Background and Objective Omeprazole is a proton pump inhibitor (PPI) that is used in acid suppression therapy in infants. In this study we aimed to develop a pediatric omeprazole suppository, with good physical and chemical stability, suitable for pharmaceutical batch production. Methods The composition of the suppository consisted of omeprazole, witepsol H15 and arginine (L) base. To achieve evenly distributed omeprazole suspension suppositories, the temperature, stirring rate, and arginine (L) base amount were varied. A previously validated quantitative high-performance liquid chromatography–ultraviolet method was modifed and a long-term stability study was performed for one year. Results Evenly distributed omeprazole suspension suppositories were obtained by adding 100 mg arginine (L) base and pouring at a temperature of 34.7 °C and a stirring speed of 200 rpm. The long-term stability study showed no signs of discoloration and a stable omeprazole content between 90 and 110% over 1 year if stored in the dark at room temperature. Conclusion We developed a pediatric omeprazole suppository. This formulation may provide a good alternative to manipulated commercial or extemporaneously compounded omeprazole oral formulations for infants. Clinical studies are needed to establish efcacy and safety in this young population.

Additional Metadata
Persistent URL dx.doi.org/10.1007/s13318-020-00629-1, hdl.handle.net/1765/130716
Journal European Journal of Drug Metabolism and Pharmacokinetics
Citation
Bestebreurtje, P., Roeleveld, N, Knibbe, C.A.J., van Sorge, A.A., Plötz, F.B., & de Wildt, S.N. (2020). Development and Stability Study of an Omeprazole Suppository for Infants. European Journal of Drug Metabolism and Pharmacokinetics, 45(5), 627–633. doi:10.1007/s13318-020-00629-1