Quality control of anti-tuberculosis FDC formulations in the global market: part II-accelerated stability studies.
Int J Tuberc Lung Dis
; 9(11): 1266-72, 2005 Nov.
Article
en En
| MEDLINE
| ID: mdl-16333936
ABSTRACT
OBJECTIVE:
To determine the quality and performance of rifampicin (RMP) containing fixed-dose combination (FDC) formulations of anti-tuberculosis drugs sourced from the international market with respect to physical, chemical and dissolution properties after storage at accelerated stability conditions (40 degrees C/75% relative humidity) and to identify appropriate storage specifications.METHODS:
Formulations across different companies and combinations were subjected to 6-month accelerated stability testing in packaging conditions recommended by the manufacturer. Various pharmacopeial and nonpharmacopeial tests for tablets were performed for 3- and 6-month samples.RESULTS:
All the formulations were found to be stable, where extent of dissolution was within +/- 10% of that of the initial value, and all formulations passed the pharmacopeial limits for assay and content uniformity of 90-110% and +/- 15% of average drug content, respectively.CONCLUSIONS:
Good quality RMP-containing FDCs that remain stable after 6-month accelerated stability testing are available in the marketplace.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Control de Calidad
/
Rifampin
/
Antibióticos Antituberculosos
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Int J Tuberc Lung Dis
Año:
2005
Tipo del documento:
Article
País de afiliación:
India