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Transdermal Testosterone Delivery: Comparison Between Scrotal and Nonscrotal Delivery Systems
The purpose of this investigation was to study the bioequivalence of two testosterone transdermal delivery systems (T-TDSs), Testoderm®, designed to deliver testosterone through scrotal skin, and Androderm®, designed for nonscrotal permeation. In vitro permeation and release kinetics as well as in v...
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Published in: | Pharmaceutical development and technology 1999, Vol.4 (3), p.405-414 |
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creator | Lin, Senshang Xing, Qing-Feng Chien, Yie W. |
description | The purpose of this investigation was to study the bioequivalence of two testosterone transdermal delivery systems (T-TDSs), Testoderm®, designed to deliver testosterone through scrotal skin, and Androderm®, designed for nonscrotal permeation. In vitro permeation and release kinetics as well as in vivo pharmacokinetics in the castrated Yucatan miniature swine (minipigs) model of both T-TDSs were studied side by side under the same experimental conditions. In vitro skin permeation kinetics studies demonstrated that testosterone permeates through minipig dorsal skin at zero-order kinetics from both T-TDSs. The nonscrotal T-TDS, however, has a permeation rate which is ∼13 times higher than that for the scrotal T-TDS. The release of testosterone from the nonscrotal T-TDS showed a biphasic release profile between cumulative amount released and time, whereas a monophasic release profile between cumulative amount released and square root of time was observed for the scrotal T-TDS. Pharmacokinetic analysis of plasma testosterone profiles in minipigs indicated a significant difference (p < 0.001) in daily dose of testosterone delivered (1.20 versus 4.83 mg day), maximum concentration (Cmax) (54.2 versus 218.0 ng dl), and area under concentration-time curve (AUC0-28) [665 versus 3208 (ng dl) × hr] between these T-TDSs. However, there is no difference in time to reach Cmax, mean residence time, and daily-delivered-dose-normalized Cmax and AUC0-28. The difference in pharmacokinetic profiles resulted from the difference in daily doses delivered, which could be attributed remarkably to the difference in permeation rate (∼13-fold) between the nonscrotal and scrotal T-TDSs. |
doi_str_mv | 10.1081/PDT-100101376 |
format | article |
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In vitro permeation and release kinetics as well as in vivo pharmacokinetics in the castrated Yucatan miniature swine (minipigs) model of both T-TDSs were studied side by side under the same experimental conditions. In vitro skin permeation kinetics studies demonstrated that testosterone permeates through minipig dorsal skin at zero-order kinetics from both T-TDSs. The nonscrotal T-TDS, however, has a permeation rate which is ∼13 times higher than that for the scrotal T-TDS. The release of testosterone from the nonscrotal T-TDS showed a biphasic release profile between cumulative amount released and time, whereas a monophasic release profile between cumulative amount released and square root of time was observed for the scrotal T-TDS. Pharmacokinetic analysis of plasma testosterone profiles in minipigs indicated a significant difference (p < 0.001) in daily dose of testosterone delivered (1.20 versus 4.83 mg day), maximum concentration (Cmax) (54.2 versus 218.0 ng dl), and area under concentration-time curve (AUC0-28) [665 versus 3208 (ng dl) × hr] between these T-TDSs. However, there is no difference in time to reach Cmax, mean residence time, and daily-delivered-dose-normalized Cmax and AUC0-28. The difference in pharmacokinetic profiles resulted from the difference in daily doses delivered, which could be attributed remarkably to the difference in permeation rate (∼13-fold) between the nonscrotal and scrotal T-TDSs.</description><identifier>ISSN: 1083-7450</identifier><identifier>EISSN: 1097-9867</identifier><identifier>DOI: 10.1081/PDT-100101376</identifier><identifier>PMID: 10434286</identifier><language>eng</language><publisher>New York, NY: Informa UK Ltd</publisher><subject>Administration, Cutaneous ; Animals ; Area Under Curve ; Biological and medical sciences ; Chromatography, High Pressure Liquid ; Drug Delivery Systems ; General pharmacology ; Hormones. Endocrine system ; Kinetics ; Male ; Medical sciences ; Nonscrotal ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Scrotal ; Scrotum - metabolism ; Skin Absorption ; Swine ; Swine, Miniature ; Testosterone ; Testosterone - administration & dosage ; Testosterone - pharmacokinetics ; Transdermal</subject><ispartof>Pharmaceutical development and technology, 1999, Vol.4 (3), p.405-414</ispartof><rights>1999 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 1999</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-b2dce55afd5c5581f955a8580d936ed647953546ff8abf2ce0ee1df5e7b21b903</citedby><cites>FETCH-LOGICAL-c415t-b2dce55afd5c5581f955a8580d936ed647953546ff8abf2ce0ee1df5e7b21b903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,4024,27923,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1891069$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10434286$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lin, Senshang</creatorcontrib><creatorcontrib>Xing, Qing-Feng</creatorcontrib><creatorcontrib>Chien, Yie W.</creatorcontrib><title>Transdermal Testosterone Delivery: Comparison Between Scrotal and Nonscrotal Delivery Systems</title><title>Pharmaceutical development and technology</title><addtitle>Pharm Dev Technol</addtitle><description>The purpose of this investigation was to study the bioequivalence of two testosterone transdermal delivery systems (T-TDSs), Testoderm®, designed to deliver testosterone through scrotal skin, and Androderm®, designed for nonscrotal permeation. In vitro permeation and release kinetics as well as in vivo pharmacokinetics in the castrated Yucatan miniature swine (minipigs) model of both T-TDSs were studied side by side under the same experimental conditions. In vitro skin permeation kinetics studies demonstrated that testosterone permeates through minipig dorsal skin at zero-order kinetics from both T-TDSs. The nonscrotal T-TDS, however, has a permeation rate which is ∼13 times higher than that for the scrotal T-TDS. The release of testosterone from the nonscrotal T-TDS showed a biphasic release profile between cumulative amount released and time, whereas a monophasic release profile between cumulative amount released and square root of time was observed for the scrotal T-TDS. Pharmacokinetic analysis of plasma testosterone profiles in minipigs indicated a significant difference (p < 0.001) in daily dose of testosterone delivered (1.20 versus 4.83 mg day), maximum concentration (Cmax) (54.2 versus 218.0 ng dl), and area under concentration-time curve (AUC0-28) [665 versus 3208 (ng dl) × hr] between these T-TDSs. However, there is no difference in time to reach Cmax, mean residence time, and daily-delivered-dose-normalized Cmax and AUC0-28. The difference in pharmacokinetic profiles resulted from the difference in daily doses delivered, which could be attributed remarkably to the difference in permeation rate (∼13-fold) between the nonscrotal and scrotal T-TDSs.</description><subject>Administration, Cutaneous</subject><subject>Animals</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Drug Delivery Systems</subject><subject>General pharmacology</subject><subject>Hormones. Endocrine system</subject><subject>Kinetics</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Nonscrotal</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Scrotal</subject><subject>Scrotum - metabolism</subject><subject>Skin Absorption</subject><subject>Swine</subject><subject>Swine, Miniature</subject><subject>Testosterone</subject><subject>Testosterone - administration & dosage</subject><subject>Testosterone - pharmacokinetics</subject><subject>Transdermal</subject><issn>1083-7450</issn><issn>1097-9867</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><recordid>eNp1kEtPxCAURonR-F66NV0Yd1VoSwvudHwmRk0cl4ZQuMQaCiN0NPPvZTLja-EKbnK-y8dBaI_gI4IZOX44H-cEY4JJ2dQraJNg3uSc1c3q_M7KvKko3kBbMb4minFM19EGwVVZFazeRM_jIF3UEHppszHEwccBgneQnYPt3iHMTrKR7ycydNG77AyGDwCXPargh5SQTmd33sXl-JXJHmdpTR930JqRNsLu8txGT5cX49F1fnt_dTM6vc1VReiQt4VWQKk0mipKGTE8DYwyrHlZg66rhtOSVrUxTLamUIABiDYUmrYgLcflNjpc7J0E_zZNvxB9FxVYKx34aRQ152VRMZ7AfAGmwjEGMGISul6GmSBYzH2K5FN8-0z8_nLxtO1B_6IXAhNwsARkVNKaZFN18YdjnOB6_i5bYJ0zPrn-8MFqMciZ9eErU_5XofkTfQFphxclA4hXPw0uef2n_CdYRKNe</recordid><startdate>1999</startdate><enddate>1999</enddate><creator>Lin, Senshang</creator><creator>Xing, Qing-Feng</creator><creator>Chien, Yie W.</creator><general>Informa UK Ltd</general><general>Taylor & Francis</general><general>Informa Healthcare</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>1999</creationdate><title>Transdermal Testosterone Delivery: Comparison Between Scrotal and Nonscrotal Delivery Systems</title><author>Lin, Senshang ; Xing, Qing-Feng ; Chien, Yie W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-b2dce55afd5c5581f955a8580d936ed647953546ff8abf2ce0ee1df5e7b21b903</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Administration, Cutaneous</topic><topic>Animals</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Drug Delivery Systems</topic><topic>General pharmacology</topic><topic>Hormones. Endocrine system</topic><topic>Kinetics</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Nonscrotal</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Scrotal</topic><topic>Scrotum - metabolism</topic><topic>Skin Absorption</topic><topic>Swine</topic><topic>Swine, Miniature</topic><topic>Testosterone</topic><topic>Testosterone - administration & dosage</topic><topic>Testosterone - pharmacokinetics</topic><topic>Transdermal</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lin, Senshang</creatorcontrib><creatorcontrib>Xing, Qing-Feng</creatorcontrib><creatorcontrib>Chien, Yie W.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmaceutical development and technology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lin, Senshang</au><au>Xing, Qing-Feng</au><au>Chien, Yie W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transdermal Testosterone Delivery: Comparison Between Scrotal and Nonscrotal Delivery Systems</atitle><jtitle>Pharmaceutical development and technology</jtitle><addtitle>Pharm Dev Technol</addtitle><date>1999</date><risdate>1999</risdate><volume>4</volume><issue>3</issue><spage>405</spage><epage>414</epage><pages>405-414</pages><issn>1083-7450</issn><eissn>1097-9867</eissn><abstract>The purpose of this investigation was to study the bioequivalence of two testosterone transdermal delivery systems (T-TDSs), Testoderm®, designed to deliver testosterone through scrotal skin, and Androderm®, designed for nonscrotal permeation. In vitro permeation and release kinetics as well as in vivo pharmacokinetics in the castrated Yucatan miniature swine (minipigs) model of both T-TDSs were studied side by side under the same experimental conditions. In vitro skin permeation kinetics studies demonstrated that testosterone permeates through minipig dorsal skin at zero-order kinetics from both T-TDSs. The nonscrotal T-TDS, however, has a permeation rate which is ∼13 times higher than that for the scrotal T-TDS. The release of testosterone from the nonscrotal T-TDS showed a biphasic release profile between cumulative amount released and time, whereas a monophasic release profile between cumulative amount released and square root of time was observed for the scrotal T-TDS. Pharmacokinetic analysis of plasma testosterone profiles in minipigs indicated a significant difference (p < 0.001) in daily dose of testosterone delivered (1.20 versus 4.83 mg day), maximum concentration (Cmax) (54.2 versus 218.0 ng dl), and area under concentration-time curve (AUC0-28) [665 versus 3208 (ng dl) × hr] between these T-TDSs. However, there is no difference in time to reach Cmax, mean residence time, and daily-delivered-dose-normalized Cmax and AUC0-28. The difference in pharmacokinetic profiles resulted from the difference in daily doses delivered, which could be attributed remarkably to the difference in permeation rate (∼13-fold) between the nonscrotal and scrotal T-TDSs.</abstract><cop>New York, NY</cop><pub>Informa UK Ltd</pub><pmid>10434286</pmid><doi>10.1081/PDT-100101376</doi><tpages>10</tpages></addata></record> |
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source | Business Source Ultimate【Trial: -2024/12/31】【Remote access available】; Taylor and Francis:Jisc Collections:Taylor and Francis Read and Publish Agreement 2024-2025:Medical Collection (Reading list) |
subjects | Administration, Cutaneous Animals Area Under Curve Biological and medical sciences Chromatography, High Pressure Liquid Drug Delivery Systems General pharmacology Hormones. Endocrine system Kinetics Male Medical sciences Nonscrotal Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Scrotal Scrotum - metabolism Skin Absorption Swine Swine, Miniature Testosterone Testosterone - administration & dosage Testosterone - pharmacokinetics Transdermal |
title | Transdermal Testosterone Delivery: Comparison Between Scrotal and Nonscrotal Delivery Systems |
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