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Glass Microneedles: A Case Study for Regulatory Approval Using a Quality by Design Approach
Ziad Sartawi1, Caroline Blackshields1, Arefe Ariamanesh1
1School of Pharmacy, University College Cork, Cork, T12 K8AF, Ireland.
Advanced Materials (Deerfield Beach, Fla.)
|November 11, 2023
Summary
This study outlines regulatory approval for microneedle drug delivery using Quality by Design. A novel 100% drug microneedle, ArrayPatch, shows promise for effective local delivery and improved pharmacokinetics.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Microneedle technology offers a promising avenue for drug delivery, enabling transdermal administration of therapeutics.
- A Quality by Design (QbD) approach is crucial for navigating the regulatory landscape of novel drug delivery systems.
- The development of microneedles fabricated entirely from the therapeutic agent eliminates the need for excipients, simplifying formulation and potentially enhancing safety.
Discussion:
- The ArrayPatch, a proprietary wearable device, utilizes dissolvable microneedles made of 100% drug for localized therapeutic delivery.
- Characterization of microneedle critical quality attributes (CQAs) under World Health Organization (WHO)-guided stability conditions is essential for assessing manufacturing readiness.
- In vivo pharmacokinetic studies comparing ArrayPatch to standard-of-care products provide valuable data for regulatory evaluation.
Key Insights:
- Identification of a Quality Target Product Profile (QTPP) and critical quality attributes (CQAs) specific to microneedle drug delivery systems.
- Demonstration of a novel fabrication method for drug-only microneedles, exemplified by the ArrayPatch technology.
- Establishment of a roadmap for regulatory approval by integrating QbD principles with comprehensive in vitro and in vivo characterization.
Outlook:
- The ArrayPatch presents a platform technology with potential for various therapeutic applications requiring localized drug delivery.
- Further research and development are expected to refine microneedle manufacturing processes and expand their clinical utility.
- Successful regulatory approval of ArrayPatch could pave the way for wider adoption of advanced microneedle drug delivery systems.
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