Development of a novel physico-chemically and microbiologically stable oral solution of flecainide for pediatrics.
Pharm Dev Technol
; 23(10): 978-985, 2018 Dec.
Article
em En
| MEDLINE
| ID: mdl-27658320
ABSTRACT
There is as yet no commercialized preparation for oral administration of flecainide acetate (FA) to children. In such cases, manipulation of commercial tablets is the usual practice in pharmacy services of hospitals and compounding pharmacies, to provide a suitable dosage form for this vulnerable pediatric population group. In this study, we have formulated FA as an oral solution, as an alternative to the suspension elaborated from commercial tablets. Due to this sensitivity of young patients, we have used the pure active pharmaceutical ingredient (API) and the lowest permitted levels of pediatric excipients. Despite being a highly soluble API, only one of the formulations appears as a transparent solution due to complete FA solubilization. The proposed formulation is physico-chemically and microbiologically stable and the mass and dose uniformity is appropriate for 30 days' storage at 25 °C.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Flecainida
/
Bloqueadores do Canal de Sódio Disparado por Voltagem
/
Antiarrítmicos
Limite:
Child
/
Humans
Idioma:
En
Revista:
Pharm Dev Technol
Assunto da revista:
FARMACIA
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Espanha