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...
Guardado en:
| Autores principales: | , , , , , , , |
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| Formato: | Articulo Comunicacion |
| Lenguaje: | Inglés |
| Publicado: |
2010
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| Materias: | |
| 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: |
| Sumario: | 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. |
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