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. 2023 Nov 1;15(11):2569.
doi: 10.3390/pharmaceutics15112569.

Etoricoxib Coated Tablets: Bioequivalence Assessment between Two Formulations Administered under Fasting Conditions

Jessica Meulman  1 , Marcelo Gomes Davanço  1 , Débora Renz Barreto Vianna  1 , Thalita Martins da Silva  1 , Fernando Costa  2 , Fernando Bastos Canton Pacheco  3 , Milla Emke de Oliveira  3 , Celso Francisco Pimentel Vespasiano  1
Affiliations

Etoricoxib Coated Tablets: Bioequivalence Assessment between Two Formulations Administered under Fasting Conditions

Jessica Meulman et al. Pharmaceutics. .

Abstract

Etoricoxib is a non-steroidal anti-inflammatory drug with high selectivity for cyclooxygenase 2 (COX-2), exerting a pronounced anti-inflammatory effect with fewer adverse events when compared to COX-1 inhibitors. The present study aimed to evaluate the bioequivalence between two etoricoxib-coated tablet formulations to meet regulatory requirements for a branded generic product registration in Brazil. A crossover study with an open-label, randomized design and a single-dose regimen with two treatments and two periods was conducted on healthy Brazilians of both genders. Subjects randomly received a single dose of a 90 mg etoricoxib coated tablet of test product Xumer® 90 mg (Adium S.A.) and the reference product Arcoxia® 90 mg (Merck Sharp & Dohme Farmacêutica Ltda.) under fasting conditions separated by a 14-day period. Blood samples were collected sequentially for up to 96 h following drug administration, and the concentrations of etoricoxib in plasma were determined using a validated UPLC-MS/MS method. Pharmacokinetic parameters were computed utilizing non-compartmental analysis methods. A total of 32 healthy subjects were enrolled, and 25 subjects completed the study. Geometric mean ratios (90% confidence intervals) for Cmax, AUC0-t, and AUC0-inf were 103.98% (95.63-113.06), 96.82% (91.82-102.09), and 95.79% (90.70-101.16), respectively. In accordance with regulatory standards, the test formulation (Xumer® 90 mg) has been deemed bioequivalent to the reference product (Arcoxia® 90 mg). As a result, these formulations can be considered interchangeable in clinical practice, with both proving to be safe and well-tolerated. The need for in vivo testing for the Xumer® 60 mg strength was waived due to the proportional similarity of the formulations and the similar in vitro dissolution profiles observed across the various strengths.

Keywords: anti-inflammatory agents; bioequivalence; cyclooxygenase 2 inhibitors; etoricoxib; non-steroidal; pharmacokinetics; safety.

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Conflict of interest statement

The authors declare that there is no conflict of interest regarding the publication of this article. The authors were fully responsible for all content and editorial decisions.

Figures

Figure 1
Figure 1
Mean etoricoxib plasma concentration vs time curves after administration of test (Xumer®) and reference (Arcoxia®) formulations in healthy subjects (male and non-pregnant female) under fasting conditions. (A) Plasma concentration from 0 to 96 h; (B) Plasma concentration vs time curves focused from 0 to 12 h.
Figure 2
Figure 2
Dispersion of test/reference ratio for Cmax between subjects (N = 25).
Figure 3
Figure 3
Dispersion of test/reference ratio for AUC0-t between subjects (N = 25).
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