Instability of lopinavir/ritonavir capsules at ambient temperatures in sub-Saharan Africa: relevance to WHO antiretroviral guidelines.
WHO recommends lopinavir/ritonavir as an antiretroviral option in resource-limited countries. Lopinavir/ritonavir is recommended to be stored at 2-8 degrees C until dispensing, and afterwards, may be kept at < or = 25 degrees C for < or = 2 months. Anticipating lopinavir/ritonavir use in countries lacking adequate cold-chains, we assessed its physical and chemical stability at 35 and 45 degrees C. Although maintaining chemical stability for 4 weeks at 35 degrees C, at 45 degrees C the capsules clumped after 7 days, supporting a need for more temperature-stable formulations for hotter climates.
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Alice K
AK
Pau
Neelambal K
NK
Moodley
Diane T
DT
Holland
Henry
H
Fomundam
Gugu U
GU
Matchaba
Edmund V
EV
Capparelli
D017954:Africa South of the Sahara; D019380:Anti-HIV Agents / Q000737:chemistry*; D002214:Capsules; D004356:Drug Storage; D017320:HIV Protease Inhibitors / Q000737:chemistry*; D061466:Lopinavir; D017410:Practice Guidelines as Topic; D011744:Pyrimidinones / Q000737:chemistry*; D019438:Ritonavir / Q000737:chemistry*; D013696:Temperature; D014944:World Health Organization
D019380:Anti-HIV Agents; D002214:Capsules; D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D061466:Lopinavir; D019438:Ritonavir