A pill is a pill. Or is it?
You may think that taking prescribed medications is a no-brainer, but think again.
Let's face it. Going to the pharmacy is a chore--something that we often dread when we have to wait in line after our doctor has called, e-prescribed or given us a paper prescription. While innovative bulk-mail delivery and local delivery remain options (PillPack and
Enter 3D printing of medications.
Scientists have developed a novel technique that may potentially change the way you not only think about, but actually take or adjust the dosage of your medications in the next decade—maybe sooner.
Thanks to novel filament technology that allows the 3D printing of pharmaceuticals, this new technique has the potential to disrupt longtime standards and traditions of the pharmaceutical industry, which have been based on manufacturing medications using a standard powder compaction method.
In fact, 3D printing has already begun to disrupt other facets of medicine including surgical subspecialties which require implants and prosthetics. Tracheal replacements, artificial joints and prosthetic limbs have now become quite common to read about in the news cycle.
MakerBot Replicator, the innovator of technology that allows the 3D printing of pills into specific geometrical shapes and sizes--translating into solutions for more rapid or sustained release kinetics—is betting that pharmakinetics can become an important driver of medication production for the consumer. This lends itself to the ongoing trend for the evolution of precision medicine, ultimately leading to the customization of medications.
It turns out that the surface area-to-volume ratio is an important property and determinant in kinetics of drug release. A pyramid and standard cylinder are not created equal—with the pyramid able to deliver drug more expediently based on kinetic studies. The take- away point is that the one-size-fits-all approach is not optimal for patients who require continuous adjustments in their dosage.
Researchers at the UCL School of Pharmacy, University College London have developed a technique using 3D printing referred to as “hot melt extrusion” to produce many odd shaped medications which are quite difficult to manufacture using standard production techniques. The true advantage of hot melt extrusion is that such odd shaped medications demonstrate improved kinetics for drug release.
Since we know that some patients require medications that are faster acting, while others need medications to be released more gradually over a longer period of time, 3D printing offers one the ability to customize medications for individual patient needs.
In addition, some patients require variable dosages of their medications, including blood thinners, immunosuppressants, or medication for seizures. By allowing the consumer to adjust dosages based on feedback from their healthcare provider, visits to physician offices and pharmacies could theoretically be reduced. This could even entail close communication with their healthcare provider, through a blue-tooth enabled medication monitoring device known as Helius, developed by Proteus Digital Health.
Some of the reasons that Pharma may want you to print your own medications from home in the future revolve around the issues of cost and access. Placing the consumer in charge could also offer theoretical advantages for persons living in remote or rural areas, where access to pharmacies is limited, other than bulk delivery of medications.
Critics of 3D printing for pharmaceuticals point out the potential for abuse in the home, especially for illicit drugs. While there may not be a reason to deal with a drug dealer in the future, those who embrace this technology could also be hit with malware or a virus which could affect the printing process, ultimately producing a harmful product.
But purchasing a printer and the raw materials is likely where the trickle-down economic effect of profit taking will likely occur. Whether cost shifting to the consumer will occur--if this technology is adopted--is not clear.
In the future, 3D printing your medications might involve a trip to the pharmacy to purchase the raw materials, or even a drone-enabled delivery.
Technology looking for an application?
While manufacturing standard tablets capsules and pills in bulk fashion certainly makes sense from a production and economic standpoint, some may question whether this is a technology looking for an application. How would this benefit the bottom line for a large pharmaceutical giant?
The answer may possibly lie with new economic alliances that could be formed by distribution networks, linking insurers, Pharma and medication management companies.
While the technology currently exits on a small scale, taking it to market will require refinement of existing technology resulting in higher speeds for more efficient 3D printing.
“I believe that 3-D printing is interesting, although I am not sure it will be a significant step for Pharma,” said Chris Rivera, President and CEO of the Washington Biotechnology and Biomedical Association, and founder and former CEO of Hyperion Therapeutics. “The future is genomic screening for each patient and developing a treatment/cure for that person. Companies likeAdaptive Biotechnologies, NanoString and Juno are on this track.”
“Traditionally, Pharma has not been on the forefront of innovation--I believe the next generation of precision medicine is already being developed by small to mid-size companies that are not wed to the traditional models,” offered Rivera.
Whether 3D printing-- if adopted--could bankrupt Pharma is unlikely. “But it could if the traditional models are deployed, explained Rivera. “Pharma is generally risk adverse.”
The important question is how and if 3D printing might fit in with payers and pharmacy benefits manager companies, and ultimately become part of reimbursement strategies.
“This is a critical question,” explained Rivera. “If this technology is not already being vetted with payers, it may not gain traction in the market.
“There needs to be evidence that the cost is worth the intervention, not only in the near term, but long term.” concluded Rivera.
