In modern medicine innovation continues to advance rapidly. One of the most remarkable developments in recent years is 3D printing, also known as additive manufacturing. This technology has gained significant attention in pharmaceutical research due to its potential to transform the development of treatments for specific medical needs.
Unlike conventional manufacturing methods that involve carving shaping or moulding raw materials into a final form, 3D printing is an additive technique. It creates three dimensional objects by layering materials such as polymers metals or ceramics. The object can be designed as a digital file using magnetic resonance imaging (MRI) or computer aided design (CAD), enabling precise adjustment of product dimensions and properties.
Developing high quality effective and safe paediatric medicines remains challenging for the pharmaceutical industry. In Europe paediatric focused treatments were extremely limited before implementation of European Union legislation on medicines for children in 2006*. As a result caregivers often manipulated adult formulations to improve acceptability, leaving products used in practice unlicensed. Common examples include crushing tablets, opening capsules, or mixing with food to make swallowing easier which can affect absorption and bioavailability. Although new medicines and indications have been authorised specifically for paediatric use since the regulation came into force, availability is still insufficient to fully meet clinical need.
3D printing offers a promising solution because it can produce accurate dosage forms with complex geometries and improved palatability. By molecularly dispersing the active pharmaceutical ingredient in the dosage matrix bitterness can be effectively masked. Starmix was introduced by Scoutaris et al as a 3D printed paediatric formulation providing precise doses immediate release and complex geometries. Sensory panel evaluations showed excellent taste masking performance and improved palatability. Tabriz et al developed a personalised paediatric dosage form of Diphenhydramine Hydrochloride an antihistamine used for allergy and common cold relief using 3D printing technology. Trained panel assessments demonstrated complete masking of bitterness and enhanced organoleptic properties.
An additional benefit of solid dispersions produced by 3D printing is improved bioavailability of poorly water soluble APIs. This can enhance therapeutic efficacy reduce required doses and potentially minimise side effects. However increasing bioavailability may raise the risk of overdose. Prescribers and pharmacists must therefore be aware of possible changes in pharmacokinetics. Further research is required to better understand the safety and therapeutic performance of molecularly dispersed APIs in 3D printed dosage forms.
3D printing presents considerable promise in health care due to its ability to produce palatable patient friendly and highly customised medicines at or near the point of care. However this also introduces new regulatory challenges. As 3D printing becomes more widely adopted regulatory frameworks must evolve to ensure that product quality and patient safety are fully maintained and that the benefits outweigh any associated risks.
*Joint Evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on Medicinal Products for Paediatric Use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. SWD/2020/163 Final. [(accessed on 4 September 2023)]. Available online: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020SC0163
Scoutaris, N., Ross, S. A., & Douroumis, D. (2018). 3D printed “Starmix” drug loaded dosage forms for paediatric applications. Pharmaceutical research
Tabriz, A. G., Fullbrook, D. H. G., Vilain, L., Derrar, Y., Nandi, U., Grau, C., … & Douroumis, D. (2021). Personalised tasted masked chewable 3D printed fruit-chews for paediatric patients. Pharmaceutics
