3PC-008 Formulation and stability study of the extemporaneous oral solutions of cardiologic drugs for personalised therapy of newborns

BackgroundIf the commercial medicinal products are unavailable on the market, the pharmacist needs to compound a preparation extemporaneously attending to the stability of the active pharmaceutical substance for a labelled time period. This typically occurs when the preparation is targeted at paediatric patients, particularly neonates.PurposeThe aim of the study was to test the stability of sterile aqueous solutions of cardiologic drugs directed at neonates.Material and methodsThe aqueous solutions of propranolol hydrochloride 2 mg/ml (PCL) and sotalol hydrochloride 5 mg/ml (SCL), respectively, were prepared by the dissolution of substances in water for injection, and for furosemide 2 mg/ml (FSM), disodium hydrogen phosphate dodecahydrate was used to reach the alkaline pH necessary to dissolve. The preparations were prepared under aseptic conditions and sterilised by membrane filtration or in an autoclave at 121°C for 15 min. The concentration of a drug was evaluated using a developed, fully validated HPLC method at the time of compounding, after the autoclaving, and thereafter at time intervals of 7 to 30 days of storage at room temperature.ResultsAt least 95% of the initial drug concentration was detected throughout the whole time period for aseptically prepared solutions and the autoclaved SCL solution. For the autoclaved PCL and FSM solutions, respectively, the concentration of drug ≥90% was detected only for 2 weeks.ConclusionAseptic preparation following membrane filtration is recommended for aqueous solutions of PCL 2 mg/ml, SCL 5 mg/ml and FSM 2 mg/ml, respectively, targeted at neonates. Solutions could be prepared in advance in the pharmacy and stored for 1 month until needed.References and/or Acknowledgements1. Supported by the project of the Ministry of Health of the Czech Republic 00064203 (University Hospital Motol, Prague, Czech Republic) and Student grant SVV 260412.No conflict of interest