A 3D-printed pill has been approved by the United States’ Food and Drug Administration (FDA) for the first time. By producing the drug through 3D printing techniques, medication can be packaged more tightly in precise dosages; making tablets easier to swallow and therefore improving a patient’s experience of taking oral treatments.
The pill Spritam levetiracetam produced by Aprecia Pharmaceuticals will be used as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.
The 3D printing method, known as ZipDose technology, is used to stitch together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that disintegrates in less than 10 seconds with a sip of liquid. It also enables the delivery of a high drug load – up to 1,000mg in a single dose – enhancing the patient experience of taking even the largest strengths of levetiracetam.
Making medication easier to take can be highly beneficial for patients who have difficulty swallowing, which particularly affects the elderly as well as people with chronic diseases. Studies have shown that difficulties in swallowing can prevent people from taking their medication as prescribed, and for epilepsy patients, this can mean they are more likely to have a breakthrough seizure.
‘In my experience, patients and caregivers often have difficulty following a treatment regimen,’ explained Marvin H Rorick III, MD neurologist at Riverhills Neuroscience in Cincinnati, Ohio. ‘Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge.’
Aprecia developed its ZipDose technology platform using 3D printing technology that originated at Massachusetts Institute of Technology (MIT). The drug products are assembled layer-by-layer without using compression forces or traditional moulding techniques. Thin layers of powdered medication are repeatedly spread on top of one another, as patterns of liquid droplets (an aqueous fluid) are deposited or printed onto selected regions of each powder layer. Interactions between the powder and liquid bond these materials together at a microscopic level.
The technology yields highly porous structures even at high loading and doses of drug.
‘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 Aprecia’s CEO, Don Wetherhold.
Spritam is expected to be available in the first quarter of 2016, but the company plans to develop other medications using its 3D printing technology platform.