Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles

The aim of this work was to develop clozapine tablets that can be classified as a pharmaceutical equivalent to a reference brand product. Tablets were produced by direct compression and dissolution tests were realized in order to evaluate the dissolution profiles. The results show that the tablets...

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Autores principales: Pavei, Cabral, Sausen, Tiago R., Silva, Ana P. C., Fialho, Sílvia L., Mayorga, Paulo
Formato: Articulo
Lenguaje:Inglés
Publicado: 2010
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/7973
http://www.latamjpharm.org/resumenes/29/5/LAJOP_29_5_1_12.pdf
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id I19-R120-10915-7973
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
clozapine; dissolution profiles; pharmaceutical equivalence
Medicamentos
Farmacología
Disolución
spellingShingle Farmacia
clozapine; dissolution profiles; pharmaceutical equivalence
Medicamentos
Farmacología
Disolución
Pavei, Cabral
Sausen, Tiago R.
Silva, Ana P. C.
Fialho, Sílvia L.
Mayorga, Paulo
Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
topic_facet Farmacia
clozapine; dissolution profiles; pharmaceutical equivalence
Medicamentos
Farmacología
Disolución
description The aim of this work was to develop clozapine tablets that can be classified as a pharmaceutical equivalent to a reference brand product. Tablets were produced by direct compression and dissolution tests were realized in order to evaluate the dissolution profiles. The results show that the tablets can be classified as immediate release dosage forms due to clozapine fast release, and such release was dependent on the amount of sodium croscarmelose in the formulation. Analysis of f1 and f2 factors was frustrated due to the fast drug release; the tablets were analyzed by the dissolution efficiency and the dissolution curve shape. The dissolution efficiency was higher than 98 % and the analysis of the dissolution shape curve showed that the tablets from one batch of the developed formulations were similar to the reference brand product. The clozapine tablets obtained in this study can be considered as pharmaceutically equivalent to the reference brand product.
format Articulo
Articulo
author Pavei, Cabral
Sausen, Tiago R.
Silva, Ana P. C.
Fialho, Sílvia L.
Mayorga, Paulo
author_facet Pavei, Cabral
Sausen, Tiago R.
Silva, Ana P. C.
Fialho, Sílvia L.
Mayorga, Paulo
author_sort Pavei, Cabral
title Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
title_short Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
title_full Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
title_fullStr Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
title_full_unstemmed Development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
title_sort development of clozapine tablets by direct compression - analysis of pharmaceutical equivalence by dissolution profiles
publishDate 2010
url http://sedici.unlp.edu.ar/handle/10915/7973
http://www.latamjpharm.org/resumenes/29/5/LAJOP_29_5_1_12.pdf
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