Bioequivalence evaluation of norfloxacin tablets based on in vitro - in vivo correlation
Pakistan Journal of Pharmaceutical Sciences. 2011; 24 (4): 421-426
em Inglês
| IMEMR
| ID: emr-137539
ABSTRACT
Present study was designed to establish in-vitro and in-vivo correlation [IVIVC] of two immediate release tablet formulations of 400mg Norfloxacin [Drug A as test and Drug B as reference]. Dissolution study was conducted in 0.1 N HC1 using USP apparatus II. In-vivo evaluation was carried out in 18 healthy humans according to a single dose, two-sequence, and cross-over randomized with a wash-out period of one week. After dosing, serial blood samples were collected for a period of 10 hours. Plasma harvested from blood, was analyzed for norfloxacin by a sensitive, reproducible and accurate HPLC method. Various pharmacokinetic parameters were determined from plasma concentrations for both the formulations. Non-significant difference was found for test/reference ratio of these parameters and the value of F was found to be 0.99 which is in good agreement with the limits given in PDA and WHO guidelines for such parameters. Difference factor [f[1]], similarity factor [f[2]] and level A IVIVC were evaluated showing that drug A is bioequivalent to drug B
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Índice:
IMEMR (Mediterrâneo Oriental)
Assunto principal:
Comprimidos
/
Disponibilidade Biológica
/
Equivalência Terapêutica
/
Norfloxacino
/
Cromatografia Líquida de Alta Pressão
/
Estudos Cross-Over
/
Área Sob a Curva
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Feminino
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Pak. J. Pharm. Sci.
Ano de publicação:
2011
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