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

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.