Using 3D Printing to Manufacture Solid Dosage Forms of Drugs
A decade ago, 3D printing was little more than an intriguing novelty. Today, this rapidly growing technology has proven to be a practical tool in a wide range of industries, including the life sciences. One of the most promising applications of 3D printing for the manufacture of solid dosage forms of drugs. The first 3D-printed solid dosage drug was approved by the FDA in 2015, and drug manufacturers have continued to work closely with the FDA to expand the commercial possibilities of this technology.1 As the manufacturing of solid dosage forms of drugs using 3D printing becomes a commercially viable possibility in the future, process developers at life science companies can utilize modern software to create and optimize manufacturing protocols.
How 3D Printing Can Improve Solid Dosage Drug Manufacturing
There are many challenges within the field of solid dosage drug manufacturing that 3D printing may be able to address. Here are a few of the most prominent:
- Improving the consistency of the manufacturing process. When developing a protocol for the manufacture of a novel drug, ensuring consistency is a top priority. Highly accurate 3D printing platforms for solid dosage drugs can make it easier for manufacturers to guarantee the safety and effectiveness of their products.
- Addressing the global problem of drug shortages. 3D printing technology may make it possible to mass produce essential drugs at significantly lower costs than are required for mass manufacturing with traditional methods. As a result, it may be possible to reduce global shortages of important medications.
- Making it easy to manufacture “personalized drugs” for unique patients. In the age of personalized medicine, clinicians and researchers alike are looking for ways to tailor treatments to meet specific patient needs. With 3D printing, it may be feasible to tweak a drug based on a particular patient’s condition and have it in hand within a matter of hours.
- Making orphan drugs more economically viable. Many life science companies are forced to avoid commercially developing drugs that can treat only a very small population of patients, simply because it is not a practical financial choice. However, because of the cost savings associated with solid dosage manufacturing using 3D printing, it may finally become possible for life science companies to put these orphan drugs on the market for the patients who need them.
- Enabling the creation of drugs with optimal release times. In August 2017, a group of academic researchers from Greece and the United Kingdom created a novel platform for the manufacture of 3D printed solid dosage drugs, demonstrating that it could be used to “fine tune” the release of drug molecules.2 The model drug that they used was hydrochlorothiazide, but their study provides proof of principle that 3D printing could enable controlled drug delivery for a wide range of oral pharmaceuticals.
- Facilitating the development of solid dosage drugs that are easier for patients to take. One of the most common complaints among patients who are prescribed solid dosage oral drugs — especially at high dosages — is that they can be hard to swallow. No patient enjoys the prospect of having to swallow multiple large pills every day, and studies suggest that the mere dislike of taking pills can cause patients to skip their daily prescriptions altogether.3 Recently, the company Aprecia used a specialty 3D printing platform to develop a version of levetiracetam that is easier for patients to swallow, and it may be possible to use 3D printing to create similarly convenient versions of other common drugs.
Future Regulatory Considerations
In the United States, the FDA has recognized the vast potential of using 3D printing for the manufacture of solid dosage drug forms. Therefore, the agency has committed to working alongside academic and industry researchers to develop this technology and set reasonable regulations to ensure responsible use in the life science industry.
To this end, the FDA started the Emerging Technology Program in August 2016, which includes an Emerging Technology Team (ETT) that has been involved in the improvement of 3D-printable oral formulations and the development of a model-based control strategy for regulation. According to the FDA’s Center for Drug Evaluation and Research (CDER), this high level of early engagement will help streamline approval processes for 3D printing for solid dosage drug manufacturing. By working closely with academic and industry partners, it will be easier for the FDA to address obstacles early and establish regulatory standards that are consistent with advances in the technology.
As pharmaceutical developers design new processes for solid dosage drug manufacturing that involve 3D printing, modern software can be a valuable tool. It can help life science companies integrate scientific and commercial data to yield relevant insights and promote sound decision-making. In addition, software can aid in the development that are compliant with FDA standards for 3D printing.
BIOVIA Made to Cure is a high-level software solution that can help your life science organization make the most of future opportunities to use 3D printing for the manufacture of solid dosage drug forms. Contact us today for more information!
- “Update on 3D printed drugs and what’s ahead for solid dosage forms,” July 2, 2017, http://www.pharmtech.com/update-3d-printed-drugs-and-what-s-ahead-solid-dosage-forms ↩
- “3D printed oral solid dosage forms containing hydrochlorothiazide for controlled drug delivery,” August 2017, http://www.sciencedirect.com/science/article/pii/S1773224717302721 ↩
- “Smart pill bottles aren’t always enough to help the medicine go down,” August 22, 2017, http://www.npr.org/sections/health-shots/2017/08/22/538153337/smart-pill-bottles-arent-enough-to-help-the-medicine-go-down ↩