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Comparative bioavailability: A new type ofin vitro-in vivo correlation exemplified by prednisone

Journal of Pharmacokinetics and Biopharmaceutics volume 4, pages 173–181 (1976)Cite this article

Abstract

The average time to reach half-maximal plasma concentration of prednisolone and the average plasma concentrations of prednisolone at 0.5 and 1 hr obtained from three crossover bioavailability studies, involving testing of commercially available 5-mg prednisone tablets, were highly correlated (r⪖0.88) with parameters derived from in vitrotablet dissolution rates performed in the spin filter apparatus of Shah. The in vitroparameters were the times to dissolve 16% or 50% of the labeled amount of prednisone or the percent of the labeled amount of prednisone dissolved in 20 min in water at 37‡C. Such correlations may be useful in the setting of in vitrodissolution rate specifications for commencal prednisone tablets.

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References

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Author notes

  1. Timothy J. Sullivan

    Present address: School of Pharmacy, The University of North Carolina, 27519, Chapel Hill, North Carolina

Affiliations

  1. College of Pharmacy and Upjohn Center for Clinical Pharmacology, The University of Michigan, 48109, Ann Arbor, Michigan

    Timothy J. Sullivan, Ermelinda Sakmar & John G. Wagner

Authors
  1. Timothy J. Sullivan
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  2. Ermelinda Sakmar
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  3. John G. Wagner
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Additional information

Supported by Contract FDA 69-22, Food and Drug Administration, Washington, D.C., and in part by Public Health Service Grant 5-P11-GM15559.

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Sullivan, T.J., Sakmar, E. & Wagner, J.G. Comparative bioavailability: A new type ofin vitro-in vivo correlation exemplified by prednisone. Journal of Pharmacokinetics and Biopharmaceutics 4, 173–181 (1976). https://doi.org/10.1007/BF01086152

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  • DOI: https://doi.org/10.1007/BF01086152

Key words

  • in vitro-in vivo correlations
  • predisone tablets
  • dissolution rates
  • spin filter apparatus
  • newin vivo parameter