Jan 2, 2016 | By Kira

There is no doubt that when it comes to the medical industry, 3D printing technology is having a revolutionary, life- and cost-saving impact. From 3D printed custom prosthetics, to 3D printed surgical implants, to 3D bioprinted tissue, the technology is giving both doctors and patients an unprecedented understanding of the human body, and the unbelievable capability to repair, alter, and improve it. One of the more rapidly-developing areas of medical 3D printing is customizable 3D printed pills, which are already in development and could very well change how we treat serious and common medical conditions, from epilepsy to chronic pain, on a patient-specific basis, making medications customizable and therefore cheaper, more accurate, and more effective than ever before.

So far, researchers have been able to 3D print custom shapes for powder-based and even liquid medicine tablets in order to make them more appealing and easier to swallow for children. New Jersey-based pharmaceutical company Aprecia also made headlines this year when it became the first company to receive FDA approval for a 3D printed prescription drug with incredibly rapid-dissipation properties, designed to treat seizures in epileptic patients.

The most recent study in favor of 3D printed pills comes from North Carolina’s Wake Forest University, where researchers developed a computer algorithm to design and calculate dosages according to patients’ biological and clinical parameters instead of using pre-determined dosages. The algorithm could then generate 3D printable files, resulting in 3D printed pills that proved to be highly accurate, increasing effectiveness while reducing unwanted side effects.

While traditional, pre-formulated medicines do not take into account the patient’s weight, race, or kidney and liver functions, this information can dramatically affect the pills’ effectiveness. This ‘one-size-fits-all’ approach to medicine can in fact be more harmful than helpful to patients in need. Thus, Wake Forest’s research focused on computational algorithms and precise 3D printing technology could be leveraged to produce completely personalized, 3D printed medications. Also known as “pharmacogenetics,” this method seeks to match patients to drugs based on DNA information, providing care, treatment and medicines customized to the individual's specific needs.

The research team, led by Min Pu, MD, professor of internal medicine at Wake Forest, developed a prototype computer algorithm, including software for 3D printing with dosage-adjustment information. Patients’ individual medical and biological characteristics are entered into the system, after which the software calculates optimal doses of the medication in question and generates 3D printable data.

For the research trial, the Wake Forest team tested the accuracy and variability of five different doses—80 3D printed pills total, ranging in dose from 124 mg to 373 mg. The researchers 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, 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.

“Our study uses the volume-concentration method to generate 3D-printed pills. What's different from current pharmaceutical industrials is that we use a computer algorithm to design and calculate dosages according to patients' biological and clinical parameters instead of using pre-determined dosages. Therefore, we can instantly create personalized pills. These personalized pills are then converted to 3D printable files and the pills can then be accurately printed using a 3D printer,” explained Dr. Pu in a presentation to the American Heart Association Scientific Sessions (AHASS) in November.

While the findings are still preliminary and will require further testing—including research into a standard adjustment formula for individual drugs as well as cost-effectiveness—they are nevertheless extremely promising. “It will change how medicine is practiced and taught and how healthcare is delivered. It will change the way research and development is regulated,” said Dr. Pu. He added that this new method is not aimed at replacing current pharmaceutical practices, but rather as a potential option for doctors treating specific medical conditions, or for patients with specific issues, such as difficulty swallowing, or the need for several pills that can in fact be combined into one.

So what does Wake Forest’s computational algorithm for 3D printed pills, or the FDA’s approval of Aprecia’s 3D printed Spritam, truly mean for the future of medicine? The benefits—and complications—are numerous. One the one hand, 3D printed pills provide several key advantages:

  • By bonding powdered drugs between liquid materials at the microscopic level, 3D printed pills can be made to be extremely porous, meaning they dissolve rapidly on contact with liquids and are much easier to swallow for children, the physically impaired, or people experiencing seizures
  • By altering the pills surface area by 3D printing complex shapes, doctors can control the strength of a released dose as well as the time over which it’s released
  • Computational algorithms can take into account biological factors, including weight, age, race, kidney and liver functions to optimize the drug’s dosage and ingredients, increasing effectiveness while reduce side-effects
  • Small batches can be produced based on individual preferences, pill size, flavors, and colors
  • Manufacturers can shift production and distribution closer to consumers. Hospitals could even manufacture drugs on-demand, eliminating the need to stock large quantities of generic formulas
  • Patient-specific drugs could be manufactured in-house, reducing waiting times and potentially saving lives in time-sensitive situations
  • In the long-term, patients might even be able to download prescription drug ‘recipes’ and 3D print them at home

On the other hand, 3D printed medication opens the door to several concerning possibilities. For example: 3D printers or 3D printing software that have been tampered with to produce counterfeit medications, or 3D printers used to manufacture and mask illegal drugs on a mass-scale. On the legal side, drug regulation authorities, such as the FDA, will need to establish strict and guaranteed guidelines to ensure the mass-marketing of 3D printed drugs is safe, reliable, and safeguarded against human error. 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. As with so many of the questions related to 3D printing and the law, it may take years of trial and error, or case-by-case studies, before satisfying solutions are found.

Nevertheless, the promise of 3D printed pills and entirely personalized medical care through computational algorithms and 3D printing data is far too attractive to ignore. While it may be some time before a ‘bespoke pharmacy’ opens near you, when it comes to technologies that have the undeniable power to save lives, we can rest assured that this is just the beginning of the personalized, 3D printed medical movement.

 

 

Posted in 3D Printing Application

 

 

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Ralph Resnick wrote at 1/2/2016 11:37:05 PM:

I continue to be amazed at how before our time the original MIT 3D Printing licensee family was! http://www.mit.edu/~tdp/medical.html



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