Development of immediate release 3D-printed dosage forms for a poorly water-soluble drug by fused deposition modeling: Study of morphology, solid state and dissolution

Fanous, Marina; Bitar, Malak; Gold, Sarah; Sobczuk, Adam; Hirsch, Stefan; Ogorka, Joerg; Imanidis, Georgios

doi:10.1016/j.ijpharm.2021.120417

Cited by 44 publications

(27 citation statements)

References 34 publications

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“…Due to its chemical characteristics, EE has been the most used in the development of 3D printed immediate drug release formulations. To improve the printability of EE filaments, mixtures with other polymers like hydroxypropyl cellulose [ 139 ], polyethylene oxide [ 136 ] and excipients like plasticizers [ 132 , 138 ] have been reported. Hydroxypropyl cellulose is an easily extrudable polymer, once its melt viscosity decreases during heating in the 3D printing process.…”

Section: 3d Printingmentioning

confidence: 99%

Eudragit®: A Versatile Family of Polymers for Hot Melt Extrusion and 3D Printing Processes in Pharmaceutics

et al. 2021

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Eudragit® polymers are polymethacrylates highly used in pharmaceutics for the development of modified drug delivery systems. They are widely known due to their versatility with regards to chemical composition, solubility, and swelling properties. Moreover, Eudragit polymers are thermoplastic, and their use has been boosted in some production processes, such as hot melt extrusion (HME) and fused deposition modelling 3D printing, among other 3D printing techniques. Therefore, this review covers the studies using Eudragit polymers in the development of drug delivery systems produced by HME and 3D printing techniques over the last 10 years. Eudragit E has been the most used among them, mostly to formulate immediate release systems or as a taste-masker agent. On the other hand, Eudragit RS and Eudragit L100-55 have mainly been used to produce controlled and delayed release systems, respectively. The use of Eudragit polymers in these processes has frequently been devoted to producing solid dispersions and/or to prepare filaments to be 3D printed in different dosage forms. In this review, we highlight the countless possibilities offered by Eudragit polymers in HME and 3D printing, whether alone or in blends, discussing their prominence in the development of innovative modified drug release systems.

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Section: 3d Printingmentioning

confidence: 99%

Eudragit®: A Versatile Family of Polymers for Hot Melt Extrusion and 3D Printing Processes in Pharmaceutics

et al. 2021

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“…Numerous studies on the application of FDM technology in the manufacturing of drug delivery systems have been published confirming the versatility of that method. They include printing orodispersible films [ 8 ], mucoadhesive films [ 9 , 10 ], mini tablets [ 11 ], immediate [ 12 , 13 ], modified [ 14 ], or sustained-release [ 15 ], tablets and capsules, pH-responsive capsules [ 16 ], floating capsules and tablets [ 17 , 18 , 19 ], and capsules with a pulsating release profile [ 20 ]. Prior to printing, the FDM method requires the preparation of the feedstock material in the form of a filament, which is usually obtained in the hot-melt extrusion (HME) process [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

“…In contrast to the traditional production of tablets, consisting mainly of pressing a mixture of powders or granules, the relatively high temperature of HME and FDM processes can significantly affect the properties of the formulation ingredients. It can lead to physicochemical changes of the active substance, causing its amorphization [ 10 , 13 , 22 ] or formation of liquid crystals [ 23 ], which can improve the drug dissolution rate. However, it is also related to a significant limitation of the application of fused deposition modeling because the formulation cannot contain thermolabile substances.…”

Section: Introductionmentioning

confidence: 99%

How to Obtain the Maximum Properties Flexibility of 3D Printed Ketoprofen Tablets Using Only One Drug-Loaded Filament?

et al. 2021

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The flexibility of dose and dosage forms makes 3D printing a very interesting tool for personalized medicine, with fused deposition modeling being the most promising and intensively developed method. In our research, we analyzed how various types of disintegrants and drug loading in poly(vinyl alcohol)-based filaments affect their mechanical properties and printability. We also assessed the effect of drug dosage and tablet spatial structure on the dissolution profiles. Given that the development of a method that allows the production of dosage forms with different properties from a single drug-loaded filament is desirable, we developed a method of printing ketoprofen tablets with different dose and dissolution profiles from a single feedstock filament. We optimized the filament preparation by hot-melt extrusion and characterized them. Then, we printed single, bi-, and tri-layer tablets varying with dose, infill density, internal structure, and composition. We analyzed the reproducibility of a spatial structure, phase, and degree of molecular order of ketoprofen in the tablets, and the dissolution profiles. We have printed tablets with immediate- and sustained-release characteristics using one drug-loaded filament, which demonstrates that a single filament can serve as a versatile source for the manufacturing of tablets exhibiting various release characteristics.

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“…In one study, the drug content was thought to be lower due to crystallization of the model drug and abrasion during the printing process [46]. In the other study it was thought that the drug degraded during the production process [47]. Overall, the dosing precision was adequate, irrespective of the printing method used, though ink-based printing methods could be of specific interest for low-dose drugs [52,60].…”

Section: Pediatric-centered Formulation Designmentioning

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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Development of immediate release 3D-printed dosage forms for a poorly water-soluble drug by fused deposition modeling: Study of morphology, solid state and dissolution

Cited by 44 publications

References 34 publications

Eudragit®: A Versatile Family of Polymers for Hot Melt Extrusion and 3D Printing Processes in Pharmaceutics

Eudragit®: A Versatile Family of Polymers for Hot Melt Extrusion and 3D Printing Processes in Pharmaceutics

How to Obtain the Maximum Properties Flexibility of 3D Printed Ketoprofen Tablets Using Only One Drug-Loaded Filament?

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

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