In vitro-in vivo correlation study on nimesulide loaded hydroxypropylmethylcellulose microparticles / 药学学报
Acta Pharmaceutica Sinica
;
(12): 772-777, 2010.
Artículo
en Inglés
| WPRIM
| ID: wpr-354534
ABSTRACT
This study involves mathematical simulation model such as in vitro-in vivo correlation (IVIVC) development for various extended release formulations of nimesulide loaded hydroxypropylmethylcellulose (HPMC) microparticles (M1, M2 and M3 containing 1, 2, and 3 g HPMC, respectively and 1 g drug in each) having variable release characteristics. In vitro dissolution data of these formulations were correlated to their relevant in vivo absorption profiles followed by predictability worth analysis of these Level A IVIVC. Nimaran was used as control formulation to validate developed formulations and their respective models. The regression coefficients of IVIVC plots for M1, M2, M3 and Nimaran were 0.834 9, 0.831 2, 0.927 2 and 0.898 1, respectively. The internal prediction error for all formulations was within limits, i.e., < 10%. A good IVIVC was found for controlled release nimesulide loaded HPMC floating M3 microparticles. In other words, this mathematical simulation model is best fit for biowaiver studies which involves study parameters as those adopted for M3 because the value of its IVIVC regression coefficient is the closest to 1 as compared to M1 and M2.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Sulfonamidas
/
Farmacocinética
/
Antiinflamatorios no Esteroideos
/
Estudios Cruzados
/
Preparaciones de Acción Retardada
/
Inhibidores de la Ciclooxigenasa 2
/
Derivados de la Hipromelosa
/
Metilcelulosa
/
Microesferas
/
Modelos Químicos
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio pronóstico
Límite:
Humanos
Idioma:
Inglés
Revista:
Acta Pharmaceutica Sinica
Año:
2010
Tipo del documento:
Artículo
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