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|a 10.1002/adma.202305834
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|a eng
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|a Sartawi, Ziad
|e verfasserin
|4 aut
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|a Glass Microneedles
|b A Case Study for Regulatory Approval Using a Quality by Design Approach
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|c 2023
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|a Text
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|a Date Completed 28.12.2023
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|a Date Revised 28.12.2023
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|a published: Print-Electronic
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|a Citation Status MEDLINE
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|a © 2023 The Authors. Advanced Materials published by Wiley-VCH GmbH.
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|a 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
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|a critical quality attributes
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|a microneedles
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|a quality by design
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|a quality target product profile
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|a regulatory approval
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|a Pharmaceutical Preparations
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|a Blackshields, Caroline
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|a Crean, Abina
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|a Devine, Ken
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|a Elkhashab, Mohamed
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|a Aldejohann, Alexander Maximilian
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