Formulation Optimization in a University Hospital: The Example of Pediatric Solutions of the ACE Inhibitor Captopril

Abstract

Many major drugs are not available in pediatric form. As a result, hospital pharmacists are often requested to provide the medical staff with liquid formulations for individualized dosage and easy administration to newborn and young patients. Such in-house formulations must of course fulfil stringent criteria of purity and stability. This paper reports the development of a liquid solution of captopril for pediatric use. A specific HPLC-UV method was developed. A number of formulations described in the literature as affording one-month stability were examined and found wanting. A simple solution of the drug (1 mg/ml) in purified water containing 0.1% EDTA-Na proved chemically and microbiologically stable at room temperature for two years.