The use of near-infrared as process analytical technology (PAT) during 3D printing tablets at the point-of-care.

Fused deposition modelling (FDM) is one of the most researched 3D printing technologies that holds great potential for low-cost manufacturing of personalised medicine. To achieve real-time release, timely quality control is a major challenge for applying 3D printing technologies as a point-of-care (PoC) manufacturing approach. This work proposes the use of a low-cost and compact near-infrared (NIR) spectroscopy modality as a process analytical technology (PAT) to monitor a critical quality attribute (drug content) during and after FDM 3D printing process.

Towards point-of-care manufacturing and analysis of immediate-release 3D printed hydrocortisone tablets for the treatment of congenital adrenal hyperplasia.

Hydrocortisone (HC) is the preferred drug in children with congenital adrenal hyperplasia due to its lower potency as well as fewer reports of side effects. Fused deposition modelling (FDM) 3D printing holds the potential to produce low-cost personalised doses for children at the point of care. However, the compatibility of the thermal process to produce immediate-release bespoke tablets for this thermally labile active is yet to be established.

Creating Acceptable Tablets 3D (CAT 3D): A Feasibility Study to Evaluate the Acceptability of 3D Printed Tablets in Children and Young People.

3D printing (3DP) has been proposed as a novel approach for personalising dosage forms for children and young people (CYP). Owing to its low cost and the lack of need for finishing steps, fused deposing modelling (FDM) 3DP has been heavily researched in solid dosage forms (SDFs) manufacturing. However, the swallowability and overall acceptability of 3D printed dosage forms are yet to be established.

A Novel Multilayer Natural Coating for Fed-State Gastric Protection.

Several nutraceutical products require gastric protection against the hostile environment in the stomach. Currently marketed synthetic and semi-synthetic coatings suffer from major shortcomings such as poor gastric protection, slow-release response to pH change, and the use of artificial ingredients. The challenge of coating natural products is further exacerbated by the relatively high gastric pH in the fed state.

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

3D printing of oral solid dosage forms is a recently introduced approach for dose personalisation. Fused deposition modelling (FDM) is one of the promising and heavily researched 3D printing techniques in the pharmaceutical field. However, the successful application of this technique relies greatly on the mass manufacturing of physically and chemically stable filaments, that can be readily available as a shelf item to be 3D printed on-demand.

Solvent-free temperature-facilitated direct extrusion 3D printing for pharmaceuticals.

In an era moving towards digital health, 3D printing has successfully proven its applicability in providing personalised medicine through a technology-based approach. Among the different 3D printing techniques, direct extrusion 3D printing has been demonstrated as a promising approach for on demand manufacturing of solid dosage forms. However, it usually requires the use of elevated temperatures and/or the incorporation of an evaporable solvent (usually water).

An innovative wax-based enteric coating for pharmaceutical and nutraceutical oral products.

In this work, a novel enteric coating based on natural waxes and alginate was reported. Initially, theophylline tablets were coated with emulsified ceresin wax in heated aqueous alginate solution using a fluidised bed coating technology. A coating level of 10% proved sufficient to prevent tablets from uptaking gastric medium (<5%) and produced a delayed release profile that complies to the pharmacopeial criteria of enteric coating release.

Temperature and solvent facilitated extrusion based 3D printing for pharmaceuticals.

On demand manufacturing of patient-specific oral doses provides significant advantages to patients and healthcare staff. Several 3D printing (3DP) technologies have been proposed as a potential digital alternative to conventional manufacturing of oral tablets. For an additive manufacturing approach to be successful for on-demand preparation, a facile process with minimal preparation steps and training requirements is needed.

A novel natural GRAS-grade enteric coating for pharmaceutical and nutraceutical products.

In this study, enteric coatings based exclusively on naturally occurring ingredients were reported. Alginate (Alg) and pectin (Pec) blends with or without naturally occurring glyceride, glycerol monostearate (GMS), were initially used to produce solvent-casted films. Incorporating GMS in the natural polymeric films significantly enhanced the acid-resistance properties in gastric medium.

Embedded 3D Printing of Novel Bespoke Soft Dosage Form Concept for Pediatrics.

Embedded three-dimensional printing (e-3DP) is an emerging method for additive manufacturing where semi-solid materials are extruded within a solidifying liquid matrix. Here, we present the first example of employing e-3DP in the pharmaceutical field and demonstrate the fabrication of bespoke chewable dosage forms with dual drug loading for potential use in pediatrics. Lego-like chewable bricks made of edible soft material (gelatin-based matrix) were produced by directly extruding novel printing patterns of model drug ink (embedded phase) into a liquid gelatin-based matrix (embedding phase) at an elevated temperature (70 °C) to then solidify at room temperature.

'Temporary Plasticiser': A novel solution to fabricate 3D printed patient-centred cardiovascular 'Polypill' architectures.

Hypertension and dyslipidaemia are modifiable risk factors associated with cardiovascular diseases (CVDs) and often require a complex therapeutic regimen. The administration of several medicines is commonly associated with poor levels of adherence among patients, to which World Health Organisation (WHO) proposed a fixed-dose combination unit (polypill) as a strategy to improve adherence. In this work, we demonstrate the fabrication of patient-specific polypills for the treatment of CVDs by fused deposition modelling (FDM) 3D printing and introduce a novel solution to meet critical quality attributes.

On demand manufacturing of patient-specific liquid capsules via co-ordinated 3D printing and liquid dispensing.

A method for the production of liquid capsules with the potential of modifying drug dose and release is presented. For the first time, the co-ordinated use of fused deposition modelling (FDM), 3D printing and liquid dispensing to fabricate individualised dosage form on demand in a fully automated fashion has been demonstrated. Polymethacrylate shells (Eudragit EPO and RL) for immediate and extended release were fabricated using FDM 3D printing and simultaneously filled using a computer-controlled liquid dispenser loaded with model drug solution (theophylline) or suspension (dipyridamole).