Extemporaneous Suspension of Propafenone: Attending Lack of Pediatric Formulations in Mexico

Background Physicians have frequently encountered difficulties when prescribing drugs not available in doses suitable for pediatric age groups. Furthermore, children have difficulty swallowing tablets. This study aimed to determine the stability of an oral propafenone suspension made from commercial tablets with a syrup vehicle and to establish its reliable use with children. Methods An extemporaneous suspension of propafenone 1.5 mg/ml was prepared with commercial tablets. Its physicochemical and microbiologic stability was established by constant monitoring during 90 days at room temperature (15 ± 5°C) and at refrigeration (3–5°C). Plasma levels of propafenona were measured in two children with supraventricular tachycardia at steady state. Results The suspension was stable, maintaining its original physicochemical and microbiologic properties. Moreover, no apparent changes in color or odor were observed. Plasma levels of propafenone in patients demonstrated therapeutic concentrations after they had taken the suspension, with no unwanted outcome. Conclusions The conservation of both physicochemical and microbiologic stability of the suspension represents an option for the administration of propafenone to children. Presented in part at the 35th Annual Meeting of American College of Clinical Pharmacology, Cambridge MA, 16–19 September 2006. Laboratorio de Farmacología, Instituto Nacional de Pediatría.