Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children.
J Pediatr
; 163(6): 1728-1732.e1, 2013 Dec.
Article
em En
| MEDLINE
| ID: mdl-23972645
OBJECTIVE: To evaluate acceptability of 2 mm solid dosage forms (mini-tablets) as an alternative administration modality in young children in comparison with syrup. STUDY DESIGN: Three hundred six pediatric in- and outpatients aged 6 months-5 years (51 in each of 6 age groups) were recruited. An open, randomized cross-over study was conducted to compare acceptability and capability to swallow 2 mm uncoated or coated mini-tablets vs 3 mL syrup. RESULTS: In the overall patient population of 306 children, the acceptability of uncoated mini-tablets was superior to syrup (difference in proportions 14.8%, 95% CI 10.2-19.4; P < .0001). In line with this finding, the level of capability to swallow was higher for uncoated mini-tablets compared with syrup as well (difference in proportions 12.3%, 95% CI 5.4-19.3; P = .0008). All 3 pharmaceutical formulations were well tolerated, and none of the 306 children inhaled or coughed because of the syrup or the uncoated mini-tablet; only 2 of the 306 children (both in age group 0.5-1 year) coughed because of the coated mini-tablet, in both cases without clinical relevance. CONCLUSIONS: Mini-tablets are a valuable alternative to syrup for children 6 months-6 years of age and are more acceptable compared with liquid formulation. Regulatory bodies such as Food and Drug Administration and European Medicine Agency are encouraged to take our data into account for guideline updates and future drug approval processes.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Comprimidos
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Soluções Farmacêuticas
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Preferência do Paciente
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Revista:
J Pediatr
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Alemanha
País de publicação:
Estados Unidos