasia,” Urology, vol. 51, no. 4, pp. 38–45, 1998. View at Publisher · View at Google Scholar · View at Scopus
  6. R. E. Eckert, U. Schreier, S. Alloussi et al., “Prostate selectivity of alpha1-adrenoceptor blockers,” Journal of Urology, vol. 161, no. l 4, pp. 233–238, 1999. View at Google Scholar
  7. F. Lefevre-Borg, S. E. O'Connor, H. Schoemaker et al., “Alfuzosin, a selective α1-adrenoceptor antagonist in the lower urinary tract,” British Journal of Pharmacology, vol. 109, no. 4, pp. 1282–1289, 1993. View at Google Scholar · View at Scopus
  8. “UROXATRAL (alfuzosin HCl) extended-release tablets,” U.S. Approval, 2003, http://products.sanofi.us/uroxatral/uroxatral.html.
  9. P. Van Kerrebroeck, A. Jardin, K. U. Laval, and P. Van Cangh, “Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia,” European Urology, vol. 37, no. 3, pp. 306–313, 2000. View at Google Scholar · View at Scopus
  10. C. G. Roehrborn and R. L. Siegel, “Safety and efficacy of doxazosin in benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies,” Urology, vol. 48, no. 3, pp. 406–415, 1996. View at Publisher · View at Google Scholar · View at Scopus
  11. “Uroxatral (alfuzosin HCl extended release tablets),” Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER), May 2009.
  12. Q. Liu and R. Fassihi, “Zero-order delivery of a highly soluble, low dose drug alfuzosin hydrochloride via gastro-retentive system,” International Journal of Pharmaceutics, vol. 348, no. 1-2, pp. 27–34, 2008. View at Publisher · View at Google Scholar · View at Scopus
  13. C. Rauch, F. Andre, and J. P. Thenot, “Bioequivalence study of a new once a day controlled release alfuzosin formulation with the 5 mg twice daily formulation,” Journal of Urology, vol. 163, no. 4, supplement, pp. 306–318, 2000. View at Google Scholar
  14. L. Maggi, U. Conte, P. Gerenier et al., “Tablet with controlled release of alfuzosin chlorhydrate,” US Patent 6, 149, 940A, 2000.
  15. V. Andrieu, J. Montel, and A. Wick, “Sustained-release pharmaceutical dosage forms containing alfuzosin hydrochloride,” European Patent 0673650, 1995.
  16. G. L. Amidon, H. Lennernas, V. P. Shah, and J. R. Crison, “A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability,” Pharmaceutical Research, vol. 12, no. 3, pp. 413–420, 1995. View at Google Scholar · View at Scopus
  17. E. G. K. Murthy, P. Sravanthi, and K. Sujana Priyadarshini, “Studies on influence of formulation variables on performance of alfuzosin HCl extended release tablets,” Invent. Rapid, NDDS, vol. 2011, Article ID Inventi:ndds/106/11, 2011. View at Google Scholar
  18. J. M. Newton, S. Boutel, and J. Chatchawalsaisin, “Preparation of spherical granules by extrusion/spheronization without microcrystalline cellulose,” in Proceedings of the 7th International Symposium on Agglomeration, pp. 337–342, Albi, France, May, 2001.
  19. T. Schaefer, Melt agglomeration with polyethylene glycols in high shear mixers [Dr Pharm. Thesis], The Royal Danish School of Pharmacy, Copenhagen, Denmark, 1996.
  20. H. Leuenberger, “New trends in the production of pharmaceutical granules: the classical batch concept and the problem of scale-up,” European Journal of Pharmaceutics and Biopharmaceutics, vol. 52, no. 3, pp. 279–288, 2001. View at Publisher · View at Google Scholar · View at Scopus
  21. H. Leuenberger, M. Usteri, G. Imanidis, and S. Winzap, “Monitoring the granulation process: granulate growth, fractal dimensionality and percolation threshold,” Bollettino Chimico Farmaceutico, vol. 128, no. 2, pp. 54–61, 1989. View at Google Scholar
  22. N. D. Eddington, G. S. Rekhi, L. J. Lesko, and L. L. Augsburger, “Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metaprolol tartrate tablet formulations,” AAPS PharmSciTech, vol. 1, no. 2, pp. 14–24, 2000. View at Publisher · View at Google Scholar · View at Scopus
  23. “Immediate Release Solid Oral Dosage Forms, Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls: In Vitro Dissolution Testing, In Vivo Bioequivalence documentation Guidance,” Federal Register, vol. 60, pp. 61638–61643, 1995.
  24. R. W. Johnstone and M. W. Thring, Pilot Plants, Models and Scale-Up Methods in Chemical Engineering, McGraw-Hill, New York, NY, USA, 1957.
  25. M. Vamsi Krishna and D. Gowri Sankar, “New diazo coupling reactions for visible spectrophotometric determination of alfuzosin in pharmaceutical preparations,” E-Journal of Chemistry, vol. 4, no. 4, pp. 496–501, 2007. View at Google Scholar · View at Scopus
  26. M. Ganesh, S. Uppatyay, R. Tivari et al., “Quantitation of alfuzosin hydrochloride in pharmaceutical formulations by RP-HPLC,” Pakistan Journal of Pharmaceutical Sciences, vol. 22, no. 3, pp. 263–266, 2009. View at Google Scholar · View at Scopus
  27. X. He, K. A. Lunday, L. C. Li, and M. J. Sacchetti, “Formulation development and process scale up of a high shear wet granulation formulation containing a poorly wettable drug,” Journal of Pharmaceutical Sciences, vol. 97, no. 12, pp. 5274–5289, 2008. View at Publisher · View at Google Scholar · View at Scopus
  28. A. Nair, R. Gupta, and S. Vasanti, “In vitro controlled release of alfuzosin hydrochloride using HPMC-based matrix tablets and its comparison with marketed product,” Pharmaceutical Development and Technology, vol. 12, no. 6, pp. 621–625, 2007. View at Publisher · View at Google Scholar · View at Scopus
  29. United States Pharmacopoeia, 27, National Formulary 22, USP Convention, Rockville 2004.
  30. P. Costa and J. M. Sousa Lobo, “Modeling and comparison of dissolution profiles,” European Journal of Pharmaceutical Sciences, vol. 13, no. 2, pp. 123–133, 2001. View at Publisher · View at Google Scholar · View at Scopus
  31. M. A. Roni, G. Kibria, and R. Jalil, “In vitro studies of controlled release alfuzosin matrix tablets prepared with ethylcellulose and hydroxypropyl methylcellulose, Iranian,” Journal of Pharmaceutical Sciences, vol. 5, no. 2, pp. 59–68, 2009. View at Google Scholar
  32. J. W. Moore and H. H. Flanner, “Mathematical comparison of dissolution profiles,” Pharmaceutical Technology, vol. 20, no. 6, pp. 64–74, 1996. View at Google Scholar · View at Scopus
  33. “Scientific discussion on bioequivalence aspect of Alfuzosin modified release tablets 'Merck NM' Alfuzosin hydrochloride,” Public Assessment Report DK/H/0899/001-002, 2006.
  34. A. Rouchouse, M. Manoha, A. Durand, and J. P. Thenot, “Direct high-performance liquid chromatographic determination of the enantiomers of alfuzosin in plasma on a second-generation α1-acid glycoprotein chiral stationary phase,” Journal of Chromatography, vol. 506, pp. 601–610, 1990. View at Publisher · View at Google Scholar · View at Scopus
  35. P. Guinebault, M. Broquaire, C. Colafranceschi, and J. P. Thenot, “High-performance liquid chromatographic determination of alfuzosin in biological fluids with fluorimetric detection and large-volume injection,” Journal of Chromatography, vol. 353, pp. 361–369, 1986. View at Google Scholar · View at Scopus
  36. “Guidance for industry extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations,” U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) September, 1997.
  37. A. Johansen, T. Schæfer, and H. Gjelstrup Kristensen, “Evaluation of melt agglomeration properties of polyethylene glycols using a mixer torque rheometer,” International Journal of Pharmaceutics, vol. 183, no. 2, pp. 155–164, 1999. View at Publisher · View at Google Scholar · View at Scopus
  38. N. Vaya, R. S. Karan, S. S. Nadkarni, and V. K. Gupta, “Modified release composition of highly soluble drugs,” US Patent 7976871a application no. 11/134631, 2011.
  39. “Pharmaceutical Manufacturers' Association,” 115 154th Street, N.W. Washington, DC, USA, 2005.
  40. J. P. Remington, Remington’S Pharmaceutical ScienceS, Mack, Easton, Pa, USA, 15th edition, 1975.
  41. J. Gottfries, J. Ahlbom, V. Harang et al., “Validation of an extended release tablet dissolution testing system using design and multivariate analysis,” International Journal of Pharmaceutics, vol. 106, no. 2, pp. 141–148, 1994. View at Publisher · View at Google Scholar · View at Scopus