Three dimensional (3D) printing is the latest buzzword ricocheting through high-tech industries and moving into all corners of research.
In fact, 3D printing is now so wide-spread that it is just as likely to be found in NASA’s laboratories as your next-door neighbour’s garage.
In come the chemists
While it’s relatively common to see tangible, macro-scale objects being 3D printed, shrinking this to the ‘molecular level’ still seems like science fiction
However, recent advances have opened up 3D printing to the world of chemistry.
In earlier blogs we’ve explored 3D printing of lithium ion batteries 3D-printing: a breakthrough in battery technology and 3D printable chemical reactors 3D printing and its layers of legal complexity.
With these tools starting to mature, it’s perhaps not surprising that medicines are the next target for 3D printing.
Moving into medicine
The medical sector has long made use of 3D printing for prosthetics, joint replacements and implants as it enables complete customisation of the article to suit the patient.
For medicines themselves, 3D printing is most commonly used for transforming active ingredients into a receivable dosage form. Although the active ingredient is key to giving a therapeutic effect, delivering it effectively to where it is needed, in the right amount and at the right time is just as important, but is often trickier.
FabRx and their “M3DIKMAKER” printer were the first to succeed in pharmaceutical 3D printing. Their printer works by extruding a molten drug-impregnated filament or a drug-powder mix through a nozzle, and depositing it onto a build plate. Layers of solidified deposit are then built up to form a pill. The nature of the filament is varied to alter the release profile, while the shape/size of each pill is used to adjust the dose.
“Polypills” can also be produced, which have multiple active ingredients. This allows for an infinite customisability to the dosage, shape, size, active combination, and release profile. This is highly sought after with the rise of personalised medicine, where treatments are no longer ‘one-size-fits-all’, but are customised on a patient-by-patient basis.
Despite this, the only regulator approved 3D printed drug is Aprecia Pharmaceuticals’ Spritam (approved in 2015). The anti-epileptic drug is adapted for pre-gastric absorption, which can be difficult to achieve at higher doses using traditional tablet fillers or capsules.
The pill, printed using Aprecia’s own ZipDose technology, dissolves virtually instantly upon contact with water – allowing for high doses to absorb directly into the oral cavity. The ZipDose method drops liquid binding agent onto a pharmaceutical-impregnated powder. The liquid unifies the powder, before more powder is added over the top, and the process is repeated to build up sequential layers of a pill.
This results in a porous internal structure, allowing for the rapid liquid impregnation and dissolution of the pill. As for the FabRx system, the size, shape and dosage of the pill can be customised to suit the patient.
Aprecia recognise that this has big benefits for patient compliance. Their pills are easier to take as no swallowing is required, and the high drug loading means fewer pills are needed per day – ultimately meaning patients are more likely to adhere to their treatment course.
Looking to the future, it’s possible that patients taking multiple pills a day might be able to switch to a single, combined pill which is 3D printed to their specification. Again, this reduces the burden on the patient meaning compliance, and consequently the treatment outcome, are improved.
Quality and intellectual property
Another key benefit of 3D printing, verses traditional manufacturing, is the decentralisation of manufacturing sites. So, while the raw active ingredients are produced centrally, the pills themselves could notionally be printed at your local pharmacy – in the same way that McDonalds makes their Big Mac® sauce in a factory, but each burger is assembled in store.
For such a heavily regulated industry, it’s yet to be seen how regulators, and big-pharma, could ensure that the quality of active ingredients is maintained in locally printed pills. However, it’s worth noting that pharmacies have long been preparing medicines on site, so perhaps this is just a modern twist on extemporaneous dispensing.
The dispersal of the supply chain in this way also makes for some tricky questions where intellectual property is concerned. As discussed in our recent blog, IP protection for 3D printed inventions, a broader set of jurisdictions and a more multifaceted network of IP rights might be needed to protect 3D printed products.
These considerations are perhaps less relevant if patents cover the active ingredient itself (as the active is still likely to be manufactured centrally), but for patents directed to pharmaceutical compositions, dosage forms or medical uses, it is unclear how enforcement will play out if the pills are made ‘locally’. Moreover, it is yet to be seen if exemptions to patent infringement for extemporaneous preparation of medicines stretch to 3D printing.
There is no doubt that medicine is becoming increasingly personalised, and it seems 3D printing is a partner which should accelerate this change.
However, the lack of regulatory approval for new 3D printed pills, and the high initial costs associated with this brand new technique may be dampening progress in this area – and perhaps explains the reserved approach taken by big-pharma so far.
On the other hand, the pandemic-induced ‘healthcare boom’ could now push 3D printed medicines over the line, as the industry looks to the sizable long-term potential of 3D printing in medicine.
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