caa a22 4500 445311576 CHVBK 20180317142631.0 cr unu---uuuuu 170323e20110101xx s 000 0 eng 10.1007/s11095-010-0174-y doi (NATIONALLICENCE)springer-10.1007/s11095-010-0174-y Transdermal Delivery of Macromolecules Using Solid-State Biodegradable Microstructures [Elektronische Daten] [Janet Wendorf, Esi Ghartey-Tagoe, Stephen Williams, Elena Enioutina, Parminder Singh, Gary Cleary] ABSTRACT: Purpose: The purpose of this work is to demonstrate the feasibility of using a proprietary technology called MicroCor™, based on solid-state, biodegradable microstructures (SSBMS), for transdermal delivery of macromolecules. Methods: The proteins FITC-BSA (66kDa) and recombinant protective antigen (rPA; 83kDa) were incorporated into SSBMS arrays using a mold-based, liquid formulation casting and drying process. Arrays were applied to the skin with a custom applicator and then inspected to assess the extent of microstructure dissolution. In vitro FITC-BSA delivery to human cadaver skin was visualized using light and fluorescence microscopy and quantified by extracting and measuring the fluorescently labeled protein. rPA-containing SSBMS arrays were applied in vivo to Sprague-Dawley rats. The resulting serum IgG response was measured by ELISA and compared with responses elicited from intramuscular (IM) and intradermal (ID) routes of administration. Results: FITC-BSA and rPA SSBMS arrays successfully penetrated the skin. Microstructure dissolution was observed over >95% of the array area and >75% of the microstructure length. FITC-BSA delivery correlated with protein content in the formulations. Antibody titers after transdermal delivery of rPA were comparable or higher than IM and ID titers. Conclusions: Transdermal delivery of macromolecules can be conveniently and effectively accomplished using the MicroCor technology. Springer Science+Business Media, LLC, 2010 rPA nationallicence vaccine nationallicence transdermal nationallicence macromolecules nationallicence solid state biodegradable microstructures nationallicence SSBMS : solid-state biodegradable microstructures nationallicence FITC-BSA : fluorescein isothiocyanate—bovine serum albumin nationallicence rPA : recombinant protective antigen (ex. Bacillus anthracis) nationallicence ID : intradermal nationallicence IM : intramuscular nationallicence IgG : immunoglobulin G nationallicence PET : polyethylene terephthalate nationallicence Wendorf Janet Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut Ghartey-Tagoe Esi Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut Williams Stephen Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut Enioutina Elena Department of Pathology, University of Utah School of Medicine, 84132, Salt Lake City, Utah, USA aut Singh Parminder Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut Cleary Gary Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/1(2011-01-01), 22-30 0724-8741 28:1<22 2011 28 11095 https://doi.org/10.1007/s11095-010-0174-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0174-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Wendorf Janet Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut NATIONALLICENCE 700 1- Ghartey-Tagoe Esi Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut NATIONALLICENCE 700 1- Williams Stephen Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut NATIONALLICENCE 700 1- Enioutina Elena Department of Pathology, University of Utah School of Medicine, 84132, Salt Lake City, Utah, USA aut NATIONALLICENCE 700 1- Singh Parminder Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut NATIONALLICENCE 700 1- Cleary Gary Corium International, Inc., 235 Constitution Drive, 94025, Menlo Park, California, USA aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/1(2011-01-01), 22-30 0724-8741 28:1<22 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer