Abstract

Personalized medicine is an emerging approach for disease management. Individuals can vary dramatically in their response to cardiovascular drugs. Personalization of medication dosing is necessary for increasing efficacy and reduction of side-effects based on the patient's race, weight, renal function, liver function or other relevant factors. However, adjustments for oral medications are not easily made due to limited formulations by pharmaceutical companies. We hypothesized it is feasible to produce personalized pills tailored to each individual patient’s clinical and biological characteristics through automated 3D-printing.

Methods: A prototype computer algorithm was developed in our laboratory. The software includes two databases: 3D volume and dosage-adjustment factors. After inputting clinical and biological factors specific to the patients (age, race, weight, GFR, etc.), the software automatically calculates a personalized dose. Once the appropriate dose is determined, 3 volume datasets are generated and transferred to a STL file of a 4x4 pill board for 3D-printing to test the accuracy and variability of 3D-printed “pills”. Five different doses (80 pills) were created with dosing increments of 25%.

Results: All pills were successfully printed using a 3D-printer (Figure). Doses of printed pills ranged from 124 mg to 373 mg. There was high reproducibility with standard deviations ranging from 3-5 mg. There were differences of 0.5-6% between the printed pills and computer-generated volumes in 5 different dose ranges indicating pills can be replicated accurately using a volume-concentration equation by the software.

Conclusion: The study demonstrates that personalized pills based on each individual's clinical and biological characteristics can be produced with high precision through 3D-printing. Further studies are needed to develop 1) a standard adjustment formula for each individual drugs 2) cost-effective 3D drug printing techniques.