Evaluation of physicochemical stability in extemporaneous omeprazole-based preparations
Volume 10, Issue 1, Page No 7-12, 2025
Author’s Name: Ezri Cruz-Pérez 1, 2, José Locia-Espinoza 1, 2, Joel Jahaziel Díaz-Vallejo 1, 2, 3, Magda Olivia Pérez-Vásquez 1, 2, Luis Morales de la Vega 1, Luz Irene Pascual-Mathey 1,2
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1 Facultad de Química Farmacéutica Biológica, Universidad Veracruzana, Xalapa, 91000, Veracruz, México
2 Maestría en Farmacia Clínica, Universidad Veracruzana, Xalapa, 91000, Veracruz, México
3 Centro de Alta Especialidad “Dr. Rafael Lucio”, Xalapa, 91020, Veracruz, México
a)whom correspondence should be addressed. E-mail: lupascual@uv.mx
Adv. Sci. Technol. Eng. Syst. J. 10(1), 7-12 (2025); 
DOI: 10.25046/aj100102
Keywords: Omeprazole, Stability, Extemporaneous preparation
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Extemporaneous omeprazole-based preparations are commonly used in hospitals; however, there are no validated studies about physicochemical stability. This study aimed to determine if temperature, luminosity, and the type of diluent affect the stability of omeprazole in the extemporaneous preparation. For stability, the methodology validated previously by our group was used. The 2k experimental design included Temperature (25ºC and 35ºC) and Luminosity (covered by light and 400 Lx) variables. Diluents were evaluated at five levels: 1) Citric acid + polyethylene glycol solution, 2) Polyethylene glycol solution, 3) Physiological saline solution, 4) Citric acid + polyethylene glycol solution + physiological saline solution, and 5) Polyethylene glycol solution + physiological saline solution. Minitab 18 software was used for data analysis, and the degradation kinetics were determined by linear regression. The optimal condition for physicochemical stability was a temperature of 25ºC covered by light (OM1-3h 49’, OM2-3h 2’, SSF-5h 8’, OM1SSF-2h 27’, OM2SSF-6h 23’). The diluent based on physiological saline solution provided more than five hours of shelf-life, and more than six hours, the diluent based on OM2 + SSF. However, the best option is physiological saline solution, considering the accessibility of the diluent. In conclusion, environmental conditions should be considered in extemporaneous omeprazole-based preparation since they are affected by temperature, luminosity, and type of diluent. Assessing shelf-life prior to administration is necessary to provide a safe and effective drug, avoiding the occurrence of side effects in patients.
Received: 20 November 2024 Revised: 18 December 2024 Accepted: 19 December 2024 Online: 19 January 2025
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