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

Abstract

In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers.

Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

“…Data were collected at home and at hospital in France (May 2015–December 2020); at hospital in Morocco (November 2018–February 2020), the United-Kingdom (June 2019–April 2021), Japan (June 2019–July 2021), India (August 2019–January 2021) and Germany (August 2020–June 2021); at home in Norway (May 2018–June 2021), Poland (July 2020) and Peru (May 2021–June 2021). The ClinSearch Acceptability Score Test (CAST), a standardized and validated tool, was used to explore medicine acceptability drivers [ 25 , 26 , 27 , 28 , 29 , 30 ]. The published methodology is briefly described in the following subsections.…”

“…The published analytical procedure is succinctly described hereafter [ 25 , 26 , 27 , 28 , 29 , 30 ]. Unsupervised methods were used to visualize the major information from the large set of 3130 standardized evaluations collected in the entire acceptability study.…”

“…Herein we used a multivariate approach [ 25 , 26 , 27 , 28 , 29 , 30 ] mining a large set of international real-life data to explore acceptability drivers of oral antibiotics in children.…”

Medicine acceptability for older people in hospital and care home: the influence of setting

“…CAST -ClinSearch Acceptability Score Test ® . Initially developed for the paediatric population [14,15], the tool has been transposed for the older population [16], to discriminate between positively and negatively accepted formulations in vulnerable populations [17][18][19][20][21][22][23].…”

Acceptability of different oral dosage forms in paediatric patients in hospital setting

“…The medicine acceptability was evaluated using a validated methodology, ClinSearch Acceptability Score Test ® (CAST) entailing a questionnaire to collect standardized evaluations of medicine intake and data analysis process to score acceptability (5,(8)(9)(10)(11)(12). Each participant was interviewed by a trained researcher and accordingly the web-questionnaire was completed as per the caretaker's and patient's response (Figure 1).…”