AccScience Publishing / IJB / Online First / DOI: 10.36922/ijb.3735
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RESEARCH ARTICLE

Development of novel skin-mimetic substrate with 3D printing to assess the adhesion properties of transdermal patches

Arvind Bagde1 ,  Keb Mosley-Kellum1 ,  Oluwaseyi Salau1 ,  Satyanarayan Dev2* ,  Nisarg Modi3 ,  Mandip Singh1*
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1 Pharmaceutical Sciences Department, Florida A&M University, Tallahassee, Florida, USA
2 Biological Systems Engineering, College of Agriculture and Food Sciences, Florida A&M University, Tallahassee, Florida, USA
3 Research and Development Department, Transdermal Research Pharm Laboratories, Inc., Long Island City, New York, USA
IJB 2024, 10(4), 3735 https://doi.org/10.36922/ijb.3735
Submitted: 22 May 2024 | Accepted: 14 June 2024 | Published: 13 August 2024
© 2024 by the Author(s).. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Transdermal system (TDS) patches, a long-standing product in the market, still grapple with issues of secure skin adherence, efficacy, and safety. Hence, there is a pressing need to study factors affecting TDS patch adhesion on skin-mimetic substrates to enhance reliability and reduce reliance on extensive in vivo testing. The present study aims to develop novel skin-mimetic substrates with fused deposition modeling (FDM)-based three-dimensional (3D) printing using materials with similar surface energy as the skin and evaluating the adhesion property of pressure-sensitive adhesives (PSAs). Additionally, the study investigates the effect of various intrinsic factors, including coat weight, elastic properties of backing membranes, and viscosity of PSAs, on the adhesion properties of PSAs. We successfully fabricated our novel polypropylene (PP) probe using FDM printing and implemented an automated robotic arm setup for adhesion testing. Probe tack test results displayed no significant difference in peak adhesive force between the skin and PP probes. However, PP probes exhibited a 10.26-fold decrease (p < 0.0001) in the adhesive force compared to stainless steel (SS) probes. Probe tack and peel adhesion tests of the marketed Salonpas patch also displayed a significant decrease (p < 0.0001) in the adhesive force for PP probes/plates compared to SS probes/plates. In terms of coating, both amine-compatible (PSA-4302) and non-amine-compatible (PSA-4501) silicone-based PSAs displayed a significant increase in their adhesion properties at 10 mg/cm2 compared to 5 mg/cm2 coating (p < 0.05). Furthermore, the selection of backing membrane and the viscosity of silicone-based PSAs also demonstrated a significant (p < 0.0001) effect on the PSA’s adhesion property. In conclusion, PP probes/plates could be a promising approach for in vitro adhesion testing of transdermal system (TDS) products. Furthermore, intrinsic properties, including coat weight and viscosity of silicone-based PSAs, could significantly affect the adhesion properties of TDS products.

Keywords
3D printing
Transdermal
Adhesion
Tack test
Peel adhesion
Skin-mimetic substrate
Funding
The research was supported by the National Institute on Minority Health and Health Disparities of the National Institutes of Health (grant number: U54 MD007582 [U54 RCMI grant]) and NSF-CREST Center for Complex Materials Design for Multidimensional Additive Processing (CoManD) (grant number: 1735968).
Conflict of interest
The authors declare they have no competing interests.
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International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing
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