Aprecia’s 3D Printed ZipDose Tablets Earn FDA Approval

You may recall that only weeks ago, we covered Aprecia Pharmaceuticals’ promising new easy to swallow quick dissolving ZipDose tablets. The pioneering 3D printed tablets combine the ease of consumption associated with liquid medicines with the precision of dosage only available in tablets. And while Mary Poppins hasn’t officially loaned her name to supporting a medicine that goes down easily, the FDA has granted approval for the production of SPRITAM levetiracetem tablets produced by 3D printing. The tablets are printed with a porous formulation that rapidly disintegrates with a sip of liquid.

Levetiracetem is an oral medicine that is part of the prescription therapies for the treatment of a variety of seizure disorders in children and adults. These disorders range from partial onset seizures, myoclonic seizures, and primary generalized tonic-clone seizures. The Chief Executive Officer of Aprecia, Don Wetherhold explained the importance of this new type of administration for an existing medicine:

“By combining 3D printing technology with a highly-prescribed epilepsy treatment, SPRITAM is designed to fill a need for patients who struggle with their current medication experience. This is the first in a line of central nervous system products Aprecia plans to introduce as a part of our commitment to transform the way patients experience taking medication.”

In the United States, there are nearly 3 million people who have been diagnosed with some form of active epilepsy and approximately 460,000 of those cases are found in children. The fact that the pill dissolves instantly with just a sip of water isn’t about the speed but rather more about the comfort of the person taking it. Dr. Marvin H. Rorick III, a neurologist at Riverhills Neuroscience Center in Cincinnati, Ohio described the importance the approval of such an easy to swallow medication:

“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 her/his medication, adherence can be a challenge. Especially for children and seniors, having an option  for patients to take their medication as prescribed is important to managing this disease.”

As a person with a seizure disorder requiring ongoing treatment with levetiracetam, I can say I would welcome such a type of medication. The pills that I take, 500 mg each, are large enough to be uncomfortable to swallow. A number of times, I have had to spit the pill out as I struggled to choke it down and each time I take the pill, there is just the slightest sensation of panic. Recognizing that I am an adult who knows that the pill is small enough for me to swallow and yet I still have difficulty, the problem of administering this medication to children becomes immediately apparent.

The result of the discomfort of this medication is that if I can ‘forget it’ I sometimes do. And it turns out that I am not alone in that as a recent survey of patients, 71% acknowledged having forgotten, missed, or just skipped a dose of their seizure medication at some point in time. Of those reporting a missed dose, almost half have reported having a seizure in the time after missing the dose.

The 500 mg dose that I require is not the highest dosage of the medication and the pills can become truly daunting in size. With the ZipDose technology, dosages of up to 1,000 mg can be administered as easily as swallowing a mouthful of juice. If this medicine can be 3D printed, then clearly there is a great deal of potential out there for this as a regular method for production of pills and the easier it is to swallow them, the more likely patients are to adhere to the necessary regimen.

When the discomfort is so great that patients are willing to risk having a break through seizure just to avoid swallowing the pill, it is obvious that a better solution needs to be created. With Aprecia Pharmaceuticals 3D printed ZipDose, we could see the door opening to making medically manageable conditions less onerous to treat than they are to experience.

Let us know your thoughts on these new 3D Printed drugs in the Aprecia ZipDose forum thread on 3DPB.com.