FDA aprueba el primer "3D Printed Drug Product"

La Agencia de Alimentos y Medicamentos (FDA por sus siglas en inglés) de Estados Unidos aprobó una medicina contra la epilepsia llamada Spritam; dicho medicamento se hace por medio de impresoras 3D y es el primero en su género que ha sido aceptado por la FDA. 

La empresa que fabricó el Spritam (Aprecia) lanzó al mercado, lo que sería hasta ahora, el único medicamento impreso que puede ser ingerido por personas. 

La realización del producto fue posible gracias a que las maquinas imprimieron capas del fármaco en polvo (método utilizado por las impresoras 3D). La estructura del medicamento es única, se disuelve fácilmente a comparación de otras píldoras además de tener un tamaño más pequeño. 

De acuerdo con los especialistas, esta pastilla será de utilidad para los médicos, ya que las dosis de medicamento se determinará en el tamaño de ésta, lo que permite recetar el medicamento según la edad del paciente. (Más)

Aprecia Pharmaceuticals Company has announced that the FDA has approved Spritam levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. 

Spritam utilizes Aprecia’s proprietary ZipDose Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA. 

“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, CEO 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 enables the delivery of a high drug load, up to 1000 mg in a single dose. As a result, Spritam enhances the patient experience — administration of even the largest strengths of levetiracetam with just a sip of liquid. In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go. Spritam is expected to be available in the first quarter of 2016. 

“In my experience, patients and caregivers often have difficulty following a treatment regimen. 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,” said Marvin H. Rorick III, neurologist at Riverhills Neuroscience in Cincinnati, Ohio. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease.” (Más)