Fixed artesunate-amodiaquine combined pre-formulation study for the treatment of malaria.
Int J Pharm
; 2010 Jun 01.
Article
en En
| MEDLINE
| ID: mdl-20685236
ABSTRACT
Artemisinin-based combination therapies, including artesunate (AS)+amodiaquine (AQ), are the currently recommended first-line treatment of uncomplicated falciparum malaria. Fixed-dose co-formulations offer logistic and adherence advantages. This paper reports the initial research phase of the pre-development process of an AS-AQ formulation, further developed by the Drug for Neglected Diseases Initiative (DNDi). Results demonstrate that AS and AQ are not compatible, and AS degradation is related to three main parameters water content (>1%), elevated temperature (80 degrees C in dry condition) and possibly the 4-aminoquinoline moiety. Furthermore, AS and AQ incompatibility led to AS degradation and pharmaco-technical changes in classical wet granulation tablets. Both active principles are stable as dry powders. These investigations led to further development of various co-formulations, including the bilayer tablet currently on the market.
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Colección:
01-internacional
Base de datos:
MEDLINE
Idioma:
En
Revista:
Int J Pharm
Año:
2010
Tipo del documento:
Article
País de afiliación:
Francia