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....

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Autores principales:	Gaete,Leonardo E, Solís G,Jaime, Venegas F,Pablo, Carrillo C,Mitzy J, Schatloff B,Oscar, Saavedra S,Iván
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Médica de Santiago 2003
Materias:	Biological availability Pharmacokinetics Risperidone
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000500008
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spelling	oai:scielo:S0034-988720030005000082004-12-13Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chilenoGaete,Leonardo ESolís G,JaimeVenegas F,PabloCarrillo C,Mitzy JSchatloff B,OscarSaavedra S,Iván Biological availability Pharmacokinetics Risperidone 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).info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.131 n.5 20032003-05-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000500008es10.4067/S0034-98872003000500008
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Biological availability Pharmacokinetics Risperidone
spellingShingle	Biological availability Pharmacokinetics Risperidone Gaete,Leonardo E Solís G,Jaime Venegas F,Pablo Carrillo C,Mitzy J Schatloff B,Oscar Saavedra S,Iván Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
description	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).
author	Gaete,Leonardo E Solís G,Jaime Venegas F,Pablo Carrillo C,Mitzy J Schatloff B,Oscar Saavedra S,Iván
author_facet	Gaete,Leonardo E Solís G,Jaime Venegas F,Pablo Carrillo C,Mitzy J Schatloff B,Oscar Saavedra S,Iván
author_sort	Gaete,Leonardo E
title	Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
title_short	Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
title_full	Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
title_fullStr	Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
title_full_unstemmed	Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
title_sort	estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno
publisher	Sociedad Médica de Santiago
publishDate	2003
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000500008
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Estudio de biodisponibilidad comparativa de dos formulaciones de risperidona existentes en el mercado chileno

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