October 25, 2021

Volume XI, Number 298

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October 25, 2021

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3D-Printed Prescription Drugs a Huge Stride Forward for Personalized Medicine

Advances in 3D printing (3DP) technology have paved the way for pharmaceutical companies to print prescription drugs. Aprecia Pharmaceuticals recently announced that the FDA has granted it approval to manufacture Spritam® (levetiracetam), an antiepileptic medication, using 3DP technology. Aprecia claims that this is the first time the FDA has approved manufacture of a 3DP drug. Aprecia is scheduled to begin production of Spritam in the first quarter of 2016.

How It Works

Using 3DP, a manufacturer can tailor the form of a medication to the specific needs of patients. Instead of using traditional powder compaction to create a pill, Aprecia’s proprietary ZipDose® Technology platform can print the tablet, layer by layer, using powdered medication stitched together with an aqueous fluid. A single sip of water can break these bonds so the tablet will disintegrate in less than ten seconds, making it much easier to swallow than a traditional pill. The ability to layer the active ingredient also allows a greater concentration of medicine in the drug. This means that high-dose pills can be even smaller than traditional pills currently on the market. These developments are a boon to epilepsy patients, who frequently suffer from swallowing disorders. 

The Future of 3DP Drugs

Aprecia’s ZipDose Technology platform uses MIT’s 3DP process. Pharmaceutical rights to that process are exclusively licensed to Aprecia. This means that the ability to print medications at home, or even in a medical office, is a long way off.

Still, the development of 3DP drugs is a huge stride forward in the field of personalized medicine. In addition to tailoring the form of drugs to the needs of particular classes of patients, 3DP opens the possibility of tailoring each individual tablet to the needs of a specific patient, regardless of the physical location of the printer. This is something that has simply not been financially feasible with mass-produced medications.

© 2021 Wilson ElserNational Law Review, Volume V, Number 259
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About this Author

Amy L. Baker, Wilson Elser, Products Liability Lawyer, Medical Device Attorney,
Associate

Amy Baker focuses her practice on product liability, medical device and pharmaceuticals litigation, and professional malpractice. She has experience in defending and prosecuting intellectual property litigation, including copyright, patent and trademark infringement along with related causes of action under state law.  Amy enjoys handling technically challenging and complex litigation, and defending matters that are factually and procedurally intricate. Amy has successfully tried several cases to verdict on behalf of a variety of companies. She has experience defending...

www.wilsonelser.com
Genese K. Dopson, Wilson Elser, Pharmaceutical Defense Lawyer, Labor Lawyer
Partner

Genese Dopson focuses her practice on the defense of companies in employment matters and in the defense of pharmaceutical and medical device manufacturers, as well as the defense of personal injury, insurance bad faith, employment and discrimination matters. She has successfully managed the defense of multi-plaintiff, multi-state litigation and has served as national coordinating counsel in pharmaceutical and medical device mass tort litigation. She is a former member of the editorial advisory board of MX Magazine, a publication that served the medical device...

415.625.9360
Russ Vignali, Wilson Elser, New York, defense of products liability matters,
Partner

Russ Vignali is a tenacious advocate who focuses his litigation practice on the defense of products liability matters and related commercial disputes in New York state and federal courts. He also handles a variety of claims in the general liability area and has experience with related insurance coverage matters. Russ joined Wilson Elser in 1982 out of law school and developed his service approach within a firm culture that values a high level of responsiveness and open communication with clients.

914.872.7250
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