title: Stability of Dihydroartemisinin-Piperaquine Tablet Halves During Prolonged Storage Under Tropical Conditions.
abstract: Dihydroartemisinin-piperaquine (DP) is recommended for the treatment of uncomplicated malaria, used in efforts to contain artemisinin resistance, and increasingly considered for mass drug administration. Because of the narrow therapeutic dose range and available tablet strengths, the manufacturers and World Health Organization recommended regimens involve breaking tablets into halves to accurately dose children according to body weight. Use of tablet fractions in programmatic settings under tropical conditions requires a highly stable product; however, the stability of DP tablet fractions is unknown. We aged full and half DP (Eurartesim®) tablets in a stability chamber at 30°C and 70% humidity level. The active pharmaceutical ingredients dihydroartemisinin and piperaquine remained at ≥ 95% over the 3 months' period of ageing in light and darkness. These findings are reassuring for DP, but highlight the need to assess drug stability under real-life settings during the drug development process, particularly for key drugs of global disease control programs.
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, United Kingdom.|Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Hodel
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.affiliation: Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.|Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
authors.forename: Dianne J
authors.initials: DJ
authors.lastname: Terlouw
mesh_terms: D000962:Antimalarials / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D037621:Artemisinins / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D004338:Drug Combinations; D004355:Drug Stability; D004356:Drug Storage / Q000706:statistics & numerical data; D006801:Humans; D011804:Quinolines / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D013607:Tablets; D013997:Time Factors; D014329:Tropical Climate; D010879:Piperazines
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D011804:Quinolines; D013607:Tablets; C039060:artenimol; C034759:piperaquine; D010879:Piperazines