Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib

Abstract

PurposeThe current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).MethodsThis was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography–ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration–time curve from time zero to the time of last observed concentration (AUC0−t), the area under plasma concentration–time curve from time zero to infinity (AUC0−∞), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), and the terminal half-life (t½).ResultsAfter a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC0–72h and Cmax of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng·h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%–108.32%) for AUC0–72h and 109.26% (100.18%–119.18%) for Cmax. No clinically significant differences in tmax and t½values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.ConclusionThe present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug.

A Phase I, open-label, randomized, crossover study in healthy subjects to evaluate the bioavailability of, and the food effect on, a pomalidomide oral liquid suspension

“…The global regulatory requirement for the equivalent BA, or the BE, of medications with different formulations has become crucial in medicine and pharmaceutical development. 26 FDA guidance of BA and BE studies for orally administered drug products suggests that studies to measure BA and/or establish BE of a product are important elements in support of investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. BA studies focus on determining the process by which a drug is released from the oral dosage form and moves to the site of action.…”

The effect of formulation and process variables on prepared etoricoxib ‎Nanosponges

“…The solubility analysis for ETX revealed that pure powder has low solubility in phosphate buffer (pH 7.4), while ETX NS showed comparatively higher solubility, as seen in Table 2. The prepared structure of NS increased surface area and improved hydrophilicity by reducing the particle size of ETX to the nanoscale using EC and PVA as well as hydrogen bonding between drug and nanosponges structure [12,13]. The solubility of prepared NS was significantly affected by increasing quantities of EC with constant amounts of ETX, as seen in Figure 1a.…”

Vitamin B and Vitamin C Affect DNA Methylation and Amino Acid Metabolism in Mycobacterium bovis BCG

“…At the same time, supplementation of some vitamins together with anti-TB drugs has been shown to improve chemotherapy outcomes (Vilcheze et al, 2018). Clinical trials have shown that Vc supplementation improves the healing process in tuberculosis patients (Tjandrawinata et al, 2018), although no clinical improvement (sputum conversion) of patients was observed when using vitamin D (V D ). Therefore, the mechanism by which some vitamins can ammeliorate TB requires further investigation.…”