A Novel Development of Levothyroxine Sodium Orodispersible Mini Tablets for the Treatment of Pediatrics Hypothyroidism.

Recent advances in drug delivery and formulation Pub Date : 2023-09-08 DOI:10.2174/2667387817666230908092551

Cecilia Henestrosa, Camila Olivera, Sabrina Flor, Silvia Lucangioli, Ariel Vacatello, Claudia A Ortega, Laura S Favier, Diego A Cifuente

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Abstract

Background: In pediatrics, developing new pharmaceutical forms that offer safety and efficacy is crucial to improve pediatric pharmaceutical care. Orodispersible tablets do not require swallowing because orodispersible tablets dissolve quickly in the mouth, reducing the risk of choking and making medication administration safer and more straightforward. There is no solid dosage form in the pharmaceutical market offering a unit dose of Levothyroxine for pediatric hypothyroidism patients.

Objective: The objective of this study is to design and develop Orodispersible mini tablets of Levothyroxine Sodium (LT4 ODMTs) for pediatric doses.

Methods: LT4 ODMTs were prepared by direct compression with 10 and 15 μg, respectively, using StarLac® and Disolcel® as excipients. United States Pharmacopeia (USP-43) guidelines evaluated and determined pre-compression properties and quality control parameters.

Results: The LT4 ODMTs met the specified limits for quality controls. The Drug Content Uniformity was 97%, Hardness was less than 2.5 N, Friability was less than 0.3%, Disintegration time was less than 25 s, and dissolution profiles (Q 80% > 45 s) followed the USP requirements. Additionally, stability and microbiology assays were realized.

Conclusion: These formulations are optimal for developing new LT4 ODMTs suitable for treating pediatric hypothyroidism.

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治疗小儿甲状腺功能减退的左旋甲状腺素钠或分散迷你片的新进展。

背景:在儿科，开发安全有效的新剂型是改善儿科药学服务的关键。口服分散片不需要吞咽，因为口服分散片在口腔中迅速溶解，减少了窒息的风险，使药物管理更安全，更直接。在医药市场上没有固体剂型为儿童甲状腺功能减退患者提供单位剂量的左甲状腺素。目的:设计和研制小儿剂量左甲状腺素钠(LT4 ODMTs)口服分散迷你片。方法:以StarLac®和Disolcel®为辅料，分别以10和15 μg直接压缩制备LT4 ODMTs。美国药典(USP-43)指南评估和确定预压缩特性和质量控制参数。结果:LT4 odmt符合规定的质量控制限度。药物含量均匀度97%，硬度小于2.5 N，脆度小于0.3%，崩解时间小于25 s，溶出度(Q 80% > 45 s)符合USP要求。此外，还实现了稳定性和微生物学检测。结论:这些配方是开发适合治疗小儿甲状腺功能减退的新型LT4 ODMTs的最佳选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Recent advances in drug delivery and formulation

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