Title:A Novel Development of Levothyroxine Sodium Orodispersible Mini
Tablets for the Treatment of Pediatrics Hypothyroidism
Volume: 17
Issue: 2
Author(s): Cecilia Henestrosa*, Camila Olivera, Sabrina Flor, Silvia Lucangioli, Ariel Vacatello, Claudia A. Ortega, Laura S. Favier and Diego A. Cifuente
Affiliation:
- Área de Tecnología Farmacéutica, Universidad Nacional de San Luis, Ejército de los Andes, San Luis (5700)
Argentina
Keywords:
Levothyroxine sodium, orodispersible mini-tablets, pediatrics use, pharmaceutical analysis, hypothyroidism, coprocessed excipients.
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.
