The scenario may seem unrealistic to many. In fact, most pharmacists in the country may dismiss it as a far-fetched ideological imagination of the perfect pharmaceutical formulation. However, with the advent of 3D printing technology, such small scale and customised manufacturing of pharmaceutical dosage forms may be a reality after all.
3D printing technology was first introduced in 1986 by Charles Hall, of which he named “stereolithography”, but the technology did not become prevalent until the late 21st century where 3D printers are available at the greater scale.
Today, 3D printers produce items of various sizes and shapes by adding the relevant materials layer upon layer according to the pre-determined computer model.
Thus far, the technology has matured up to the point where the first 3D printed medicine has been approved by the US FDA. On 22nd March 2016, Aprecia Pharmaceuticals announced that the United States regulatory agency has approved SPRITAM®, the first medicine that is manufactured using 3D printing technology.
The special design formulation allows an instantaneous release of the high dose of the active compound, which is a challenge for conventional formulation technology.
The advantages of 3D printing pharmaceuticals
3D printing holds great promises in revolutionising the production of drugs and medical devices, especially for medicine that is administered orally. Critics have been quick to point out that current technology to deliver oral medicine, such as tablets and capsules, is well established and there is little clinical need to utilise a novel yet unproven technology to push the boundary.
However, advocates of 3D printing medicine such as Dr Clive Roberts, the Chair of Pharmaceutical Nanotechnology and the Head of Pharmacy School, University of Nottingham, believe the biggest winner of this technology will be children or specific patient groups who require customised dosage form.
Another foremost benefit of such technology is enabling personalised medicine for subpopulations of patients.
Dr Robert’s vision for the future is to have a “formulation printer” that “have the ability to print 3D formulation from various drug and excipients cartridges… to achieve the dosage regime suited to an individual patient”.
He further explained in an interview with the editor-in-chief of the Controlled Release Society that “the printer would be linked via the internet to the appropriate healthcare provider, so individualised dosages could be printed, monitored, and modified remotely.”
Another attractive advantage of 3D printing of medicine is the democratisation of pharmaceutical manufacturing. In simpler words, it is the idea where technology is enabling folks from all walks of life to have access to vital medicine regardless of their geographical location.
As argued by Professor Lee Cronin, Regius Chair of Chemistry, School of Chemistry, University of Glasgow, that the distribution and the wider access to medicine made possible by 3D printers are the true winners of the technology.
The pitfall of standing at the technological edge
Although 3D printed medicine has made a significant leap forward in the past few years, doubts and criticisms of its viability still linger among healthcare professionals.
First and foremost, a systematised quality and regulatory control standards must be created, debated, tested and accepted by major stakeholders of the industry. It is unimaginable to put a mini drug factory inside just any random person that allows them to create virtually any drugs in all possible combinations.
Additionally, when the production of medicine becomes decentralised, it becomes increasingly challenging to tightly control the quality of the end products. There is no guarantee that the product will contain the right ingredient in the right amount as claimed on its label.
Should we embrace the future then?
As with all other technological breakthroughs, the benefits and risks ratio must be well balanced. As the late Steve Jobs once said “Technology is nothing. What’s important is that you have faith in people, that they’re basically good and smart, and if you give them tools, they’ll do wonderful things with them.” MIMS
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