Is 3D Printing the Answer to Custom Medication with One Pill Solution?

June 4, 2024 TruthUSA

While 3D-printed pills promise personalized medicine, safety and regulatory challenges remain.

Imagine a future where every pill is tailor-made for you. No more juggling multiple medications at different times of the day. Instead, a single pill could deliver all the drugs you need precisely when you need them. University of Nottingham researchers are working to bring this vision to reality.

Custom Pills With Precise Drug Release

The research, led by Dr. Yinfeng He, utilizes multi-material inkjet 3D printing to create custom pills capable of delivering multiple drugs at controlled rates. This method integrates different medications into a single tablet capable of releasing each drug at specific times as tailored to individual patient needs.

The key to this innovation is a material called poly-4-acryloylmorpholine (poly-ACMO). This water-soluble material can be combined with an insoluble substance, enabling the creation of tablets that release medication at varying speeds—slow, fast, or in stages.

The research team used ultraviolet (UV) light to print and solidify the tablets, demonstrating the effectiveness of their method for creating customized medications. They applied this technology to incorporate aspirin into their formulations.

“This is an exciting step forwards in the development of personalised medication,” Dr. He said in a press release. “This breakthrough not only highlights the potential of 3D printing in revolutionizing drug delivery but also opens up new avenues for the development of next-generation personalized medicines.”

Simplifying Medication Regimens

This new technology could benefit patients with complex medication schedules, particularly those with chronic conditions. The authors said that by combining multiple drugs into a single pill, the regimen becomes simpler, making it easier for patients to adhere to their prescribed treatments.

“Up to 50% of people in the UK alone don’t take their medicines correctly … A single pill approach would simplify taking multiple medications at different times and this research is an exciting step towards that,” said co-author and University of Nottingham professor Felicity Rose in a press release.

Another advantage of this technology is its scalability. The researchers demonstrated the ability to print up to 56 pills in one batch, showcasing the potential for large-scale production. This capability is “essential for the manufacturing of personalised medicines” the study reads.

Beyond Concept: 3D-Printed Medications in Use Today

In 2015, the U.S. Food and Drug Administration (FDA) approved the first 3D-printed drug, Spritam, manufactured by Aprecia Pharmaceuticals for treating epilepsy. Using a unique 3D printing method called ZipDose Technology, Aprecia created a porous pill that dissolves rapidly with just a sip of water.

Triastek, a Chinese pharmaceutical innovator, has secured FDA Investigational New Drug (IND) approvals for three specialized treatments. In January 2022, the company received approval for T19, a drug targeting rheumatoid arthritis. This was followed by an April 2022 approval for T20, a drug designed for heart and clotting disorders. Most recently, in February 2024, Triastek announced its IND approval for T21, a gastric retention drug aimed at treating ulcerative colitis. These drugs are currently being tested on humans in clinical trials and are not yet available to the general public.

The market for 3D-printed drugs is experiencing rapid growth. Valued at $80.5 million in 2023, the market is expected to increase to $283.19 million by 2031, fueled by a compound annual growth rate of 15 percent from 2023 to 2031.

Navigating the Challenges of 3D-Printed Pharmaceuticals

The 3D-printed medications field presents challenges, especially in quality control. Unlike traditional drug manufacturing, which is highly standardized for consistency, 3D printing allows modifications that can lead to batch-to-batch inconsistencies.

A 2023 article in Pharmaceutics highlighted these challenges, saying, “Regulatory and quality control issues must be addressed to ensure the safety and efficacy of 3D-printed pharmaceutical products.” This raises concerns about the FDA’s ability to enforce stringent inspection protocols in environments where drugs are 3D printed on demand, potentially even at home.

According to the insurance firm Connor, Strong, and Buckelew, the rise of 3D-printed pharmaceuticals introduces additional risks. The technology’s vulnerability to cyber threats increases the danger of counterfeit medicines, with potential repercussions for patient health, they say.

Regulatory challenges present another significant hurdle. Although the FDA has authorized the first 3D-printed tablets, there are currently no specific regulations or guidelines for 3D-printed medicines. “To date, no regulatory body has established guidelines for 3D-printed formulations, creating an urgent need for regulatory standards,” said the authors of a 2023 paper in Pharmaceutics.

The University of Nottingham’s research on 3D-printed pharmaceuticals illustrates progress towards personalized medicine. However, as this technology develops, experts say that addressing regulatory and quality control challenges will be important.

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