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Titre du document / Document title

Bioequivalence study of carbamazepine tablets : in vitro/in vivo correlation

Auteur(s) / Author(s)

JUNG H. (1) ; MILAN R. C. (1) ; GIRARD M. E. (2) ; LEON F. (2) ; MONTOYA M. A. (2) ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

(1) Departamento de Farmacia, División de Estudios de Posgrado, Facultad de Quimica, U.N.A.M., 04510 México, DF, MEXIQUE
(2) Instituto Mexicano del Seguro Social, Unidad de Control Técnico de Insumos, José Urbano Fonseca # 6, Magdalena de las Salinas, 07760 México, DF, MEXIQUE

Résumé / Abstract

After the in vitro dissolution profiles of three Mexican carbamazepine products and the innovator product (Tegretol) in four different dissolution media: HCl 0.1 N, simulated gastric fluid, simulated intestinal fluid, and water containing 1% sodium lauryl sulfate (USP method) were assesed, their bioequivalence was evaluated in 12 healthy volunteers in a randomized crossover study. Single oral doses of 400 mg of each product were administered at intervals of 2 weeks. The products tested in this study showed significant differences in the peak concentration and the area under the curve (p < 0.05). A faster dissolution was observed when USP method was used; however, no correlation was observed between the in vivo parameters and the in vitro dissolution results with this method. A linear relationship was found between the area under the curve and the percent dissolved at 45, 60 and 90 min when simulated intestinal fluid was used.

Revue / Journal Title

International journal of pharmaceutics    ISSN  0378-5173   CODEN IJPHDE 

Source / Source

1997, vol. 152, no1, pp. 37-44 (19 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, Amsterdam, PAYS-BAS  (1978) (Revue)

Mots-clés anglais / English Keywords

Carbamazepine

;

Biological activity

;

Anticonvulsant

;

Tablet

;

Dosage form

;

Pharmaceutical technology

;

Dissolution

;

In vitro

;

In vivo

;

Bioequivalence

;

Oral administration

;

Release

;

Active ingredient

;

Human

;

Bioavailability

;

Tricyclic compound

;

Normal

;

Blood plasma

;

Pharmacokinetics

;

Mots-clés français / French Keywords

Carbamazépine

;

Activité biologique

;

Anticonvulsivant

;

Comprimé

;

Forme pharmaceutique

;

Technologie pharmaceutique

;

Dissolution

;

In vitro

;

In vivo

;

Bioéquivalence

;

Voie orale

;

Libération

;

Principe actif

;

Homme

;

Biodisponibilité

;

Composé tricyclique

;

Normal

;

Plasma sanguin

;

Pharmacocinétique

;

Mots-clés espagnols / Spanish Keywords

Carbamazepina

;

Actividad biológica

;

Anticonvulsivante

;

Tableta

;

Forma farmacéutica

;

Tecnología farmacéutica

;

Disolución

;

In vitro

;

In vivo

;

Bioequivalencia

;

Vía oral

;

Liberación

;

Principio activo

;

Hombre

;

Biodisponibilidad

;

Compuesto tricíclico

;

Normal

;

Plasma sanguíneo

;

Farmacocinética

;

Localisation / Location

INIST-CNRS, Cote INIST : 16510, 35400006739420.0050

Nº notice refdoc (ud4) : 2738582



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