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

HENESTROSA C; OLIVERA C; FLOR S.; LUCANGIOLI S.; VACATELO A.; ORTEGA C.; FAVIER S; CIFUENTES A.

Recent Advances in Drug Delivery & Formulation

BENTHAN SCI

Año: 2023 vol. 17 p. 152 - 159

2667-3886

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