In the last years, at least once, all of us have watched on internet these cool videos of people using 3D printers for making toys, tools, gadgets and even houses! But what would you think if I tell you that this technology could be used to improve the people's life? Nowadays 3D printers are used by the pharmaceutical companies to produce drugs in industrial scale, the main technologies are inkjet printing and binder jetting. Furthermore , a novel application of 3D printers could be in clinical field, where, because of the specific features of the technology, tailored-made drugs could be prepared to satisfy the particular needs of the patients, issues that today represent a challenge for the patients treatment-compliance and the treatment effect by itself, like dose personalization, modified release profile and combination of many drugs in a single pill (concept similar to the actual bilayer pills) according to the need of patients. Since 2015, approved by FDA, there is available in the market the very first 3D printed drug Spritam (Levetiracetam) a prescription drug for epilepsy developed by Aprecia Pharmaceuticals. In this article we will point out the two 3D technologies mentioned above, and their application based on the paper of Marcia & Kumar 2020.
Inkjet Printing method:
In general, inkjet printing describes systems which use pattern generating devices to digitally control and place small liquid drops on a substrate. In pharmaceuticals, appropriate mixtures of drug, along with suitable excipients (known as ink) are deposited as small drops in a layer wise fashion on a suitable substrate. Continuous inkjet printing (CIJ) and drop on demand (DoD) are the two main inkjet printing platforms (Marcia & Kumar, 2021). Application: One of the main applications of inkjet printing in pharmaceuticals is in the preparation of orodispersible film
(ODF) formulations. They are single sheets or multilayered, made up of appropriate materials having drugs loaded on to them, which liberate the drug rapidly in the mouth to form a solution or suspension in the saliva without chewing or water consumption (Musazzi, Khalid, Selmin, Minghetti, & Cilurzo, 2020).
Binder Jet Printing:
Binder jet printing, also known as drop-on-powder method is an application of inkjet printing technology. The printhead of a binder jet printer can either be thermal or piezoelectric. It composes of a powder bed which is fused in a layer wise fashion. A printer nozzle which contains the binder (and/or drug) fluid is programmed to jet the liquid onto the loose powder bed by moving along an x-y-axis. The powder is in turn moistened by the liquid drops which lead to hardening and solidification of the layer. The powder solidification occurs either by forming binder bridges or by the dissolution and re-crystallization of particles. Application: There has been a lot of research on the applications of binder jetting for the fabrication of tablets. The type and concentration of excipients used in the tablet manufacture process by binder jetting have a great impact on the tablet characteristics. It was demonstrated that filling agents having high water solubility, moistening agent having high water content and binders with high viscosity in solution can enhance the hardness and binding strength of the tablets and extend their disintegration time (Tian, et al., 2019).
In the article of Marcia and Kumar 2021, (DOI: 10.1208/s12249-020-01905-8) readers can find a table presented below and extended information about the pros, cons of the technologies mentioned in the present article but also of other technologies not that common but with a high relevance and probably a potential development of novel drugs or the enhancement of well-known drugs.
In conclusion the fast development of 3D printer technologies in pharmaceutical fields could improve both the mass manufacturing yield of drugs and the personalized therapy of patients treated with tailored made pill, capsule, etc. However, the biggest challenge is the lack of regulatory framework. FDA has provided guidance regarding the medical devices derived from 3D technologies, indeed, there are, in the market, many approved medical devices that come from these technologies, but only one 3D drug (Spritam) and unfortunately no official guides about safety, quality control nor implementation.
Marcia, V., & Kumar, L. (2021). 3D printing as a Promising Tool in personalized Medicine. Pharmaceutical Science thechnology , 22-49.
Musazzi, U., Khalid, G., Selmin, F., Minghetti, P., & Cilurzo, F. (2020). Trends in the production methods of orodispersible fimls. International Journal Pharmaceutical, 576.
Tian, P., Yang, F., Yu, L., Lin, M., Lin, W., & Lin , Q. (2019). Applications of excipients in the field of 3D printed pharmaceuticals. Drug Development and Industrial Pharmacy, 905-913.