Developed at the Massachusetts Institute of Technology (MIT), computer-aided 3D-printing technology has opened up exciting and revolutionary new possibilities in customized medicines.
Aprecia successfully deployed the technology and developed the world’s first 3D-printed Spritam (chemical name: Levetiracetam), a drug to treat seizures in epileptic patients. Produced by sandwiching a powdered form of the drug between liquid materials and bonding them at a microscopic level, these printed pills are superbly porous and dissolve rapidly on contact with liquids. It’s an unparalleled feature for sure, and one that makes it remarkably effective in its core purpose — countering sudden seizures.
3D printing has enabled the creation of high-dose rapid-dissipation pills, affording doctors reliable customization and complete control over the speed and strength of delivered dosage.
By simply altering a pill’s surface area through the printing of complex shapes, one can control not only the strength of a released dose but also the time over which it’s released. This goes a long way toward making administered dosage safer and far more effective.
Manufacturers can also modify their products according to individual preferences, with customized dose strength, pill size, flavors, and colors to choose from. Assuming easy availability of pharmaceutical compounds in powder form, patients can ditch unwieldy tablets, capsules, or liquids in favor of medicines that are far easier to consume. Customizability is especially useful when preparing doses for patients who find swallowing difficult, such as young children or the physically impaired.
3D printing represents a significant breakthrough in an era of customized medicine and tailored treatments.
This breakthrough technology could also allow manufacturers to shift their production and distribution processes closer to consumers. With constant improvements in design and operational efficiency, printers of varying sizes and capacities could be deployed at bespoke locations that are convenient for patients. Hospitals and pharmacies could manufacture prescriptions on their own premises, eliminating the need to stock vast quantities of generics. They would also be able to produce specialized or uncommon compounds in-house, saving patients a considerable wait, and perhaps saving more lives in time-sensitive critical situations. With such flexibility and scalability afforded to supply chains, both suppliers and consumers can benefit from the low costs and prices that operational efficiencies bring.
Some speculate 3D printing will become so commonplace that patients could even print their own drugs at home.
The technology could, in theory, allow users to print drugs of any size, shape, and dosage with ease. All they’d need is a downloadable recipe, basically a set of instructions that the printer reads and follows. As long as their home printer is stocked with the necessary base compounds, they could synthesize any and every formulation they’d need. It’d be just like using recipes from a cookbook, only it’d take only half as much work:
To make a batch of cookies you’ve never made before:
- Find the recipe you want
- Download a copy
- Print
- Follow the recipe
- Bake
- Clean up after yourself
To make a batch of pharmaceutical prescriptions you’ve never made before:
- Find the recipe you want
- Download a copy
- Print
When it’s easier to make a batch of pills than it is to bake cookies, it ought to make you wonder.
While there’s little scope for tampering in current pharmaceutical manufacturing processes, there’s some concern about its likelihood when implementing 3D printing methodologies. There’s also the possibility of hacked machines producing counterfeit medications or being used to mask illegal drugs as legitimate medication.
The wide reach and global nature of such technologies also means the lines for liabilities are blurry.
Drug companies would need to ensure that their products’ recipes and regulatory norms are adhered to. They’d have to ensure foolproof print processes that are safeguarded against human error as well as sabotage. They would also need to ensure their devices are well secured in case unscrupulous entities try to reverse-engineer proprietary products. Drug regulatory authorities would also have to establish unprecedented guidelines for the approval of mass-marketed 3D-printed drug products.
More importantly, in case of technical errors or malfunctions that result in incorrectly printed dosages that cause harm to or the demise of a patient, who is to blame?
Does the onus fall on the drug company that created the recipe, on the patient who printed the recipe, or on an intermediary that manufactures doses or maintains the machines?
While there are several significant concerns that need addressing before 3D pharmaceutical printing technology goes mainstream, the benefits are well worth the bother.
This technology stands to revolutionize the pharmaceutical manufacturing industry, with possibilities that sound straight out of science fiction. Pills created to release a cocktail of drugs over definite intervals could wrap up a whole day’s worth of dosage into a single, easy-to-swallow pill. Tell grandpa to toss out that old pill organizer; he’ll get everything he needs from a single tab, no fuss or chance to forget. Imagine the possibilities for specialized pills that treat niche ailments, which can be developed and produced at a fraction of current costs, all tailored to your prescription and individual preferences.
making it cheaper because the whole process of testing drugs would become more efficient. While the home 3D printing of drugs may not be possible any time soon, it might be possible to 3D print sample tissues and organs for drug testing purposes. Imagine testing out drugs on 3D human organs instead of on animals or synthetic models. And 3D printing might allow for new types of compounds and medications, based on new geometries and configurations made possible with 3D printing.
Of course, the big wildcard in all this is the approval process of the FDA. Yes, this is the same FDA that sometimes gets blamed for the long process of bringing new drugs to market quickly and efficiently. Add in the “gee whiz” aspect of 3D printing, and it’s easy to see potential regulatory nightmares facing other FDA approvals.
We may never do away with the need for the corner pharmacy to fill prescriptions – but 3D printers could fundamentally change the way patients take certain types of medicine. 3D printers could make possible a world of bespoke medicine in which patients play an active role in bringing their own custom-designed pills to market.
