Integrating pressure sensor control into semi-solid extrusion 3D printing to optimize medicine manufacturing

Díaz-Torres, Eduardo; Rodríguez-Pombo, Lucía; Ong, Jun Jie; Basit, Abdul W.; Santoveña, Ana; Fariña, José; Álvarez-Lorenzo, Carmen; Goyanes, Álvaro

doi:10.1016/j.ijpx.2022.100133

Cited by 11 publications

(12 citation statements)

References 30 publications

(43 reference statements)

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“…The limitation of this preparation, however, is the consistency within the batch that could result in inaccurate dosing, which needs to be optimised by adjusting the paste formulation to reach a more homogenous texture, as mentioned before. The drug loading of 90.56 (±0.29)% was possibly due to an improper printing process, such as clogging, or intermittent extrusion where air was present in the paste, which would result in the loss of wet mass and thus the low drug content [ 36 ].…”

Section: Resultsmentioning

confidence: 99%

Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use

Fitaihi

Abukhamees

et al. 2023

Pharmaceutics

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One of the main challenges to paediatric drug administration is swallowing difficulties, hindering the acceptability of the medicine and hence clinical outcomes. This study aims at developing a child-appropriate dosage form, the orodispersible mini-tablet (ODMT), using the model drug carbamazepine (CBZ). This dosage form was prepared and 3D-printed via a semi-solid extrusion technique. Design of Experiment methods were applied for optimising the formulation. The formulation with 40% (w/w) of SSG (superdisintegrant) and 5% (w/w) of PVP K30 (binder) was selected and loaded with CBZ. The drug-loaded tablets were characterised by a mean hardness of 18.5 N and a disintegrating time of 84 s, along with acceptable friability. The mean drug loading ratio of the tablets was tested as 90.56%, and the drug release rate in 0.1 M HCl reached 68.3% at 45 min. Excipients showed proper compatibility with the drug in physical form analysis. Taste assessment via an E-tongue was also conducted, where the drug did not show bitter taste signals at a low concentration in the taste assessment, and the sweetener also blocked bitterness signals in the testing. To this end, ODMTs were found to be potential candidates for child-appropriate dosage forms delivering CBZ.

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Section: Resultsmentioning

confidence: 99%

Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use

Fitaihi

Abukhamees

et al. 2023

Pharmaceutics

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“…An extrudability profile was performed using a TA adapted for the proposed task (TA.HDplusC, Stable Micro Systems Ltd., Surrey, UK) in a compression mode obtaining the applied force as a function of time, Figure 1 A. For this purpose, 10 g of each semi-solid formulation was filled into 20 mL Luer-Lock syringe (B. Braun Medical Inc. OEM, Melsungen, Germany), commonly used by SSE-P of the pharmaceutical 3DP platform (M3DIMAKER, FabRx Ltd., London, UK) [ 23 ]. To perform the different extrusion cycles, the syringe was equipped with a tapered plastic nozzle with an inner diameter of 0.61 mm (20 Gauge) (Fisnar QuantX™, Germantown, WI, USA).…”

Section: Methodsmentioning

confidence: 99%

“…Such is the importance of monitoring and controlling printing pressure that the research group created and patented an innovative pressure instrumentalized SSE motor-driven printhead (SSE-P) which is able to record the printing pressure over time [ 23 ]. This component is the first step to introduce a process analytical technology (PAT) strategy, which enables in-line manufacturing process control and detects dose units with poor-quality features in SSE 3DP [ 24 ].…”

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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“…The selection of the most suitable nozzle diameter (syringe tip) was performed on the basis of (i) gel consistency, (ii) gel rheological behavior, and (iii) quality of the printed material [ 26 ]. Different nozzle diameters, from 0.80 mm to 1.62 mm, were evaluated to extrude the material.…”

Section: Methodsmentioning

confidence: 99%

The Optimization of Pressure-Assisted Microsyringe (PAM) 3D Printing Parameters for the Development of Sustainable Starch-Based Patches

Pérez Gutiérrez,

Cottone,

Pagano

et al. 2023

Polymers

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The aim of this work was to develop sustainable patches for wound application, using the biopolymer starch, created using a low-cost 3D printing PAM device. The composition of a starch gel was optimized for PAM extrusion: corn starch 10% w/w, β-glucan water suspension (filler, 1% w/w), glycerol (plasticizer, 29% w/w), and water 60% w/w. The most suitable 3D printing parameters were optimized as well (nozzle size 0.8 mm, layer height 0.2 mm, infill 100%, volumetric flow rate 3.02 mm3/s, and print speed 15 mm/s). The suitable conditions for post-printing drying were set at 37 °C for 24 h. The obtained patch was homogenous but with low mechanical resistance. To solve this problem, the starch gel was extruded over an alginate support, which, after drying, becomes an integral part of the product, constituting the backing layer of the final formulation. This approach significantly improved the physicochemical and post-printing properties of the final bilayer patch, showing suitable mechanical properties such as elastic modulus (3.80 ± 0.82 MPa), strength (0.92 ± 0.08 MPa), and deformation at break (50 ± 1%). The obtained results suggest the possibility of low-cost production of patches for wound treatment by additive manufacturing technology.

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Integrating pressure sensor control into semi-solid extrusion 3D printing to optimize medicine manufacturing

Cited by 11 publications

References 30 publications

Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use

Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use

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

The Optimization of Pressure-Assisted Microsyringe (PAM) 3D Printing Parameters for the Development of Sustainable Starch-Based Patches

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