Improving the quality and clinical efficacy of subdivided levothyroxine sodium tablets by 3D printing technology

The study examined the advantages of semi-solid extrusion 3D printing technology in improving the quality and clinical efficacy of subdivide drugs. Levothyroxine sodium was used as a model drug, and its subdivision demand were investigated based on prescriptions from two 3A hospitals. Levothyroxine sodium tables were subdivided via 3D printing were compared with those subdivided via manual method (grinding and shearing) and then their weight variability, weight loss, drug content and content uniformity were compared to evaluate quality. Levothyroxine sodium tables subdivided by both methods were administered to low birth weight (LBW), very low birth weight (ELBW) and very low birth weight (VLBW) premature infants with transient hypothyroxinemia, and their thyroid hormone levels and weight changes were recorded to compare efficacy. Results showed that the quality of the manual subdivision drugs did not meet the requirements of the European Pharmacopoeia, U.S. Food and Drug Administration's Tablet Scoring industry guidelines and Chinese guidelines, while that of the 3D-printed drugs did. Thyroid level were elevated in all levothyroxine sodium-treated infant; however, the thyroid level of 3D-ELBW and 3D-VLBW infants showed significant elevation (p＜0.05 versus manual groups). The 3D-VLBW infants began their first suckling faster, and needed the days of intravenous nutrition fewer (p＜0.05 versus manual groups). The cumulative weight gain curves of 3D-ELBW and 3D-VLBW infants were higher than that of manual group and their maximum difference reached 132.31 g and 94.32 g, respectively. Conclusively, 3D printing technology is a superior method for subdividing drugs that can prepared precise dose to improve drug efficacy.