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Evaluation of Rosin Gum and Eudragit® RS PO as a Functional Film Coating Material

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Abstract

Polymers are essential tools in the research and development of new therapeutic devices. The diversity and flexibility of these materials have generated high expectations in the composition of new materials with extraordinary abilities, especially in the design of new systems for the modified release of pharmaceutically active ingredients. The natural polymer rosin features moisture protection and pH-dependent behavior (i.e., it is sensitive to pH > 7.0), suggesting its possible use in pharmaceutical systems. The synthetic polymer Eudragit® RS PO is a low-permeability material, the disintegration of which depends on the time of residence in the gastrointestinal tract. The present study developed a polymeric material with desirable physicochemical characteristics and synergistic effects that resulted from the inherent properties of the associated polymers. Isolated films were obtained by solvent evaporation and subjected to a water vapor transmission test, scanning electron microscopy, calorimetry, Fourier transform-infrared (FT-IR) spectroscopy, micro-Raman spectroscopy, and mechanical analysis. The new polymeric material was macroscopically continuous and homogeneous, was appropriately flexible, had low water permeability, was vulnerable in alkaline environments, and was thermally stable, maintaining an unchanged structure up to temperatures of ∼400°C. The new material also presented potentially suitable characteristics for application in film coatings for oral solids, suggesting that it is capable of carrying therapeutic substances to distal regions of the gastrointestinal tract. These findings indicate that this new material may be added to the list of functional excipients.

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ACKNOWLEDGEMENTS

Suélen Plaza Pomin would like to thank the financial support of CAPES and support of PCF-UEM and also acknowledges Socer Brasil for donating the rosin gum sample. Osvaldo Albuquerque Cavalcanti thanks to PPG-UEM (Research Project 9113/2015).

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Authors and Affiliations

  1. Postgraduate in Pharmaceutical Sciences, State University of Maringá, Colombo Avenue, 5790, Maringá, PR, CEP 87020-900, Brazil

    Suélen Plaza Pomin

  2. Departament of Pharmacy, Laboratory of Pharmaceutical Nanotechnology, Midwestern State University/UNICENTRO, Guarapuava, PR, Brazil

    Isabela Angeli de Lima

  3. Department of Physics, State University of Maringá, Maringá, PR, Brazil

    Rogério Ribeiro Pezarini

  4. Department of Pharmacology and Therapeutics, State University of Maringá, Maringá, PR, Brazil

    Osvaldo Albuquerque Cavalcanti

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  1. Suélen Plaza Pomin
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  2. Isabela Angeli de Lima
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  3. Rogério Ribeiro Pezarini
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  4. Osvaldo Albuquerque Cavalcanti
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Correspondence to Suélen Plaza Pomin.

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Pomin, S.P., de Lima, I.A., Pezarini, R.R. et al. Evaluation of Rosin Gum and Eudragit® RS PO as a Functional Film Coating Material. AAPS PharmSciTech 18, 2854–2861 (2017). https://doi.org/10.1208/s12249-017-0766-5

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  • DOI: https://doi.org/10.1208/s12249-017-0766-5

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