Excerpt of an article by Susan Scutti | Medical Daily
The Food and Drug Administration (FDA) approved a three-dimensional (3D) printed drug, Spritam (levetiracetam), for the treatment of seizures in adults and children with epilepsy. Drug-maker, Aprecia Pharmaceuticals Company, reported it is the first company to use this technology to develop and manufacture an approved drug at commercial scale.
Privately-owned Aprecia said it plans to introduce multiple products using its ZipDose Technology, focusing first on central nervous system drugs. The technology, which originated in part at MIT, makes use of 3D printing to manufacture a porous formulation that rapidly disintegrates with a sip of liquid. The company holds an exclusive license for pharmaceutical applications of the technology, which enables a high drug load, up to 1,000 mg in a single dose.
Spritam is expected to be available in the first quarter of 2016.
In a 2012 TED Talk, Professor Lee Cronin discussed 3D technology and the future of medicine. His vision of the future focused on the discovery process yet also included these predictions: “You don’t need to go to the chemist anymore. We can print drugs at point of need. We can download new diagnostics.”
Many analysts believe 3D technologies will impact, most immediately, the drug discovery phase. The ability to print human tissues and human organs on which to test new medications will eliminate less accurate animal or synthetic models. New 3D technology will also eliminate the need for expensive prototype fabrication costs. Other visionaries imagine a future where doctors no longer write prescriptions, instead provide algorithms that allow patients to print their own medication at home.
Naturally, critics of 3D printing see the potential for abuse and harms. If you possess the ability to print a pharmaceutical drug at home, you also can print illicit drugs. And, as this article in Forbes suggests, malware or a virus could impact the printing process and produce a harmful drug.
Epilepsy is a disorder of the brain that causes seizures. The Centers for Disease Control and Prevention estimates nearly three million people in the United States have been diagnosed with active epilepsy. An estimated 460,000 of those cases occur in children. The primary sign and symptom of epilepsy is a seizure. In some instances, seizures look like staring spells, while in other instances, seizures cause a person to fall, shake, and lose awareness. Epilepsy may be caused by stroke, brain tumor, brain infection, or a genetic disorder, yet there is no known cause for two out of every three patients with epilepsy.
Thanks to Aprecia Pharmaceuticals Company for committing its resources to inventing the technology; Susan Scutti from writing the article from which this excerpt came; Medical Daily for committing their resources to printing an article about this technology; Google for helping me find the article; and all the people who, directly or indirectly, made it possible to include the picture and text in this post.