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dc.contributor.authorHaywood, A
dc.contributor.authorBurrell, A
dc.contributor.authorVan Breda, K
dc.contributor.authorGeorge, R
dc.contributor.authorTesta, C
dc.contributor.authorNorris, R
dc.contributor.editorLoyd V Allen Jr
dc.date.accessioned2017-05-03T14:23:16Z
dc.date.available2017-05-03T14:23:16Z
dc.date.issued2009
dc.date.modified2010-06-18T03:55:54Z
dc.identifier.issn1092-4221
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.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.format.extent6073683 bytes
dc.format.mimetypeapplication/pdf
dc.languageeng
dc.language.isoen_AU
dc.publisherInternational Journal of Pharmaceutical Compounding, Inc
dc.publisher.placeUnited States
dc.publisher.urihttp://www.ijpc.com/
dc.publisher.urihttp://www.ijpc.com/Abstracts/Abstract.cfm?ABS=2910
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom170
dc.relation.ispartofpageto174
dc.relation.ispartofissue2
dc.relation.ispartofjournalInternational Journal of Pharmaceutical Compounding
dc.relation.ispartofvolume13
dc.rights.retentionY
dc.subject.fieldofresearchPharmaceutical Sciences
dc.subject.fieldofresearchPharmacology and Pharmaceutical Sciences
dc.subject.fieldofresearchcode111504
dc.subject.fieldofresearchcode1115
dc.titleStability of melatonin in an extemporaneously compounded sublingual solution and hard gelatin capsule
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.facultyGriffith Health, School of Pharmacy
gro.rights.copyright© 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.
gro.date.issued2009
gro.hasfulltextFull Text
gro.griffith.authorHaywood, Alison
gro.griffith.authorBurrell, Anthony H.


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