3D printing tablets for high-precision dose titration of caffeine.

Through 3D printing (3DP), many parameters of solid oral dosage forms can be customised, allowing for truly personalised medicine in a way that traditional pharmaceutical manufacturing would struggle to achieve. One of the many options for customisation involves dose titration, allowing for gradual weaning of a medication at dose intervals smaller than what is available commercially. In this study we demonstrate the high accuracy and precision of 3DP dose titration of caffeine, selected due to its global prevalence as a behavioural drug and well-known titration-dependent adverse reactions in humans. This was achieved using a simple filament base of polyvinyl alcohol, glycerol, and starch, utilising hot melt extrusion coupled with fused deposition modelling 3DP. Tablets containing 25 mg, 50 mg, and 100 mg doses of caffeine were successfully printed with drug content in the accepted range prescribed for conventional tablets (90 - 110%), and excellent precision whereby the weights of all doses showed a relative standard deviation of no more than 3%. Importantly, these results proved 3D printed tablets to be far superior to splitting a commercially available caffeine tablet. Additional assessment of filament and tablet samples were reviewed by differential scanning calorimetry, thermogravimetric analysis, HPLC, and scanning electron microscopy, showing no evidence of degradation of caffeine or the raw materials, with smooth and consistent filament extrusion. Upon dissolution, all tablets achieved greater than 70% release between 50 and 60 min, showing a predictable rapid release profile regardless of dose. The outcomes of this study highlight the benefits that dose titration with 3DP can offer, especially to more commonly prescribed medications that can have even more harmful withdrawal-induced adverse reactions.

3D printing hybrid materials using fused deposition modelling for solid oral dosage forms.

3D printing in the pharmaceutical and healthcare settings is expanding rapidly, such as the rapid prototyping of orthotics, dental retainers, drug-loaded implants, and pharmaceutical solid oral dosage forms. Through 3D printing, we have the capability to precisely control dose, release kinetics, and several aesthetic features of dosage forms such as colour, shape, and texture. Additionally, polypills can be created with combinations of medications in one solid dosage form at completely customisable strengths that would be extremely difficult to obtain commercially. As the technology and formulations developed through 3D printing are expanding, the development of new hybrid materials to obtain superior formulations are also gaining momentum. In this review we collate data on the importance of developing hybrid formulations of polymers, drugs and excipients necessary to produce reliable and high-quality 3D printed dosage forms with a special emphasis on fused deposition modelling (FDM). FDM technology is one of the most widely used forms of 3D printing and has demonstrated compatibility with unique polymer-based hybrids to allow for enhanced drug delivery, protection of thermolabile drugs, modifiable release kinetics, and more. The data collated covers different categories of hybrids as well as the methods used to fabricate them, and their respective effects on the properties of 3D printed solid oral dosage forms. Therefore, this review will provide an overview of upcoming and emerging trends in pharmaceutical 3D printing formulation compositions.