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Abstract:  Omeprazole is used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger–Ellison syndrome. Omeprazole is marketed by AstraZeneca under a number of names, most notably Prilosec and Losec, as well as being available from a number of generic manufacturers. Omeprazole is available in both tablet and capsule form, with varying strengths of each. The need for other administration options for those patients who cannot take tablets or capsules has led compounding pharmacies to seek other alternatives. One possible alternative is the use of a suspending agent to create an oral solution or suspension. In the past, this has been accomplished using a sodium bicarbonate solution as the vehicle. However, sodium bicarbonate/omeprazole combination imparts a bitter and unpleasant taste. SyrSpend SF Alka (reconstituted) is a vehicle for making a suspension which has a pleasant taste, thus increasing palpability and compliance. The objective of this study was to determine the stability of omeprazole in SyrSpend SF Alka (for reconstitution). The studied sample was compounded into a 2-mg/mL suspension and stored in a low-actinic plastic prescription bottle at temperatures between 2oC and 8oC. Six samples were assayed at each time point out to 92 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced degradation studies. The shelf life of this product is at least 92 days, based on data collected when refrigerated and protected from light.

Related Keywords: Paul A. Whaley, BS, Mark A. Voudrie II, MS, PMP, Bridget Sorensen, CAPM, omeprazole, peptic ulcer disease, gastroesophageal reflux disease, GERD, dyspepsia, suspension, stability

Related Categories: EXCIPIENTS, GASTROENTEROLOGY, PACKAGING, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STORAGE

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