Can filaments be stored as a shelf-item for on-demand manufacturing of oral 3D printed tablets? An initial stability assessment

This work gives a brief overview of carrier materials currently used in pharmaceutical studies on the three-dimensional (3D) semi-solid extrusion (SSE) printing of medicines for pediatrics. The suitability of using these carrier materials in pediatric formulations, concerning safety and toxicity, was reviewed by consulting the ‘Safety & Toxicity of Excipients for Pediatrics’ (STEP) database and the Food and Drug Administration (FDA) regulations. In the second part of this work, carrier materials were tested on their ability to form a semi-solid mixture with lactose by dual asymmetric centrifugation (DAC) and printing by SSE. With the combination of theoretical and experimental studies, this work will guide research toward grounded decision-making when it comes to carrier material selection for pharmaceutical pediatric 3D SSE printing formulations.

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“…Eudragit EPO: TEC: Theophylline (50: 3.25: 46.75) was extruded at 90 °C and printed using FDM at 145 °C [ 20 ]…”

Section: Resultsmentioning

confidence: 99%

The Quest for Child-Friendly Carrier Materials Used in the 3D Semi-Solid Extrusion Printing of Medicines

et al. 2022

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“…In this last case, the production efficiency is improved when compared to conventional compounding methods [33], enabling true on-demand manufacturing. However, few research articles have been found on the manufacturing and storage stability of these intermediate products [48,76]. Challenges remain with the storage expiration date.…”

Section: Discussionmentioning

confidence: 99%

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

et al. 2022

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3D printing of pediatric-centered drug formulations can provide suitable alternatives to current treatment options, though further research is still warranted for successful clinical implementation of these innovative drug products. Extensive research has been conducted on the compliance of 3D-printed drug products to a pediatric quality target product profile. The 3D-printed tablets were of particular interest in providing superior dosing and release profile similarity compared to conventional drug manipulation and compounding methods, such as oral liquids. In the future, acceptance of 3D-printed tablets in the pediatric patient population might be better than current treatments due to improved palatability. Further research should focus on expanding clinical knowledge, providing regulatory guidance and expansion of the product range, including dosage form possibilities. Moreover, it should enable the use of diverse good manufacturing practice (GMP)-ready 3D printing techniques for the production of various drug products for the pediatric patient population.

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“…The formulation is shown in Table 1. The formulation table refers to the research of Okwuosa [15] et al Collect the filaments and measure the diameter every 1-2cm with a micrometer. After extrusion, the filaments were stored in a sealed box (temperature 20°C).…”

Section: Preparation Of Filamentsmentioning

confidence: 99%

Effects of Hot-Melt-Extrusion process parameters on the Feedability of Fused Deposition Modeling filaments

Liu

Liang

Zhao

et al. 2022

J. Phys.: Conf. Ser.

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Fused deposition modelling (FDM) has shown its advantages in the field of personalized oral medicine due to its low cost, simplicity and flexible manufacturing for on- demand doses. However, most pharmaceutical-grade polymers that can be hot-melt extruded do not have the mechanical properties for high-quality FDM feedstock, and it is considered a barrier to further development of FDM pharmaceutical applications. In this paper, the impacts of Hot- Melt Extrusion (HME) process parameters on the mechanical properties of FDM filaments is explored for the brittle polymer polyvinylpyrrolidone (PVP). The results show that the feed rate greatly influences the mechanical properties of the filaments. Through the exploration of HME process parameters, the preparation method of FDM raw filaments has been further improved, and the application of brittle polymers in FDM pharmaceuticals has been broadened.

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Can filaments be stored as a shelf-item for on-demand manufacturing of oral 3D printed tablets? An initial stability assessment

Cited by 17 publications

References 43 publications

The Quest for Child-Friendly Carrier Materials Used in the 3D Semi-Solid Extrusion Printing of Medicines

The Quest for Child-Friendly Carrier Materials Used in the 3D Semi-Solid Extrusion Printing of Medicines

3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids?—A Scoping Review

Effects of Hot-Melt-Extrusion process parameters on the Feedability of Fused Deposition Modeling filaments

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