Aprecia Pharmaceuticals has been granted several patents to print drugs, using 3D printers to make pills. If that’s not unusual enough, the FDA has already approved the first printed drug, Spiritam, and it will be available shortly. Spiritam is an anti-seizure medication that can be used to treat some types of epilepsy.
3D printers using plastics and other compounds are already being used to in medicine to make some simple organs (or organ segments) like tracheas 3D printers have already fashioned some superficial body structures like ears and noses that can be used to replace those damaged by trauma. As research and technology advance, 3D printing may soon allow the production of whole organs. This would be an incredible advance in organ transplantation.
There are about 125,000 people in the U.S. on various transplant lists (heart, kidney, liver, etc.). Many die while waiting for a transplant to become available. For example, almost half of those waiting for a kidney transplant who are age 60 will die before a donated organ becomes available. When 3D printed organs become available, the number of available donors won’t be a limiting factor for transplants. Additionally, it’s possible that some on the transplant list will be able to get replacement organs made from their own cells, eliminating the risk of rejection.
But back to Aprecia and it’s printed drug. Why is this such an advancement?
The vehicle the drug is in makes it dissolve really quickly. That allows it to be absorbed faster than other oral medications. But that’s small potatoes compared with the much more important issue. The patient’s medication can be dosed individually for that patient. No more one-size-fits-all dosing.
Now medications come in a set number of strengths. So, when a doctor writes a prescription, they may only have one or two strengths to choose from. Sometimes that’s not a bad thing. However, if the patient has a concomitant disease, like liver disease, and the prescribed drug is detoxified by the liver, the doctor may not want to use that particular drug because it may make the liver disease worse. If things go well, he may be able to find a different drug that may be detoxified by the kidney and be able to use that instead. But that isn’t always an option.
Sometimes, there is no alternative drug that won’t worsen the liver disease. That leaves the choice of treating the disease with the newly added drug and hoping that the patient’s liver doesn’t fail, or not adding the new drug and hoping that the patient can get through without it. Neither one may be a good choice.
But with printable medications, it would be easy to print a smaller dose of the new medication — one that might work to cure the new disease without worsening the underlying liver disease. Just program the printer to make a 100 mg drug instead of the 350 mg drug, which would normally be the only option. If the 100 mg dose doesn’t seem to be working, then have a 125 mg dose printed. Those lower doses may be enough to do the job without causing additional liver problems. We could titer the strength of the drug to do just what we need it to do, reducing the risk of harmful side effects.
Of course, printable individualized dosing is still in the future. Right now the FDA has only approved Spiritam to be made like this. And right now, Spiritam will only be available in four strengths. However, using the 3D printer techniques is opening the door to individualized dosing. More similar drugs could be on the way soon.