GMP Issues for 3D Printed Pills Resolved But Is It Really a Big Deal?
[Posted on: Monday, August 17, 2015]
On 31st July 2015, FDA approved the World’s first 3D printed pill and it was widely celebrated as a major milestone and, in my ways it is, but for the reasons one may think. The approval is for a new formulation of a well-established epilepsy drug, levetiracetam, called Spritam®. With more than 80 generic drugs containing levetiracetam in the US market, this new drug approved under the 505(b)(2) regulatory pathway will likely not be a big money maker for the developer, Aprecia Pharmaceuticals. The drug is not as customizable as one would think reading the pundits; it is approved at 4 fixed doses not different from the other generic versions. The biggest advantage of the formulation is its high solubility but there are oral solutions of the drug available that could likely easily out-compete Spritam. However, this approval is indeed a milestone for the developers of other 3D printed products. So far, the best known applications of 3D technology have been in the field of medical devices where several products ranging from artificial limbs to implantable splits. This is the first time the theory of creating chemical drugs using 3D printing technology has gone through FDA’s review.
Despite all the hope of the technology, there always has been a nagging unanswered question; what would FDA expect to meet GMP requirements for a 3D printed drug. It is obvious that Aprecia solved the riddle for all of us. The FDA approval letter indicates that the company worked very closely with the FDA to seek approval filing as many as 28 responses to FDA during the NDA review process. The technology behind Spritam was invented at MIT almost 2 decades ago. Spritam established the proof-of-concept which will be enormously useful for the future developers of 3D printed drugs. It is unlikely that 3D printed drugs would be the norm for manufacturing drugs since most drugs are needed at defined known doses but it does provide a way to design special formulations or small volume formulations such as those for orphan drugs. It is going to be an interesting journey as we explore new uses of this new technology and “boldly go where no drug has gone before”.
Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research