Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles

A predictive in vitro-invivo correlation (IVIVC) can empower in vitro dissolution as a surrogate for in vivo bioavailability / bioequivalence. IVIVCs can decrease regulatory burden by decreasing the number of biostudies required in support of a drug product. The present study concerns the establishm...

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Autores principales: Khan, Shujaat A., Ahmad, Mahmood, Shoaib, Harris M., Murtaza, Ghulam, Aamir, Muhammad N., Kousar, Rozina, Rasool, Fatima, Madni, Asadullah
Formato: Articulo Comunicacion
Lenguaje:Inglés
Publicado: 2010
Materias:
Farmacia
dissolution studies; bioavailability; internal prediction error; IVIVC; nimesulide
Farmacología
Disolución
Biodisponibilidad
Medicamentos
Agentes antiinflamatorios
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8022
http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_2_7.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-8022
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
dissolution studies; bioavailability; internal prediction error; IVIVC; nimesulide
Farmacología
Disolución
Biodisponibilidad
Medicamentos
Agentes antiinflamatorios
spellingShingle Farmacia
dissolution studies; bioavailability; internal prediction error; IVIVC; nimesulide
Farmacología
Disolución
Biodisponibilidad
Medicamentos
Agentes antiinflamatorios
Khan, Shujaat A.
Ahmad, Mahmood
Shoaib, Harris M.
Murtaza, Ghulam
Aamir, Muhammad N.
Kousar, Rozina
Rasool, Fatima
Madni, Asadullah
Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
topic_facet Farmacia
dissolution studies; bioavailability; internal prediction error; IVIVC; nimesulide
Farmacología
Disolución
Biodisponibilidad
Medicamentos
Agentes antiinflamatorios
description A predictive in vitro-invivo correlation (IVIVC) can empower in vitro dissolution as a surrogate for in vivo bioavailability / bioequivalence. IVIVCs can decrease regulatory burden by decreasing the number of biostudies required in support of a drug product. The present study concerns the establishment of in vitro-in vivo correlation for three different sustained release nimesulide loaded ethylcellulose microparticulate formulations (M1, M2 and M3) and conventional tablet (100 mg Nimaran®-Novartis, Pakistan). In vitro dissolution study was conducted in phosphate buffer pH 6.8 stirred at 50 rpm and 37 ± 0.5ºC. A validated HPLC method was adopted to conduct bioavailability studies in young healthy human volunteers. Ultimately IVIVC of prepared microparticles and conventional tablet was established using Wagner-Nelson method. M1 and M2 formulations and Nimaran® exhibited good linear IVIVC (R<sup>2</sup> = 0.9220, 0.9124, 0.8728, respectively) as compared to M3 (R<sup>2</sup> = 0.9449). The results substantiate the success of this mathematical simulation study encourage researchers to conduct biowaiver studies for other BCS class II drugs.
format Articulo
Comunicacion
author Khan, Shujaat A.
Ahmad, Mahmood
Shoaib, Harris M.
Murtaza, Ghulam
Aamir, Muhammad N.
Kousar, Rozina
Rasool, Fatima
Madni, Asadullah
author_facet Khan, Shujaat A.
Ahmad, Mahmood
Shoaib, Harris M.
Murtaza, Ghulam
Aamir, Muhammad N.
Kousar, Rozina
Rasool, Fatima
Madni, Asadullah
author_sort Khan, Shujaat A.
title Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
title_short Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
title_full Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
title_fullStr Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
title_full_unstemmed Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
title_sort development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
publishDate 2010
url http://sedici.unlp.edu.ar/handle/10915/8022
http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_2_7.pdf
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