Breakthroughs in the 3D-printed drug market could have a resounding effect on the global healthcare system in the coming years. Notably, 3D drug printing is more popular than ever due to the multitude of benefits it provides. Now, a group of engineers from NIST have taken steps to create and integrate a quality-by-design (QbD) structure into the market. Here”s what you need to know.
The goal of the research is to raise the level of consistency and trackability of these devices while improving their ability to identify critical quality attributes (CQAs). Their findings have the potential to make pharmacies more flexible and improve consistency. As such, many see their research as a crucial step in driving mainstream adoption of 3D-printed drugs in the future.
3D-Printed Drugs
When you think of 3D printers, you probably envision a device creating some sort of plastic tool or item. While these are the most popular types of 3D printers, the technology has come a long way over the last decade. Now, it’s easy for manufacturers to print metals, composites, food, and even medications.
Source – NIST
These devices operate like traditional inkjet printers in that there are miniature ink wells that distribute their contents on a tray or capsules when directed. Each ink well can be fitted with a particular medicine, enabling the device to create precise and customized doses when needed. Additionally, these devices are also capable of printing the medicine as thin dissolvable mouth strips.
History of 3D Printed Drugs
The history of 3D-printed medication is an interesting story that spans multiple industries and technologies. Only recently have these devices become accurate enough to be able to handle these critical tasks. In 2015, an epilepsy drug called Spritam (levetiracetam) became the first 3D-printed drug to receive approval from the Food and Drug Administration.
This decision marked a huge shift in momentum, as it demonstrated that the concept of printing drugs on-site was now a reality. Since then, considerable effort has gone into improving the devices, logistics, and framework needed to support a 3D-printed drug industry. As such, the researchers’ study into improving the quality and consistency of these drugs seeks to create new standards that can help prevent miscalculations in the future in real-time.
3D Printed Drug Stats
There’s a lot of excitement surrounding the 3D-printed drugs movement. Healthcare workers and patients are eager to see these convenient and more accessible options go into services. According to researchers, the industry has seen a 7% growth rate annually and is expected to continue at this pace until 2025, when it is predicted to hit $437M in revenue.
Roadblocks to Large-Scale Adoption of 3D-Printed Drugs
3D printer manufacturers and users will need to overcome some concerns if they want to make these devices the future industry standard. The first concern is ensuring that the printers can accurately and consistently produce the required drugs. Automated stringent quality control measures need to be put in place before these devices can be relied on to create life-altering drugs.
Legal Concerns
Another major concern for manufacturers and pharmacies is legal ramifications. There are already many precedents set in terms of medical malpractice. Pharmacists have a lot of responsibility as they must mix and create the medicine their patients require. When they mess up on a prescription, it can have horrible results, including death.
In the past, these cases would be examined, and the medical practitioner’s actions would be reviewed for negligence. When dealing with an automated printing device, the idea of legal ramifications becomes more convoluted. Who is responsible for the printer errors? What if the error is in the prescription requested or the person the pharmacist gives it to? All of these concerns have left legal teams scrambling to find variable solutions.
Study
Understanding that quality control is by far one of the biggest obstacles that need to be overcome to drive this technology forward, a group of researchers from NIST has put together a unique way to help improve 3D printing results. Their cause-and-effect analysis enables developers to up their quality control monitoring while reducing workload.
The new protocol can measure the quantity of the drugs added, nozzle diameter, system pressure channels, and the number of drops dispensed (CPPs) for each drug printed. This detailed report enables printer healthcare practitioners to evaluate their approaches and reduce inefficiencies. It also helps to create safety standards while evaluating best practices concerning ensuring the accurate dosage.
The study integrated LEDs and photodiodes at the nozzles of the 3D printer. These lights are designed to measure consistency, ingredients, and other key metrics of the drug creation process in real-time and onsite. It’s vital to understand that onsite quality control is a crucial step toward improving the sector’s quality procedures.
Researchers
A team of engineers from the NIST research facility, led by scientist Thomas P. Forbes conducted the study. Their goal to introduce a quality-by-design protocol to the industry has proven to be successful in determining the critical material attributes (CMAs) and critical process parameters (CPPs) needed to improve the pharmaceutical manufacturing paradigm.
Framework
The research team’s work didn’t end with onsite quality control. They continue to put effort into developing, deploying, and managing the necessary infrastructure needed to support a 3D-printed drug economy. These tasks include creating pharmaceutical ingredient manufacturers and improving the distribution methods in place wherever possible.
Test
The researchers began their test by reviewing the ingredients. Medicines can degrade for many reasons, so all ingredients must undergo a quality control test before use. To accomplish this test, the team employed ultraviolet-visible (UV-Vis) spectroscopy.
This quality control method leverages ultraviolet light that gets shone on the drops of medicine. The reflected light can then be used to determine the chemical composition of the medicine. Notably, each nozzle has one of these quality lights attached to it at the tip.
Each drop must pass through the ultraviolet lighting, ensuring that there is quality control data on each drop used. This method enables researchers to ensure that the nozzles are working, and are free of particles from dust, dirt, or other contaminants.
Results
The study’s final results showed that the lighting system significantly improved quality control. The researchers could consistently track uniformity using the low-cost, onsite method. Notably, levothyroxine sodium single-dose liquid vials of glycerin/water were used for the test because they can be quickly checked for quality control. Specifically, the team measured the inline drop counting during dispensing with exact accuracy, the volume of each drug added, and other crucial data points.
Benefits that 3D Printed Drugs Bring to the Market
It’s easy to see that 3D-printed drugs could be the way of the future. They provide the advantage of being created onsite. Imagine walking into your local pharmacy, handing them your prescription, and an automated printer creating the precise doses you need.
This strategy would represent a major upgrade to the current methods of distribution that require human interactions along the journey. Each human interaction raises the risk of an error. If the researchers’ work can be completed successfully, these 3D-printed drugs will be more effective and accessible for all.
Individualized Healthcare
Another major benefit of this approach is that medicines can be customized to fit the patient’s specific needs. For Example, 3D-printed drugs can take into account a person’s key metrics including their age, health, immune system, and even their genetic profile. This approach will make remedies more effective and less dangerous for users.
Combined Drugs
For those who need to take lots of medications daily, the prospect of a 3D printer combining pills into one daily option is a huge plus. Seniors who forget their daily pills or others suffering from extensive medical requirements will gain a better quality of life using these machines.
Vaccine distribution
Another key area where 3D-printed medications could improve the current system is vaccine distribution. During the COVID-19 pandemic, the world got to see the difficulty in distributing vaccines to the population. Remote areas and other off-track locations were the last to receive the vaccines.
In the future, distributed and point-of-care (POC) manufacturing facilities will dominate the market. These locations will leverage 3D printers to provide their patients with advanced healthcare options including personalized medications designed specifically to meet the needs of the patient, saving hospitals the trouble of figuring out a reliable distribution strategy.
Better Tasting Drugs
It may not seem like a major issue, but the taste of drugs is a concern for developers. Children, in particular, are more likely to consume their prescriptions if they don’t taste horrible. The age-old saying, “Just a spoonful of sugar helps the medicine go down” will soon be obsolete as 3D printers will be able to make nearly any flavor of medicine when desired.
Companies that Could Benefit from the Results of this Study
Several healthcare and drug providers could leverage this research and drive their businesses forward. The 3D printing healthcare movement is in full swing, and some major contenders have been pioneering these efforts for years. Here are a few companies that could see serious revenue boosts from these discoveries.
Aprecia Pharmaceuticals
Aprecia Pharmaceuticals is a US-based commercial-scale pharmaceutical manufacturer that continues to pioneer the 3D printing sector. The firm has accomplished some notable milestones, including being the first provider to get a 3D-printed drug (levetiracetam) approved by the FDA. These developments place Aprecia Pharmaceuticals at the forefront of 3D printing in the medical revolution.
Stratasys Ltd. 
Another pioneering manufacturer that has the potential to capitalize on this research is Stratasys Ltd. This healthcare and medical tech firm provides a lot of products designed to improve surgical planning, doctor training, and patient-specific models. As such, the company holds a strong position in the market as a pioneering force.
Stratasys stock is considered a strong “hold” due to the company’s positioning and research. The manufacturer has made some internal changes as well that have helped entice more investors to its cause. Specifically, this year saw the appointment of Amir Kleiner as Chief Operating Officer. This maneuver improved company operations and stock prices.
Future of 3D-Printed Drugs
The future of 3D-printed drugs is going to be exciting to watch. These devices will continue to get smaller and more reliable. Additionally., their support network will improve. Soon, you could see a doctor send a patient home with a printer that will automatically produce the drugs needed depending on their ailment.
3D Printed Drugs Improve Healthcare
It’s easy to see that 3D-printed drugs are the future of the healthcare industry. Shipping and travel are two of the biggest risks to medicines, and they can degrade quickly in the wrong temperatures, locations, pressure, and environmental factors. The quality control measures introduced by the NIST research team have the potential to raise the bar and create reliable standards that will help the entire 3D-printed drug market develop consistently and transparently.
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