Review on Transdermal Patches: Optimization in Drug Administration
Keywords:
Transdermal Patches, Drug Delivery Systems, Cutaneous, Bioequivalence, Bioavailability, AdhesivesArticle Sidebar
Main Article Content
Objectives: To synthesize technical, clinical, and regulatory knowledge on transdermal patches and identify persistent gaps affecting safe and effective use.
Data sources: PubMed, Scopus, ScienceDirect, and Google Scholar; regulatory agency websites (FDA, EMA, ANVISA, INVIMA); and official pharmacopoeial and methodological sources (USP–NF, European Pharmacopoeia, OECD). English, Spanish, and Portuguese sources were considered, with no a priori time restriction. Last update: September 9, 2025.
Selection methods: Narrative approach including published reviews, relevant primary studies, official regulatory guidances/Q&A, and pharmacopoeial standards related to design, release/permeation, bioavailability/bioequivalence, adhesion, and regulatory frameworks. Non-authoritative or commercial webpages and duplicates were excluded, with priority given to official and peer-reviewed sources.
Results: Transdermal systems offer sustained delivery and adherence benefits, but their performance is constrained by biological variability, patient misuse, and fragmented regulatory requirements. Adhesion remains a critical quality attribute with heterogeneous test methods and limited alignment between in vitro metrics and clinical outcomes.
Conclusions: Stronger harmonization of adhesion and bioequivalence standards, together with patient education and testing under real-life stress conditions, is required to ensure the quality, safety, and interchangeability of innovator and generic transdermal products.
Juan José Sarmiento Giraldo, Universidad ICESI
https://orcid.org/0009-0006-4995-0199
Pharmaceutical Chemistry, Universidad Icesi
Julian A. Gonzalez, Universidad Icesi
https://orcid.org/0000-0001-8668-3452
Pharmaceutical chemist, MSc Pharmaceutical Sciences, PhD Biomedical sciences
Head of the Department of Pharmaceutical, Biomedical and Veterinary Sciences Universidad Icesi
Francisco Moncada Cardona, Icesi University
https://orcid.org/0009-0005-7738-9813
Pharmaceutical chemistry Universidad ICESI
Ana Maria Calad, Freelance
https://orcid.org/0009-0007-6100-4338
Pharmacuetical Chemistry, Universidad de Antioquia
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