Determinación de la biodisponibilidad relativa de una formulación de administración intramuscular de ETORICOXIB de GINSBERG Ecuador S.A.

Abstract

The objective of this study was to determine the relative bioavailability of an intramuscular administration formulation called ECOXIB BLISPACK of 90 mg / mL, concentration, with respect to a reference formulation ARCOXIA of 90 mg in Wistar Rattus norvegicus rats. The samples studied consisted of prefilled syringes of ECOXIB BLISPACK of 90 mg / ml assigned with the letter (T1) for lot 16088 and as a reference (R) ARCOXIA tablets of 90 mg lot 17553. The protocol consisted of administering a single intramuscular dose of the ECOXIB BLISPACK formulation and an oral formulation of ARCOXIA, 10 mg / kg in each case to 12 rats, after a 12-hour fast, through a completely randomized design, to later determine the plasmatic concentrations of the drug in predetermined periods of time until 24 hours by means of high pressure liquid chromatography. With the data of plasma concentrations, the average plasma profile was constructed, at the time the ABC ot pharmacokinetic parameters were obtained: 64.2516 ug / mL*h, C máx: 4.3233 ug / mL and tmáx: 1h for T1 and ABC o-t: 47, 7209 ug/mL*h, Cmáx: 3,7715 ug /mL and t máx: 4h for R. Finally, the relative bioavailability was calculated resulting in a percentage of 134.6%. In conclusion, through the pharmacokinetic parameters it can be appreciated that the ECOXIB BLISPACK formulation administered intramuscularly reaches a higher plasma concentration and has a faster action with respect to the reference formulation.