1. Synnöve Lindemalm, MD, PhD, Astrid Lindgren Children's Hospital
In-situ coating of tablets and capsules - tolerance and acceptance in pediatric patients
Ranaa El Edelbi MSc Pharm, PhD student , Astrid Lindgren Children's Hospital , Staffan Eksborg professor, Astrid Lindgren Children's Hospital,
Synnöve Lindemalm, MD, PhD, Astrid Lindgren Children's Hospital
Methods
A non-randomized intervention study was performed at Astrid Lindgren Children´s Hospital. A total number of 78 pediatric patients were included in the study (43 females and 35 males). The ability of patients (median age 9 years; range 2-17 years) to swallow tablets/capsules was evaluated by questionnaires.
Results
Swallowing ability and palatability was improved by in-situ coating. Sixty-six out of 77 pediatric patients (86%; 95%CI: 76 to 93%) reported facilitated drug treatment after in-situ coating (Figure 1.). Many children included in our study were able to swallow tablets and capsules larger than those proposed by EMA (European Medicines Agency), (Fig ure 2.).
Introduction
To swallow tablets/capsules is challenging in pediatric oral drug treatment. Factors that influence the childrens ability to swallow include taste, smell and texture. Children and older adults share similarities in drug acceptability and swallowing ability for tablets and capsules. Appropriate formulations are therefore crucial to increase the acceptability of medicines in order to improve therapeutic outcome, safety and compliance .
MedCoat® is an in-situ coating device aimed to facilitate swallowing and hide unpleasant taste for tablets/capsules.
Aim
To study tolerance and acceptance in pediatric patients for MedCoat® in-situ coating of tablets/capsules.
Figure 2. Tablets/capsules size intake in different age groups
The longest tablets/capsules sizes that were swallowed by the 3 study groups before the use of in-situ coating. The shaded part of each study groups refers to the size interval proposed by EMA (European Medicines Agency).
Conclusion: Drug therapy was facilitated and in-situ coating was well accepted and tolerated for most pediatric patients.
Figure 1. Facilitation of in-situ coating in different age groups
All pediatric patients reported difficulty to swallow tablets/capsules before the use of in-situ coating. The striped columns show number of patients where drug treatment improved. The open columns show not improved drug treatment after first in-situ coated dose.
ACKNOWLEDGEMENTS
Financial support was provided through the regional agreement on medical training and clinical research (ALF), project , between Stockholm County Council and Karolinska Institutet for all authors.
MedCoat AB for supporting the study with MedCoat® samples and placebo tablets. Pediatric nurses at Astrid Lindgren Children’s Hospital and pharmacist student Nora Shabo who helped us conduct the study.
References
1. Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, et al. Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs 2014; 74:
2. Kimland E, Nydert P, Odlind V, Bottiger Y, Lindemalm S. Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study. Acta Paediatr 2012; 101:772-8.
3. Kolch M, Schnoor K, Fegert JM. The EU-regulation on medicinal products for paediatric use: impacts on child and adolescent psychiatry and clinical research with minors. Eur Child Adolesc Psychiatry 2007; 16:
4. Agency EM. Clinical Investigation of Medicinal Products in the Paediatric
Population CPMP⁄ ICH ⁄ 2711 ⁄ 99. ICH Topic E 11.
5. El edelbi R, Eksborg S, Lindemalm S. In-situ coating of tablets and capsules - tolerance and acceptance in pediatric patients. Acta Paediatr 2015 (in press).
Karolinska Institutet
Ranaa El Edelbi
PhD student, Dep. Of women´s and children´s Health.
Karolinska University Hospital
Ranaa El Edelbi
Astrid Lindgren Children’s Hospital
H2:03 • Stockholm, Sweden
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