Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects
Abstract To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles wer...
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| Veröffentlicht in: | Biomaterials 2017-06, Vol.128, p.1-7 |
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| creator | Arya, Jaya Henry, Sebastien Kalluri, Haripriya McAllister, Devin V Pewin, Winston P Prausnitz, Mark R |
| description | Abstract To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology. |
| doi_str_mv | 10.1016/j.biomaterials.2017.02.040 |
| format | Article |
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Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology.</description><identifier>ISSN: 0142-9612</identifier><identifier>EISSN: 1878-5905</identifier><identifier>DOI: 10.1016/j.biomaterials.2017.02.040</identifier><identifier>PMID: 28285193</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Acceptability ; Administration, Cutaneous ; Adolescent ; Adult ; Advanced Basic Science ; clinical trials ; Dentistry ; Dissolvable microneedle patch ; Drug delivery ; Drug Delivery Systems ; erythema ; Human study ; Humans ; Image Processing, Computer-Assisted ; Middle Aged ; Needles - adverse effects ; pain ; patients ; Punctures ; Research Subjects ; Skin ; Skin vaccination ; Tolerability ; Usability ; Young Adult</subject><ispartof>Biomaterials, 2017-06, Vol.128, p.1-7</ispartof><rights>2017 Elsevier Ltd</rights><rights>Copyright © 2017 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c575t-ead2ea6e50cfc3acb95d3af930a13cab2da373fc6efce5d9d4293c2b6a03528f3</citedby><cites>FETCH-LOGICAL-c575t-ead2ea6e50cfc3acb95d3af930a13cab2da373fc6efce5d9d4293c2b6a03528f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S014296121730128X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28285193$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Arya, Jaya</creatorcontrib><creatorcontrib>Henry, Sebastien</creatorcontrib><creatorcontrib>Kalluri, Haripriya</creatorcontrib><creatorcontrib>McAllister, Devin V</creatorcontrib><creatorcontrib>Pewin, Winston P</creatorcontrib><creatorcontrib>Prausnitz, Mark R</creatorcontrib><title>Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects</title><title>Biomaterials</title><addtitle>Biomaterials</addtitle><description>Abstract To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology.</description><subject>Acceptability</subject><subject>Administration, Cutaneous</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Advanced Basic Science</subject><subject>clinical trials</subject><subject>Dentistry</subject><subject>Dissolvable microneedle patch</subject><subject>Drug delivery</subject><subject>Drug Delivery Systems</subject><subject>erythema</subject><subject>Human study</subject><subject>Humans</subject><subject>Image Processing, Computer-Assisted</subject><subject>Middle Aged</subject><subject>Needles - adverse effects</subject><subject>pain</subject><subject>patients</subject><subject>Punctures</subject><subject>Research Subjects</subject><subject>Skin</subject><subject>Skin vaccination</subject><subject>Tolerability</subject><subject>Usability</subject><subject>Young Adult</subject><issn>0142-9612</issn><issn>1878-5905</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkktv1DAUhSMEokPhL6CIFQsS_IjzYFGpKk-pEguKxM66sW86Do492MlI8-9xNNOqsIGVX-ccX9_PWfaKkpISWr8dy974CWYMBmwsGaFNSVhJKvIo29C2aQvREfE42xBasaKrKTvLnsU4krQmFXuanbGWtYJ2fJONN95igN5YMx_e5Es8TXNwOgelcDff7fgh1yZGb_fG3eaTUcE7RG0x38GstjnoyTgT5wCz8S43Lt8uE7g8Lv2Iao7PsydDqhdfnMbz7PvHDzdXn4vrr5--XF1eF0o0Yi4QNEOoURA1KA6q74TmMHScAOUKeqaBN3xQNQ4Khe50xTquWF8D4YK1Az_PLo65u6WfUCt0qSQrd8FMEA7Sg5F_njizlbd-LwVvWdPxFPD6FBD8rwXjLCcTFVoLDv0SJSOEVJzVSfsvaaJRt7RqWpKk747S1LcYAw73FVEiV65ylA-5ypWrJEwmrsn88uGb7q13IJPg_VGAqbN7g0FGZdAp1Cak5kvtzf_dc_FXjLIJqgL7Ew8YR78Et3qojMkgv60_bP1gtOGEsvYH_w1c9NUe</recordid><startdate>20170601</startdate><enddate>20170601</enddate><creator>Arya, Jaya</creator><creator>Henry, Sebastien</creator><creator>Kalluri, Haripriya</creator><creator>McAllister, Devin V</creator><creator>Pewin, Winston P</creator><creator>Prausnitz, Mark R</creator><general>Elsevier Ltd</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>7X8</scope><scope>7S9</scope><scope>L.6</scope><scope>5PM</scope></search><sort><creationdate>20170601</creationdate><title>Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects</title><author>Arya, Jaya ; Henry, Sebastien ; Kalluri, Haripriya ; McAllister, Devin V ; Pewin, Winston P ; Prausnitz, Mark R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c575t-ead2ea6e50cfc3acb95d3af930a13cab2da373fc6efce5d9d4293c2b6a03528f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acceptability</topic><topic>Administration, Cutaneous</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Advanced Basic Science</topic><topic>clinical trials</topic><topic>Dentistry</topic><topic>Dissolvable microneedle patch</topic><topic>Drug delivery</topic><topic>Drug Delivery Systems</topic><topic>erythema</topic><topic>Human study</topic><topic>Humans</topic><topic>Image Processing, Computer-Assisted</topic><topic>Middle Aged</topic><topic>Needles - adverse effects</topic><topic>pain</topic><topic>patients</topic><topic>Punctures</topic><topic>Research Subjects</topic><topic>Skin</topic><topic>Skin vaccination</topic><topic>Tolerability</topic><topic>Usability</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Arya, Jaya</creatorcontrib><creatorcontrib>Henry, Sebastien</creatorcontrib><creatorcontrib>Kalluri, Haripriya</creatorcontrib><creatorcontrib>McAllister, Devin V</creatorcontrib><creatorcontrib>Pewin, Winston P</creatorcontrib><creatorcontrib>Prausnitz, Mark R</creatorcontrib><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><collection>AGRICOLA</collection><collection>AGRICOLA - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Biomaterials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Arya, Jaya</au><au>Henry, Sebastien</au><au>Kalluri, Haripriya</au><au>McAllister, Devin V</au><au>Pewin, Winston P</au><au>Prausnitz, Mark R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects</atitle><jtitle>Biomaterials</jtitle><addtitle>Biomaterials</addtitle><date>2017-06-01</date><risdate>2017</risdate><volume>128</volume><spage>1</spage><epage>7</epage><pages>1-7</pages><issn>0142-9612</issn><eissn>1878-5905</eissn><abstract>Abstract To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>28285193</pmid><doi>10.1016/j.biomaterials.2017.02.040</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Acceptability Administration, Cutaneous Adolescent Adult Advanced Basic Science clinical trials Dentistry Dissolvable microneedle patch Drug delivery Drug Delivery Systems erythema Human study Humans Image Processing, Computer-Assisted Middle Aged Needles - adverse effects pain patients Punctures Research Subjects Skin Skin vaccination Tolerability Usability Young Adult |
| title | Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects |
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