Pharmaceutical 3D printing: Design and qualification of a single step print and fill capsule

Smith, Derrick; Kapoor, Yash; Klinzing, Gerard R.; Procopio, Adam

doi:10.1016/j.ijpharm.2018.03.056

Cited by 82 publications

(40 citation statements)

References 20 publications

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“…In both the conventional and proposed modular product concepts, assembly may be physical assembly (e.g., gluing tablets, compression of bilayer tablets, and filling) [ 43 , 52 , 81 ], virtual assembly (e.g., through CAD models or additive deposition of modules to generate a product during additive manufacturing) [ 53 , 54 , 82 , 83 ], or hybrid assembly (e.g., compartmentalized devices, which can be filled with solids or liquids downstream) [ 44 , 84 , 85 , 86 ]. Importantly, prior to this demonstration of reconfigurable modularization, for conventional modular pharmaceutical product concepts, beyond customization, neither affordable customization nor the industrial adaption necessary for patient access to individualized therapies were sufficiently addressed.…”

Section: Discussionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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Independent individualization of multiple product attributes, such as dose and drug release, is a crucial overarching requirement of pharmaceutical products for individualized therapy as is the unified integration of individualized product design with the processes and production that drive patient access to such therapy. Individualization intrinsically demands a marked increase in the number of product variants to suit smaller, more stratified patient populations. One established design strategy to provide enhanced product variety is product modularization. Despite existing customized and/or modular product design concepts, multifunctional individualization in an integrated manner is still strikingly absent in pharma. Consequently, this study aims to demonstrate multifunctional individualization through a modular product design capable of providing an increased variety of release profiles independent of dose and dosage form size. To further exhibit that increased product variety is attainable even with a low degree of product modularity, the modular design was based upon a fixed target dosage form size of approximately 200 mm3 comprising two modules, approximately 100 mm3 each. Each module contained a melt-extruded and molded formulation of 40% w/w metoprolol succinate in a PEG1500 and Kollidon® VA64 erodible hydrophilic matrix surrounded by polylactic acid and/or polyvinyl acetate as additional release rate-controlling polymers. Drug release testing confirmed the generation of predictable, combined drug release kinetics for dosage forms, independent of dose, based on a product’s constituent modules and enhanced product variety through a minimum of six dosage form release profiles from only three module variants. Based on these initial results, the potential of the reconfigurable modular product design concept is discussed for unified integration into a pharmaceutical mass customization/mass personalization context.

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Section: Discussionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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“…APIs can be loaded into the filament crudely through immersion of the raw polymer into a drug-laden solution, 118 or more subtly via hot-melt extrusion of custom filaments. 119 Production of oral drug doses via this methodology is limited, with print formulation and ultimately drug release profiles being restricted by fixed filament composition.…”

Section: Drug Deliverymentioning

confidence: 99%

3D printing for chemical, pharmaceutical and biological applications

et al. 2018

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“…Therefore, to achieve a good printing quality, the filaments are required to withstand both the mechanical and thermal stresses to which they are subjected in the FDM print head [ 30 ]. However, most polymeric excipients, traditionally used in pharmaceutics, do not present suitable thermal and mechanical properties, precluding 3D printing [ 31 ]. With the adequate selection of formulation and processing conditions, HME can produce good quality thermoplastic filaments, to feed FDM 3D printers.…”

Section: Hot-melt Extrusionmentioning

confidence: 99%

Polymer Selection for Hot-Melt Extrusion Coupled to Fused Deposition Modelling in Pharmaceutics

et al. 2020

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Three-dimensional (3D) printing offers the greatest potential to revolutionize the future of pharmaceutical manufacturing by overcoming challenges of conventional pharmaceutical operations and focusing design and production of dosage forms on the patient’s needs. Of the many technologies available, fusion deposition modelling (FDM) is considered of the lowest cost and higher reproducibility and accessibility, offering clear advantages in drug delivery. FDM requires in-house production of filaments of drug-containing thermoplastic polymers by hot-melt extrusion (HME), and the prospect of connecting the two technologies has been under investigation. The ability to integrate HME and FDM and predict and tailor the filaments’ properties will extend the range of printable polymers/formulations. Hence, this work revises the properties of the most common pharmaceutical-grade polymers used and their effect on extrudability, printability, and printing outcome, providing suitable processing windows for different raw materials. As a result, formulation selection will be more straightforward (considering the characteristics of drug and desired dosage form or release profile) and the processes setup will be more expedite (avoiding or mitigating typical processing issues), thus guaranteeing the success of both HME and FDM. Relevant techniques used to characterize filaments and 3D-printed dosage forms as an essential component for the evaluation of the quality output are also presented.

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Pharmaceutical 3D printing: Design and qualification of a single step print and fill capsule

Cited by 82 publications

References 20 publications

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

3D printing for chemical, pharmaceutical and biological applications

Polymer Selection for Hot-Melt Extrusion Coupled to Fused Deposition Modelling in Pharmaceutics

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