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
View All Articles in Issue

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

Related Categories: EXCIPIENTS, FORMULATIONS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, STORAGE

Purchase this article for download in electronic PDF format from IJPC at for $35 at:
http://www.ijpc.com/Products/ProductAddToCart.cfm?PID=2910

Search the entire IJPC archive by keyword, topic, or issue at:
http://ijpc.com/Products