Sunday, February 24, 2019

Drugs on Demand - 3D Printed Pills and the Future of Drug Delivery

3DP (three-dimensional printing) technology is not new in the field of medicine, as it has been used since the mid-1990s to form anatomical models for bony reconstructive surgery planning. Since then, 3D printing has changed medicine in many areas with new prosthetics, implants and even 3D printed tissues and cells. Now, research is being conducted in the area of drug delivery to see if 3D printing can revolutionize how medication is manufactured and delivered.

The first instance of 3D printed medication occurred in 2015, when the Food and Drug Administration provided their first approval of a 3DP drug, Spritam (levetiracetam), indicated for seizure treatment in adults and children with epilepsy. The company behind Spirtam, Aprecia Pharmaceutical Company, is certain that they are the first company to use this technology to manufacture an already approved drug for commercial sale, through their use of ZipDose 3DP. ZipDose technology was originally developed at MIT and consisted of tablet assembly using layers of powders and printed droplets, leading to the binding of the tablet material at the microscopic level1. This technology is now the sole proprietorship of Aprecia Pharmaceutical Company.

ZipDose – 3D printed tablets
Highly porous, rapid disintegration
Orodispersable tablets that can melt on the tongue in seconds
High dose loading (up to 1000 mg of drug)
Avoids dosing with multiple tablets/pills

The clinical advantages of using a 3D printed tablet is improved adherence and compliance. As commented by the CEO of Aprecia, Don Wetherhold, “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.”1

This technology can help improve medication adherence and its associated complications. Just under 140 000 Canadians live with epilepsy and 30 000 within this group are children2. Many patients, particularly children and older adults, have trouble swallowing pill due to size, and being adherent to taking a number of doses throughout the day. In one study, about 71% of patients reported that they have forgotten, missed, or skipped a dose of their epilepsy treatment, and of the same study, half of the surveyed patients experienced a seizure event after one missed dose1.

Alongside improving adherence, 3D printed medication allows for customization of drug doses, which will greatly help with dosing of medications for pediatric patients. “This technology could revolutionise the way we look at children’s medicines, both in terms of what they take and the ability to keep changing the dose as they grow,” says Steve Tomlin, consultant pharmacist at Evelina London Children’s Hospital, UK1. Whereas adult patient dosing is not largely based on weight, the reverse is true for pediatric patients, and liquid medications are used to ensure correct weight based dosing for each child. However, studies have shown that even younger children prefer to take tablets, so the ability to customize the dose of each 3D printed pill will be greatly welcomed.

ZipDose technology is just the beginning of what 3D printed medication can do to optimize drug delivery. Many patients require variable dosages of their medications, so allowing the consumer or pharmacist to adjust dosages easily could reduce visits to the physician. 3D printed’s ability to form drugs in novel shapes will also allow for greater control over the kinetics of drug release; this leads to better control over whether a medication is fast acting or released gradually over the time3.

The approval of Spritam by the FDA demonstrates the willingness of industry and regulators to seriously consider the viability of 3D printed drugs. Spritam has hit the market in the spring of 2016, and Aprecia is planning on introducing multiple new products using the ZipDose technology in upcoming years. Clearly, the potential for 3D printed in pharmaceuticals will soon be determined.

Further Reading:

  1. Aprecia Pharmaceuticals. (2015). FDA approves the first 3D printed drug product [Press release]. Retrieved from Spritam_FDA_Approval_Press_Release.pdf
  2. Prasad AN, Burneo JG, Corbett B. Epilepsy, comorbid conditions in Canadian children: analysis of cross-sectional data from cycle 3 of the National Longitudinal Study of Children and Youth. Seizure. 2014;23(10):869-73.
  3. Sanderson K. 3D printing: the future of manufacturing medicine. Pharm J. 2015;294(7865):598-600.