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Abstract:  Midazolam is a short-acting benzodiazepine central nervous system depressant available as an injection, tablet, or oral syrup. The need for alternative dosage form options for patients unable to take tablets and shortages of other forms of the drug have led compounding pharmacies to seek alternatives, mainly solutions and suspensions. Additionally, some patients are unable to use suspending agents containing alcohol or sorbitol. The objective of this study was to determine the stability of midazolam in sorbitol-free, alcohol-free SyrSpend SF and SyrSpend SF Cherry suspending agents. The studied samples were compounded into a 1-mg/mL suspension and stored in low-actinic plastic bottles at temperatures between 2°C to 8°C and at room temperature conditions. Six samples were assayed at each time point out to 58 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The samples remained within 90% to 110% of the initial concentration throughout the course of the study. Based on the data collected, the beyond-use date of these preparations is at least 58 days when protected from light at both refrigerated and room temperature storage conditions.

Related Keywords: Christine M. Geiger, MS, Bridget Sorenson, BS, CAPM, Paul A. Whaley, BS, midazolam, benzodiazepine, oral suspension, stability-indicating high-performance liquid chromatography, HPLC, forced degradation studies, storage conditions

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, NEUROLOGY, STORAGE

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