Novel rotation-based spray-coating method extends release profile of dissolving microneedle arrays
Background
Microneedle arrays (MNAs) offer a minimally invasive route for delivering water-soluble active ingredients like peptides and proteins, bypassing the Stratum corneum with minimal pain and improved patient compliance. While dissolving microneedles (DMNAs) are promising, achieving an extended-release profile remains a significant challenge, often limited by carrier and API compatibility. Current immediate-release DMNAs necessitate frequent application, hindering their utility for therapies requiring sustained drug levels. Developing methods to control drug release from DMNAs is crucial for expanding their therapeutic applications, particularly for chronic conditions or those requiring prolonged systemic exposure. This gap highlights the need for innovative coating techniques to modulate release kinetics.
Study Design
Researchers developed a novel rotation-based spray-coating method to modify the release profile of dissolving microneedle array (DMNA) cores. The DMNAs contained fluorescein isothiocyanate-labelled bovine serum albumin (FITC-BSA), a model protein, as the active ingredient. For the coating material, the pH-independent methacrylate polymer, Eudragit RS, was utilized. The study employed various analytical techniques including microscopic and Raman mapping experiments to assess coating uniformity. Texture analysis and mechanical penetration studies were conducted to confirm successful skin penetration. Finally, dissolution and ex vivo permeation studies were performed to verify the extended-release profile achieved by the coating layer.
Results
The novel rotation-based spray-coating technique successfully produced uniformly coated dissolving microneedle arrays.
Microscopic and
Raman mappingexperiments unequivocally demonstrated the coating's uniformity across the DMNA surface, indicating precise control over the application process. Furthermore,texture analysisandmechanical penetration studiesconfirmed the robust mechanical integrity of the coated DMNAs, verifying their ability to successfully penetrate the skin barrier. Crucially, subsequentdissolutionandex vivo permeation studiesprovided clear evidence that the applied Eudragit RS coating layer effectively extends the release profile of the model protein FITC-BSA. This modification transformed the immediate-release characteristics of the DMNAs into a sustained-release system, a critical advancement for therapeutic delivery.
Key Findings
- Novel rotation-based spray-coating method uniformly coats dissolving microneedle arrays.
- Coated DMNAs successfully penetrate the skin barrier.
- Eudragit RS coating layer extends the release profile of model protein FITC-BSA.
- Method offers a promising foundation for extended-release or drug-in-coating MNAs.
Why It Matters
This innovative coating method represents a significant step towards developing next-generation microneedle arrays capable of sustained drug delivery. For peptide users and clinicians, this could mean less frequent dosing and improved patient compliance for therapies currently requiring multiple daily injections or patches. The ability to precisely control release kinetics opens doors for delivering sensitive biologics like peptides and proteins over extended periods, potentially reducing systemic fluctuations and enhancing therapeutic efficacy. While currently a foundational research finding, this technique could pave the way for clinically translatable extended-release DMNA products, moving beyond immediate-release limitations. Future protocols might involve pre-coated DMNAs for specific peptides, optimizing release for chronic conditions.
microneedle-arrays
drug-delivery
extended-release
protein-delivery
coating-method
in-vitro