Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach.

In this paper, we provide a roadmap for the regulatory approval of one of the exciting and dynamic drug delivery fields, microneedles, by using a Quality by Design (QbD) approach to pharmaceutical product development. In this regard, a quality target product profile (QTPP) and the critical quality attributes (CQA) of microneedles are identified. We discuss a case study of our recently patented method of fabricating glass microneedles entirely from a therapeutic agent, thus eliminating the requirement for additional excipients. 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 characterisation 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. This article is protected by copyright. All rights reserved.