CorMedix Inc. — Department of Health and Human Services SBIR Phase I: 300

Description

ABSTRACT Burn injury care has improved in the past decadesbut complications still occur and lead to prolonged hospital stays and potentially to deathThe risk of infection rises as a result of burns since the skin layerswhich function as a barrier and prevent pathogens from accessing the susceptible body tissuesare no longer intactImportantlyinfections involving gram negative or gram positive pathogens are still the most common cause of mortality in burn injury patientsAlthough topical treatments existthere is a need for an antiseptic that can effectively penetrate to the site of infection and that can be used for treatment of pathogens found in medical facilitiesTo address this needCorMedix proposes to develop a combination of taurolidine encased in digestible nanosystems as topical treatment at burn sitesThis proposed gel formulation will be administered to the skin surface and will penetrate through to the epidermal dermal junction at which it will be digested by local tissue enzymesreleasing taurolidinea taurine amino acid derivative with broad antibacterial action against gram positive and gram negative bacteriamycobacteria and some clinically relevant fungiCorMedixandapos s proposed product will combine the proven antiseptic capabilities of taurolidine with effective delivery to the site of infectionallowing prevention and treatment of infections including those caused by pathogens that have already been found to be resistant to currently used antisepticsCorMedix will develop this proposed product and demonstrate successful penetration of taurolidine to the site of infection through two Specific AimsIn Specific Aima gel formulation with taurolidine containing nanoparticles will be developed bySelection of a buffer that facilitates taurolidine stability during the nanosystem manufacturing processSelection of material for nanosystem surfaceTesting of nanosystem susceptibility to subcutaneous tissue enzymesandSelection of gel matrix for suspension of nanoparticlesIn Specific Aimthe developed formulation will be tested in vitro using a Franz cells model NARRATIVE Burn injury care has improved in the past decadesbut complications including bacterial infections still occur and lead to longer hospital stays and potentially to deathTo address this needCorMedix proposes to develop a topical treatment that will allow delivery of taurolidinea proven antisepticto deeper layers of the skin at burn sites