Étude de la stabilité physico-chimique d’une préparation magistrale liquide orale a visée pédiatrique : oméprazole en suspension a 2mg/ml

Abstract

Oral dosage forms are commonly used in pharmacy for their simple and quick administration. Most oral forms are marketed in solid or dry form, due to their stability and taste. However, they can be difficult to swallow for some elderly patients suffering from dysphagia, or, in this case, for young children who often have difficulty swallowing solid forms. It’s the case of omeprazole, a proton pump inhibitor class, used to treat gastric acid related disorder. This drug is marketed as a gastro-resistant tablet or capsule, as it is very unstable, especially in acidic solutions. The objective of this work is to determine the stability of omeprazole oral suspension 2 mg/ml over a period of 45 days and to evaluate the stability of a partial dose (<20 mg) after exposure to 0.1N HCl solution for 2 hours. In this work, the stability of an extemporaneously prepared oral liquid was studied to evaluate the effect of various factors on the stability of omeprazole in suspension. These factors included temperature, light and pH. Samples were collected and analyzed by high performance liquid chromatography coupled to a diode array detector at a detection wavelength of 305 nm. The assay method was validated according to ICH guidelines, and was found to be accurate, precise, linear and specific. As results, Omeprazole-sodium bicarbonate 2mg/ml suspension prepared from 20mg capsules was stable for at least 44 days at 5°C and stable only for 14 days at room temperature. The 13mg partial dose was not stable after treatment with 0.1N HCl for 2 hours, it degraded to 13.2%.