Table 1.
Target product profile of developed ASAQ formulation
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$ |