Lazic, Milica (59569283700)Milica (59569283700)LazicDjukic, Milan (23988377500)Milan (23988377500)DjukicVukomanovic, Vladislav (55881072000)Vladislav (55881072000)VukomanovicBijelic, Maja (56807060700)Maja (56807060700)BijelicObarcanin, Emina (54973943600)Emina (54973943600)ObarcaninBajcetic, Milica (15727461400)Milica (15727461400)Bajcetic2025-06-122025-06-122025https://doi.org/10.3390/jcm14030915https://www.scopus.com/inward/record.uri?eid=2-s2.0-85217782651&doi=10.3390%2fjcm14030915&partnerID=40&md5=63ea4f20a76c9ad649d64dfd0a870e6ehttps://remedy.med.bg.ac.rs/handle/123456789/643Background: Angiotensin-converting enzyme inhibitors, such as enalapril, are foundational in treating pediatric heart failure. However, they are often administered off-label to young children using extemporaneous formulations. This study, conducted as part of the EU-funded Labeling of Enalapril from Neonates up to Adolescents (LENA) project, aimed to evaluate the acceptability and palatability of an age-appropriate enalapril orodispersible minitablet (ODMT). These factors are critical for ensuring adherence, efficacy, and safety in pediatric patients. Methods: An 8-week trial was conducted in children with heart failure caused by dilated cardiomyopathy or congenital heart disease. Enalapril ODMTs (0.25 mg or 1.0 mg) were dose-titrated and administered to 38 children aged 0–6 months and 22 children aged 6 months to 6 years. This study aimed to assess its acceptability and palatability, key factors contributing to adherence, and therefore, efficacy and safety. Results: Across all 169 assessments in 38 children aged 0–6 months and 22 aged 6 months to 6 years, complete or partial swallowability was observed, and the acceptability rate was 100%. There were no cases of choking, inhalation/coughing, or spitting out. A favorable or neutral rating was observed in 96% of palatability assessments based on observations of facial expressions. Acceptability and palatability were higher in subjects aged 6 months–6 years than 0–6 months, with no significant influence from repeated administration. Conclusions: Enalapril ODMTs are widely accepted and well-tolerated among young children, including neonates, with heart failure. These findings suggest that ODMTs are a suitable and effective method for administering pediatric medicinal products. © 2025 by the authors.acceptabilityenalaprilheart failureinfants and toddlerspalatabilitypediatric cardiologypediatric drug formulations