National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
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.