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Industrial Development of a 3D-Printed Nutraceutical Delivery Platform in the Form of a Multicompartment HPC Capsule

  • Research Article
  • Theme: Printing and Additive Manufacturing
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Abstract

Following recent advances in nutrigenomics and nutrigenetics, as well as in view of the increasing use of nutraceuticals in combination with drug treatments, considerable attention is being directed to the composition, bioefficacy, and release performance of dietary supplements. Moreover, the interest in the possibility of having such products tailored to meet specific needs is fast growing among costumers. To fulfill these emerging market trends, 3D-printed capsular devices originally intended for conveyance and administration of drugs were proposed for delivery of dietary supplements. Being composed of separate inner compartments, such a device could yield customized combinations of substances, relevant doses, and release kinetics. In particular, the aim of this work was to face early-stage industrial development of the processes involved in fabrication of nutraceutical capsules for oral pulsatile delivery. A pilot plant for extrusion of filaments based on pharmaceutical-grade polymers and intended for 3D printing was set up, and studies aimed at demonstrating feasibility of fused deposition modeling in 3D printing of capsule shells according to Current Good Manufacturing Practices for dietary supplements were undertaken. In this respect, the stability of the starting material after hot processing and of the resulting items was investigated, and compliance of elemental and microbiological contaminants, as well as of by-products, with internal specifications was assessed. Finally, operating charts highlighting critical process variables and parameters that would serve as indices of both intermediate and final product quality were developed.

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Authors and Affiliations

  1. Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche “Maria Edvige Sangalli”, Università degli Studi di Milano, via G. Colombo 71, 20133, Milan, Italy

    Alice Melocchi, Alessandra Maroni, Andrea Gazzaniga & Lucia Zema

  2. Multiply Labs, 1760 Cesar Chavez Street Unit D, San Francisco, California, 94124, USA

    Alice Melocchi & Federico Parietti

  3. Gimac, Via Roma 5, 21040, Castronno, VA, Italy

    Simone Maccagnan

  4. Dipartimento di Chimica, Università degli Studi di Milano, via Golgi 19, 20133, Milan, Italy

    Marco Aldo Ortenzi & Stefano Antenucci

  5. LamPo, Dipartimento di Chimica, Università degli Studi di Milano, via Golgi 19, 20133, Milan, Italy

    Marco Aldo Ortenzi & Stefano Antenucci

  6. Dipartimento di Chimica, Materiali e Ingegneria Chimica “G. Natta”, Politecnico di Milano, piazza Leonardo da Vinci 32, 20133, Milan, Italy

    Francesco Briatico-Vangosa

Authors
  1. Alice Melocchi
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  2. Federico Parietti
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  3. Simone Maccagnan
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  4. Marco Aldo Ortenzi
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  5. Stefano Antenucci
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  6. Francesco Briatico-Vangosa
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  7. Alessandra Maroni
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  8. Andrea Gazzaniga
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  9. Lucia Zema
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Corresponding author

Correspondence to Alessandra Maroni.

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Guest Editors: Niklas Sandler and Jukka Rantanen

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Melocchi, A., Parietti, F., Maccagnan, S. et al. Industrial Development of a 3D-Printed Nutraceutical Delivery Platform in the Form of a Multicompartment HPC Capsule. AAPS PharmSciTech 19, 3343–3354 (2018). https://doi.org/10.1208/s12249-018-1029-9

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  • DOI: https://doi.org/10.1208/s12249-018-1029-9

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