Advertisement

Examples of in Vitro-in Vivo Relationships with a Diverse Range of Quality

  • Russell J. Rackley
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 423)

Abstract

The purpose of this chapter is to present an introduction of in vivo - in vitro relationships (IVIVRs) and illustrate a number of examples which IVIVRs may be used to evaluate oral, modified-release formulations. Examples given are meant to portray applications to extended-release formulations, which may be defined as a dosage form allowing for a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (1). “Controlled-release” throughout this chapter refers to an extended-release dosage form. In this chapter, in accordance with the meeting, IVIVR is used interchangeably with IVIVC (in vivo - in vitro correlation).

Keywords

Dosage Form Oral Dosage Form Dissolution Data Solid Oral Dosage Form Pharmacokinetic System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    AAPS/USP/FDA Workshop on Scale-Up of Extended-Release Dosage Forms; Crystal Gateway Mariott Hotel, Arlington, VA; Sept. 8-10, 1992; and Skelly JP, Van Buskirk GA, Arbit HM, et al.; Pharm Res 10(12):1800-1805, 1993.Google Scholar
  2. 2.
    Pharmacopeial Forum; July–August, 1988; pg. 4160.Google Scholar
  3. 3.
    Cardot JM and Beyssac E, Eur J Drug Metab Pharmacokin, 18(1): 113–120, 1993.CrossRefGoogle Scholar
  4. 4.
    Skelly JP and Shiu GF; Eur J Drug Metab Pharmacokin, 18(1): 121–129, 1993.CrossRefGoogle Scholar
  5. 5.
    Cohen JL, Hubert BB, Leeson LJ, et al.; Pharm Res, 7: 983–987, 1990.PubMedCrossRefGoogle Scholar
  6. 6.
    Lindenbaum J, Butler VP, Murphy JE et al.; Lancet, June 2(1): 1215–1217, 1973.CrossRefGoogle Scholar
  7. 7.
    Johnson BF, McCrerie J, Greer H, et al.; Lancet, June 30(1): 1473–1475, 1973.CrossRefGoogle Scholar
  8. 8.
    Shaw TRD, Raymond K, Howard MR, et al.; Br Med J, 4: 763–766, 1973.PubMedCrossRefGoogle Scholar
  9. 9.
    Leeson LJ; LJL Associates, Inc., personal communication.Google Scholar
  10. 10.
    Siewert M; Eur J Drug Metab Pharmacokin, 18(1): 7–18, 1993.CrossRefGoogle Scholar
  11. 11.
    Oosterhuis B and Jonkman JHG; Eur J Drug Metab Pharmacokin, 18(1): 19–30, 1993.CrossRefGoogle Scholar
  12. 12.
    Pharmacopeial Forum, 19(3):5366-5379; May–June, 1993.Google Scholar
  13. 13.
    Generic Drugs Advisory Committee, Open Session; Rockville, MD; Jan. 11-12, 1994.Google Scholar
  14. 14.
    Wagner JG and Nelson E; J Pharm Sci, 52(6): 610–611, 1963.PubMedCrossRefGoogle Scholar
  15. 15.
    Loo JCK and Riegelman S; J Pharm Sci, 57: 918–928, 1968.PubMedCrossRefGoogle Scholar
  16. 16.
    Gillespie WR; PCDCON: Deconvolution for Pharmacokinetic Applications; The University of Texas at Austin, Austin, TX.Google Scholar
  17. 17.
    Chan K, Langenbucher F, and Gibaldi M; J Pharm Sci, 76(6): 446–450, 1987.PubMedCrossRefGoogle Scholar
  18. 18.
    PCNONLIN; Statistical Consultants, Inc.; Lexington, KY.Google Scholar
  19. 19.
    SAS; SAS Institute, Inc.; Cary, NC.Google Scholar
  20. 20.
    NONMEM; NONMEM Project Group, University of California; San Francisco, CA.Google Scholar
  21. 21.
    Leeson LJ, Adair D, Clevenger J, et al.; J Pharmacokin Biopharm, 13(5): 493–514, 1985.CrossRefGoogle Scholar
  22. 22.
    Stella II; High Performance Systems, Inc.; Hanover, NH.Google Scholar
  23. 23.
    Hwang SS, Bayne W, Theeuwes F; J Pharm Sci, 82(11): 1145–1150, 1993.PubMedCrossRefGoogle Scholar
  24. 24.
    Holford NHG and Sheiner LB; Clin Pharmacokin, 6: 429–453, 1981.CrossRefGoogle Scholar
  25. 25.
    Langenbucher F; Pharm Ind, 38(5) 472–477, 1976.Google Scholar
  26. 26.
    Rescigno A; Pharm Res, 9(7): 925–928, 1992.PubMedCrossRefGoogle Scholar
  27. 27.
    Moore JW and Flanner HH, Pham Tech, June 1996, pg 64–74.Google Scholar
  28. 28.
    McCall TW. Diehl D, Baumgarner C, et al.; 11th Annual AAPS Meeting, October, 1996, Poster PDD 7279 [TIMERx is a trademark of TIMERx Technologies].Google Scholar
  29. 29.
    USP XXII; Chapter <711>,pg 1578-1579; and Chapter <724>, pg 1580-1581.Google Scholar
  30. 30.
    Malinowski H, Marroum P, Uppoor VR, et al.; Guidance for Industry; Extended Release Solid Oral Dosage Forms; Development, Evaluation, and Application of in vitro — in vivo Correlations; Center for Drug Evaluation and Research (CDER), July 1, 1996.Google Scholar

Copyright information

© Plenum Press, New York 1997

Authors and Affiliations

  • Russell J. Rackley
    • 1
  1. 1.Biopharmaceutics Purepac Pharmaceutical Co., a subsidiary of Faulding, Inc.ElizabethUSA

Personalised recommendations