Skip to main content
SpringerLink
Log in

In Vitro-In Vivo Relationship of Oral Extended-Release Dosage Forms

  • Published:
Pharmaceutical Research Aims and scope Submit manuscript

Abstract

Purpose. A method to establish the in vitro-in vivo relationship of oral extended-release products is proposed.

Methods. The approach utilizes incremental amounts of drug released and absorbed within defined time intervals, to construct a χ2 distributed variable for testing in vitro-in vivo similarity.

Results. A case study is used to demonstrate that the similarities between incremental values of in vivo absorbed and in vitro dissolved fractions are distinguishable for different dissolution profiles despite naturally significant linear correlations between cumulative in vivo absorbed and in vitro dissolved fractions (with different dissolution tests) of an oral extended-release product.

Conclusions. The method enables investigators to compare different in vitro dissolution profiles of an oral extended-release product to find an optimized dissolution profile to be the surrogate of the in vivo release process of the product.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

REFERENCES

  1. USP, XIV, 1950.

  2. USP Subcommittee on Biopharmaceutics. Pharm. Forum 4160–4161 (1988).

  3. F. Y. Liu, N. C. Sambol, R. P. Giannini and C. Y. Liu. Pharm. Res. 1995, 12:720–728.

    Google Scholar 

  4. J. Drewe and P. Guitard. J. Pharm. Sci. 1993, 82:132–137.

    Google Scholar 

  5. J. P. Skelly, G. L. Amidon, et al., Pharm. Res. 1990, 7:975–982.

    Google Scholar 

  6. Z. Hussein and M. Friedman. Pharm. Res. 1990, 7:1167–1171.

    Google Scholar 

  7. K-H. Yuen, A. A. Arvind, A. Desmukh and J. M. Newton. Pharm. Res. 1993, 10:588–592.

    Google Scholar 

  8. H. Humbert, M-D. Cabiac and H. Bosshard. J. Pharm. Sci. 1994, 83:131–136.

    Google Scholar 

  9. P. Mojaverian, E. Radwanski, et al. Pharm. Res. 1992, 9:450–456.

    Google Scholar 

  10. S. L. Beal and L. B. Sheiner. NONMEM User's Guides, UCSF: NONMEM Project Group, San Francisco, 1992.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Impax Pharmaceuticals, Fremont, California, 94539

    Fang-Yu Liu

  2. Department of Pharmacy, University of California, San Francisco, California, 94143-0446

    Nancy C. Sambol & Chui Yu Liu

  3. Watson Laboratories, Corona, California, 91720

    Robert P. Giannini

Authors
  1. Fang-Yu Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nancy C. Sambol
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Robert P. Giannini
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Chui Yu Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Liu, FY., Sambol, N.C., Giannini, R.P. et al. In Vitro-In Vivo Relationship of Oral Extended-Release Dosage Forms. Pharm Res 13, 1501–1506 (1996). https://doi.org/10.1023/A:1016023428028

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1016023428028

Search

Navigation