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Rheological Characterization of Ethylcellulose-Based Melts for Pharmaceutical Applications

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ABSTRACT

Rheological characterization of ethylcellulose (EC)-based melts intended for the production, via micro-injection moulding (μIM), of oral capsular devices for prolonged release was carried out. Neat EC, plasticized EC and plasticized EC containing solid particles of a release modifier (filler volume content in the melt around 30%) were examined by capillary and rotational rheometry tests. Two release modifiers, differing in both chemical nature and particle geometry, were investigated. When studied by capillary rheometry, neat EC appeared at process temperatures as a highly viscous melt with a shear-thinning characteristic that progressively diminished as the apparent shear rate increased. Thus, EC as such could not successfully be processed via μIM. Plasticization, which induces changes in the material microstructure, enhanced the shear-thinning characteristic of the melt and reduced considerably its elastic properties. Marked wall slip effects were noticed in the capillary flow of the plasticized EC-based melts, with or without release modifier particles. The presence of these particles brought about an increase in viscosity, clearly highlighted by the dynamic experiments at the rotational rheometer. However, it did not impair the material processability. The thermal and rheological study undertaken would turn out a valid guideline for the development of polymeric materials based on pharma-grade polymers with potential for new pharmaceutical applications of μIM.

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ACKNOWLEDGMENTS

The authors are grateful to ITW Test and Measurement Italia S.r.l.—Instron CEAST Division (Pianezza, Torino, Italy) for the capillary rheometer kindly placed at authors’ disposal; Ms. I. Peroni and Ms. G. Spagnoli of Dipartimento di Ingegneria Meccanica e Industriale of Università degli Studi di Brescia (Italy) for the contribution to the preparation of the materials and for the DSC analyses kindly performed; and Ms. V. Ferrari of Dipartimento di Ingegneria Meccanica e Industriale of Università degli Studi di Brescia (Italy) for the SEM analyses kindly performed.

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Authors and Affiliations

  1. Dipartimento di Ingegneria Meccanica e Industriale, Università degli Studi di Brescia, Brescia, Italy

    Francesco Baldi, Juri Ragnoli, Davide Zinesi & Fabio Bignotti

  2. Dipartimento di Chimica, Materiali e Ingegneria Chimica “G. Natta”, Politecnico di Milano, Milano, Italy

    Francesco Briatico-Vangosa

  3. Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche “Maria Edvige Sangalli”, Università degli Studi di Milano, Via G. Colombo 71, I-20133, Milano, Italy

    Federica Casati, Giulia Loreti, Alice Melocchi & Lucia Zema

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  1. Francesco Baldi
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  2. Juri Ragnoli
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  3. Davide Zinesi
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  7. Giulia Loreti
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  8. Alice Melocchi
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  9. Lucia Zema
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Correspondence to Lucia Zema.

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Baldi, F., Ragnoli, J., Zinesi, D. et al. Rheological Characterization of Ethylcellulose-Based Melts for Pharmaceutical Applications. AAPS PharmSciTech 18, 855–866 (2017). https://doi.org/10.1208/s12249-016-0577-0

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  • DOI: https://doi.org/10.1208/s12249-016-0577-0

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