A new dimension in drug manufacturing

Published: 5-Feb-2016

The FDA approval of the first 3D printed drug for public use signals changes ahead for the pharma manufacturing sector

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The development of 3D printing is coming on apace and is making waves in pharmaceutical manufacturing. In August last year the US Food and Drug Administration (FDA) approved a 3D-printed dissolvable tablet called Spritam (levetiracetam) produced by US-based Aprecia Pharmaceuticals, which treats certain types of seizures caused by epilepsy.

The company says a lack of high-dosage rapid dissolvable tablets on the market spurred the creation of Spritam. Its 3D printing system can manufacture potent drug doses of up to 1,000 milligrams in individual tablets. The company plans to launch Spritam in the US in the first quarter of 2016.

Significant segments of patients in the CNS therapeutic area would benefit from having a new dosing option

‘Our initial pipeline includes a set of four high-dose, highly-prescribed molecules used for treating central nervous systems (CNS) conditions,’ said Tom West, Project Director and Manager of Intellectual Property at Aprecia. ‘We believe that high-dose medicines remain largely unaddressed by prior “fast-melt” technologies, and that significant segments of patients in the CNS therapeutic area would benefit from having a new dosing option that is premeasured and does not need to be swallowed intact.’

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