{"71451":{"#nid":"71451","#data":{"type":"news","title":"Study Demonstrates Effectiveness of Microneedles","body":[{"value":"\u003Cp\u003EIn what is believed to be the first peer-reviewed study of its kind involving human subjects, researchers at the University of Kentucky and the Georgia Institute of Technology have demonstrated that patches coated on one side with microscopic needles can facilitate transdermal delivery of clinically-relevant doses of a drug that normally cannot pass through the skin.  \u003C\/p\u003E\n\u003Cp\u003EReported in the journal \u003Cem\u003EProceedings of the National Academy of Sciences\u003C\/em\u003E, the study could help advance the use of microneedles as a painless method for delivering drugs, proteins, DNA and vaccines into the body.  The research also found other advantages for the microneedles, including an ability to produce therapeutic drug levels with lower doses, and lowered production of metabolites that may cause side-effects.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022This proof-of-concept study shows that microneedles work in humans for transdermal drug delivery,\u0022 said Daniel Wermeling, associate professor of pharmacology in the University of Kentucky\u0027s College of Pharmacy.  \u0022Success with microneedles could cause us to rethink the convergence of the drug and delivery system and lead to a more integrated approach merging engineering with pharmaceutical technology.\u0022\n\u003C\/p\u003E\n\u003Cp\u003EThe research was supported by the National Institutes of Health and the University of Kentucky Research Foundation.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022This study represents an important landmark in the development of microneedles into drug delivery devices suitable for use in clinical medicine,\u0022 said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering. \u0022This method may be useful for a broad range of drugs that cannot normally be delivered without a hypodermic needle.\u0022\n\u003C\/p\u003E\n\u003Cp\u003ETransdermal drug delivery has proven successful in a number of applications, including pain management, congestive heart failure and hormone replacement.  Transdermal administration offers advantages over other delivery techniques, but existing systems can only be used for a narrow range of compounds that easily pass through the skin.\n\u003C\/p\u003E\n\u003Cp\u003EBy painlessly punching a series of microscopic holes in the outer layer of skin known as the stratum corneum, microneedles promise to expand the range of drugs and vaccines that can be delivered transdermally.  Until this study, however, the only published research demonstrating drug delivery using microneedles had involved studies in animals and on human cadaver skin.\n\u003C\/p\u003E\n\u003Cp\u003ECollaborating with Prausnitz and his Georgia Tech research team, Wermeling and colleagues Stan Banks, David Hudson and Audra Stinchcomb set out to determine whether microneedle patches could indeed help deliver useful amounts of drug compounds that otherwise couldn\u0027t pass through the skin.  As a test compound, they chose the drug naltrexone, a skin-impermeable compound that is used to treat opiate and alcohol addiction.\n\u003C\/p\u003E\n\u003Cp\u003EWorking with a small group of non-addicted human test subjects, they first prepared a section of skin on each subject\u0027s arm by pressing and removing thumb-sized patches that contained 50 stainless steel microneedles each about 620 microns - about 1\/40th of an inch - in length.  Next, gel containing naltrexone was applied to the prepared area, which was then covered by a protective dressing.  \n\u003C\/p\u003E\n\u003Cp\u003EThe concentration of the drug in each subjects\u0027 bloodstream was monitored for 72 hours.  The researchers quickly saw levels of the drug reach pharmacologically active concentrations, and those levels remained steady for at least 48 hours in the six test subjects.\n\u003C\/p\u003E\n\u003Cp\u003EControl subjects were treated in the same way, but without the microneedle preparation prior to application of the naltrexone gel.  None of the control subjects had detectable levels of the drug in their bloodstream.\n\u003C\/p\u003E\n\u003Cp\u003EAs part of the study, electrical resistance testing of the skin was done on separate subjects to determine how long the pores created by the microneedles remained open.  Those tests suggested that drug could pass through treated skin for at least 48 hours before natural healing processes closed up the tiny punctures.\n\u003C\/p\u003E\n\u003Cp\u003EBeyond maintaining a steady level of the naltrexone, microneedle delivery may offer another advantage over oral administration: a reduction in the presence of compounds metabolized from the drug.  The primary metabolite, known as naltrexol, is rapidly produced by the liver and intestines when the drug is administered orally, creating blood levels as much at ten times that of the parent drug - which can cause undesirable side effects.  With microneedle administration, however, the levels of naltrexol stayed well below those of the naltrexone.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022During the first week of treatment using oral naltrexone, 10 to 20 percent of patients drop out of treatment because of side effects,\u0022 Wermeling said.  \u0022If you can change the way the parent drug is presented in a way that affects how the metabolites are formed, you could improve the safety or side effects of the drug.\u0022\n\u003C\/p\u003E\n\u003Cp\u003EMicroneedle administration also reduced the amount of drug required to produce therapeutic levels, replacing a 50 milligram tablet with 10-12 milligrams of drug in the gel.  Use of the microneedles also produced steady bloodstream levels of the drug, without the initial peak that occurs with oral delivery.\n\u003C\/p\u003E\n\u003Cp\u003EThe study represents a first step in demonstrating the broad range of potential uses for microneedles, said Prausnitz, who has been developing the devices for more than ten years.  In addition to Prausnitz, the Georgia Tech research team also included Harvinder Gill and Jyoti Gupta.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022There are a number of ways in which microneedles can be used,\u0022 Prausnitz noted.  \u0022This study addressed the simplest use of microneedles in which the needles are just inserted and removed from the skin and a drug patch applied.  To understand how broadly microneedles can be used in medicine, we will also need to study delivery of other therapeutics, such as lidocaine, insulin and flu vaccine.\u0022\n\u003C\/p\u003E\n\u003Cp\u003EThe study has special significance for University of Kentucky researcher and co-author Stan Banks.  The work is the capstone of his thesis, and represents four years of preclinical studies with naltrexone and delivery systems under an NIH grant to Audra Stinchcomb, an associate professor in the University of Kentucky College of Pharmacy and also a co-author of the paper. \n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\nGeorgia Institute of Technology\u003Cbr \/\u003E\n75 Fifth Street, N.W., Suite 100\u003Cbr \/\u003E\nAtlanta, Georgia  30308  USA\u003C\/strong\u003E\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EMedia Relations Contacts\u003C\/strong\u003E: John Toon, Georgia Tech (404-894-6986); E-mail: (\u003Ca href=\u0022mailto:jtoon@gatech.edu\u0022\u003Ejtoon@gatech.edu\u003C\/a\u003E) or Ann Blackford, University of Kentucky (859-323-6363, ext. 230).\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EWriter\u003C\/strong\u003E: John Toon\n\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":[{"value":"First peer-reviewed human study shows devices can deliver drugs"}],"field_summary":[{"value":"In what is believed to be the first peer-reviewed human study of its kind, researchers have demonstrated that patches coated on one side with microscopic needles can facilitate transdermal delivery of clinically-relevant doses of a drug that normally cannot pass through the skin.","format":"limited_html"}],"field_summary_sentence":[{"value":"Microneedles are effective in delivering drugs"}],"uid":"27303","created_gmt":"2008-02-04 01:00:00","changed_gmt":"2016-10-08 03:03:24","author":"John Toon","boilerplate_text":"","field_publication":"","field_article_url":"","dateline":{"date":"2008-02-04T00:00:00-05:00","iso_date":"2008-02-04T00:00:00-05:00","tz":"America\/New_York"},"extras":[],"hg_media":{"71452":{"id":"71452","type":"image","title":"Microneedle array","body":null,"created":"1449177376","gmt_created":"2015-12-03 21:16:16","changed":"1475894637","gmt_changed":"2016-10-08 02:43:57"},"71453":{"id":"71453","type":"image","title":"Microneedle array","body":null,"created":"1449177376","gmt_created":"2015-12-03 21:16:16","changed":"1475894637","gmt_changed":"2016-10-08 02:43:57"},"71454":{"id":"71454","type":"image","title":"Microneedle array","body":null,"created":"1449177376","gmt_created":"2015-12-03 21:16:16","changed":"1475894637","gmt_changed":"2016-10-08 02:43:57"}},"media_ids":["71452","71453","71454"],"related_links":[{"url":"http:\/\/www.chbe.gatech.edu\/","title":"School of Chemical \u0026 Biomolecular Engineering"},{"url":"http:\/\/www.chbe.gatech.edu\/fac_staff\/faculty\/prausnitz.php","title":"Mark Prausnitz"}],"groups":[{"id":"1188","name":"Research Horizons"}],"categories":[{"id":"141","name":"Chemistry and Chemical Engineering"},{"id":"146","name":"Life Sciences and Biology"},{"id":"135","name":"Research"}],"keywords":[{"id":"7497","name":"drug-delivery"},{"id":"7496","name":"microneedles"},{"id":"7499","name":"painless"},{"id":"7031","name":"pharmaceutical"},{"id":"7498","name":"transdermal"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cstrong\u003EJohn Toon\u003C\/strong\u003E\u003Cbr \/\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\u003Ca href=\u0022http:\/\/www.gatech.edu\/contact\/index.html?id=jt7\u0022\u003EContact John Toon\u003C\/a\u003E\u003Cbr \/\u003E\u003Cstrong\u003E404-894-6986\u003C\/strong\u003E","format":"limited_html"}],"email":["jtoon@gatech.edu"],"slides":[],"orientation":[],"userdata":""}}}