Development and Stability Study of an Omeprazole Suppository for Infants
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ORIGINAL RESEARCH ARTICLE
Development and Stability Study of an Omeprazole Suppository for Infants Petra Bestebreurtje1 · Nel Roeleveld2 · Catherijne A. J. Knibbe3,4 · Adriaan A. van Sorge5 · Frans B. Plötz6,7 · Saskia N. de Wildt8,9
© The Author(s) 2020
Abstract 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 modified 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 efficacy and safety in this young population.
* Frans B. Plötz [email protected] 1
Key Points We report the development of a pediatric omeprazole suppository, by adding witepsol and 100 mg arginine (L) base and pouring at a temperature of 34.7 °C and a stirring speed of 200 rpm.
Department of Clinical Pharmacology, Tergooi Hospital, Hilversum, The Netherlands
2
Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
3
Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands
4
Division of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands
5
Department of Clinical Pharmacology, Rijnstate Hospital, Arnhem, The Netherlands
6
Department of Paediatrics, Tergooi Hospital, Hilversum, The Netherlands
7
Department of Paediatrics, Emma Children’s Hospital, Amsterdam UMC, Amsterdam, The Netherlands
1 Introduction
8
Department of Pharmacology and Toxicology, Radboud Institute Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
9
Paediatric Intensive Care and Department of Paediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands
Omeprazole (5-methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole), a proton pump inhibitor (PPI), inhibits gastric acid secretion by inactivating the H +/K + ATPase molecules of the parietal cell in
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