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• W1970490491 abstract "You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Basic Research (II)1 Apr 20131019 ORAL DELIVERY OF MELANOTANûII (MT-II) IN THE RODENT MODEL Natan Bar-Chama, Mike Wyllie, and Naifang Wang Natan Bar-ChamaNatan Bar-Chama New York, NY More articles by this author , Mike WyllieMike Wyllie Roslyn Heights, NY More articles by this author , and Naifang WangNaifang Wang Valhalla, NY More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.604AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Melanotan ûII (MT-II) is a synthetic cyclic peptide that functions as a centrally acting melanocortin analog. In humans, subcutaneous (SC) administration of MT-II has demonstrated efficacy and safety for psychogenic as well as organic erectile dysfunction (ED) (Wessells, H., N. et al. (2000). Int J Impot Res 12 Suppl 4: S74-9). Our objective was to determine if MT-II absorption through the gastrointestinal tract can be achieved in the rodent model using a novel oral drug delivery technology. METHODS Male Sprague-Dawley rats (SD rat) were purchased from Taconic Farms Inc. (Hudson, NY USA) weighing 250 grams. SD rats where administered MT-II either subcutaneously (SC) or orally by dosing syringe after a 2 minute inhalation anesthesia. Prior to the oral experiment rats were placed in a fasting state for 12 hours. The novel oral delivery technology is solely comprised of pharmacopeia agents recognized as “GRAS”, (an acronym used by the US Food and Drug Administration for the phrase Generally Recognized As Safe) and contains no new chemical entities (NCEs). MT-II was dosed at 160 μg/kg for the control SC injections (n=5), 800 μg/kg in 2 oral experiments (n=9) and 1,600 μg/kg for the third oral experiment (n=4). The tablets where prepared by a standard simple mixture method and compression procedure. 150 μl of blood was collected per sample at specific time points using the tail clipping method and stored at -20 degrees Celsius pending further blood analyses. The blood serums were analyzed for MT-II by liquid chromatography/tandem mass spectrometry (LC-MS/MS). RESULTS The pharmacokinetic (PK) profile of the novel oral MT-II formulation is characterized by a rapid T max. The calculated bioavailability is in excess of 25% when comparing oral versus SC administration. See attached figure. CONCLUSIONS We have for the first time demonstrated the ability to deliver the synthetic protein MT-II orally in the rodent model. The pharmacokinetic profile achieved is clinically useful and supportive of proceeding with formulation optimization and initial human studies. Melanotan-II (MT-II) a centrally acting synthetic melanocortin analog may in the future provide an oral as needed therapy for men with erectile dysfunction. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e418 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Natan Bar-Chama New York, NY More articles by this author Mike Wyllie Roslyn Heights, NY More articles by this author Naifang Wang Valhalla, NY More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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• W1970490491 title "1019 ORAL DELIVERY OF MELANOTANûII (MT-II) IN THE RODENT MODEL" @default.
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