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Acceptability of Uncoated Mini-Tablets in Neonates--A Randomized Controlled Trial.
Klingmann, Viviane; Seitz, Annika; Meissner, Thomas; Breitkreutz, Jörg; Moeltner, Andreas; Bosse, Hans Martin.
Afiliação
  • Klingmann V; Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
  • Seitz A; Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
  • Meissner T; Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
  • Breitkreutz J; Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Düsseldorf, Germany.
  • Moeltner A; Kompetenzzentrum für Prüfungen in der Medizin, Heidelberg, Germany.
  • Bosse HM; Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
J Pediatr ; 167(4): 893-896.e2, 2015 Oct.
Article em En | MEDLINE | ID: mdl-26259675
OBJECTIVE: To evaluate the suitability of drug-free solid dosage forms (2 mm mini-tablets) as an alternative administration modality in neonates in comparison with syrup. STUDY DESIGN: A total of 151 neonates (inpatients; aged 2-28 days; median 4 days) were recruited. An open, randomized, prospective cross-over study was conducted to compare the acceptability and swallowability of 2 mm uncoated mini-tablets compared with .5 mL syrup. RESULTS: All neonates (N = 151) accepted the uncoated mini-tablet as well as the syrup (both formulations 100%; 95% CI 97.6%-100.0%; primary objective). The level of swallowability of uncoated mini-tablets was not inferior (P < .0001), in fact even higher (difference in proportions 10.0%; 95% CI 1.37%-19.34%; P = .0315) compared with syrup. Both pharmaceutical formulations were well tolerated, and in none of the 151 neonates, serious adverse events occurred; particularly none of the neonates inhaled or coughed in either of the formulations. CONCLUSIONS: The administration of uncoated mini-tablets proved to be a valuable alternative to syrup for term neonates. Our data on neonates close the age gap of prior findings in toddlers and infants: uncoated mini-tablets offer the potential of a single formulation for all age groups. These findings further shift the paradigm from liquid toward small-sized solid drug formulations for children of all age groups, as the World Health Organization proposes. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien [DRKS; germanctr.de]): DRKS00005609.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Comprimidos / Administração Oral Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Female / Humans / Male / Newborn Idioma: En Revista: J Pediatr Ano de publicação: 2015 Tipo de documento: Article País de afiliação: Alemanha País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Comprimidos / Administração Oral Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Female / Humans / Male / Newborn Idioma: En Revista: J Pediatr Ano de publicação: 2015 Tipo de documento: Article País de afiliação: Alemanha País de publicação: Estados Unidos