The Lidose Hard Capsule Formulation of Fenofibrate is Suprabioavailable Compared to the Nanoparticle Tablet Formulation Under High-fat Fed Conditions

Authors

  • Roger K Verbeeck Louvain Drug research Institute Catholic University of Louvain Brussels
  • Sophie De Niet Laboratoires SMB, Brussels, Belgium; 4 Galephar MF, Marche-en-Famenne, Belgium
  • Sonia Lebrun Laboratoires SMB, Brussels, Belgium; 4 Galephar MF, Marche-en-Famenne, Belgium
  • Mickael Tremege Laboratoires SMB, Brussels, Belgium; 4 Galephar MF, Marche-en-Famenne, Belgium
  • Tim W. Rennie School of Pharmacy, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia
  • Monte Coffiner Laboratoires SMB, Brussels, Belgium; 4 Galephar MF, Marche-en-Famenne, Belgium
  • Bruno Streel Galephar MF, Marche-en-Famenne, Belgium
  • Bernard Cahay Galephar MF, Marche-en-Famenne, Belgium

DOI:

https://doi.org/10.18433/J3FG7G

Abstract

Purpose: The therapeutic equivalence of multiple registered fenofibrate formulations, several of which are suprabioavailable and therefore marketed at lower dosage strengths than their reference products, is based on the results of bioequivalence studies. Most of these formulations show a higher bioavailability when taken with a high-fat meal. The relative bioavailability of two of these formulations, the 200 mg Lidose hard capsules and the 145 mg nanoparticle tablets, was assessed when taken with a high-fat meal. Methods: In this single dose, 2-way, randomized, crossover study, 24 healthy subjects received a 200 mg fenofibrate Lidose hard capsule (Test) and a 145 mg nanoparticle tablet (Reference) under high-fat fed conditions. Plasma concentrations of fenofibric acid were measured up to 72 hours by using a validated LC-MS/MS method. Results: The geometric mean ratios (Test/Reference) and the 90% confidence intervals for AUC0-t and Cmax were 1.37 (131.58 – 142.88) and 1.38 (124.60 – 152.93), respectively. The median (range) Tmax­ values of fenofibric acid were 4.5 h (3.0 – 8.0 h) and 3.25 h (1.0 – 6.5 h) after administration of the Lidose hard capsule and the nanoparticle tablet, respectively. Conclusion: Under high-fat fed conditions the extent of fenofibrate absorption was 37% higher for the 200 mg Lidose hard capsule compared to the 145 mg nanoparticle tablet, which is exactly as expected based on a mg-to-mg weight basis. The results of the present study underline the importance of assessing bioequivalence of fenofibrate formulations under identical fed conditions, and preferentially after a high-fat meal as this condition represents the worst-case scenario. Furthermore, the results of this study demonstrate that the 145 mg nanoparticle tablet is not bioequivalent to the 200 mg Lidose hard capsule when administered under high-fat meal conditions. 

 

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Author Biography

Roger K Verbeeck, Louvain Drug research Institute Catholic University of Louvain Brussels

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Published

2015-02-03

How to Cite

Verbeeck, R. K., Niet, S. D., Lebrun, S., Tremege, M., Rennie, T. W., Coffiner, M., … Cahay, B. (2015). The Lidose Hard Capsule Formulation of Fenofibrate is Suprabioavailable Compared to the Nanoparticle Tablet Formulation Under High-fat Fed Conditions. Journal of Pharmacy & Pharmaceutical Sciences, 18(1), 61–67. https://doi.org/10.18433/J3FG7G

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Section

Pharmaceutical Sciences; Review Articles