In a world first, the US FDA has approved a 3D printed drug for manufacture.
This type of printing has previously been used to manufacture medical devices, including prosthetics.
The new drug developed by Aprecia Pharmaceuticals, headquartered in Langhorne, PA, called Spritam levetiracetam, is for oral use to control seizures in adults and children with epilepsy.
The company said this is the first in a line of central nervous system products planned for its 3D platform.
Spritam uses Aprecia’s ZipDose technology in which 3D printing (3DP) is used to produce a porous formulation that rapidly disintegrates with a sip of liquid.
'By combining 3DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,' said Don Wetherhold, Chief Executive of Aprecia. 'This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.'
ZipDose Technology combines formulation science with the unique manufacturing capabilities of 3DP. Powder-liquid 3DP technology was developed at Massachusetts Institute of Technology (MIT) in the late 1980s as a rapid-prototyping technique. This technology uses an aqueous fluid to stitch together multiple layers of powder using a unique, patent-protected process to create a wide range of products.
Using 3DP as a catalyst, Aprecia is developing formulations of medicines that rapidly disintegrate with a sip of liquid, even at high dose loads up to 1,000mg. In addition, no measuring is required as each dose is individually packaged, making it easy for patients to carry this treatment with them on the go.
Aprecia intends to manufacture the products on its proprietary equipment. The company holds an exclusive, worldwide licence for pharmaceutical applications of MIT's technology.
Spritam will be available in the first quarter of 2016, the company said.
