Pharmaceutical applications of powder-based binder jet 3D printing process – A review

Sen, Koyel; Mehta, Tanu; Sansare, Sameera; Sharifi, Leila; Anson, W. K.; Chaudhuri, Bodhisattwa

doi:10.1016/j.addr.2021.113943

Cited by 76 publications

(36 citation statements)

References 73 publications

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“…The model is accurate when the errors between the predicted and measured PK parameters (C max , AUC) for different dosing regimens are within 20% of the measured and predicted values. The formula for the absolute prediction error is shown in for Equation (1):…”

Section: Pbpk Modeling Of Lev In Chinese Adultsmentioning

confidence: 99%

“…Binder jet 3D printing (BJ-3DP) is a technology that constructs objects; in this process, digital models are first designed with the aid of a computer, then the objects are printed layer by layer, eventually turning the computer blueprint into a physical object [1]. Compared to traditional formulation manufacturing processes, 3D printing technology is extremely suitable for personalized drug delivery because it provides flexibility in adjusting drug doses, drug combinations, and production methods [2], especially for pediatric patients.…”

Section: Introductionmentioning

confidence: 99%

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In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

Li¹,

Liang

Hong³

et al. 2021

Pharmaceutics

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Recently, the development of Binder Jet 3D printing technology has promoted the research and application of personalized formulations, which are especially useful for children’s medications. Additionally, physiological pharmacokinetic (PBPK) modeling can be used to guide drug development and drug dose selection. Multiple technologies can be used in combination to increase the safety and effectiveness of drug administration. In this study, we performed in vivo pharmacokinetic experiments in dogs with preprepared 3D-printed levetiracetam instant-dissolving tablets (LEV-IDTs). Bioequivalence analysis showed that the tablets were bioequivalent to commercially available preparations (Spritam®) for dogs. Additionally, we evaluated the bioequivalence of 3D-printed LEV-IDTs with Spritam® by a population-based simulation based on the established PBPK model of levetiracetam for Chinese adults. Finally, we established a PBPK model of oral levetiracetam in Chinese children by combining the physiological parameters of children, and we simulated the PK (pharmacokinetics) curves of Chinese children aged 4 and 6 years that were administered the drug to provide precise guidance on adjusting the dose according to the effective dose range of the drug. Briefly, utilizing both Binder jet 3D printing technology and PBPK models is a promising route for personalized drug delivery with various age groups.

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Section: Pbpk Modeling Of Lev In Chinese Adultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

Li¹,

Liang

Hong³

et al. 2021

Pharmaceutics

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“…Although, 3DP techniques have gained great popularity in the pharmaceutical research sector, for a long time Spritam® by Aprecia Pharmaceuticals was the only approved drug product by the U.S. Food and Drug Administration (FDA), which is produced using the technique drop-on-powder (DoP). Recently, Triastek received IND clearance for clinical studies by the FDA for their product T19, produced by Melt Extrusion Deposition (MED™) ( Sen et al, 2021a ). 3D printed products can be beneficial in clinical studies due to flexible dose adjustment and easy scalability ( Sen et al, 2021a ; Seoane-Viaño et al, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Drop-on-powder 3D printing of amorphous high dose oral dosage forms: Process development, opportunities and printing limitations

Gottschalk

Burkard

Quodbach

et al. 2023

International Journal of Pharmaceutics: X

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“…Many studies in this area have focused on the equilibrium saturation of the binder in a powder, with particular emphasis on the effect of granule size. − Studies in adjacent fields, such as wet granulation in pharmaceuticals or soil hydrology in civil engineering, have also contributed to understanding the equilibrium state of powder–binder composites. − Developments in the study of BJP contribute to this wider context of fluid infiltration of porous media. Additionally, advances in BJP support progress in many fields, such as tissue engineering, microelectronics, and pharmaceuticals. − …”

Section: Introductionmentioning

confidence: 99%

Physicochemical Limitations of Capillary Models Applied to High-Concentration Polymer Solutions

et al. 2022

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Advances in binder jet printing (BJP) require the development of new binder–powder systems, for example, to increase compatibility with better performance metal alloys or to increase the strength of parts using stronger binders. The dynamics of binder absorption are principally understood through capillary models. However, validation of these models in BJP has focused on variation of powder properties. Using a design-of-experiments approach and an optical observation method to track absorption of droplets, this study tests the influence of fluid properties on absorption time against the predictions of capillary models. Properties specific to polymeric binders, such as molecular weight and entanglement state, are also considered. Capillary models are found to be generally accurate in predicting absorption time in dilute systems; however, these predictions are not accurate for highly concentrated binder solutions. The effect of polymer entanglement becomes prevalent as the solution concentration increases, which can also potentially occur as a result of increased evaporation due to powder bed heating. Specifically, concentrated solutions close to the onset of entanglement will absorb much more slowly than predicted. Future models of BJP systems must account for the possibility of polymer entanglement throughout the absorption process. Improved models will provide a more accurate understanding of the flow and solidification of the binder in the powder, allowing faster development of new binders for improved performance in printing.

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Pharmaceutical applications of powder-based binder jet 3D printing process – A review

Cited by 76 publications

References 73 publications

In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

Drop-on-powder 3D printing of amorphous high dose oral dosage forms: Process development, opportunities and printing limitations

Physicochemical Limitations of Capillary Models Applied to High-Concentration Polymer Solutions

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