Clinical study on the bioequivalence of two tablet formulations of flurbiprofen

Abstract

Flurbiprofen (CAS 5104-49-4) is a member of phenylalkanoic acid derivative group of nonsteroid anti-inflammatory drugs. It exhibits anti-inflammatory, analgesic and antipyretic activities. Two different tablets containing flurbiprofen (FLU) were investigated in 24 healthy volunteers to prove the bioequivalence between both treatments after single oral dose administrations. Fluroben 100 mg tablet and 100 mg tablet of the originator product were used as test and reference preparation respectively. The study was performed open label, randomized, two period cross-over design with 15 days wash out period. Blood samples were taken up to 24 hours for pharmacokinetic profiling. The plasma concentrations of flurbiprofen were determined with validated HPLC-UV method. Maximum plasma concentration (Cmax) of FLU 19,143.65 ng/ml and 19,164.22 ng/ml were found for test and reference formulation respectively. Areas under the plasma concentration time curve AUC(0-infinity), of 118 501.4 ng.h/ml and 111,339.8 ng.h/ml were calculated test and reference formulation respectively. Primary target parameters AUC (0-infinity) and Cmax, both of them were tested parametrically by analysis of variance (ANOVA); 90% confidence intervals were between 100.5%-111.18% for AUC(0-infinity), and 87.6%-115.0% for Cmax. All these values were within the acceptance range (80%-125%) for bioequivalence studies.

Rapid identification of potential nonsteroidal anti‐inflammatory drug overdose–induced liver toxicity and prediction of follow‐up exposure: Integrating bioanalytical and population pharmacokinetic assay

“…One hundred twenty‐one APAP concentrations (Achterbergh et al, 2019; Baraka et al, 1990; Garcia Aguirre et al, 2019; Grattan et al, 2000; Raffa et al, 2018; Seideman, 1991; Singla et al, 2012; Volak et al, 2013; Yin et al, 2001), 145 FLB concentrations (Greenblatt et al, 2006; Hanley et al, 2013; Liu et al, 2009; Ozbay et al, 2009; Qayyum et al, 2011; Szpunar et al, 1987; Taburet et al, 1995), 124 ASP concentrations (Angiolillo et al, 2020; Benedek et al, 1995; Cryer et al, 1999; Hobl et al, 2015; Husted et al, 1983; Itthipanichpong et al, 1992; Koch et al, 1978; Misawa et al, 1985; Muir et al, 1997; Nakayasu et al, 2003), and 306 IBP concentrations (Al‐Meshal et al, 1994; De Brabander et al, 2004; Dewland et al, 2009; Gillespie et al, 1982; Hammami et al, 2017; Hattrem et al, 2018; Idkaidek & Arafat, 2011; Kapil et al, 2004; Kimura et al, 1992; Koenigsknecht et al, 2017; Laneury et al, 1998; Lapatto‐Reiniluoto et al, 1999; Neuvonen, 1991; Shin et al, 2017; Sugár et al, 2019) were extracted from 11 groups of APAP data, 11 groups of FLB data, 14 groups of ASP data, and 22 groups of IBP data. Demographics and study details are summarized in Table S1, and the line charts of plasma concentration–time after doses are shown in Figure S1.…”

Potential Use of Nanostructured Lipid Carriers for Topical Delivery of Flurbiprofen

“…Therefore, NLC could have a greater local anti-inflammatory activity than the traditional pharmaceutical formulations. [33][34][35][36] Differential Scanning Calorimetry and X-Ray Diffraction…”

Development, evaluation, and optimization of flurbiprofen nanoemulsions gel using quality by design concept

“…[15] Flurbiprofen (log P = 4.09) is generally recommended for the treatment of rheumatoid arthritis, osteoarthritis [16,17] and also has analgesic and anti-pyretic activity. [18] Prolonged administration of the drug generally results in gastrointestinal bleeding and gastric ulcer. [19] Thus, the transdermal route of administration increases patient compliance avoiding first-pass metabolism and maintains plasma drug level for a prolonged period.…”