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Artículo

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

Henestrosa, Cecilia Mariel; Olivera, CamilaIcon ; Flor, Sabrina AndreaIcon ; Lucangioli, Silvia EdithIcon ; Vacatello, Ariel; Ortega, Claudia Alicia; Favier, Laura Silvina; Cifuente, Diego AlbertoIcon
Fecha de publicación: 07/2023
Editorial: Bentham Science Publishers
Revista: Recent Advances in Drug Delivery and Formulation
e-ISSN: 2667-3886
Idioma: Inglés
Tipo de recurso: Artículo publicado
Clasificación temática:
Otras Ciencias de la Salud

Resumen

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.
Palabras clave: Levothyroxine sodium , orodispersible mini-tablets , pediatrics use , pharmaceutical analysis
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info:eu-repo/semantics/restrictedAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)
Identificadores
URI: http://hdl.handle.net/11336/234582
DOI: http://dx.doi.org/10.2174/2667387817666230908092551
URL: https://www.eurekaselect.com/article/134349
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Articulos de OFICINA DE COORDINACION ADMINISTRATIVA HOUSSAY
Citación
Henestrosa, Cecilia Mariel; Olivera, Camila; Flor, Sabrina Andrea; Lucangioli, Silvia Edith; Vacatello, Ariel; et al.; A Novel Development of Levothyroxine Sodium Orodispersible Mini Tablets for the Treatment of Pediatrics Hypothyroidism; Bentham Science Publishers; Recent Advances in Drug Delivery and Formulation; 17; 2; 7-2023; 152-159
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