3D print gives enormous possibilities to the medical industry. Thanks to it, it is possible to produce f.e. implants and prosthesis. We wrote several times about its application during surgical operations or in less invasive cases, like for example dental surgery. But at the same time, an area, where this technology has still not became popular is pharmacy, so 3D printing of medicine.
In August 2015 FDA (Food and Drug Administration) officially approved to distribute spirtam – a medicine against epilepsy in form of 3D printed pills produced by Aprecia Pharmaceuticalis from Pennsylvania. Its distribution began one year later. Because of the fact, that this branch of industry is relatively not developed, there are a lot of facts and myths about it, which I would like to explain.
Although the information about distributing the drug against epilepsy produced with 3D prints came to light in August 2015, the conception is not brand new. The first attempts were carried out almost 20 years ago – in 1997. Researchers from pharmaceutical company Therics from Ohio established cooperation with the Massachusetts Institute of Technology, to prepare a 3D printed medicament. This enterprise came unfortunately to grief. An analyst Terry Wohlers (a founder of Wohlers Associates) claims, that the market wasn’t ready than for such a breakthrough and the company returned the pharmaceutical rights back to MIT. So, distribution of 3D printed medicine on the market is something new, but the idea of manufacturing them is almost 20 years old.
The 3D printed tablets of spirtam differ from standard ones. They have different composition and properties. 3D print lets to produce pills containing up to 1000 mg of medical substance. It is essential, because a normal dose is only 50 mg. When it is bigger, tablets don’t solve as easily. Why is it so important? A good solubility of medicine is a key matter for people who have problems with swallowing. It concerns a huge group of patients: children, people older than 65 years, suffering from Alzheimer, tumours of neck and diseases of the nervous system. A video, which I am presenting below, shows the difference between a normal pill and the medicine worked out by Aprecia.
Aprecia Pharmaceuticalis patented its own system for 3D printing of medicine called “ZipDose”, however the process proceeds conventionally. The technology bases on combining powder and liquid mixtures to create a porous pill that dissolves quickly on contact with liquid. The process involves spreading a thin layer of powder followed by droplets of liquid, according to a pre-programmed design, which is repeated for 20–40 layers. On drying, the printed regions bind together.
Aprecia Pharmaceuticalis is the first company, which product was approved by the FDA. Working on it and completing of formalities connected with its distribution took it 12 years. The company is going to work out the next three 3D printed drugs, but it requires a lot of time. Wohlers stresses, that Therics 3D printed several pills. There were only experimental attempts and none of them was destined for commercial use.
3D printing helps to personalise medicine. As I mentioned in point no. 2 – the 3D printed pills are more soluble, what is an unquestionable advantage for patients who have problems with swallowing. Important is also increasing of dose of the substance to 1000 mg. This idea was also took up by a group from the Wake Forest University in North Carolina, which developed a computer algorithm to design and calculate dosages according to patients’ biological and clinical parameters instead of using pre-determined dosages.
The algorithm generates 3D printable files, resulting in 3D printed pills that proved to be highly accurate, increasing effectiveness while reducing unwanted side effects. The system selects a proper dose according to the DNA of a patient an his physical parameters (like f.e. height or weight).
The researchers from the Wake Forest tested the accuracy and variability of five different doses—80 3D printed pills total, ranging in dose from 124 mg to 373 mg. They found a high rate of reproducibility, with standard deviations ranging from 3 mg to 5 mg, and little variability. They also observed differences of just 0.5% to 0.6% between the printed pills and standard computer-generated volumes, which, according to Dr. Pu, who managed with the team, shows that using 3D printing to produce personalized pills is not only possible, it is potentially a new method for formulating powerful medications and treating patients with more accuracy
3D printing of drugs is not developed, but it is clear, that a lot of pharmaceutical concerns will invest in it. Aprecia Pharmaceuticalis is preparing the next 3 projects. This technology will help by producing of so-called “tailor-made medicine”, according to patients’ biological and clinical parameters like: weight, height, race, diseases of kidneys or leaver instead of using pre-determined dosages. It can help to eliminate side effects and problems with swallowing them. Probably hospitals will order preparations like that, nonetheless it will be rather a niche phenomenon. In the long-term, patients might even be able to download prescription drug “recipes” and 3D print them at home, but for the time being, it’s just a dream.
On the other hand, popularisation of 3D printing of medicine can mask production of illegal drugs on a mass-scale. Distribution of medicine requires approval of special institutions, but in the case of technical errors or malfunctions that result in physical harm to patients, legal authorities will need to determine whether the 3D printer manufacturer, drug company, or another party is to blame.