Delayed release tablet dissolution related to coating thickness by terahertz pulsed image mapping

  1. John A. Spencer1,*,
  2. Zongming Gao1,
  3. Terry Moore1,
  4. Lucinda F. Buhse1,
  5. Philip F. Taday2,
  6. David A. Newnham2,
  7. Yaochun Shen2,
  8. Alessia Portieri2,
  9. Ajaz Husain3

Article first published online: 23 AUG 2007

DOI: 10.1002/jps.21051

Issue

Journal of Pharmaceutical Sciences

Journal of Pharmaceutical Sciences

Volume 97, Issue 4, pages 1543–1550, April 2008

Total views since August 2010: 481

Additional Information

How to Cite

Spencer, J. A., Gao, Z., Moore, T., Buhse, L. F., Taday, P. F., Newnham, D. A., Shen, Y., Portieri, A. and Husain, A. (2008), Delayed release tablet dissolution related to coating thickness by terahertz pulsed image mapping. J. Pharm. Sci., 97: 1543–1550. doi: 10.1002/jps.21051

Author Information

  1. 1

    U.S. Food & Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St. Louis, Missouri 63101

  2. 2

    TeraView Ltd., Cambridge, CB4 0WS, UK

  3. 3

    Sandoz, Princeton, New Jersey

*U.S. Food & Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St. Louis, Missouri 63101. Telephone: 314-539-3859; Fax: 314-539-2113.

Publication History

  1. Issue published online: 27 FEB 2008
  2. Article first published online: 23 AUG 2007
  3. Manuscript Accepted: 25 APR 2007
  4. Manuscript Revised: 14 MAR 2007
  5. Manuscript Received: 13 DEC 2006

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (499K)

Keywords:

  • Asacol;
  • mesalamine;
  • mesalazine;
  • delayed release;
  • terahertz pulsed imaging;
  • coating mapping;
  • mean dissolution time (MDT);
  • process analytical technology (PAT)

Abstract

Delayed release dosage forms such as Asacol® employ coatings that are engineered to breakdown and release the drug topically at the nominal pH of the lower intestinal tract. Asacol tablets were found to dissolve in an erratic fashion when they are dissolved in buffers below pH 7 which can occur naturally. In this study Terahertz pulsed imaging (TPI) was used to accurately map the coating thickness of a group of Asacol tablets that were subsequently dissolved using the USP method at pH 6.8. The mean dissolution times were found to correlate with the average coating thickness measured over all surfaces. Thickness values for a single randomly selected face did not correlate well with the dissolution results. The speed and ease of TPI mapping may make it an attractive replacement for wet dissolution testing both in product development and eventually for process analysis. © 2007 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:1543–1550, 2008

View Full Article (HTML) Get PDF (499K)