Exploring tablet design options for tailoring drug release and dose via fused deposition modeling (FDM) 3D printing

Buyukgoz, Guluzar Gorkem; Soffer, David; Defendre, Jackenson; Pizzano, Gia M.; Davé, Rajesh N.

doi:10.1016/j.ijpharm.2020.119987

Cited by 39 publications

(23 citation statements)

References 75 publications

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“…All the tested mixtures were easily extruded at 85 • C, even those containing 50% wt of paracetamol, indicating that higher concentrations of API could be processable, as observed by Bialleck et al [47], who achieved the pelletization of starch based mixtures loaded with APIs up to 80% wt. The use of a blend of starch and HPC with the paracetamol resulted in a combination easy to process at lower temperatures than those identified in the literature, which are above 160 • C for blends with HPC processed by FDM [23,27,29] and in the same level of temperatures (70-80 • C) needed to process starch based blends processed by SSE [54,55].…”

Section: Discussionmentioning

confidence: 94%

“…The tested samples were paralepidids copying the geometry of the outlet of the extruder and did not present any tailored dimensions, porosity or surface to volume ratio that can be easily controllable by means of 3DP tablet design. Nevertheless, they exhibited slow drug release compared to the commercial tablet, but very fast compared to other formulations found in the literature [23,24,27,61]. This release rate can be controlled by designing the tablet geometry [62,63] or by modifying drug carrier matrix materials [64].…”

Section: Discussionmentioning

confidence: 94%

“…They succeeded in extruding filaments and printing with drug loads up to 48% wt at 130 • C but their polymer-drug blends underwent two thermal processes, and although the processing temperature was under the melting point of the paracetamol, their samples showed yellowish discoloration, indicating some degradation or oxidation of the components. Gorkem Buyukgoz et al [27] extruded filament based on Hydroxypropyl Cellulose (HPC) loaded with Griseofulvin at 140 • C to subsequently 3D print it at 170 • C. Other examples of drug loaded filament preparation to feed the 3D printer can be found in [28][29][30][31][32].…”

Section: Introductionmentioning

confidence: 99%

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Direct Powder Extrusion of Paracetamol Loaded Mixtures for 3D Printed Pharmaceutics for Personalized Medicine via Low Temperature Thermal Processing

Mendibil

Tena

Duque³

et al. 2021

Pharmaceutics

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Three-dimensional printed drug development is nowadays an active area in the pharmaceutical industry, where the search for an appropriate edible carrier that permits the thermal processing of the mixture at temperature levels that are safe for the drug is an important field of study. Here, potato starch and hydroxypropyl cellulose based mixtures loaded with paracetamol up to 50% in weight were processed by hot melt extrusion at 85 °C to test their suitability to be thermally processed. The extruded mixtures were tested by liquid chromatography to analyze their release curves and were thermally characterized. The drug recovery was observed to be highly dependent on the initial moisture level of the mixture, the samples being prepared with an addition of water at a ratio of 3% in weight proportional to the starch amount, highly soluble and easy to extrude. The release curves showed a slow and steady drug liberation compared to a commercially available paracetamol tablet, reaching the 100% of recovery at 60 min. The samples aged for 6 weeks showed slower drug release curves compared to fresh samples, this effect being attributable to the loss of moisture. The paracetamol loaded mixture in powder form was used to print pills with different sizes and geometries in a fused deposition modelling three-dimensional printer modified with a commercially available powder extrusion head, showing the potential of this formulation for use in personalized medicine.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Direct Powder Extrusion of Paracetamol Loaded Mixtures for 3D Printed Pharmaceutics for Personalized Medicine via Low Temperature Thermal Processing

Mendibil

Tena

Duque³

et al. 2021

Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…The design of the object should consider the volume, which determines the dosage depending on the drug-load of the filament. There are two opportunities to influence the drug release properties of 3D printed objects: changing the composition of the filaments and adapting the surface area to volume (SA/V) ratio [ 22 , 23 , 24 , 25 ]. Since printing technologies allow one to manufacture a wide range of geometries without further development efforts, changing the SA/V ratio is the preferred option.…”

Section: Introductionmentioning

confidence: 99%

Predicting Drug Release from 3D Printed Oral Medicines Based on the Surface Area to Volume Ratio of Tablet Geometry

2021

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3D printing offers the advantage of being able to modify dosage form geometry, which can be exploited to modify release characteristics. In this study, we investigated the influence of the surface area to volume ratio (SA/V) to change and predict release profiles of 3D printed dosage forms. Geometries with varying SA/V and dosages were designed and printed, and drug dissolution was investigated. Three drug substances were used: pramipexole, levodopa (both BCS I) and praziquantel (BCS II). Two polymers were chosen as matrix formers: polyvinyl alcohol (water-soluble) and ethylene vinyl acetate (inert). Drug release was characterized using the mean dissolution time (MDT) and established equations that describe complete dissolution curves were applied. Predictions were validated with previously un-printed dosage forms. Based on an identified MDT-SA/V correlation, the MDT can be predicted with a deviation of ≤5 min for a given SA/V. Using correlations of fit parameters and SA/V, RMSEP values of 0.6–2.8% and 1.6–3.4% were obtained for the BCS I formulations and RMSEP values of 1.0–3.8% were obtained for the BCS II formulation, indicating accurate prediction over a wide range of dissolution profiles. With this approach, MDT and release profiles of dosage forms with a given SA/V can be precisely predicted without performing dissolution tests and vice versa, the required SA/V can be predicted for a desired release profile.

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“…In precision medicine, dosage control is as important as the release of the drug. For example, in FDM, dose tuning was achieved by varying either the drug ratio in the formulation, the size of the printlets or the internal porosity of the printlet (infill rate) [ 105 , 106 ]. However, in the case of SLS, only the modification of the formulation composition has been explored to control the dispensed drug dose [ 27 ].…”

Section: Applications Of Sls In Personalized Medicinementioning

confidence: 99%

Selective Laser Sintering (SLS), a New Chapter in the Production of Solid Oral Forms (SOFs) by 3D Printing

et al. 2021

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3D printing is a new emerging technology in the pharmaceutical manufacturing landscape. Its potential advantages for personalized medicine have been widely explored and commented on in the literature over recent years. More recently, the selective laser sintering (SLS) technique has been investigated for oral drug-delivery applications. Thus, this article reviews the work that has been conducted on SLS 3D printing for the preparation of solid oral forms (SOFs) from 2017 to 2020 and discusses the opportunities and challenges for this state-of-the-art technology in precision medicine. Overall, the 14 research articles reviewed report the use of SLS printers equipped with a blue diode laser (445–450 nm). The review highlights that the printability of pharmaceutical materials, although an important aspect for understanding the sintering process has only been properly explored in one article. The modulation of the porosity of printed materials appears to be the most interesting outcome of this technology for pharmaceutical applications. Generally, SLS shows great potential to improve compliance within fragile populations. The inclusion of “Quality by Design” tools in studies could facilitate the deployment of SLS in clinical practice, particularly where Good Manufacturing Practices (GMPs) for 3D-printing processes do not currently exist. Nevertheless, drug stability and powder recycling remain particularly challenging in SLS. These hurdles could be overcome by collaboration between pharmaceutical industries and compounding pharmacies.

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Exploring tablet design options for tailoring drug release and dose via fused deposition modeling (FDM) 3D printing

Cited by 39 publications

References 75 publications

Direct Powder Extrusion of Paracetamol Loaded Mixtures for 3D Printed Pharmaceutics for Personalized Medicine via Low Temperature Thermal Processing

Direct Powder Extrusion of Paracetamol Loaded Mixtures for 3D Printed Pharmaceutics for Personalized Medicine via Low Temperature Thermal Processing

Predicting Drug Release from 3D Printed Oral Medicines Based on the Surface Area to Volume Ratio of Tablet Geometry

Selective Laser Sintering (SLS), a New Chapter in the Production of Solid Oral Forms (SOFs) by 3D Printing

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