Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study
This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2–<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administrati...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-02-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/15/2/701 |
| _version_ | 1797618667213553664 |
|---|---|
| author | Juliane Münch Carolin Kloft Madhi Farhan Vladislav Fishman Sining Leng Hans Martin Bosse Viviane Klingmann |
| author_facet | Juliane Münch Carolin Kloft Madhi Farhan Vladislav Fishman Sining Leng Hans Martin Bosse Viviane Klingmann |
| author_sort | Juliane Münch |
| collection | DOAJ |
| description | This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2–<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administration of 16 (group A) or 32 (group B) mini-tablets with soft food or 16 (group C) or 32 (group D) mini-tablets with water. Children in each group were stratified by age group (2–<3 years; 3–<4 years; 4–<5 years; 5–<6 years; and 6–<7 years). Groups C and D were pooled for statistical analyses. The rates of acceptability (swallowed ≥80% of the mini-tablets with or without chewing), swallowability (swallowed all mini-tablets without chewing or any leftover), and palatability (positive/neutral responses) were ≥80.0%, ≥42.0%, and ≥82.0%, respectively, across the study groups. No marked differences were observed between groups or across age groups. No adverse events or issues of clinical relevance with deglutition were reported. Mini-tablets taken with soft food or water provide a suitable method for administering medicines to children aged ≥2–<7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617). |
| first_indexed | 2024-03-11T08:15:44Z |
| format | Article |
| id | doaj.art-5b6560658f2a4014952f4718f015ec82 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-11T08:15:44Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-5b6560658f2a4014952f4718f015ec822023-11-16T22:43:27ZengMDPI AGPharmaceutics1999-49232023-02-0115270110.3390/pharmaceutics15020701Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised StudyJuliane Münch0Carolin Kloft1Madhi Farhan2Vladislav Fishman3Sining Leng4Hans Martin Bosse5Viviane Klingmann6Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Moorenstraße 5, 40225 Düsseldorf, GermanyDepartment of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Moorenstraße 5, 40225 Düsseldorf, GermanyActelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, 4123 Allschwil, SwitzerlandIQVIA RDS, Inc., Durham, NC 27703, USAActelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, 4123 Allschwil, SwitzerlandDepartment of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Moorenstraße 5, 40225 Düsseldorf, GermanyDepartment of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Moorenstraße 5, 40225 Düsseldorf, GermanyThis single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2–<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administration of 16 (group A) or 32 (group B) mini-tablets with soft food or 16 (group C) or 32 (group D) mini-tablets with water. Children in each group were stratified by age group (2–<3 years; 3–<4 years; 4–<5 years; 5–<6 years; and 6–<7 years). Groups C and D were pooled for statistical analyses. The rates of acceptability (swallowed ≥80% of the mini-tablets with or without chewing), swallowability (swallowed all mini-tablets without chewing or any leftover), and palatability (positive/neutral responses) were ≥80.0%, ≥42.0%, and ≥82.0%, respectively, across the study groups. No marked differences were observed between groups or across age groups. No adverse events or issues of clinical relevance with deglutition were reported. Mini-tablets taken with soft food or water provide a suitable method for administering medicines to children aged ≥2–<7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617).https://www.mdpi.com/1999-4923/15/2/701formulationpaediatricmini-tabletacceptabilityswallowabilitypalatability |
| spellingShingle | Juliane Münch Carolin Kloft Madhi Farhan Vladislav Fishman Sining Leng Hans Martin Bosse Viviane Klingmann Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study Pharmaceutics formulation paediatric mini-tablet acceptability swallowability palatability |
| title | Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study |
| title_full | Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study |
| title_fullStr | Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study |
| title_full_unstemmed | Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study |
| title_short | Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study |
| title_sort | acceptability swallowability palatability and safety of multiple film coated mini tablets in children aged ≥2 7 years results of an open label randomised study |
| topic | formulation paediatric mini-tablet acceptability swallowability palatability |
| url | https://www.mdpi.com/1999-4923/15/2/701 |
| work_keys_str_mv | AT julianemunch acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT carolinkloft acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT madhifarhan acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT vladislavfishman acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT siningleng acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT hansmartinbosse acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy AT vivianeklingmann acceptabilityswallowabilitypalatabilityandsafetyofmultiplefilmcoatedminitabletsinchildrenaged27yearsresultsofanopenlabelrandomisedstudy |