Evaluation of the maternal–fetal transfer of granisetron in an ex vivo placenta perfusion model
•Observed that granisetron has concentration dependent placental transfer.•At systemic granisetron concentrations achieved with IV administration, fetal exposure was greater than 30ng/mL.•At systemic granisetron concentrations achieved with transdermal patch, there was no placental transfer detected...
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| Veröffentlicht in: | Reproductive toxicology (Elmsford, N.Y.) N.Y.), 2014-11, Vol.49, p.43-47 |
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| container_title | Reproductive toxicology (Elmsford, N.Y.) |
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| creator | Julius, Justin M. Tindall, Andrew Moise, Kenneth J. Refuerzo, Jerrie S. Berens, Pamela D. Smith, Judith A. |
| description | •Observed that granisetron has concentration dependent placental transfer.•At systemic granisetron concentrations achieved with IV administration, fetal exposure was greater than 30ng/mL.•At systemic granisetron concentrations achieved with transdermal patch, there was no placental transfer detected.
The objective of this study was to estimate maternal–fetal transplacental passage of granisetron in an ex vivo placental perfusion model. Term human placentas (N=8) were collected immediately after delivery. A single cotyledon from each placenta was perfused granisetron concentration to mimic systemic maternal peak plasma concentrations following either IV (50ng/mL) or transdermal administration (5ng/mL). To assess drug transfer and accumulation, samples were collected from maternal and fetal compartments.
In the 50ng/mL open model, the mean transport fraction was 0.21±0.08 with clearance index of 0.53±0.66. Fetal peak concentrations achieved was 5.6±6.6ng/mL with mean accumulation of 5.35±6.4ng/mL. No drug was detected in the fetal compartment with the 5ng/mL models.
Transplacental passage of granisetron was inconsistent at the 50ng/mL concentration that achieved with IV dosing. However, there consistently was no detectable passage in all the placentas evaluated of the granisetron at 5ng/mL concentration that would be achieved after transdermal patch administration. |
| doi_str_mv | 10.1016/j.reprotox.2014.06.003 |
| format | Article |
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The objective of this study was to estimate maternal–fetal transplacental passage of granisetron in an ex vivo placental perfusion model. Term human placentas (N=8) were collected immediately after delivery. A single cotyledon from each placenta was perfused granisetron concentration to mimic systemic maternal peak plasma concentrations following either IV (50ng/mL) or transdermal administration (5ng/mL). To assess drug transfer and accumulation, samples were collected from maternal and fetal compartments.
In the 50ng/mL open model, the mean transport fraction was 0.21±0.08 with clearance index of 0.53±0.66. Fetal peak concentrations achieved was 5.6±6.6ng/mL with mean accumulation of 5.35±6.4ng/mL. No drug was detected in the fetal compartment with the 5ng/mL models.
Transplacental passage of granisetron was inconsistent at the 50ng/mL concentration that achieved with IV dosing. However, there consistently was no detectable passage in all the placentas evaluated of the granisetron at 5ng/mL concentration that would be achieved after transdermal patch administration.</description><identifier>ISSN: 0890-6238</identifier><identifier>EISSN: 1873-1708</identifier><identifier>DOI: 10.1016/j.reprotox.2014.06.003</identifier><identifier>PMID: 25019977</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Cutaneous ; Administration, Intravenous ; Antiemetics - administration & dosage ; Antiemetics - metabolism ; Antiemetics - pharmacology ; Female ; Granisetron ; Granisetron - administration & dosage ; Granisetron - metabolism ; Granisetron - pharmacology ; Humans ; Maternal-Fetal Exchange - drug effects ; Models, Biological ; Nausea ; Placenta - drug effects ; Placental perfusion ; Pregnancy ; Vomiting</subject><ispartof>Reproductive toxicology (Elmsford, N.Y.), 2014-11, Vol.49, p.43-47</ispartof><rights>2014 Elsevier Inc.</rights><rights>Copyright © 2014 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-eaafd8684ee0e4c4b58333ce3fd2baa0e2e576dad9ddfafaf04e9f65665d31a23</citedby><cites>FETCH-LOGICAL-c467t-eaafd8684ee0e4c4b58333ce3fd2baa0e2e576dad9ddfafaf04e9f65665d31a23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.reprotox.2014.06.003$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25019977$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Julius, Justin M.</creatorcontrib><creatorcontrib>Tindall, Andrew</creatorcontrib><creatorcontrib>Moise, Kenneth J.</creatorcontrib><creatorcontrib>Refuerzo, Jerrie S.</creatorcontrib><creatorcontrib>Berens, Pamela D.</creatorcontrib><creatorcontrib>Smith, Judith A.</creatorcontrib><title>Evaluation of the maternal–fetal transfer of granisetron in an ex vivo placenta perfusion model</title><title>Reproductive toxicology (Elmsford, N.Y.)</title><addtitle>Reprod Toxicol</addtitle><description>•Observed that granisetron has concentration dependent placental transfer.•At systemic granisetron concentrations achieved with IV administration, fetal exposure was greater than 30ng/mL.•At systemic granisetron concentrations achieved with transdermal patch, there was no placental transfer detected.
The objective of this study was to estimate maternal–fetal transplacental passage of granisetron in an ex vivo placental perfusion model. Term human placentas (N=8) were collected immediately after delivery. A single cotyledon from each placenta was perfused granisetron concentration to mimic systemic maternal peak plasma concentrations following either IV (50ng/mL) or transdermal administration (5ng/mL). To assess drug transfer and accumulation, samples were collected from maternal and fetal compartments.
In the 50ng/mL open model, the mean transport fraction was 0.21±0.08 with clearance index of 0.53±0.66. Fetal peak concentrations achieved was 5.6±6.6ng/mL with mean accumulation of 5.35±6.4ng/mL. No drug was detected in the fetal compartment with the 5ng/mL models.
Transplacental passage of granisetron was inconsistent at the 50ng/mL concentration that achieved with IV dosing. However, there consistently was no detectable passage in all the placentas evaluated of the granisetron at 5ng/mL concentration that would be achieved after transdermal patch administration.</description><subject>Administration, Cutaneous</subject><subject>Administration, Intravenous</subject><subject>Antiemetics - administration & dosage</subject><subject>Antiemetics - metabolism</subject><subject>Antiemetics - pharmacology</subject><subject>Female</subject><subject>Granisetron</subject><subject>Granisetron - administration & dosage</subject><subject>Granisetron - metabolism</subject><subject>Granisetron - pharmacology</subject><subject>Humans</subject><subject>Maternal-Fetal Exchange - drug effects</subject><subject>Models, Biological</subject><subject>Nausea</subject><subject>Placenta - drug effects</subject><subject>Placental perfusion</subject><subject>Pregnancy</subject><subject>Vomiting</subject><issn>0890-6238</issn><issn>1873-1708</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAQhi0EokvLK1Q-ckkYx4md3EBVSytV4gJnazYeF6-SeLGdVbnxDrwhT4JX23Kt5jBz-P5_pP9n7FJALUCoj7s60j6GHB7rBkRbg6oB5Cu2Eb2WldDQv2Yb6AeoVCP7M_YupR0AtHrQb9lZ04EYBq03DK8POK2YfVh4cDz_ID5jprjg9Pf3H0cZJ54jLslRPAIP5faJciy8XzgunB75wR8C30840pKR7ym6NR0N52BpumBvHE6J3j_tc_b95vrb1W11__XL3dXn-2pslc4VITrbq74lAmrHdtv1UsqRpLPNFhGooU4ri3aw1mEZaGlwqlOqs1JgI8_Zh5NvieXnSimb2aeRpgkXCmsyQosCQzOIl1HVahCN0rqg6oSOMaQUyZl99DPGX0aAOTZhdua5CXNswoAypYkivHz6sW5nsv9lz9EX4NMJoBLKwVM0afS0jGR9pDEbG_xLP_4BvdGhWw</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>Julius, Justin M.</creator><creator>Tindall, Andrew</creator><creator>Moise, Kenneth J.</creator><creator>Refuerzo, Jerrie S.</creator><creator>Berens, Pamela D.</creator><creator>Smith, Judith A.</creator><general>Elsevier Inc</general><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>7U7</scope><scope>C1K</scope><scope>7X8</scope></search><sort><creationdate>20141101</creationdate><title>Evaluation of the maternal–fetal transfer of granisetron in an ex vivo placenta perfusion model</title><author>Julius, Justin M. ; Tindall, Andrew ; Moise, Kenneth J. ; Refuerzo, Jerrie S. ; Berens, Pamela D. ; Smith, Judith A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c467t-eaafd8684ee0e4c4b58333ce3fd2baa0e2e576dad9ddfafaf04e9f65665d31a23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Administration, Cutaneous</topic><topic>Administration, Intravenous</topic><topic>Antiemetics - administration & dosage</topic><topic>Antiemetics - metabolism</topic><topic>Antiemetics - pharmacology</topic><topic>Female</topic><topic>Granisetron</topic><topic>Granisetron - administration & dosage</topic><topic>Granisetron - metabolism</topic><topic>Granisetron - pharmacology</topic><topic>Humans</topic><topic>Maternal-Fetal Exchange - drug effects</topic><topic>Models, Biological</topic><topic>Nausea</topic><topic>Placenta - drug effects</topic><topic>Placental perfusion</topic><topic>Pregnancy</topic><topic>Vomiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Julius, Justin M.</creatorcontrib><creatorcontrib>Tindall, Andrew</creatorcontrib><creatorcontrib>Moise, Kenneth J.</creatorcontrib><creatorcontrib>Refuerzo, Jerrie S.</creatorcontrib><creatorcontrib>Berens, Pamela D.</creatorcontrib><creatorcontrib>Smith, Judith A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>MEDLINE - Academic</collection><jtitle>Reproductive toxicology (Elmsford, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Julius, Justin M.</au><au>Tindall, Andrew</au><au>Moise, Kenneth J.</au><au>Refuerzo, Jerrie S.</au><au>Berens, Pamela D.</au><au>Smith, Judith A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the maternal–fetal transfer of granisetron in an ex vivo placenta perfusion model</atitle><jtitle>Reproductive toxicology (Elmsford, N.Y.)</jtitle><addtitle>Reprod Toxicol</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>49</volume><spage>43</spage><epage>47</epage><pages>43-47</pages><issn>0890-6238</issn><eissn>1873-1708</eissn><abstract>•Observed that granisetron has concentration dependent placental transfer.•At systemic granisetron concentrations achieved with IV administration, fetal exposure was greater than 30ng/mL.•At systemic granisetron concentrations achieved with transdermal patch, there was no placental transfer detected.
The objective of this study was to estimate maternal–fetal transplacental passage of granisetron in an ex vivo placental perfusion model. Term human placentas (N=8) were collected immediately after delivery. A single cotyledon from each placenta was perfused granisetron concentration to mimic systemic maternal peak plasma concentrations following either IV (50ng/mL) or transdermal administration (5ng/mL). To assess drug transfer and accumulation, samples were collected from maternal and fetal compartments.
In the 50ng/mL open model, the mean transport fraction was 0.21±0.08 with clearance index of 0.53±0.66. Fetal peak concentrations achieved was 5.6±6.6ng/mL with mean accumulation of 5.35±6.4ng/mL. No drug was detected in the fetal compartment with the 5ng/mL models.
Transplacental passage of granisetron was inconsistent at the 50ng/mL concentration that achieved with IV dosing. However, there consistently was no detectable passage in all the placentas evaluated of the granisetron at 5ng/mL concentration that would be achieved after transdermal patch administration.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25019977</pmid><doi>10.1016/j.reprotox.2014.06.003</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0890-6238 |
| ispartof | Reproductive toxicology (Elmsford, N.Y.), 2014-11, Vol.49, p.43-47 |
| issn | 0890-6238 1873-1708 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Administration, Cutaneous Administration, Intravenous Antiemetics - administration & dosage Antiemetics - metabolism Antiemetics - pharmacology Female Granisetron Granisetron - administration & dosage Granisetron - metabolism Granisetron - pharmacology Humans Maternal-Fetal Exchange - drug effects Models, Biological Nausea Placenta - drug effects Placental perfusion Pregnancy Vomiting |
| title | Evaluation of the maternal–fetal transfer of granisetron in an ex vivo placenta perfusion model |
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