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.
journal_name
Pharm Dev Technoljournal_title
Pharmaceutical development and technologyauthors
Santoveña A,Charola I,Suárez-González J,Teigell-Pérez N,García-van Nood S,Soriano M,Fariña JBdoi
10.1080/10837450.2016.1238484subject
Has Abstractpub_date
2018-12-01 00:00:00pages
978-985issue
10eissn
1083-7450issn
1097-9867journal_volume
23pub_type
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