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....

Descripción completa

Guardado en:
Detalles Bibliográficos
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:
Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000500008
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:scielo:S0034-98872003000500008
record_format dspace
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
work_keys_str_mv AT gaeteleonardoe estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
AT solisgjaime estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
AT venegasfpablo estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
AT carrillocmitzyj estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
AT schatloffboscar estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
AT saavedrasivan estudiodebiodisponibilidadcomparativadedosformulacionesderisperidonaexistentesenelmercadochileno
_version_ 1718436092816916480