Extemporaneous preparation of paediatric oral formulations with sildenafil citrate

Abstract

The paediatric population is composed of several very different subgroups, each with its own specific characteristics. For this reason, children cannot be considered “small adults”. The development of formulations suitable for children is a complex process, as it must consider the physiological changes that occur during childhood and the impact they have on the absorption of drugs. Sildenafil citrate is a drug with a narrow therapeutic index used in paediatrics to treat pulmonary hypertension. In the present work, technological approaches for extemporaneous preparation of paediatric oral forms containing sildenafil citrate for personalized therapy in children were studied. The prepared formulations were tested for physical and microbiological stability, in-use stability, and determination of active substance content. All tested oral formulations remained unchanged in terms of appearance during the entire period of stability monitoring at the selected storage conditions – room temperature 25 °C ± 5 °C and in a refrigerator at 5 °C ± 2 °C. The established pH values suggest that the formulations remained chemically stable during the stability study. The content of sildenafil citrate in all prepared oral formulations remained above 95% w/v. The microbiological quality of the prepared compositions was confirmed. Rational strategies for preparation of extemporaneous formulations were proposed based on the analysis of experimental data.