Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Area of Science:

• Pediatrics
• Pharmacology
• Immunology

Background:

• Acceptability is crucial for treatment compliance, safety, and efficacy in pediatric care.
• Recurrent respiratory tract infections (RRTIs) are common in children, necessitating effective prophylactic treatments.
• Polyvalent mechanical bacterial lysate (PMBL) sublingual tablets are indicated for RRTI prophylaxis in children over 3 years old.

Purpose of the Study:

• To evaluate the acceptability of 50-mg PMBL sublingual tablets in children aged 3 to 5 years.
• To assess the appropriateness of sublingual formulations for young children.
• To compare the acceptability of PMBL sublingual tablets with standard oral/buccal medications in preschoolers.

Main Methods:

• A multivariate approach was used to assess medication acceptability.
• Standardized observer reports on medication intake were collected on days 1, 2, and 10.
• Data from 37 pediatric patients aged 3 to 5 years were analyzed using the acceptability reference framework.

Main Results:

• 50-mg PMBL sublingual tablets were classified as "positively accepted" by children aged 3 to 5 years across all evaluation days.
• No significant difference was found between the acceptability of PMBL sublingual tablets and the average acceptability of oral/buccal medicines in preschoolers.
• The sublingual formulation demonstrated high acceptability in the target pediatric age group.

Conclusions:

• 50-mg PMBL sublingual tablets are well-accepted by preschoolers (3-5 years old).
• Sublingual formulations are a viable and appropriate option for pediatric use in this age group.
• Positive acceptability supports potential for improved compliance and efficacy in managing pediatric RRTIs.