Syahrul Tuba

Conference 2023 Presentation

 

Project title

Quantitative Analysis of Generic Cefixime in Healthy Subjects Using UPLC-MS/MS and Its Bioavailability and Pharmacokinetics Evaluation Utilization

 

Authors and Affiliations

Yuli Subiakto1,2, Haris Rismawan 2, Syahrul Tuba1

1. Faculty of Military Pharmacy, The Republic of Indonesia Defense University, Sentul, Indonesia
2. Air Force Pharmacy Institution Roostyan Effendie, Bandung, Indonesia

 

Abstract

Background

This study aims to compare the bioavailability of Lafsefik Dry Syrup (Lafsefik DS) containing 100 mg/5 ml cefixime with Suprax Oral Suspension (Suprax OS).

Methods

The bioequivalence test was carried out with a cross-sectional study design with two stages, a randomized, crossover, two-way, double-blind, single-dose control, with pharmacokinetic parameters including AUC 0-t, Cmax, Tmax T1/2, which included 21 male and female healthy adult individuals under fasting conditions. Blood plasma levels were measured using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC–MS/MS). The comparative dissolution test of the Lafsefik DS test drug product was 28.82% at pH 1.2, 62.99% at pH 4.5, and 69.90% at pH 6.8, as indicated by the F2 value. The F2 value was <50% with Suprax OS at pH 1.2 and >50% at pH 4.5 and pH 6.8.

Results

The results of the bioequivalence test showed AUC0-32= 22.857±7.639 ng ml-1 hour, AUC0-inf = 23.440±7.720 ng mL-1.hour, Cmax = 2.695± 858 ng mL-1, Tmax= 4.05 ±0.79 hours, and T½= 3.98 ± 0.38 hours. The values of the Suprax OS were AUC0-32 = 21.496±5.849 ng mL-1.hour, AUC0-inf = 22.032±5.863 ng mL-1hour, Cmax = 2.561±554 ng mL-1, Tmax = 4.19 ±0.84 hours, and T½ = 4.02 ±0.51 hours. The geometric mean ratio of test drug to innovator drug (90% CI) showed bioequivalence with values of AUC0-32= 104.71% (98.13-111.23), Cmax= 102.61% (95.79-109.61), CV intrasubject of AUC0-32= 11.70%, and Cmax = 11.31%.

Conclusions

The Lafsefik DS test drug product has an F2 value greater than 50% and is bioequivalent.