3D Printing (3DP) for Pharmaceutical Solid Dosage Forms – A Follow-up

Many of you reading this blog may not remember the Star Trek “Replicator”. In the Trek far future, members of the crew, when hungry, would simply walk up to this device and key in what they wanted to eat. The Replicator would then build a suitable, tasty meal by mixing the right combinations of materials. These raw materials provided the desired texture, smell, taste, shape, and the output was an instant, palatable, custom prepared meal. Welcome to the future of pharmaceutical formulations. Aprecia Pharmaceuticals Company has announced the first FDA approved drug product (Spritam®)(see previous blog post here) made using 3DP technology1. Spritam® claims its product platform provides an advantage for certain clinical environments where large amounts of active are required to gain effective treatment outcomes. Spritam® allows the delivery of large doses of active in a single tablet. For the Spritam® tablet formulation, the large doses can be delivered based on designing a very porous 3D tablet structure, having a high surface area which facilitates rapid dissolution upon contact with saliva or water. Patients do not swallow a large tablet they swallow a partially or totally dissolved tablet. The uniqueness of a 3D printed tablet resides in controlling the accuracy of positioning and subsequent mass deposition of the powders and liquids that make up the tablet. These materials can be placed anywhere within the three dimensions of the tablet. Actives, binders, disintegrants, wetting agents, sweeteners, and other excipients can be deposited in the three dimensional space with micron precision. This allows the 3DP technology to capably manufacture and reproduce drug product that can meet an infinite array of critical dosing constraints. These include extended release, modified release, pulsed release, multiple strength release, and combination therapy formulations. Several proponents of the technology have suggested an array of uses and advantages for 3DP in the pharmaceutical industry. Formulation scientist will no doubt have a field day with 3DP technology and the numerous possibilities for effective drug delivery. These include personalized drug product tailored to specific patient needs, similar to the concept of compounding. Futurists have envisioned all of us with our own 3DP capability. NIH has a 3D Print Exchange website for biomedical applications where groups and individuals can share three-dimensional models of medical interest. A novel approach to fight counterfeit drug product has been patented which uses the three dimensional printing capability to imbed markers into the tablet structure that would be coded and difficult to duplicate. Because of the computer control and mechanical precision involved, it is quite possible that 3DP technology will be amenable to parametric release scenarios. To gain acceptance for this technology, we need to consider the regulatory environment. For the application approval of a 3DP drug product, the validation of the software, controllers, and deposition mechanisms is an extensive undertaking. For approval to manufacture, the company must move this technology to a shop floor and realize an entire GMP compliant operation. In the light of current regulations, the above and other 3DP possibilities will involve substantial regulatory discussion and require new thinking. The future of 3DP drugs is showing promising potential. It appears that the pharmaceutical industry will need to consider these types of issues in the not too distant future. 1 https://www.aprecia.com/zipdose-platform/3d-printing.php