title: 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.
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.|b Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias (IUETSPC), Universidad de La Laguna (ULL), Avenida Astrofísico Francisco Sánchez s/n , La Laguna (Tenerife) , Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Santoveña
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.
authors.forename: Irma
authors.initials: I
authors.lastname: Charola
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Suárez-González
authors.affiliation: b Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias (IUETSPC), Universidad de La Laguna (ULL), Avenida Astrofísico Francisco Sánchez s/n , La Laguna (Tenerife) , Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Teigell-Pérez
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: García-van Nood
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.
authors.forename: Mabel
authors.initials: M
authors.lastname: Soriano
authors.affiliation: a Departamento de Ingeniería Química y TecnologÍa Farmacéutica, Facultad de Ciencias de la Salud , Universidad de La Laguna (ULL), Campus de Anchieta , La Laguna (Tenerife) , Spain.|b Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias (IUETSPC), Universidad de La Laguna (ULL), Avenida Astrofísico Francisco Sánchez s/n , La Laguna (Tenerife) , Spain.
authors.forename: José B
authors.initials: JB
authors.lastname: Fariña
mesh_terms: D000284:Administration, Oral; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000737:chemistry; D058491:Bacterial Load; D002648:Child; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry; D005424:Flecainide / Q000008:administration & dosage* / Q000737:chemistry; D006801:Humans; D010372:Pediatrics; D019999:Pharmaceutical Solutions / Q000737:chemistry; D012995:Solubility; D013535:Suspensions / Q000737:chemistry; D061567:Voltage-Gated Sodium Channel Blockers / Q000008:administration & dosage* / Q000737:chemistry
chemical_list: D000889:Anti-Arrhythmia Agents; D005079:Excipients; D019999:Pharmaceutical Solutions; D013535:Suspensions; D061567:Voltage-Gated Sodium Channel Blockers; D005424:Flecainide
keywords: Flecainide acetate oral solution; dose uniformity; mass uniformity; microbiological stability; physico-chemical stability