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 clef 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 bioavailabilily of a local risperidone formulation (Spiron(R)) was compared with the original formulation of the drug (Risperdal(R)) 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 (ABC(0-infinity)) and from 0 to 24 h (ABC(0-24)), early exposure (ABC from 0 to maximal time) and maximal plasma concentrations were significantly lower for Spiron(R). Half life lone and Nine 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(R) and Spiron(R), cannot be considered interchangeable (Rev Med Chile 2003; 131: 527-34).