Vol. 22 No. 3 (2019) Cover Image
Vol. 22 No. 3 (2019)

Published: October 31, 2019

Pages: 222-226

Articles

Comparative Study of Compartmental Modeling of Sustained Release Oral Dosage Forms and Intramuscular Injection

Abstract

This study has been performed to compare the compartmental modeling of two types of extravascular routes, sustained-release (SR) oral dosage forms and intramuscular (IM) injection. Twenty healthy volunteers received a single dose of 100 mg Diclofenac Sodium (DS) sustained-release tablet, then 75 mg DS Intramuscular injection after two weeks washout period. The concentrations of DS in plasma were measured using reverse-phase high-performance liquid chromatography (HPLC). The data analyzed using compartmental modeling, with single time-variant input and output. Primary kinetic parameters for both formulations, ( , , ) and other kinetic parameters were evaluated. The result shows that the IM injection needs a shorter time to reach the maximum concentration with convergent bioavailability to SR oral dosage forms, in another hand the data of IM injection fitted to single-compartment model with a correlation coefficient of 0.93 and the data of SR tablet fitted to two-compartment models with a correlation coefficient of 0.97.

References

  1. Frazer, J.K. & Capra, J.D. Immunoglobulins: structure and function. In Fundamental Immunology 4th edn. (ed. Paul, W.E.) 37–74 (Lippincott-Raven, Philadelphia, PA, (1999(.
  2. Kohler, G. & Milstein, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256, 495–497 (1975) .
  3. Shein-Chung Chow, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition, Chapman and hall-CRC, pp. 7-12(2008).
  4. Larry Bauer, "Applied Clinical Pharmacokinetics", McGraw-Hill Medical, pp.36-50, (2008).
  5. Sara Rosenbaum, "Basic Pharmacokinetics and Pharmacodynamics", by John Wiley & Sons pres, pp.30-42 (2011).
  6. Dusane Abhijit Ratilal, Gaikwad Priti D, "A review on Sustained release technology", IJRAP, Vol.2, No.6, pp. 1701-1708(2011).
  7. S.Ramakrishna, V.Mihira, K.Raja Vyshnavi1, "Design And Evaluation Of Drug Release Kinetics Of Meloxicam Sustained Release Matrix Tablets", International Journal of Current Pharmaceutical Research, Vol. 4, Issue 1, pp. 90-99 (2012).
  8. Larry Bauer, "Applied Clinical Pharmacokinetics", McGraw-Hill Medical, pp.36-50, (2008).
  9. Jean-Maurice Vergnaud, Iosif-Daniel Rosca, "Assessing Bioavailability of Drug Delivery Systems Mathematical Modeling", Taylor & Francis Group, pp.6-13, (2005).
  10. S. Sunil Jambhekar, J. Philip Breen, "Basic Pharmacokinetics", Pharmaceutical Press, pp 15-282, (2009).
  11. Todd PA, Sorkin EM. Diclofenac sodium. "A reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs". pp. 244–285(1988).
  12. Jing Yuan, He Ma, Nannan Cen, Ai Zhou, and Hengxun Tao "A pharmacokinetic study of diclofenac sodium in rats", Biomedical Reports, Vol.7, No.2, pp. 179–182 (2017).
  13. Joseph Bronzino, "Introduction to Biomedical Engineering"3rd ed., Academic Press Series in Biomedical Engineering, pp.82-379, (2012).
  14. Milo Gibaldi, Donald Perrier, "Pharmacokinetics" 2nd edition, Informa Healthcare USA,pp.145-434, (2007).
  15. Peter A. Todd, Eugene M. Sorkin, " Diclofenac Sodium A Reappraisal of its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Efficacy" Drugs, Volume 35, Issue 3, pp 244–28, (1988).
  16. Dhaneshwar Shep, Ashwini Ojha, Sweta Patel, “Pharmacokinetic profile of an intradeltoid diclofenac injection in obese Indian volunteers”, Journal of Pain Research, pp 235–240, (2010).