Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno / Comparative bioavailability study of two formulations of risperidone available in the Chilean market
Rev. méd. Chile
;
131(5): 527-534, mayo 2003.
Artículo
en Español
| LILACS
| ID: lil-356107
ABSTRACT
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 ANDMETHODS:
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-infinity) 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 per cent confidence interval for the difference of long transformed mean pharmacokinetic parameters), the formulations Risperdal and Spiron, cannot be considered interchangeable.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Antipsicóticos
/
Risperidona
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio pronóstico
Límite:
Adolescente
/
Adulto
/
Humanos
/
Masculino
País/Región como asunto:
America del Sur
/
Chile
Idioma:
Español
Revista:
Rev. méd. Chile
Asunto de la revista:
Medicina
Año:
2003
Tipo del documento:
Artículo
País de afiliación:
Chile
Institución/País de afiliación:
Universidad de Chile/CL
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