Table 1.
Location of study | Formulation and manufacturer | Manufacture information |
---|---|---|
Forced degradation | ||
60°C oven (LSHTM) Study date October 2013 to December 2013 | Winthrop® (100 mg AS/270 mg AQ) Sanofi-Aventis Group, Maphar Laboratories, Morocco | Lot 5491 Expiry: May 2015 |
Coartem® (20 mg AM/120 mg LUM) Novartis, China | Lot X1607 Expiry: September 2014 | |
Waipa (30 mg DHA/225 mg PIP) Kunimed Pharmachem Ltd., Nigeria | Lot SFH08 Expiry: December 2013 | |
Natural aging | ||
Ghana (KHRC) Study date January 2011 to January 2014 | Winthrop® (100 mg AS/270 mg AQ) Sanofi-Aventis Group, Maphar Laboratories, Morocco | Lot 5186 Expiry: June 2012 |
Coartem® (20 mg AM/120 mg LUM) Novartis, China | Lot X1448 Expiry: December 2012 | |
Stability chamber (LSHTM) | Winthrop® (100 mg AS/270 mg AQ) Sanofi-Aventis Group, Maphar Laboratories, Morocco | Lot 5186 Expiry: June 2012 |
Coartem® (20 mg AM/120 mg LUM) Novartis, China | Lot X1448 Expiry: December 2012 |
AM = artemether; AS = artesunate; AQ = amodiaquine; DHA = dihydroartemisinin; KHRC = Kintampo Health Research Center; LSHTM = London School of Hygiene and Tropical Medicine; LUM = lumefantrine; PIP = piperaquine.