Development of a novel physico-chemically and microbiologically stable oral solution of flecainide for pediatrics.

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 Technol

authors

Santoveña A,Charola I,Suárez-González J,Teigell-Pérez N,García-van Nood S,Soriano M,Fariña JB

doi

10.1080/10837450.2016.1238484

subject

Has Abstract

pub_date

2018-12-01 00:00:00

pages

978-985

issue

10

eissn

1083-7450

issn

1097-9867

journal_volume

23

pub_type

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