TY - JOUR
T1 - Glass Microneedles
T2 - A Case Study for Regulatory Approval Using a Quality by Design Approach
AU - Sartawi, Ziad
AU - Blackshields, Caroline
AU - Ariamanesh, Arefe
AU - Farag, Fatma Fawzy
AU - Griffin, Brendan
AU - Crean, Abina
AU - Devine, Ken
AU - Elkhashab, Mohamed
AU - Aldejohann, Alexander Maximilian
AU - Kurzai, Oliver
AU - Faisal, Waleed
N1 - Publisher Copyright:
© 2023 The Authors. Advanced Materials published by Wiley-VCH GmbH.
PY - 2023/12/27
Y1 - 2023/12/27
N2 - 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.
AB - 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.
KW - critical quality attributes
KW - microneedles
KW - quality by design
KW - quality target product profile
KW - regulatory approval
UR - https://www.scopus.com/pages/publications/85177420506
U2 - 10.1002/adma.202305834
DO - 10.1002/adma.202305834
M3 - Article
C2 - 37950607
AN - SCOPUS:85177420506
SN - 0935-9648
VL - 35
JO - Advanced Materials
JF - Advanced Materials
IS - 52
M1 - 2305834
ER -
