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

Ana Santoveña1,2, Irma Charola1, Javier Suárez-González1

  • 1a 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.

Pharmaceutical Development and Technology
|September 24, 2016
PubMed

Insights

A new oral flecainide acetate (FA) solution was developed for pediatric patients, offering a stable and uniform alternative to manipulated tablets. This formulation ensures accurate dosing for children requiring this medication.

Area of Science:

  • Pharmaceutical Science
  • Pediatric Pharmacology

Background:

  • No commercial oral flecainide acetate (FA) preparations exist for pediatric use.
  • Current practice involves manipulating tablets, posing challenges for accurate pediatric dosing.

Purpose of the Study:

  • To formulate a stable oral flecainide acetate (FA) solution for pediatric administration.
  • To provide an alternative to compounded suspensions derived from commercial tablets.

Main Methods:

  • Utilized pure active pharmaceutical ingredient (API) flecainide acetate.
  • Incorporated minimal pediatric excipients to ensure safety and palatability.
  • Evaluated formulation for complete solubilization, physical-chemical stability, microbiological stability, and dose uniformity.

Main Results:

  • One flecainide acetate (FA) formulation achieved complete solubilization, appearing as a transparent oral solution.
  • The proposed formulation demonstrated appropriate mass and dose uniformity.
  • The formulation proved to be physico-chemically and microbiologically stable for 30 days of storage at 25°C.

Conclusions:

  • A stable and uniform oral flecainide acetate (FA) solution suitable for pediatric use has been successfully developed.
  • This new formulation offers a reliable alternative to manipulated tablets for pediatric patients.
  • The study addresses a critical need for a standardized pediatric dosage form of flecainide acetate.

Keywords:
Flecainide acetate oral solutiondose uniformitymass uniformitymicrobiological stabilityphysico-chemical stability

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