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Development of a Novel Physico-Chemically and Microbiologically Stable Oral Solution of Flecainide for Pediatrics

Development of a Novel Physico-Chemically and Microbiologically Stable Oral Solution of Flecainide for Pediatrics

Ana Santoveña, Irma Charola, Javier Suárez-González, Nuria Teigell-Pérez, Susana García-van Nood, Mabel Soriano, José B Fariña

Pharm Dev Technol. 2018 Dec;23(10):978-985.

PMID: 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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP54143554	(±)-Flecainide solution		54143-55-4	Price

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