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Table 1 Target product profile of developed ASAQ formulation

From: The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership

Attribute

Target product characteristics

API

AS and AQ

Population targeted

pediatric and adult

Posology

based on [7]

ASAQ low strength 25/67.5 mg (equivalent AQ base) for children

ASAQ high strength 100/270 mg (equivalent AQ base) for older children and adults

Drug release

rapid disintegration and fast drug release (> 75% in 45 minutes in vitro dissolution test, Pharmacopoeia standards)

Drug form

compatible with pediatric use: minimal size for facilitating swallowing; a fixed dose combination

Stability/Conditioning

compatible with climatic zone IV (tropical conditions): ICH Q1A(R2)

Cost

< 1$