In August 2015, the U.S. Food and Drug Administration (FDA) approved the first three-dimensional (3D) printed drug for commercial use when it allowed Pennsylvania-based Aprecia Pharmaceuticals to manufacture and market its anti-epileptic pill Spritam. The company relied on additive printing technology to create a rapidly dissolving pill that could be consumed with very little water. One of the main goals was to benefit patients who are unable to swallow medications, especially during an epileptic fit.
The licensed ZipDose technology used by Aprecia Pharmaceuticals combines formulation and material science with additive printing technology. The process involves deposition a thin layer of the powdered medicine on a substrate followed by the addition of a liquid to bind the particles into porous layer. The process is repeated multiple times to create a pill of the desired size and concentration. The success of Spritam has encouraged Aprecia Pharmaceuticals to use ZipDose technology to develop medications for other serious illnesses as well.
- Dosage – Additive printing allows pharma companies to print drugs at specific dosages. Consequently, the patients do not have to suffer from poor prognosis associated with low-dose medications or consume high doses of drugs that can lead to unwanted side effects. As 3D printing technology becomes more prevalent in the pharmaceutical world, doctors can request for a specific dose of the drug instead of choosing from the available options.
- Solubility – Although rapidly disintegrating, porous pills have been in use for several years, they usually provide lower doses of the active ingredient. Three-dimensional printing technology has allowed Aprecia Pharmaceuticals to add up to 1,000 mg of the potent drug into one Spritam pill while retaining its solubility. This can benefit a large section of the population including young children, elderly, and patients suffering from complex neurological disorders.
- Compatible shape – Additive printing also helps produce pills in a variety of shapes and sizes, as per the needs of the consumer. Drug companies can produce small batches of the drug based on specific demand.
- Distribution of Production and Distribution – Unlike large machines, 3D printers are easy to setup and operate. The manufacturer can shift the production of the drug to a location that is closer to the consumer and thereby, lower transportation and distribution costs and reduce wait times for patients with potentially life-threatening conditions.
- Simplify Research and Development - 3D printing can also simplify research and development of new medications by making the process more efficient and cost-effective. Potential compounds can be printed in the laboratory and tested on 3D printed organs and cell lines for immediate results.
Recent developments in additive printing have forced most drug companies to sit up and take notice. They are investing millions of dollars in the technology to speed up drug development. While the time to replace medication prescriptions with printer algorithms is not yet here, 3D printing is bound to have a huge impact on the way companies develop and manufacture drugs in the near future.