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dc.contributor.authorHaywood, Alisonen_US
dc.contributor.authorBurrell, Anthonyen_US
dc.contributor.authorVan Breda, Karinen_US
dc.contributor.authorGeorge, Ranien_US
dc.contributor.authorTesta, Chrisen_US
dc.contributor.authorNorris, Rossen_US
dc.contributor.editorLoyd V Allen Jren_US
dc.date.accessioned2017-05-03T14:23:16Z
dc.date.available2017-05-03T14:23:16Z
dc.date.issued2009en_US
dc.date.modified2010-06-18T03:55:54Z
dc.identifier.issn10924221en_US
dc.identifier.urihttp://hdl.handle.net/10072/28546
dc.description.abstractThis study examined the stability of melatonin in a 10-mg/mL oral sublingual solution stored at 4àor 25àand in 3-mg capsules stored at ambient (25û 60% relative humidity) and accelerated (40û 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 4àor 25î 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 high-performance 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 were assayed at 7, 14, 28, 60, and 90 days. The mean concentration of melatonin exceeded 98% of the initial concentration throughout the 90-day study period for the sublingual solution and capsules under all storage conditions. There were no detectable changes in color, odor, taste, or pH, and no visible microbial growth in any of the sublingual solution samples. Compendia requirements for content uniformity were met for the extemporaneously prepared capsules. Melatonin in an extemporaneously compounded sublingual solution (10 mg/mL) was stable for at least 90 days when stored in prescription amber glass bottles at 4àor 25î Melatonin in extemporaneously prepared capsules (3 mg) was stable for at least 90 days when stored in prescription amber glass bottles at ambient or accelerated conditions.en_US
dc.description.peerreviewedYesen_US
dc.description.publicationstatusYesen_AU
dc.format.extent6073683 bytes
dc.format.mimetypeapplication/pdf
dc.languageEnglishen_US
dc.language.isoen_AU
dc.publisherInternational Journal of Pharmaceutical Compounding, Incen_US
dc.publisher.placeUnited Statesen_US
dc.publisher.urihttp://www.ijpc.com/en_US
dc.publisher.urihttp://www.ijpc.com/Abstracts/Abstract.cfm?ABS=2910en_US
dc.relation.ispartofstudentpublicationNen_AU
dc.relation.ispartofpagefrom170en_US
dc.relation.ispartofpageto174en_US
dc.relation.ispartofissue2en_US
dc.relation.ispartofjournalInternational Journal of Pharmaceutical Compoundingen_US
dc.relation.ispartofvolume13en_US
dc.rights.retentionYen_AU
dc.subject.fieldofresearchPharmaceutical Sciencesen_US
dc.subject.fieldofresearchcode111504en_US
dc.titleStability of melatonin in an extemporaneously compounded sublingual solution and hard gelatin capsuleen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Peer Reviewed (HERDC)en_US
dc.type.codeC - Journal Articlesen_US
gro.facultyGriffith Health, School of Pharmacyen_US
gro.rights.copyrightCopyright 2009 International Journal of Pharmaceutical Compounding. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.en_AU
gro.date.issued2009
gro.hasfulltextFull Text


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