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Stability of Melatonin in an Extemporaneously Compounded Sublingual Solution and Hard Gelatin Capsule

Author(s):  Haywood Alison, Burrell Anthony, van Bred Karin, George Rani, Testa Chris, Norris Ross

Issue:  Mar/Apr 2009 - Sterile Compounding
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Abstract:  This study examined the stability of melatonin in a 10-mg/mL oral sublingual solution stored at 4°C or 25°C and in 3-mg capsules stored at ambient (25°C; 60% relative humidity) and accelerated (40°C; 75% relative humidity) conditions over a period of 90 days. A sublingual solution of melatonin 10 mg/mL was prepared with glycerin, ethyl alcohol, stevia powder extract, and tutti-frutti flavor. Six identical solutions were prepared and stored in prescription amber glass bottles at 4°C or 25°C. Triplicate 1-mL samples from each of the six solutions were assayed immediately after preparation and after 7, 14, 28, 60, and 90 days with a stability-indicating highperformance liquid chromatographic method. Six batches of 100 melatonin 3-mg capsules were prepared with Methocel E4M and lactose anhydrous and stored in prescription amber glass bottles at ambient or accelerated conditions. A sample of 10 capsules from each batch was assayed immediately after preparation, and additional samples from each storage condition we

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