Application of in vitro– in vivo Correlation as a Predictive Tool for Bioequivalence of Generic Paracetamol Immediate Release Oral Tablets

  • Rogers Atebe Regal Pharmaceuticals Ltd, P.O. Box 44421-00100 Nairobi GPO
  • Lucy J Tirop Department of Pharmaceutics and Pharmacy Practice, University of Nairobi
  • Shital M Maru Department of Pharmaceutics and Pharmacy Practice, University of Nairobi
  • Kimani A.M. Kuria Department of Pharmaceutics and Pharmacy Practice, University of Nairobi
Keywords: paracetamol, in-vitro in-vivo correlation, generic, bioequivalence, dissolution profile

Abstract

An in vitro – in vivo correlation (IVIVC) model can predict the bioavailability of
some drug substances, and mitigate against the high cost of bioequivalence studies,
long generic product development lead times, and the exposure of human subjects to
drug substances they do not need. In this study a total of three batches of generic
paracetamol immediate release oral tablets and one batch of the comparator
product, were subjected to dissolution testing to generate a dissolution profile from
which the blood drug concentration – time profile and specifically the bioavailability
parameters AUC and Cmax were computed using an IVIVC tool. Statistical analysis
demonstrated sameness between the generic product and the reference product. The
IVIVC method can thus be a surrogate for in vivo human studies, providing a
scientific justification for biowaiver for generic products of candidate drug
substances.

Published
2019-03-25
How to Cite
Atebe, R., Tirop, L., Maru, S., & Kuria, K. (2019). Application of in vitro– in vivo Correlation as a Predictive Tool for Bioequivalence of Generic Paracetamol Immediate Release Oral Tablets. The East and Central African Journal of Pharmaceutical Sciences, 20((1-3), 17-26. Retrieved from https://uonjournals.uonbi.ac.ke/ojs/index.php/ecajps/article/view/218
Issue
Vol 20 No (1-3) (2017): January-December 2017
Section
Articles