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

Liu, Lu; Fu, Kaixia; Hong, Shijie; Wang, Zhouyan; Mo, Mingming; Li, Siting; Yu, Yaying; Chen, Junli; Chen, Jieyan; Zeng, Weiqiang; Chen, Jinjin; Yang, Fan

doi:10.1016/j.jddst.2023.105008

Cited by 8 publications

(1 citation statement)

References 48 publications

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“…However, due to their novelty and rapid advancement, there exists a lack of a comprehensive regulatory framework, with no specific guidelines dedicated to the development of printed pharmaceutical forms. Limited clinical studies have been conducted using 3D printing technologies, specifically SSE [ 74 , 149 , 150 ]. Recently, a study tested placebo printlets in six human subjects [ 151 ].…”

Section: Regulatory and Financial Challengesmentioning

confidence: 99%

3D Printing of Dietary Products for the Management of Inborn Errors of Intermediary Metabolism in Pediatric Populations

Carou-Senra,

Rodríguez-Pombo,

Monteagudo-Vilavedra

et al. 2023

Nutrients

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The incidence of Inborn Error of Intermediary Metabolism (IEiM) diseases may be low, yet collectively, they impact approximately 6–10% of the global population, primarily affecting children. Precise treatment doses and strict adherence to prescribed diet and pharmacological treatment regimens are imperative to avert metabolic disturbances in patients. However, the existing dietary and pharmacological products suffer from poor palatability, posing challenges to patient adherence. Furthermore, frequent dose adjustments contingent on age and drug blood levels further complicate treatment. Semi-solid extrusion (SSE) 3D printing technology is currently under assessment as a pioneering method for crafting customized chewable dosage forms, surmounting the primary limitations prevalent in present therapies. This method offers a spectrum of advantages, including the flexibility to tailor patient-specific doses, excipients, and organoleptic properties. These elements are pivotal in ensuring the treatment’s efficacy, safety, and adherence. This comprehensive review presents the current landscape of available dietary products, diagnostic methods, therapeutic monitoring, and the latest advancements in SSE technology. It highlights the rationale underpinning their adoption while addressing regulatory aspects imperative for their seamless integration into clinical practice.

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