(303f) The Transdermal Delivery of Biologics Using 3M's Microstructed Transdermal System (MTS)

3M’s microstructured transdermal system (MTS) is a delivery system that enables the transdermal delivery of therapeutic proteins, vaccines, and monoclonal antibodies.  The MTS delivery system is composed of either solid or hollow microneedles.  The solid microneedles (sMTS) are composed of 300 to 1200 microneedles that range in height from ~200 to 700 microns.  These solid microstructures can be coated with a therapeutic dose of up to ~500µg of an active pharmaceutical ingredient (API).  The hollow microneedles (hMTS) are composed of 18 hollow microstructures that are about 900 microns in height and can be used to deliver up to 2mL of a concentrated API solution to a patient.  The delivery method works by forcing the microstructures through the stratum corneum of the skin, the main barrier to transdermal delivery of large molecules.  Once below the stratum corneum the API is either dissolved off of the microstructures or infused into the patient.  This work will highlight 3M’s ability to deliver ~500µg of API from the sMTS system and up to 2mL of API formulations with hMTS, using the Yorkshire swine as an in vivo model.  A variety of proteins and vaccines were investigated including bovine serum albumin, ovalbumin, lysozyme, human growth hormone (hGH) and each will be discussed.  Greater than 80% of the API that is coated onto the sMTS system was delivered within a wear time of 15 minutes or less and 2mL of API solution could be delivered within 1.5-15 minutes of application of the hMTS device, depending on the formulation.  Both MTS  platforms leverage the therapeutic benefits of intradermal delivery of biologics, including dose sparing delivery of vaccines and the more rapid and complete uptake of large molecule APIs following intradermal delivery.