This Small Business Innovation Research (SBIR)Phase I project proposes to test the feasibility of extended delivery of ciprofloxacin from a novel lipid drug delivery vehicle : the vesosome. Ciprofloxacin is a valuable antibiotic whose therapeutic index would be enhanced with an extended release vehicle. Ciprofloxacin remains stably encapsulated in conventional unilamellar liposomes during storage in buffer. However, ciprofloxacin is known to leak rapidly from conventional liposomes in vivo, even with optimized compositions, which limits the therapeutic benefits. This difference is believed to be due to membrane degradation by macromolecular serum components. Hence, fundamental stability advantages are expected in vivo with a multi-membrane vesosome. In this Phase I project, ciprofloxacin will be loaded into vesosomes by standard chemical gradient techniques and the formulation efficiency, stability during storage, and release rates (in serum) will be measured. If performance is found to be superior to optimized unilamellar liposomes, clinical development of vesosomal ciprofloxacin would follow. The commercial application of this project will be in the area of drug delivery, particularly for delivery of ciprofloxacin. Therapeutic indications would include critical blood-borne infections, lung infections, and localized infections
