Impact of Monomer Selection and Behavior on Transdermal Drug Delivery Systems: Regulatory and Formulation Perspectives
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| Format: | Recurso digital |
| Sprache: | Englisch |
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2026
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| _version_ | 1866901055418138624 |
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| author | Piyush, Modi Jigneshkumar, Modasiya Dhaval, Desai |
| author_facet | Piyush, Modi Jigneshkumar, Modasiya Dhaval, Desai |
| contents | <p>This review article provides a comprehensive overview of the main monomers used in transdermal drug<br>delivery systems (TDDS), such as acrylates, methacrylates, polyethylene glycol acrylates, crosslinking<br>monomers, and specialty monomers. It examines their impact on key quality attributes (critical quality<br>attributes), including drug release kinetics, adhesion-cohesion balance, mechanical strength, and stability<br>under thermal and humidity stress. The article also summarizes Food and Drug Administration and<br>European Medicines Agency requirements for monomer characterization in regulatory submissions, details<br>analytical techniques for measuring residual monomers and analyzing the resulting polymers, and<br>highlights recent developments in the regulatory landscape. Monomer selection is emphasized as a vital<br>scientific and regulatory factor that influences TDDS quality, performance, and patient safety.</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_7759_cureus_104819 |
| institution | Zenodo |
| language | eng |
| publishDate | 2026 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Impact of Monomer Selection and Behavior on Transdermal Drug Delivery Systems: Regulatory and Formulation Perspectives Piyush, Modi Jigneshkumar, Modasiya Dhaval, Desai Transdermal Patch acrylic and methacrylate adhesives critical quality attributes monomers, Polymer chemistry, polymer-drug interactions regulatory expectations residual monomers transdermal drug delivery system <p>This review article provides a comprehensive overview of the main monomers used in transdermal drug<br>delivery systems (TDDS), such as acrylates, methacrylates, polyethylene glycol acrylates, crosslinking<br>monomers, and specialty monomers. It examines their impact on key quality attributes (critical quality<br>attributes), including drug release kinetics, adhesion-cohesion balance, mechanical strength, and stability<br>under thermal and humidity stress. The article also summarizes Food and Drug Administration and<br>European Medicines Agency requirements for monomer characterization in regulatory submissions, details<br>analytical techniques for measuring residual monomers and analyzing the resulting polymers, and<br>highlights recent developments in the regulatory landscape. Monomer selection is emphasized as a vital<br>scientific and regulatory factor that influences TDDS quality, performance, and patient safety.</p> |
| title | Impact of Monomer Selection and Behavior on Transdermal Drug Delivery Systems: Regulatory and Formulation Perspectives |
| topic | Transdermal Patch acrylic and methacrylate adhesives critical quality attributes monomers, Polymer chemistry, polymer-drug interactions regulatory expectations residual monomers transdermal drug delivery system |
| url | https://doi.org/10.7759/cureus.104819 |