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.

Keywords:

• Flecainide acetate oral solution
• mass uniformity
• dose uniformity
• physico-chemical stability
• microbiological stability

Acknowledgements

The authors are very grateful to the following for their collaboration: the hospital pharmacy services of Hospital Universitario Nuestra Señora de la Candelaria, Farmacia Feria, Instituto Tecnológico del Medicamento Individualizado (ITMI) and the Comisión Nacional de Unificación de Criterios en Formulación Pediátrica. The authors also wish to thank Jonatan Martín Rodríguez from the Organic Chemistry Department of La Laguna University for his advice on employment of the McFarland Densitometer and standard set.

Disclosure statement

The authors report no conflicts of interest.