Pharma and Health from Ingredients to Pills: 3D Printing for Personalized Medicine

Personalized medicines are becoming more popular as they enable the use of patient’s unique characteristics which could play a vital role in the treatment of life-threatening diseases. (1) The goal of personalized medicine is to ensure that each patient is treated as an individual and pair them to the precise solutions for their ailments, that includes all the aspects of varying dosage, duration, release profiles, and combination of multiple medicines. Such technology would be a significant step in helping to make sure medications are accepted by the body, thus reducing the chances of undesirable side-effects. 

3D printing technology for personalized medicine has already been used in the medical field to aid in the production of components for replacement limbs, joints, etc. However, until relatively recently its capabilities had been untapped in the realm of pharmaceutical manufacturing.  With recent FDA approvals, and a road path to regulation, the novel design of personalized medicines is getting the green light to move past the R&D phase. (2) 3D Printing in the Pharmaceutical Sector Imagine a future where a doctor or pharmacist could take a prescription, complete with specific biological data about that particular patient, feed it into a computer, and have a machine automatically start producing tablets, which can be easily adjusted in the size, appearance and shape. However, dosage strength becomes relevant, as different patients with various conditions can benefit from higher or lower strengths of medicine than would be provided as standard, when it comes to those drugs designed to help patients give up harmful habits, such as nicotine or illegal drugs.  Consider, if you will, a 3D printed course of methadone medication that gradually reduces in strength as the addict weans, but with the option of bringing the dosage back up in the event of a relapse. (3)
3D printing can also be used to personalize medicines in other ways. Size, shape, color, texture, and flavor can all make a drug more, or less, appealing, especially regarding children. By experimenting with different combinations of these qualities, drug makers can facilitate and improve medicine taking adherence, a significant obstacle to effective healthcare.
3D printing technologies can also aid the drug discovery step.(2) With the ability to “dial in” specific formulations, small scale batches can be created and evaluated in a fraction of the time and potentially at a significantly cheaper price point.  Being able to alter a formulation on the fly through the software would be greatly beneficial to the chemists involved in this step of the drug pipeline. Spritam is the First 3D-printed (3DP) Medicine
The 3D printing is a novel approach of producing 3D pharmaceuticals from digital designs, in a layer-by-layer fashion. The first 3D printed drug Spritam was approved by the FDA in early 2016, by Aprecia Pharmaceuticals. This technology allowed for the drug to be capable of dissolving with just a sip of water. In 2018 this resulted in the FDA commissioner indicating that the agency will begin to create a clear regulatory pathway for the manufacturing process of 3D printed drugs. He went on to indicate that 3D printing along with other advances in manufacturing processes could wind up saving $60 billion per year in the US if they are adopted. (3)
A separate technology developed by the company, known as ZipDose, makes high-dose medications easier to swallow. The technology produces rapidly disintegrating medical formulations in the same manner as other oral medicines which meant it could package up to 1,000 milligrams into individual tablets. On the other hand, an inkjet process prints aqueous fluid onto layer upon layer of powdered medication to produce a water-soluble drug without compression or any other traditional molding techniques.

“It’s exciting to see the ways 3D printing is being used in the medical environment,” said Editorial Director for Future Medicine, publishers of Journal of 3D Printing in Medicine, Laura Dormer. “To date, this has predominantly involved printing of plastics and metals, such as surgical planning, prosthetics, or reconstructive surgery. Surgeons are now able to 3D print accurate models of their patients’ organs, allowing them to plan complex procedures with a higher degree of confidence than with imaging alone. 3D printing of pharmaceuticals is less advanced but offers an exciting opportunity for the future.” (3) Challenges
3D printing is revolutionizing the pharmaceutical expectations towards customized medicines. Along with the need to develop the regulatory landscape to bring 3D printing out of start-up R&D labs, there are still several challenges faced by introducing the novel technology to industry.  While not insurmountable, it will take time for industry adoption to become viable as currently the industrial model is that of large batch manufacturing.  Shifting the industrial paradigm always incurs the challenge of funding.  With major companies less than excited to invest in a technology which will cost them a lot in the short term to retrofit plants, those researching 3D printed pharmaceuticals are relegated primarily to small start-ups and academic research centers who rely on grants and donor funding.
Large manufacturers can argue that all of the capabilities that 3D printing brings already exist in their plants.  By sacrificing the time component that 3D printed technologies hold an advantage in, a pharmaceutical company can develop small batch runs indicated for a particular need.  While not a cost effective for the patient, it does not require any changes to the production facility.
Furthermore, the reproducible consistency of printed medications has still yet to be significantly studied.  All 3D printers have some degree of error
associated with their print.  While usually small, this needs to be better studied to address lot stability and efficacy in the long run.   

Conclusion:
With various market sectors already flocking to 3D printed technologies, pharma is primed for the large-scale introduction of such technologies.  With the 2016 approval of medication utilizing this technology and the FDA acknowledgement of the need to develop clear pathways towards regulation, the technology itself could outpace the regulation in market adoption.
While funding is currently a bottleneck for the development of large production capabilities, small organizations and universities continue the push for market introduction. For large pharma to scale up the manufacturing of drugs via 3D printing, they will first have to see clear cost and time benefits.
3D printing drugs is driving the pharmaceutical industry towards personalized medicine. The introduction of such technologies could allow doctors and/or pharmacists to produce individualized medicines on an as needed basis on the spot for management of certain ailments.  Scientists and pharmaceutical researchers believe that 3D printed technologies may be an answer to most of the problems associated with drug intake. 
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References: 

1 Curr Pharm Des.   2018;24(42):5062-5071. 

2 Outsourcing-Pharma.  (2019) https://www.outsourcing-pharma.com/ Article/2019/02/01/Personalized-medicine-enabled-by-3D-printing.  

3 ManuPharma. (2020). https://manupharma.wbresearch.com/blog/ could-3d-printing-solve-the-challenges-of-personalised-medicines. 

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.

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