Impact of Monomer Selection and Behavior on Transdermal Drug Delivery Systems: Regulatory and Formulation Perspectives

Fuente: Zenodo
Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: Piyush, Modi, Jigneshkumar, Modasiya, Dhaval, Desai
Format: Recurso digital
Sprache:Englisch
Veröffentlicht: Zenodo 2026
Schlagworte:
Online-Zugang:
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
_version_ 1866901055418138624
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