3D Printing May Lead to Personalized Pills

ORLANDO, Fla. — Personalized medications based on a patient’s medical and biological profiles can be produced with high precision through 3D printing, according to a study presented at the American Heart Association Scientific Sessions.

Traditional pre-formulated medicines have not allowed for customization that accounts for a patient’s weight, race, and kidney and liver functions. However, adjusting for these factors could be a new way of increasing effectiveness and reducing side effects, researchers explained.

At this meeting, Min Pu, MD, a professor of internal medicine at Wake Forest University in Winston-Salem, North Carolina, highlighted the potential of 3D printing to significantly advance the practice of precision medicine.

Dr Pu and colleagues developed a prototype computer algorithm, including software for 3D printing with dosage-adjustment information.

After inputting patients’ individual medical and biological characteristics, the software calculates personalized doses and automatically generates 3D printing data. The researchers tested the accuracy and variability of 5 different doses (80 pills) of 3D-printed pills in the testing material.

“This is one of the earliest studies I know to use 3D printing for medicine compounding for precision medicine,” said study investigator Min Pu, MD, who is a professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, North Carolina.

All tested pills, ranging in dose from 124 mg to 373 mg, were successfully printed using a 3D-printer. There was high reproducibility, with standard deviations ranging from 3 mg to 5 mg, and little variability, according to the study results.

The researchers observed differences of 0.5% to 0.6% between the printed pills and computer-generated volumes in the 5 different dose ranges. This suggests that pills can be replicated accurately by using a volume-concentration equation by the software.

Precision medicine includes new therapies based on the molecular pathology of the condition and a person’s specific genotype. This study, said Dr Pu, shows that using 3D printing to produce personalized pills is possible and potentially provides a new method to formulate medicines based on a patient’s clinical characteristics.

“Pharmacogenetics, which matches patients to drugs based on DNA information, offers an opportunity to provide care, treatment, and medicines customized to the individual. This type of personalized precision medicine requires physicians to prescribe customized drug products containing unique drug-dosage combinations and/or formulations specifically for individual patients,” Dr Pu told Endocrinology Advisor.

Most retail pharmacies no longer offer compounding services, but hospital pharmacies still commonly compound intravenous medications. Fewer pharmacists are trained and experienced in the relevant skills used in medicine compounding, especially regarding oral dosage forms, which are almost always mass-produced, he noted.

“Our study uses the volume-concentration method to generate 3D-printed pills. What’s different from current pharmaceutical industrials is that we use a computer algorithm to design and calculate dosages according to patients’ biological and clinical parameters instead of using pre-determined dosages. Therefore, we can instantly create personalized pills. These personalized pills are then converted to 3D printable files and the pills can then be accurately printed using a 3D printer,” explained Dr Pu.

This new method is not aimed at replacing the current ways the pharmaceutical industry makes medicine, he explained, but will instead add a new method to compound medications.

For endocrinologists, Dr Pu noted that 3D-printing may provide clinicians with new ways to titrate diabetes medications tailored to a patient’s individual blood glucose level, kidney function, or other biological markers.

“It will change how medicine is practiced and taught and how healthcare is delivered. It will change the way research and development is regulated. Most clinical trials or medical treatments have been designed for the average patient. As a result of ‘this one-size-fits-all-approach,’ treatments can be very successful for some patients but not for others. Personalized precision medicine can change this and offer another chance for nonresponders or decrease side effects for patients already on treatment,” Dr Pu said.

The investigators said more research is needed so that a standard adjustment formula for individual drugs can be established. Also, studies will need to look at the cost-effectiveness of 3D drug printing techniques.

Reference

1. Yuang K, Pu S, Pu M. M 2081 – 3D Printing for Precision Drug Therapy: An Initial Proof of Concept Study. Presented at the American Heart Association Scientific Sessions; November 7-11, 2015; Orlando, FL.