{Reference Type}: Video-Audio Media
{Title}: Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach.
{Author}: Sartawi Z;Blackshields C;Ariamanesh A;Farag FF;Griffin B;Crean A;Devine K;Elkhashab M;Aldejohann AM;Kurzai O;Faisal W;
{Journal}: Adv Mater
{Volume}: 35
{Issue}: 52
{Year}: 2023 Dec 11
{Factor}: 32.086
{DOI}: 10.1002/adma.202305834
{Abstract}: In this paper, a roadmap is provided for the regulatory approval of one of the exciting and dynamic drug delivery fields, microneedles, by using a Quality by Design approach to pharmaceutical product development. In this regard, a quality target product profile (QTPP) and the critical quality attributes (CQA) of microneedles are identified. A case study of the recently patented method of fabricating glass microneedles entirely from a therapeutic agent, thus eliminating the requirement for additional excipients is discussed. The glass microneedle, ArrayPatch, is a propriety wearable device with platform potential consisting of an array of sharp, but painless, dissolvable microneedles manufactured with 100% drug. The microneedles penetrate the skin on application and dissolve to deliver a locally effective dose. The in vitro characterization of the microneedle CQAs under WHO-guided stability conditions will be described to assess the manufacturing readiness of ArrayPatch.  A live technical video is also provided, presenting a unique procedure of jugular vein cannulation through the ear vein of a pig animal model to study the in vivo pharmacokinetics of ArrayPatch compared to standard-of-care marketed products.