Characteristics and Efficacy of Warfarin Sodium Tablet Subdivided by 3D Printing Technology: A Retrospective Cohort Study of Patients After Prosthetic Valve Replacement.

BACKGROUND

Due to the individual-level clinical variation in dosing requirements in commercially available drugs, attaining the objective of clinical individualization and precise drug administration continues to pose a global challenge. Currently, the optimal approach for preparing personalized and precise medications within the clinical setting is unknown.

AIM

This study aimed to explore the effectiveness, safety and satisfaction of three-dimensional (3D) printing technology as a novel subdivision method in providing precise warfarin sodium (WFS) subdivided tablets for patients after prosthetic valve replacement (PVR).

METHODS

The optimal formulation, preparation process, parameters, and the relationship between dose and the printing volume were investigated, and the quality of the six specifications of WFS 3D-printed subdivided and pharmacist-split tablets was studied. A retrospective cohort study evaluated the effectiveness, safety, and satisfaction of patients taking WFS 3D-printed subdivided or pharmacist-split tablets.

RESULTS

The hardness, weight variation, drug content, and content uniformity of the six specifications of WFS pharmacist-split tablets did not comply with the European Pharmacopoeia, United States Pharmacopoeia, and Chinese Pharmacopoeia. In contrast, all doses of 3D-printed subdivided tablets met the requirements. The 3D-printed subdivided group showed a significantly higher target international normalized ratio (INR) compliance rate (P<0.05) and lower over-anticoagulation rate (P<0.05) than the pharmacist-split group. Also, 66.67% of patients preferred taking 3D-printed subdivided tablets.

CONCLUSION

3D printing technology is superior to the traditional subdivision method, as it can improve the effectiveness and safety of patients receiving WFS anticoagulation after PVR.