Manufacturing pharmaceutical mini-tablets for pediatric patients using drop-on-demand printing

Sundarkumar, Varun; Wang, Wanning; Nagy, Zoltan; Reklaitis, Gintaras

doi:10.1016/j.ijpharm.2023.123355

Cited by 5 publications

(4 citation statements)

References 32 publications

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“…The inkjet printing requires materials with low viscosity, which makes it less applicable in manufacturing of oral solid dosage forms containing pharmaceutical-grade polymers [ 22 ]. The binder jet printing has a nozzle containing a binder liquid that moves along an x-y axis, depositing the liquid onto a flat powder surface.…”

Section: 3d Printing In Pharmaceutical Areasmentioning

confidence: 99%

Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects

Ianno,

Vurpillot,

Prillieux

et al. 2024

Pharmaceutics

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Three-dimensional printing (3DP) technology in pharmaceutical areas is leading to a significant change in controlled drug delivery and pharmaceutical product development. Pharmaceutical industries and academics are becoming increasingly interested in this innovative technology due to its inherent inexpensiveness and rapid prototyping. The 3DP process could be established in the pharmaceutical industry to replace conventional large-scale manufacturing processes, particularly useful for personalizing pediatric drugs. For instance, shape, size, dosage, drug release and multi-drug combinations can be tailored according to the patient’s needs. Pediatric drug development has a significant global impact due to the growing needs for accessible age-appropriate pediatric medicines and for acceptable drug products to ensure adherence to the prescribed treatment. Three-dimensional printing offers several significant advantages for clinical pharmaceutical drug development, such as the ability to personalize medicines, speed up drug manufacturing timelines and provide on-demand drugs in hospitals and pharmacies. The aim of this article is to highlight the benefits of extrusion-based 3D printing technology. The future potential of 3DP in pharmaceuticals has been widely shown in the last few years. This article summarizes the discoveries about pediatric pharmaceutical formulations which have been developed with extrusion-based technologies.

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Section: 3d Printing In Pharmaceutical Areasmentioning

confidence: 99%

Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects

Ianno,

Vurpillot,

Prillieux

et al. 2024

Pharmaceutics

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“…Additive manufacturing, or three-dimensional printing (3DP), is a rapidly evolving technology that offers flexibility and diversity to the field of individualised medicine. It is possible to provide quality dosage forms (printlets) when a child-friendly medicine is not commercially available for treating paediatrics [ 1 , 2 , 3 ]. Because of its wide applicability, healthcare professionals are aware of the benefits and prospects of 3DP for the production of individualised medicines and their incorporation in point-of-care settings [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Revolutionizing Three-Dimensional Printing: Enhancing Quality Assurance and Point-of-Care Integration through Instrumentation

Suárez-González,

Díaz-Torres,

Monzón-Rodríguez

et al. 2024

Pharmaceutics

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Three-dimensional printing in the field of additive manufacturing shows potential for customized medicines and solving gaps in paediatric formulations. Despite successful clinical trials, 3D printing use in pharmaceutical point-of-care is limited by regulatory loopholes and a lack of Pharmacopoeia guidelines to ensure quality. Semi-solid extrusion is a 3D printing technology that stands out for its versatility, but understanding the fluid dynamics of the semi-solid mass is critical. The aim of this research is to look into the advantages of instrumenting a 3D printer with a semi-solid extrusion motor-driven printhead, which is able to record the printing pressure over time, for in situ characterization of the semi-solid mass and quality evaluation of dosage forms. Four formulations using hydrochlorothiazide as the active pharmaceutical ingredient and several excipients were used. Their flow properties were studied at different printing speeds and temperatures using traditional techniques (rheometer and Texture Analyzer) and the proposed semi-solid extrusion motor-driven printhead incorporated into a printing platform. In addition, the influence of printing speed in the printing process was also evaluated by the study of printing pressure and printlet quality. The results demonstrated the similarities between the use of a Texture Analyzer and the semi-solid extrusion motor-driven. However, the latter enables temperature selection and printing speed in accordance with the printing process which are critical printing parameters. In addition, due to the incorporation of a sensor, it was possible to conclude, for the first time, that there is a link between changes in essential printing parameters like printing speed or formulations and variations in printing pressure and printlet quality attributes such as the energy require to obtain a single dosage unit, weight or diameter. This breakthrough holds a lot of potential for assuring the quality of 3D printing dosage forms and paving the way for their future incorporation into point-of-care settings.

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“…DoD printing techniques have also been developed to directly manufacture mini-tablets from a melt-based solution of molten excipient. 20 In recent years, industry has developed economical, rapid, and precise DoD non-contact liquid handling/microdispensing platforms based on acoustic 21 or pressure pulse 22 technologies, which can be directly applied to DM/POC manufacturing avenues. Developing the measurement science to enable POC manufacturing of medicines using microdispensing technologies for rapid response and personalized medicine is at an inflection point.…”

Section: Introductionmentioning

confidence: 99%

Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine

Forbes,

Gillen,

Feeney

et al. 2024

Preprint

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Distributed and point-of-care (POC) manufacturing facilities enable an agile pharmaceutical production paradigm that can respond to localized needs, providing personalized and precision medicine. These capabilities are critical for narrow therapeutic index drugs and pediatric or geriatric dosing, among other specialized needs. Advanced additive manufacturing, 3D printing, and drop-on-demand (DoD) dispensing technologies have begun expanding into pharmaceutical production. We employed a quality by design (QbD) framework to identify critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs) of a pharmaceutical manufacturing framework that encompasses the production of active pharmaceutical ingredient (API) ‘inks’ at a centralized facility, which are distributed to POC sites for DoD dispensing into/onto delivery vehicles (e.g., orodispersible films, capsules, single liquid dose vials). QbD considerations and cause-and-effect analyses identified the dispensed API quantity and solid state form (CQAs), as well as nozzle diameter, system pressure channel, and number of drops dispensed (CPPs) for detailed investigation. Final assay quantification and content uniformity CQAs were measured from demonstrative levothyroxine sodium single-dose liquid vials of glycerin/water, meeting standard acceptance values. Each POC facility is unlikely to maintain full quality control laboratory capabilities, requiring development of appropriate atline or inline methods to ensure quality control. We developed control strategies, including, atline UV-Vis verification of the API ink prior to dispensing, inline drop counting during dispensing, intermediate atline dispensed volume checks, and offline batch confirmation by LC-MS/MS following production.

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Manufacturing pharmaceutical mini-tablets for pediatric patients using drop-on-demand printing

Cited by 5 publications

References 32 publications

Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects

Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects

Revolutionizing Three-Dimensional Printing: Enhancing Quality Assurance and Point-of-Care Integration through Instrumentation

Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine

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