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

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

© 2023 The Authors. Advanced Materials published by Wiley-VCH GmbH.

Bibliographische Detailangaben
Veröffentlicht in:Advanced materials (Deerfield Beach, Fla.). - 1998. - 35(2023), 52 vom: 22. Dez., Seite e2305834
1. Verfasser: Sartawi, Ziad (VerfasserIn)
Weitere Verfasser: Blackshields, Caroline, Ariamanesh, Arefe, Farag, Fatma Fawzy, Griffin, Brendan, Crean, Abina, Devine, Ken, Elkhashab, Mohamed, Aldejohann, Alexander Maximilian, Kurzai, Oliver, Faisal, Waleed
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2023
Zugriff auf das übergeordnete Werk:Advanced materials (Deerfield Beach, Fla.)
Schlagworte:Video-Audio Media Journal Article critical quality attributes microneedles quality by design quality target product profile regulatory approval Pharmaceutical Preparations
Beschreibung
Zusammenfassung:© 2023 The Authors. Advanced Materials published by Wiley-VCH GmbH.
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
Beschreibung:Date Completed 28.12.2023
Date Revised 02.01.2024
published: Print-Electronic
Citation Status MEDLINE
ISSN:1521-4095
DOI:10.1002/adma.202305834