Another dimension

According to the UK’s National Health Service, 40-70% of one-size-fits-all medication is ineffective and many lead to adverse reactions causing one-in-15 hospital admissions.

Personalisation would solve these issues, but the preparation of personalised prescriptions is still widely carried out by hand, with little innovation past the weighing of powders and splitting of mass-manufactured tablets.

This prevents the personalisation of most treatments and causes a variety of safety concerns such as the inaccurate dosing of sometimes highly potent drugs.

These somewhat old-fashioned techniques represent an €8 billion market, begging the question, why are we not modernising this?

3D printing – a well-known technique for rapidly creating custom objects – is now being used to personalise medicine.

Three clinical studies have already taken place. This research demonstrated the accuracy of printed tablets – ‘printlets’ – while showing that they retained bioequivalence and in, some cases, improved it in response to treatment acceptability.

FABRX is the start-up company leading the charge, carrying out the first clinical study in the world in 2018 and launching the first-ever pharmaceutical 3D printer for personalised medicine in 2020.

The company is now engaged in several clinical studies worldwide and is collaborating with large pharmaceutical companies to develop novel pharma-ink (pre-printed formulation) to supply to pharmacists.

Additionally, it is incorporating 3D printing into clinical trial workflows to enhance their efficiency.

By digitising personalised medicine manufacture with 3D printing, personalisation, precision and safety are automated, allowing increased uptake to improve healthcare in a virtuous cycle.

A patient’s personalised prescription can be printed with only a few clicks, incorporating different flavours, colours and drug combinations to encourage treatment adherence. With various 3D printing technologies available, the best one for drug and target printlet characteristics can be used.

For example, semi-solid extrusion can print gels to create chewable printlets for improved patient acceptability, or it can print pastes at room temperature for thermosensitive molecules.

Fused deposition modelling uses filaments made via hot melt extrusion, improving drug solubility and producing pharma-ink with extended shelf life.

Direct powder extrusion prints powders and can be used for extended-release medication or when only small amounts of the drug are available, for example, in clinical trial batch manufacture.

Regulation is rapidly evolving to fully prepare for pharmaceutical 3D printing in hospitals and community pharmacies. The FDA, EMA and MHRA are all preparing legislation to be published next year following public consultation with field stakeholders.

To get involved, hospitals and pharmacies can implement 3D printing under compounding regulations and carry out clinical studies in collaboration with universities or companies like FABRX for new treatment pathways.

Pharmaceutical companies can invest in the development of new pharma-ink to supply to pharmacists as pre-prepared cartridges. This not only increases the safety and efficiency of the printing process but can be used to extend patents of drugs nearing the end of their IP lifespan.

With multiple collaborations emerging across the world, this is a great time to get involved in this transformative arena.

Dr Alvaro Goyanes is Cofounder of FABRX.
Go to fabrx.co.uk/contact to find out more