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On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl
Purpose At elevated temperatures, the rate of drug release and skin permeation from transdermal delivery systems (TDS) may be higher than at a normal skin temperature. The aim of this study was to compare the effect of heat on the transdermal delivery of two model drugs, nicotine and fentanyl, from...
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| Published in: | Pharmaceutical research 2017-09, Vol.34 (9), p.1817-1830 |
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| container_end_page | 1830 |
| container_issue | 9 |
| container_start_page | 1817 |
| container_title | Pharmaceutical research |
| container_volume | 34 |
| creator | Shin, Soo Hyeon Ghosh, Priyanka Newman, Bryan Hammell, Dana C. Raney, Sam G. Hassan, Hazem E. Stinchcomb, Audra L. |
| description | Purpose
At elevated temperatures, the rate of drug release and skin permeation from transdermal delivery systems (TDS) may be higher than at a normal skin temperature. The aim of this study was to compare the effect of heat on the transdermal delivery of two model drugs, nicotine and fentanyl, from matrix-type TDSs with different formulations, using
in vitro
permeation tests (IVPT).
Methods
IVPT experiments using pig skin were performed on two nicotine and three fentanyl TDSs. Both continuous and transient heat exposures were investigated by applying heat either for the maximum recommended TDS wear duration or for short duration.
Results
Continuous heat exposure for the two nicotine TDSs resulted in different effects, showing a prolonged heat effect for one product but not the other. The J
max
enhancement ratio due to the continuous heat effect was comparable between the two nicotine TDS, but significantly different (
p
|
| doi_str_mv | 10.1007/s11095-017-2189-0 |
| format | article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_1924202155</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A747438702</galeid><sourcerecordid>A747438702</sourcerecordid><originalsourceid>FETCH-LOGICAL-c439t-e151e02c4318b0c11e5cdb037b4cef0565b204ef96307e03e0cc2be049e21ba63</originalsourceid><addsrcrecordid>eNp1kc1u1DAUhS0EotPCA7BBltjAIuXaccYJu2qY0kqFVjBU7CzHuWldJXawPS3zUjwjHk35k0Be2L7-zvG9OoQ8Y3DIAOTryBg0VQFMFpzVTQEPyIxVsiwaEF8ekhlILopaCrZH9mO8AYCaNeIx2eP1PB8FzMj3c0fTNdKPXnc0efoWb3Hw04guUd9T7ah19NKm4OkFhhF1st7RFcZEX55eXqxe0fe-w2ErXfhx0gHpSYbosu_RpEi3cNAudlmsh2w_2FsMG_ppExOO8Q1dfpsGH3Ty22JadxYjvbPpmn6wxifrMPfQ0ePcj3ab4Ql51Osh4tP7_YB8Pl6uFifF2fm708XRWWFE2aQCWcUQeL6wugXDGFama6GUrTDYQzWvWg4C-2ZegkQoEYzhLYJokLNWz8sD8mLnOwX_dZ2nVTd-HVz-UrGGCw6cVdVv6koPqKzrfQrajDYadSSFFGUtgWfq8B9UXh2OeUaHvc31vwRsJzDBxxiwV1Owow4bxUBtg1e74FUOXm2DV5A1z-8bXrcjdr8UP5POAN8BMT-5Kwx_TPRf1x-i-rg0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1924202155</pqid></control><display><type>article</type><title>On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl</title><source>Springer Link</source><creator>Shin, Soo Hyeon ; Ghosh, Priyanka ; Newman, Bryan ; Hammell, Dana C. ; Raney, Sam G. ; Hassan, Hazem E. ; Stinchcomb, Audra L.</creator><creatorcontrib>Shin, Soo Hyeon ; Ghosh, Priyanka ; Newman, Bryan ; Hammell, Dana C. ; Raney, Sam G. ; Hassan, Hazem E. ; Stinchcomb, Audra L.</creatorcontrib><description>Purpose
At elevated temperatures, the rate of drug release and skin permeation from transdermal delivery systems (TDS) may be higher than at a normal skin temperature. The aim of this study was to compare the effect of heat on the transdermal delivery of two model drugs, nicotine and fentanyl, from matrix-type TDSs with different formulations, using
in vitro
permeation tests (IVPT).
Methods
IVPT experiments using pig skin were performed on two nicotine and three fentanyl TDSs. Both continuous and transient heat exposures were investigated by applying heat either for the maximum recommended TDS wear duration or for short duration.
Results
Continuous heat exposure for the two nicotine TDSs resulted in different effects, showing a prolonged heat effect for one product but not the other. The J
max
enhancement ratio due to the continuous heat effect was comparable between the two nicotine TDS, but significantly different (
p
< 0.05) among the three fentanyl TDSs. The J
max
enhancement ratios due to transient heat exposure were significantly different for the two nicotine TDSs, but not for the three fentanyl TDSs. Furthermore, the transient heat exposure affected the clearance of drug from the skin depot after TDS removal differently for two drugs, with fentanyl exhibiting a longer heat effect.
Conclusions
This exploratory work suggests that an IVPT study may be able to discriminate differences in transdermal drug delivery when different TDS are exposed to elevated temperatures. However, the clinical significance of IVPT heat effects studies should be further explored by conducting
in vivo
clinical studies with similar study designs.</description><identifier>ISSN: 0724-8741</identifier><identifier>EISSN: 1573-904X</identifier><identifier>DOI: 10.1007/s11095-017-2189-0</identifier><identifier>PMID: 28608140</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Administration, Cutaneous ; Analgesics, Opioid - administration & dosage ; Analgesics, Opioid - pharmacokinetics ; Analysis ; Animal experimentation ; Animals ; Biochemistry ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Central nervous system depressants ; Dermatologic agents ; Dermatology ; Drug Compounding ; Drug delivery ; Drug Delivery Systems - instrumentation ; Drug Delivery Systems - methods ; Exposure ; Fentanyl ; Fentanyl - administration & dosage ; Fentanyl - pharmacokinetics ; Formulae, receipts, prescriptions ; Formulations ; Heat ; Heat transfer ; Hot Temperature ; Medical Law ; Nicotine ; Nicotine - administration & dosage ; Nicotine - pharmacokinetics ; Nicotinic Agonists - administration & dosage ; Nicotinic Agonists - pharmacokinetics ; Permeability ; Pharmacology/Toxicology ; Pharmacy ; Research Paper ; Skin ; Skin - metabolism ; Skin Absorption ; Studies ; Swine ; Temperature effects ; Test procedures ; Transdermal medication ; Transdermal Patch</subject><ispartof>Pharmaceutical research, 2017-09, Vol.34 (9), p.1817-1830</ispartof><rights>Springer Science+Business Media New York 2017</rights><rights>COPYRIGHT 2017 Springer</rights><rights>Pharmaceutical Research is a copyright of Springer, 2017.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-e151e02c4318b0c11e5cdb037b4cef0565b204ef96307e03e0cc2be049e21ba63</citedby><cites>FETCH-LOGICAL-c439t-e151e02c4318b0c11e5cdb037b4cef0565b204ef96307e03e0cc2be049e21ba63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28608140$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shin, Soo Hyeon</creatorcontrib><creatorcontrib>Ghosh, Priyanka</creatorcontrib><creatorcontrib>Newman, Bryan</creatorcontrib><creatorcontrib>Hammell, Dana C.</creatorcontrib><creatorcontrib>Raney, Sam G.</creatorcontrib><creatorcontrib>Hassan, Hazem E.</creatorcontrib><creatorcontrib>Stinchcomb, Audra L.</creatorcontrib><title>On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl</title><title>Pharmaceutical research</title><addtitle>Pharm Res</addtitle><addtitle>Pharm Res</addtitle><description>Purpose
At elevated temperatures, the rate of drug release and skin permeation from transdermal delivery systems (TDS) may be higher than at a normal skin temperature. The aim of this study was to compare the effect of heat on the transdermal delivery of two model drugs, nicotine and fentanyl, from matrix-type TDSs with different formulations, using
in vitro
permeation tests (IVPT).
Methods
IVPT experiments using pig skin were performed on two nicotine and three fentanyl TDSs. Both continuous and transient heat exposures were investigated by applying heat either for the maximum recommended TDS wear duration or for short duration.
Results
Continuous heat exposure for the two nicotine TDSs resulted in different effects, showing a prolonged heat effect for one product but not the other. The J
max
enhancement ratio due to the continuous heat effect was comparable between the two nicotine TDS, but significantly different (
p
< 0.05) among the three fentanyl TDSs. The J
max
enhancement ratios due to transient heat exposure were significantly different for the two nicotine TDSs, but not for the three fentanyl TDSs. Furthermore, the transient heat exposure affected the clearance of drug from the skin depot after TDS removal differently for two drugs, with fentanyl exhibiting a longer heat effect.
Conclusions
This exploratory work suggests that an IVPT study may be able to discriminate differences in transdermal drug delivery when different TDS are exposed to elevated temperatures. However, the clinical significance of IVPT heat effects studies should be further explored by conducting
in vivo
clinical studies with similar study designs.</description><subject>Administration, Cutaneous</subject><subject>Analgesics, Opioid - administration & dosage</subject><subject>Analgesics, Opioid - pharmacokinetics</subject><subject>Analysis</subject><subject>Animal experimentation</subject><subject>Animals</subject><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Central nervous system depressants</subject><subject>Dermatologic agents</subject><subject>Dermatology</subject><subject>Drug Compounding</subject><subject>Drug delivery</subject><subject>Drug Delivery Systems - instrumentation</subject><subject>Drug Delivery Systems - methods</subject><subject>Exposure</subject><subject>Fentanyl</subject><subject>Fentanyl - administration & dosage</subject><subject>Fentanyl - pharmacokinetics</subject><subject>Formulae, receipts, prescriptions</subject><subject>Formulations</subject><subject>Heat</subject><subject>Heat transfer</subject><subject>Hot Temperature</subject><subject>Medical Law</subject><subject>Nicotine</subject><subject>Nicotine - administration & dosage</subject><subject>Nicotine - pharmacokinetics</subject><subject>Nicotinic Agonists - administration & dosage</subject><subject>Nicotinic Agonists - pharmacokinetics</subject><subject>Permeability</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Research Paper</subject><subject>Skin</subject><subject>Skin - metabolism</subject><subject>Skin Absorption</subject><subject>Studies</subject><subject>Swine</subject><subject>Temperature effects</subject><subject>Test procedures</subject><subject>Transdermal medication</subject><subject>Transdermal Patch</subject><issn>0724-8741</issn><issn>1573-904X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1kc1u1DAUhS0EotPCA7BBltjAIuXaccYJu2qY0kqFVjBU7CzHuWldJXawPS3zUjwjHk35k0Be2L7-zvG9OoQ8Y3DIAOTryBg0VQFMFpzVTQEPyIxVsiwaEF8ekhlILopaCrZH9mO8AYCaNeIx2eP1PB8FzMj3c0fTNdKPXnc0efoWb3Hw04guUd9T7ah19NKm4OkFhhF1st7RFcZEX55eXqxe0fe-w2ErXfhx0gHpSYbosu_RpEi3cNAudlmsh2w_2FsMG_ppExOO8Q1dfpsGH3Ty22JadxYjvbPpmn6wxifrMPfQ0ePcj3ab4Ql51Osh4tP7_YB8Pl6uFifF2fm708XRWWFE2aQCWcUQeL6wugXDGFama6GUrTDYQzWvWg4C-2ZegkQoEYzhLYJokLNWz8sD8mLnOwX_dZ2nVTd-HVz-UrGGCw6cVdVv6koPqKzrfQrajDYadSSFFGUtgWfq8B9UXh2OeUaHvc31vwRsJzDBxxiwV1Owow4bxUBtg1e74FUOXm2DV5A1z-8bXrcjdr8UP5POAN8BMT-5Kwx_TPRf1x-i-rg0</recordid><startdate>20170901</startdate><enddate>20170901</enddate><creator>Shin, Soo Hyeon</creator><creator>Ghosh, Priyanka</creator><creator>Newman, Bryan</creator><creator>Hammell, Dana C.</creator><creator>Raney, Sam G.</creator><creator>Hassan, Hazem E.</creator><creator>Stinchcomb, Audra L.</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</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>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20170901</creationdate><title>On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl</title><author>Shin, Soo Hyeon ; Ghosh, Priyanka ; Newman, Bryan ; Hammell, Dana C. ; Raney, Sam G. ; Hassan, Hazem E. ; Stinchcomb, Audra L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-e151e02c4318b0c11e5cdb037b4cef0565b204ef96307e03e0cc2be049e21ba63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Administration, Cutaneous</topic><topic>Analgesics, Opioid - administration & dosage</topic><topic>Analgesics, Opioid - pharmacokinetics</topic><topic>Analysis</topic><topic>Animal experimentation</topic><topic>Animals</topic><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Central nervous system depressants</topic><topic>Dermatologic agents</topic><topic>Dermatology</topic><topic>Drug Compounding</topic><topic>Drug delivery</topic><topic>Drug Delivery Systems - instrumentation</topic><topic>Drug Delivery Systems - methods</topic><topic>Exposure</topic><topic>Fentanyl</topic><topic>Fentanyl - administration & dosage</topic><topic>Fentanyl - pharmacokinetics</topic><topic>Formulae, receipts, prescriptions</topic><topic>Formulations</topic><topic>Heat</topic><topic>Heat transfer</topic><topic>Hot Temperature</topic><topic>Medical Law</topic><topic>Nicotine</topic><topic>Nicotine - administration & dosage</topic><topic>Nicotine - pharmacokinetics</topic><topic>Nicotinic Agonists - administration & dosage</topic><topic>Nicotinic Agonists - pharmacokinetics</topic><topic>Permeability</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Research Paper</topic><topic>Skin</topic><topic>Skin - metabolism</topic><topic>Skin Absorption</topic><topic>Studies</topic><topic>Swine</topic><topic>Temperature effects</topic><topic>Test procedures</topic><topic>Transdermal medication</topic><topic>Transdermal Patch</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shin, Soo Hyeon</creatorcontrib><creatorcontrib>Ghosh, Priyanka</creatorcontrib><creatorcontrib>Newman, Bryan</creatorcontrib><creatorcontrib>Hammell, Dana C.</creatorcontrib><creatorcontrib>Raney, Sam G.</creatorcontrib><creatorcontrib>Hassan, Hazem E.</creatorcontrib><creatorcontrib>Stinchcomb, Audra L.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest - Health & Medical Complete保健、医学与药学数据库</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shin, Soo Hyeon</au><au>Ghosh, Priyanka</au><au>Newman, Bryan</au><au>Hammell, Dana C.</au><au>Raney, Sam G.</au><au>Hassan, Hazem E.</au><au>Stinchcomb, Audra L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl</atitle><jtitle>Pharmaceutical research</jtitle><stitle>Pharm Res</stitle><addtitle>Pharm Res</addtitle><date>2017-09-01</date><risdate>2017</risdate><volume>34</volume><issue>9</issue><spage>1817</spage><epage>1830</epage><pages>1817-1830</pages><issn>0724-8741</issn><eissn>1573-904X</eissn><abstract>Purpose
At elevated temperatures, the rate of drug release and skin permeation from transdermal delivery systems (TDS) may be higher than at a normal skin temperature. The aim of this study was to compare the effect of heat on the transdermal delivery of two model drugs, nicotine and fentanyl, from matrix-type TDSs with different formulations, using
in vitro
permeation tests (IVPT).
Methods
IVPT experiments using pig skin were performed on two nicotine and three fentanyl TDSs. Both continuous and transient heat exposures were investigated by applying heat either for the maximum recommended TDS wear duration or for short duration.
Results
Continuous heat exposure for the two nicotine TDSs resulted in different effects, showing a prolonged heat effect for one product but not the other. The J
max
enhancement ratio due to the continuous heat effect was comparable between the two nicotine TDS, but significantly different (
p
< 0.05) among the three fentanyl TDSs. The J
max
enhancement ratios due to transient heat exposure were significantly different for the two nicotine TDSs, but not for the three fentanyl TDSs. Furthermore, the transient heat exposure affected the clearance of drug from the skin depot after TDS removal differently for two drugs, with fentanyl exhibiting a longer heat effect.
Conclusions
This exploratory work suggests that an IVPT study may be able to discriminate differences in transdermal drug delivery when different TDS are exposed to elevated temperatures. However, the clinical significance of IVPT heat effects studies should be further explored by conducting
in vivo
clinical studies with similar study designs.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>28608140</pmid><doi>10.1007/s11095-017-2189-0</doi><tpages>14</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Pharmaceutical research, 2017-09, Vol.34 (9), p.1817-1830 |
| issn | 0724-8741 1573-904X |
| language | eng |
| recordid | cdi_proquest_journals_1924202155 |
| source | Springer Link |
| subjects | Administration, Cutaneous Analgesics, Opioid - administration & dosage Analgesics, Opioid - pharmacokinetics Analysis Animal experimentation Animals Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Central nervous system depressants Dermatologic agents Dermatology Drug Compounding Drug delivery Drug Delivery Systems - instrumentation Drug Delivery Systems - methods Exposure Fentanyl Fentanyl - administration & dosage Fentanyl - pharmacokinetics Formulae, receipts, prescriptions Formulations Heat Heat transfer Hot Temperature Medical Law Nicotine Nicotine - administration & dosage Nicotine - pharmacokinetics Nicotinic Agonists - administration & dosage Nicotinic Agonists - pharmacokinetics Permeability Pharmacology/Toxicology Pharmacy Research Paper Skin Skin - metabolism Skin Absorption Studies Swine Temperature effects Test procedures Transdermal medication Transdermal Patch |
| title | On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl |
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