It’s an integral part of sci-fi. Even Star Trek had the Replicator that would print food for the hungry crew in 3D. The Replicator was designed to build a tasty meal by mixing material in the right combination to provide the desired texture, smell, taste and shape instantly.
Forget food, 3D printers have gone beyond that to print a human heart that beats. And in the world of pharmaceuticals, 3D printing can now make medicines tailored to your needs. In a first such move, FDA has approved the first 3D-printed (3DP) drug.
A medicine for you, and you alone
The idea behind 3DP medicines is that it can be customized to an individual’s medical requirement. If the dosage of medicine is 11 mg of a particular chemical, or if a patient is allergic to a certain compound that can be replaced with a more suitable one, a 3D printed drug can make it just that way in a safer and more effective manner. Even better, the size, dosage, appearance and rate of delivery of a drug can be designed to suit an individual’s requirements.
In the last half a century, drugs were manufactured as tablets in factories and shipped to hospitals and pharmacies. 3D printing now provides a means to produce tablets much closer to the patient and tailored to be more effective. One such example is the FDA approved Spritam that was 3D printed to create a more porous pill which is easier to swallow. Being porus allows Spritam to rapidly disintegrate with a sip of liquid and is believed to help epileptic patients swallow the medicine with ease.
Spritam has been created using Aprecia’s ZipDose technology that utilizes a three-dimensional printing platform. The process involves stitching multiple layers of a medicated powder using a fluid to produce the pores. It also has a water-soluble matrix that rapidly disintegrates when it comes in contact with a liquid. The ZipDose platform does not rely on compression forces or molding techniques that can otherwise limit dose ranges for orodispersible medications. Instead, it utilizes a technology that can achieve high doses (up to 1,000 mg) while maintaining rapid medication disintegration. Aprecia has the rights to more than 50 patents related to pharmaceutical applications of 3DP, and has filed patent applications to protect the proprietary manufacturing system through 2033. However, it’s ZipDose technology is strongly based on patent US 8,888,480.
3D challenge to patent owners
While patent owners make hay during the 20 years of patent protection that shines over them, it is the generic drug manufacturing industry that gleans for decades after the 20-year shield fades away, under the FDA’s watchful eye.
While 3D printing of drugs is sure to open doors to sophisticated healthcare, there is a huge IP infringement hole that gapes are patent holding pharma entities. With 3D printers, individual pharmacies and smaller entities may be able to reverse engineer and copy patent-protected drugs easily.
Also, the FDA does not seem well equipped to monitor regulations with regard to customized 3D printed medicines. The next step forward is for pharmaceutical companies to consider manufacturing 3D printed medicines in a regulated environment with validated software, controllers and deposition systems in place. Until there is a global consensus in this regard, 3DP medicines will require substantial discussions on regulations and require innovative thinking.
(Featured image source: https://pixabay.com/en/medications-capsule-capsules-health-3322081/)