A Long-Term Anti-Malaria Drug-Releasing Implant

The U.S. Army routinely deploys personnel in malaria-endemic regions as part of normal operations. Preventative measures to malaria infection include a highly-effective daily oral prophylactic antibiotic which is provided to personnel prior to deployment. However, due to side effects including nausea and photosensitivity coupled with organizational culture, poor adherence to the prescribed regimen is common. The U.S. Army seeks the development of a novel polymer implant that can be loaded with FDA-approved malarial chemoprophylaxis antibiotics. This implant should be implanted subcutaneously and release its antibiotic payload into the surrounding tissue through dissolution-controlled diffusion resulting in passive tissue absorption to maintain a steady prophylactic blood level for up to 12 months. This solution will provide safe and non-toxic delivery of doxycycline or Malarone to the affected personnel with demonstrated zero-order release kinetics. Furthermore, initial technology development will enable feasibility studies of scaled-up manufacturing for subsequent testing and marketability. Phase II efforts will focus on developing a working prototype, validating the prototype efficacy using pre-clinical animal models, and developing packaging and application components to augment use at a Role 3 facility. This innovative technology will provide a rapid improvement in malaria prophylaxis for U.S. Army personnel.