Shelf life study of extemporaneously prepared omeprazole oral suspension

Abstract

Context: The commercially available oral solid dosage forms are used to prepare suitable liquid dosage forms extemporaneously by the pharmacists for pediatric, geriatric, and other patients with inability of swallowing tablets or capsules. These extemporaneous preparations are not subjected to tests for quality and stability like commercial products. The stability of extemporaneous preparations should be determined in hospital settings, but the practice is to rely on published information. Unavailability of stability data limits the availability of many medicines for special patients. The extemporaneously prepared omeprazole suspension is regularly used in hospital settings. Aim: This research was taken up to perform the stability study of extemporaneous omeprazole oral suspension frequently used in a referral hospital to determine the shelf life. Materials and Methods: Stability studies were performed by keeping the freshly constituted preparations in small containers at 2°C–8°C and 25°C ± 5°C; samples were withdrawn at 0, 7, 14, 21, and 28 days and assayed by spectrophotometric method at 301 nm. The percent degradation or stability was calculated for each preparation, and data were extrapolated to find out the shelf life. Results: It was found that the shelf life (t90%) of omeprazole oral suspension, prepared extemporaneously, is 32 days at room temperature (25°C ± 5°C) and 54 days in refrigerator (2°C–8°C). Conclusion: Study outcomes shall help the hospital pharmacist to improve pharmaceutical services by dispensing the extemporaneous preparations with the knowledge of their stability and storage condition.

Keywords

• Extemporaneous preparation
• omeprazole suspension
• shelf life
• stability study