Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno

Background: Bioavailability of a particular drug can vary according to the formulation used. Therefore, studies of comparative bioavailability of different formulations of a same drug are worthwhile. Aim: To compare the bioavailability of two risperidone formulations available in the Chilean market. Material and methods: The bioavailability of a local risperidone formulation (Spiron®) was compared with the original formulation of the drug (Risperdal®) in 12 healthy volunteers, aged 19±1 years. A single dose of 3 mg was given orally, using a randomized double blind protocol in two periods. Fifteen blood samples were obtained at regular intervals, until 24 h after drug administration. Risperidone plasma levels were measured by high pressure liquid chromatography. Pharmacokinetic parameters were calculated using a computer program that is independent of compartmental analysis. Results: The area under the curve of plasma concentration versus time, from 0 to infinite (ABC0-∞) and from 0 to 24 h (ABC0-24), early exposure (ABC from 0 to maximal time) and maximal plasma concentrations were significantly lower for Spiron®. Half life time and time to achieve the maximal concentration were similar for the two formulations. Conclusions: According to bioequivalence tests suggested by the Food and Drug Administration (FDA) of the United States (90% confidence interval for the difference of log transformed mean pharmacokinetic parameters), the formulations Risperdal® and Spiron®, cannot be considered interchangeable (Rev Méd Chile 2003; 131: 527-34).

Bibliographic Details

Main Authors:	Gaete,Leonardo E, Solís G,Jaime, Venegas F,Pablo, Carrillo C,Mitzy J, Schatloff B,Oscar, Saavedra S,Iván
Format:	Digital revista
Language:	Spanish / Castilian
Published:	Sociedad Médica de Santiago 2003
Online Access:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000500008
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