STABILITY OF MIDAZOLAM HYDROCHLORIDE IN EXTEMPORANEOUSLY PREPARED FLAVORED GELATIN

The stability of midazolam hydrochloride in flavored gelatin was evaluated after storage at 4-degrees-C for 14 days and at -20-degrees-C for 28 days. A flavored liquid gelatin mixture was prepared and mixed with midazolam hydrochloride injection in final concentrations of midazolam 1 and 2 mg/mL. Gelatin Cups containing 5 and 15 mg of midazolam were prepared by measuring appropriate volumes of the gelatin stock solutions and were stored in a refrigerator at 4-degrees-C or in a freezer at -20-degrees-C. Immediately after preparation and at 7 and 14 days, three refrigerated and three frozen gelatin samples of each midazolam concentration were visually inspected, tested for pH, and assayed for midazolam concentration by high-performance liquid chromatography. The frozen gelatin samples were also evaluated at 21 and 28 days; three whole and three partial gelatin samples were assayed for midazolam content to determine the uniformity of drug distribution within each sample. All samples maintained greater than 96% of the initial midazolam concentration throughout the study. There was no appreciable change in color, odor, or pH. The midazolam content of the gelatin in the cups was uniform. An extemporaneously compounded preparation of midazolam hydrochloride in flavored gelatin was stable when stored for 14 days at 4-degrees-C and for 28 days at -20-degrees-C. Distribution of midazolam hydrochloride in the gelatin was uniform.