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Article

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

1
Department of Lung Diseases and Rheumatology in Children, Medical University in Lublin, Aleje Racławickie 1, 20-059 Lublin, Poland
2
Alergotest s.c. Specjalistyczne Centrum Medyczne, Jana Sapiehy 2/Lok. 4A, 20-095 Lublin, Poland
3
ClinSearch, 110 Avenue Pierre Brossolette, 92240 Malakoff, France
4
Department of Pediatric Nursing, Medical University in Lublin, Aleje Racławickie 1, 20-059 Lublin, Poland
5
Lallemand Pharma AG, Via Selva 2, C.P 5183, 6900 Massagno, Switzerland
*
Author to whom correspondence should be addressed.
Academic Editor: José B. Fariña
Received: 29 January 2021 / Revised: 15 February 2021 / Accepted: 17 February 2021 / Published: 23 February 2021
(This article belongs to the Special Issue Development and Adaptation of New and Better Pediatric Drugs)
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.
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Keywords: acceptability; medicine; sublingual; formulation; pediatric; children; polyvalent mechanical bacterial lysate; respiratory tract infections; prophylaxis; ClinSearch acceptability score test (CAST) acceptability; medicine; sublingual; formulation; pediatric; children; polyvalent mechanical bacterial lysate; respiratory tract infections; prophylaxis; ClinSearch acceptability score test (CAST)
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MDPI and ACS Style

Emeryk, A.; Vallet, T.; Wawryk-Gawda, E.; Jędrzejewski, A.; Durmont, F.; Ruiz, F. Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years. Pharmaceutics 2021, 13, 294. https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13020294

AMA Style

Emeryk A, Vallet T, Wawryk-Gawda E, Jędrzejewski A, Durmont F, Ruiz F. Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years. Pharmaceutics. 2021; 13(2):294. https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13020294

Chicago/Turabian Style

Emeryk, Andrzej, Thibault Vallet, Ewelina Wawryk-Gawda, Arkadiusz Jędrzejewski, Frederic Durmont, and Fabrice Ruiz. 2021. "Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years" Pharmaceutics 13, no. 2: 294. https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13020294

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