Tapered conical polymer microneedles fabricated using an integrated lens technique for transdermal drug delivery

Administration of protein and DNA biotherapeutics is limited by the need for hypodermic injection. Use of micron-scale needles to deliver drugs in a minimally invasive manner provides an attractive alternative, but application of this approach is limited by the need for suitable microneedle designs and fabrication methods. To address this need, this paper presents a conical polymer microneedle design that is fabricated using a novel integrated lens technique and analyzed for its ability to insert into the skin without mechanical failure. Microneedle master structures were fabricated using microlenses etched into a glass substrate that focused light through SU-8 negative epoxy resist to produce sharply tapered structures. Microneedle replicates were fabricated out of biodegradable polymers by micromolding. Because microneedle mechanical properties are critical to their insertion into the skin, we theoretically modeled two failure modes (axial mode and transverse mode), and analytical models were compared with measured data showing general agreement. Guided by this analysis, polymer microneedles were designed and demonstrated to insert to different depths into porcine skin in vitro. "Long" polymer microneedles were also demonstrated in human subjects to insert deeply without failure.