Amiodarone chewable gels as a potential appproach for paediatric congenital cardiopathies treatment: Comparison between animal and vegetal gelling agents

• Published in: European journal of pharmaceutics and biopharmaceutics 2024-08, Vol.201, p.114370, Article 114370
• Main Authors: Pereyra, Romina B., Gonzalez Vidal, Noelia L.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Amiodarone - administration & dosage; Amiodarone - chemistry; Animals; Anti-Arrhythmia Agents - administration & dosage; Anti-Arrhythmia Agents - chemistry; Antiarrhythmic; Chemistry, Pharmaceutical - methods; Child; Design of experiments; Drug Compounding - methods; Drug Liberation; Gelatin - chemistry; Gelatine gummies; Gels; Heart Defects, Congenital - drug therapy; Humans; Lowmethoxyl pectin; Oral administration devices; Paediatrics formulations; Pectins - chemistry; Semi-solid formulations; Solubility; Vegan gummies
• ISSN: 0939-6411; 1873-3441; 1873-3441
• DOI: 10.1016/j.ejpb.2024.114370

[Display omitted] The difficulty in swallowing is a frequent problem when oral solid dosage forms (conventional tablets or capsules) are administered to paediatric population or patients with dysphagia. An interesting alternative to overcome these problems are non-conventional formulations like chewable gels, commonly known as ’gummies’. Therefore, this work addresses the design, development and characterization of gummies using gelatine and pectin, for the vehiculization of the antiarrhythmic amiodarone (AMIO). Applying a Design of Experiments (DoE) approach, four gelatine (GG1-GG4) and eight pectin formulations (PG1-PG8) were developed. Considering the obtained results for responses during DoE evaluation (i.e., volume, syneresis, hardness, and gumminess), GG3 and PG8 were selected for complete characterization. Water activity, pH, drug content, texture parameters (adhesiveness, springiness, cohesiveness, and fracturability), disintegration time, in vitro dissolution, and microbiological features were evaluated. The obtained results were within the expected values for this type of formulation. The dissolution profiles showed a 94 % − 99 % of the AMIO content released for GG3 and PG8, respectively, so they could be considered suitable as immediate release dosage forms. In conclusion, the chewable gels were successfully developed and characterised, suggesting a potential means to accomplish a final prototype for the improvement of congenital cardiopathies treatment.