(189t) Once Weekly Oral Ivermectin for Prevention of Malaria Transmission in Zone IVb

In regions where malaria is endemic, there is an unmet need for malaria vector control. Insecticide treated nets (ITN) have provided significant reduction in malaria transmission [1] but are only effective when users are physically confined in the nets. Oral ivermectin administration has been proposed as a method to provide vector control outside of nets.

Malaria is most prevalent in sub-Saharan Africa, where temperature and humidity are high. ICH classifies the region as zone IVb and defines long term storage condition as 30°C with 75% relative humidity (RH) [2]. Moreover, US military has shown that shipping crates being transported to zone IVb region in Panama have recorded temperatures as high as 57°C. To provide ivermectin for prevention of malaria transmission in sub-Saharan Africa without cold chain storage, ivermectin oral medications should have stable performance after exposure to 60°C.

An oral ultra-long acting dosage form developed by Lyndra Therapeutics incorporates polycaprolactone (PCL) to deliver ivermectin for 14 days via gastric retention [3]. In this study, gastric resident ivermectin formulations were evaluated for their stability to high temperature excursions. Formulations were exposed to 60°C for hours to days and tested for performance, including physical shape retention, in vitro drug release, drug purity, and in vivo pharmacokinetics (PK) in a dog model.

1. WHO. World Malaria Report 2017. ISBN 978 92 4 156552 3.
2. WHO Technical Report Series, No. 1010, 2018 Annex 10. ISBN 978-92-4-121019-5
3. Kanasty et al. A pharmaceutical answer to nonadherence: Once weekly oral memantine for Alzheimer’s disease. 2019. Journal of Controlled Release, doi https://doi.org/10.1016/j.jconrel.2019.03.022.