Class of 2011 Abstract / OBJECTIVES: To determine the solubility and stability of hydrocortisone in a ‘magic mouthwash; suspension. METHODS: A literature review was conducted to establish the most common ingredients in a ‘magic mouthwash’ suspension It was decided that the test suspension would consist of 75% commercially available diphenhydramine solution, 12.5% nystatin suspension (100,000 units/ml) , and 12.5% lidocaine solution (2% lidocaine). Powdered hydrocortisone was then added to the test suspensions at different concentrations and stored at 27C, 38C, and 48C. Aliquots were taken from each of the test samples at the time of compounding and at 4, 7, 13, 19, and 26 days to be analyzed by HPLC for degradation of hydrocortisone and percent hydrocortisone in suspension. RESULTS: At 27C, 98.5% of hydrocortisone was recovered after 26 days, versus 33.7% at 38C, and 7% at 48C. The solubility of hydrocortisone in the suspension was higher at higher temperatures, with 82% in solution at 48C, 70% at 38C, and 38% at 27C. CONCLUSION: The amount of hydrocortisone recovered deteriorated over time and at higher temperatures, and solubility of hydrocortisone in the suspension was greater at higher temperatures.

Purpose: Beyond-use dating (BUD) of lidocaine alone and in two “magic mouthwash” preparations stored in amber oral syringes at room temperature was determined. Methods:Two formulations of mouthwash containing oral topical lidocaine 2% (viscous), diphenhydramine 2.5 mg/mL, and aluminum hydroxide–magnesium hydroxide–simethicone were prepared in 1:1:1 and 1:2.5:2.5 ratios, divided into 3-mL samples, and stored in unit-dose oral amber syringes. Unit-dose single-product lidocaine samples were also prepared to serve as controls and stored in oral amber syringes. The lidocaine concentrations in these samples were measured periodically for 90 days. A stability-indicating high-performance liquid chromatographic method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity, and robustness. Results: Based on the calculated percentages versus the initial concentration and the results from an analysis of variance comparing the two formulations, a BUD of 21 days is deemed appropriate for both magic mouthwash formulations. Based on the stability data, published safety concerns, and lack of efficacy in combination, packaging and dispensing lidocaine separately from other ingredients are recommended when administering magic mouthwash mixtures. Utilizing a 90-day BUD, lidocaine can be packaged separately from other magic mouthwash ingredients in individual dosage units and applied to the oral cavity using the swish-and-spit method. The delivery of the diphenhydramine and aluminum hydroxide–magnesium hydroxide–simethicone could be separated, allowing for a swish-and-swallow method of administration.Conclusion: A BUD of 21 days is recommended for lidocaine prepared with diphenhydramine and aluminum hydroxide–magnesium hydroxide–simethicone in ratios of 1:1:1 and 1:2.5:2.5 and stored at room temperature in amber oral plastic syringes.