International harmonization of generic drugs: in vitro dissolution tests for Japanese and American generic tablets.
Biomed Mater Eng
; 16(2): 129-35, 2006.
Article
en En
| MEDLINE
| ID: mdl-16477121
ABSTRACT
Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0+/-0.5 degrees C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Comprimidos
/
Ibuprofeno
/
Guías como Asunto
/
Evaluación Preclínica de Medicamentos
Tipo de estudio:
Evaluation_studies
/
Guideline
País/Región como asunto:
America do norte
/
Asia
Idioma:
En
Revista:
Biomed Mater Eng
Asunto de la revista:
BIOTECNOLOGIA
/
ENGENHARIA BIOMEDICA
Año:
2006
Tipo del documento:
Article
País de afiliación:
Japón