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...
Guardado en:
Autores principales: | , , , , |
---|---|
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 |
Aporte de: |
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 |
work_keys_str_mv |
AT paveicabral developmentofclozapinetabletsbydirectcompressionanalysisofpharmaceuticalequivalencebydissolutionprofiles AT sausentiagor developmentofclozapinetabletsbydirectcompressionanalysisofpharmaceuticalequivalencebydissolutionprofiles AT silvaanapc developmentofclozapinetabletsbydirectcompressionanalysisofpharmaceuticalequivalencebydissolutionprofiles AT fialhosilvial developmentofclozapinetabletsbydirectcompressionanalysisofpharmaceuticalequivalencebydissolutionprofiles AT mayorgapaulo developmentofclozapinetabletsbydirectcompressionanalysisofpharmaceuticalequivalencebydissolutionprofiles |
bdutipo_str |
Repositorios |
_version_ |
1764820487106461696 |