Formulation Study of a Poly(amino methacrylate) Film-Forming Solution for Transdermal Administration

Background/Objectives: The objective of this paper is to design a novel film-forming system (FFS) based on Eudragit<sup>®</sup> E PO (EuE) polymeric solutions, differing in volatile solvents (i.e., isopropanol and ethanol) and plasticizers (i.e., tributylcitrate, glycerine, triacetin and...

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Main Authors: Chiara G. M. Gennari, Antonella Casiraghi, Francesca Selmin, Francesco Cilurzo
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Pharmaceutics
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Online Access:https://www.mdpi.com/1999-4923/17/1/88
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Summary:Background/Objectives: The objective of this paper is to design a novel film-forming system (FFS) based on Eudragit<sup>®</sup> E PO (EuE) polymeric solutions, differing in volatile solvents (i.e., isopropanol and ethanol) and plasticizers (i.e., tributylcitrate, glycerine, triacetin and PEG 400). Methods: The physicochemical and mechanical properties of the FFS and dried films were evaluated in terms of formation time, stickiness, T<sub>g</sub>, tensile strength, break elongation and Young’s modulus. The in vitro skin permeation studies were conducted on formulations containing caffeine and testosterone. Results: The FFS, consisting of EuE and PEG400 in isopropyl alcohol and ethanol (80:20, <i>v</i>/<i>v</i>), exhibited rapid film formation within about 5 min and the dried film allowed a high skin permeability compared to other formulations due to the ability to increase the thermodynamic activity of both drugs. When triiodothyronine (T3) was loaded as a model of a very low soluble drug, tocopherol polyethylene glycol succinate (TPGS) was added as a co-solvent and it allowed for the improvement of T3 retention in the skin. Conclusions: Among the formulative variables, the nature and the amount of plasticizer represent the most critical variables to obtain an EuE-based film with satisfying physical and biopharmaceutical properties.
ISSN:1999-4923