Fernández-Santos A, Martínez-Rossier L, Amancio-Chassin O, Gómez-Sánchez M, Marcelin-Jiménez G, Ángeles-Moreno AP, Martín-Campo A, Higuera-Ramírez F

Language: Spanish
References: 13
Page: 83-89
PDF size: 96.74 Kb.

ABSTRACT

Sodic diclofenac is nonsteroid anti-inflammatory agent that administered by oral route in rheumatic disorders. Objective: to evaluate pharmacokinetic of the sodic diclofenac of 100 mg with pharmaceutical form of prolonged liberation produced by a national pharmaceutical laboratory and quantify the adverse events. Material and methods: the experimental test was made in 24 masculine healthy subjects. 5 doses of diclofenac were administered to obtain the steady state. Study design consisted of a treatment, a period, a sequence, randomized, longitudinal and prospective. The analytical method by high performed liquid chromatography was used with UV-visible detector. The pharmacokinetic parameters were calculated with software WINNONLIN v. 3.1, through a model noncompartimental. Results: The area under the plasma drug concentration-time curve from 0 to t (AUC0-t) 2318 + 182.84 ng h/ml, maximum plasma drug concentration (Cmax) 1120.98 + 191.82 ng/ml and time maximum concentration (Tmax) 1.96 + 0.35 h. The adverse events were abdominal pain and pirosis. Conclusions: In relation to the absorption of diclofenac this one appeared in fast form with a similar Tmáx to the reported, previous the Cmáx was observed a plateau of 1. 5 h and having a two compartimental model could bring with himself a better antiinflammatory effect, which would have to be demonstrated with some study with patients. Diclofenac has therapeutic concentrations with to say that the studied pharmaceutical form is delayed release.

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