FDA approved first 3D printed prescription drug market
March 29, 2016 Source: Arterial Network
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 23, 2016, Aprecia Pharmaceuticals announced that the first FDA-approved prescription drug product SPRITAM Instant Tablet (Levetiracetam), which was approved by 3D printing technology, was officially launched for the treatment of epileptic seizures. In August last year, SPRITAM received FDA approval for listing.
First, the drug achieves rapid dissolution and solves the problem of difficulty in swallowing drugs.
Aprecia Pharmaceuticals, headquartered in Pennsylvania, is the only pharmaceutical company in the world to develop 3D printing drugs. Powder 3D printing technology is a technology developed by the Massachusetts Institute of Technology in the 1980s. This technique uses a water soluble liquid to bond multiple layers of powder together to form a three dimensional structure.
Aprecia acquired the application of MIT 3D printing technology in medicine, and developed the ZipDose technology platform, instead of using traditional tableting technology, it uses a layer of printing to make drugs. With a small amount of water, it can dissolve quickly in less than 10 seconds, bringing a new oral experience to patients. In the comparison video released by Aprecia Pharmaceuticals, it can be seen that the average OTC tablet dissolves for more than 40 seconds, and SPRITAM completes the process in 4 seconds.
SPRITAM can now assist in the treatment of local sudden onset, myoclonic and most tonic-clonic seizures. In 2013, nearly three million people living in the United States suffered from epilepsy. There are now about 150,000 new cases every year. Because of the difficulty in swallowing when epileptic seizures occur, solving the problem of swallowing has always been a major problem for pharmaceutical manufacturers. According to an online survey conducted in the United States, 40% to 50% of Americans surveyed, even those without epilepsy, have difficulty phagocytosis.
Don Wetherhold, CEO of Aprecia, said: "When we try to apply 3D technology to the production of prescription drugs, we need to consider whether the form of the drug really meets the needs of patients. This is very important. SPRITAM is our transformation. The first of the products for epilepsy, we offer more treatment options for patients and caregivers."
Second, break the traditional dose limit, the highest dose up to 1000 mg
The traditional range of soluble drug doses is limited by compression or model technology, and the ZipDose technology based on 3D printing does not depend on this. ZipDose can achieve up to 1000 mg of the drug while maintaining rapid dissolution. Standardized, commercial production of SPRITAM has the advantage of four dosage units, including 250 mg, 500 mg, and 750 mg 1000 mg.
Third, 3D printing leads the new medical revolution
Nowadays, the application of 3D printing technology in the medical field is becoming more and more popular, especially in in vitro medical devices, 3D printing implants, 3D printing cells and organs have made great progress. 3D printing prescription drugs may be just the beginning. In the future, with the advancement of technology, we can print different doses of pills according to different personal conditions, or print them into different interesting shapes according to our preferences to achieve personalized medicine. .
Hudi Lipson, a professor of mechanical engineering and computer science at Cornell University, put forward the concept of a "3D printing life ladder" that arranges parts of the body into a ladder. The bottom layer of the ladder is an inanimate prosthesis; the middle layer is simple active tissue such as bones and cartilage; the upper part is the vein and the skin; the closest to the top of the ladder is the complex and critical organs such as the heart, liver and brain; the top of the life ladder It will be a complete life unit – perhaps one day it will be a fully functional artificial life form.
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