FabRx: The First Clinical Study Using Personalized 3D Printed Pills (In Humans)

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3D printing technology is becoming disruptive to the pharmaceutical industry. The manufacturing of personalized medicine, such as patient-specific pills, can make customized drug delivery and dosing change the way people take their medicines forever. Still, the manufacturing technology appears to be at an early stage, with a lot of research but few outcomes. The first 3D printed prescription drug was finally commercially available in 2016, officially approved by the FDA and released to the US market.

But up to now, there were no 3D printers on the market adapted for printing personalized medicines, until pharma-tech pioneering experts, FabRx, successfully completed the world’s first-in-human clinical study using their proprietary Printlets technology which relies on personalized 3D printed dosage forms to treat children with a rare metabolic disease.

The study demonstrates for the first time that 3D printing offers a feasible, rapid and automated approach to prepare oral tailored-dose therapies in a hospital setting, proving to be an effective manufacturing technology to develop chewable doses of the drug isoleucine in the form of Printlets as a treatment for Maple syrup urine disease (MSUD) with good acceptability.

The study is a big step for personalized medicines, which are becoming more popular as they enable better drug design with fewer side effects and where several doses can be combined into one dosage. A major limitation of medicines today is that they are only manufactured in a limited number of specific strengths and sizes, so current medication sets available are not easily adaptable and patients suffer from significant problems swallowing large tablets. FabRx’s new development in 3D printed medicine looks to resolve these issues by, for instance, making their Printlets chewable. That’s a big issue for children, with between 20 to 40 percent being unable to swallow a standard-size pill, let alone many in one day. This could even benefit adults since, for example, 40 percent of American grownups have difficulty swallowing capsules. Not to mention elderly patients, that, on average, take more than five prescription medications daily. 3D printing can solve many issues, giving the industry a clear advantage and a lot of room for research, development, and growth.

Chewable Printlets (3D printed tablets) in different flavors, color, and doses

The new 3D printing system is faster than any manual method and allows the preparation of a blister pack equivalent to one month’s therapy (28 Printlets) in less than eight minutes. After six months of monitoring MSUD patients, the study showed that the Printlets were as effective as the conventional medication prepared manually in controlling the patients’ blood levels of isoleucine. Furthermore, isoleucine blood concentrations following the administration of Printlets were closer to the isoleucine target value with less variation when compared with blood levels achieved by conventional compounded treatment. The ability of the 3D printing system to create Printlets with different colors and flavors had a further positive impact on patients’ acceptability of the treatment.

MSUD is a rare metabolic disorder with a worldwide prevalence of one in every 185,000 live births. However, certain populations display a significant overexpression of the disorder where incidence is reported to be one in every 52,541 new-borns. In current clinical practice, practitioners still have to prepare extemporaneous formulations due to the lack of suitable oral treatments for MSUD.

So the pioneering step brings the 3D printing of pharmaceutical products closer to the clinic with a promise in shifting pharmaceutical practice towards a personalized patient approach.

Alvaro Goyanes

“This is a big step forward because we proved that the technology can be used in clinic right now. Pharmaceutical development normally takes many years, but we are planning to start more clinical studies with a much higher number of patients involving more than one hospital next year,” said Alvaro Goyanes, co-founder and Director of Development at FabRx to 3DPrint.com.

This investigation was a single-center, prospective crossover experimental study of a collaboration between researchers from University College London (UCL), University of Santiago de Compostela (USC) and the Clinical University Hospital in Santiago de Compostela, Spain, where four pediatric patients with MSUD between the ages of three and 16 were treated.

“There is a real need for new manufacturing systems to prepare personalised medicines. The potential application of 3D printing for rare diseases are countless and it could help make the medicines safer and more attractive to children,” suggested Maria Luz Couce, Head of the Pediatrics Section and Director of the Diagnostic and Treatment of Congenital Metabolic Diseases Unit of the Clinical University Hospital in Santiago de Compostela.

According to the study, the primary objective was to evaluate isoleucine blood levels after six months of treatment with two types of formulations: conventional capsules prepared by manual compounding and personalized chewable formulations prepared by automated 3D printing.

Goyanes went on to explain that “the selection of the dose is done by the clinician (paediatrician in this case) based on the concentration of drugs in blood. Then they send a digital prescription to the pharmaceutical unit and the medicines are prepared using a 3D printer. Since it is printed in an automatic way you do not need people manually preparing medicines, so the labour costs are reduced.”

The Printlets

“We tested different 3D printing technologies, but the one that was best suited for personalised medicines at the dispensing point were semisolid extrusion (the one used in this study), direct powder extrusion and FDM. FabRx manufactures and sells equipment and software for pharmaceutical applications, and provides knowhow in formulations development,” revealed the expert.

FabRx, a spin-out company from UCL School of Pharmacy, was founded in 2014 by academics to develop printed medicines and drug-loaded medical devices. They have been working at the Advanced 3D Printing Lab at UCL conducting research around 3D printed medicines for over five years.

The study shows a clear focus on specific products for children, one of the most vulnerable populations worldwide. According to UNICEF, 10 million children under five years old will die by the end of this year, while specific products could save two-thirds of them. In first world countries, more than half of children have even taken drugs that are not approved for them, which means this technology offers an alternative. A rapidly growing biotech industry holds a strong potential for 3D printers to revolutionize the way medicines are manufactured and delivered to patients. That seems to be the path that FabRx is taking.

[Images: FabRx]

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