This month, Aprecia Pharmaceuticals received FDA approval to manufacture a 3D printed drug tablet. (See press release for “Aprecia Introduces its First Product Using the ZipDose Formulation Platform for the Treatment of Epilepsy”). Cool Stuff!
Over the last few years, several clients have asked why is it even necessary to 3D print a drug. After all, there are other more stable and scalabable manufacturing methods of tablets that can be run at much lower cost (and have already withstood regulatory and quality scrutiny). I see 3DP drugs having two main advantages:
The first advantage of 3DPrinted drugs, is that it enables the drug itself to dissolve at quicker rate than many traditional 'filler-based' methods of manufacturing.
Specifically, the 3DP technology enables a 'porous formulation that rapidly disintegrates with a sip of liquid'. Thus, certain drugs can then have quicker effects, which loosely translates to better patient experiences. There are a variety of ways to engineer a drug to disintegrate faster, but most require other formulation chemistries or materials.
Also, printed drugs allow doctors to perfectly tailor a drug dose (mg) to an individual patient based on weight, patient profile, etc. Most drugs are often produced in set quantities, and to create a unique dose requires compounding (usually manually intensive) or secondary processes.
The printing technology may enable a streamlined supply chain for creating personalised doses. (e.g. no more pill cutting, taking doses larger than necessary, etc.)
While applying a novel 3DP technology in this industry sector and doing it in a way to survive FDA regulatory scrutiny is quite the 'win', we’ll only witness a true 'victory', as more drugs following suit and gain approval.
However, before any of this can happen, business models need to evolve. Many organisations are simply not ready to adopt 3DP.
There are a lot of IT-intensive challenges with functional groups (R&D, clinical regulatory, IP, and supply chain.) These need to be addressed before organising any ticker tape parades.
3DP is often characterised as 'interesting' or 'neat'. It is often positioned as a technology in search of a solution. While 3DP technology advancements continue to create exciting opportunities across a variety of industry sectors, the 'hype' (or hysteria) must be kept in check...
Article by Michael Shanler, Gartner research director.
Michael Shanler covers industry technologies used by manufacturers, with a specific focus on R&D, product innovation and laboratory informatics, including Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN).