Rapid Intradermal Delivery of Liquid Formulations Using a Hollow Microstructured Array

Purpose The purpose of this work is to demonstrate rapid intradermal delivery of up to 1.5 mL of formulation using a hollow microneedle delivery device designed for self-application. Methods 3M's hollow Microstructured Transdermal System (hMTS) was applied to domestic swine to demonstrate deliv...

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Veröffentlicht in:Pharmaceutical research 2011-01, Vol.28 (1), p.31-40
Hauptverfasser: Burton, Scott A, Ng, Chin-Yee, Simmers, Ryan, Moeckly, Craig, Brandwein, David, Gilbert, Tom, Johnson, Nathan, Brown, Ken, Alston, Tesha, Prochnow, Gayatri, Siebenaler, Kris, Hansen, Kris
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container_end_page 40
container_issue 1
container_start_page 31
container_title Pharmaceutical research
container_volume 28
creator Burton, Scott A
Ng, Chin-Yee
Simmers, Ryan
Moeckly, Craig
Brandwein, David
Gilbert, Tom
Johnson, Nathan
Brown, Ken
Alston, Tesha
Prochnow, Gayatri
Siebenaler, Kris
Hansen, Kris
description Purpose The purpose of this work is to demonstrate rapid intradermal delivery of up to 1.5 mL of formulation using a hollow microneedle delivery device designed for self-application. Methods 3M's hollow Microstructured Transdermal System (hMTS) was applied to domestic swine to demonstrate delivery of a variety of formulations including small molecule salts and proteins. Blood samples were collected after delivery and analyzed via HPLC or ELISA to provide a PK profile for the delivered drug. Site evaluations were conducted post delivery to determine skin tolerability. Results Up to 1.5 mL of formulation was infused into swine at a max rate of approximately 0.25 mL/min. A red blotch, the size of the hMTS array, was observed immediately after patch removal, but had faded so as to be almost indistinguishable 10 min post-patch removal. One-mL deliveries of commercial formulations of naloxone hydrochloride and human growth hormone and a formulation of equine anti-tetanus toxin were completed in swine. With few notable differences, the resulting PK profiles were similar to those achieved following subcutaneous injection of these formulations. Conclusions 3M's hMTS can provide rapid, intradermal delivery of 300-1,500 µL of liquid formulations of small molecules salts and proteins, compounds not typically compatible with passive transdermal delivery.
doi_str_mv 10.1007/s11095-010-0177-8
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Methods 3M's hollow Microstructured Transdermal System (hMTS) was applied to domestic swine to demonstrate delivery of a variety of formulations including small molecule salts and proteins. Blood samples were collected after delivery and analyzed via HPLC or ELISA to provide a PK profile for the delivered drug. Site evaluations were conducted post delivery to determine skin tolerability. Results Up to 1.5 mL of formulation was infused into swine at a max rate of approximately 0.25 mL/min. A red blotch, the size of the hMTS array, was observed immediately after patch removal, but had faded so as to be almost indistinguishable 10 min post-patch removal. One-mL deliveries of commercial formulations of naloxone hydrochloride and human growth hormone and a formulation of equine anti-tetanus toxin were completed in swine. With few notable differences, the resulting PK profiles were similar to those achieved following subcutaneous injection of these formulations. Conclusions 3M's hMTS can provide rapid, intradermal delivery of 300-1,500 µL of liquid formulations of small molecules salts and proteins, compounds not typically compatible with passive transdermal delivery.</description><subject>Animals</subject><subject>Antibodies, Monoclonal - administration &amp; dosage</subject><subject>Antibodies, Monoclonal - immunology</subject><subject>Bioavailability</subject><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Drug Delivery Systems - instrumentation</subject><subject>Drug Delivery Systems - methods</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Guinea Pigs</subject><subject>Hogs</subject><subject>hollow microstructures</subject><subject>Injections, Intradermal</subject><subject>intradermal</subject><subject>Male</subject><subject>Medical Law</subject><subject>Microinjections - instrumentation</subject><subject>Microinjections - methods</subject><subject>microneedles</subject><subject>Microstructure</subject><subject>MTS</subject><subject>Needles</subject><subject>Pharmaceutical Preparations - administration &amp; 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Ng, Chin-Yee ; Simmers, Ryan ; Moeckly, Craig ; Brandwein, David ; Gilbert, Tom ; Johnson, Nathan ; Brown, Ken ; Alston, Tesha ; Prochnow, Gayatri ; Siebenaler, Kris ; Hansen, Kris</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c558t-c49e478c032bde56a977ed83c4cd9bcb49578fde8d1db545de0c82b1c0227f173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Animals</topic><topic>Antibodies, Monoclonal - administration &amp; dosage</topic><topic>Antibodies, Monoclonal - immunology</topic><topic>Bioavailability</topic><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Drug Delivery Systems - instrumentation</topic><topic>Drug Delivery Systems - methods</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Guinea Pigs</topic><topic>Hogs</topic><topic>hollow microstructures</topic><topic>Injections, Intradermal</topic><topic>intradermal</topic><topic>Male</topic><topic>Medical Law</topic><topic>Microinjections - instrumentation</topic><topic>Microinjections - methods</topic><topic>microneedles</topic><topic>Microstructure</topic><topic>MTS</topic><topic>Needles</topic><topic>Pharmaceutical Preparations - administration &amp; 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Methods 3M's hollow Microstructured Transdermal System (hMTS) was applied to domestic swine to demonstrate delivery of a variety of formulations including small molecule salts and proteins. Blood samples were collected after delivery and analyzed via HPLC or ELISA to provide a PK profile for the delivered drug. Site evaluations were conducted post delivery to determine skin tolerability. Results Up to 1.5 mL of formulation was infused into swine at a max rate of approximately 0.25 mL/min. A red blotch, the size of the hMTS array, was observed immediately after patch removal, but had faded so as to be almost indistinguishable 10 min post-patch removal. One-mL deliveries of commercial formulations of naloxone hydrochloride and human growth hormone and a formulation of equine anti-tetanus toxin were completed in swine. With few notable differences, the resulting PK profiles were similar to those achieved following subcutaneous injection of these formulations. Conclusions 3M's hMTS can provide rapid, intradermal delivery of 300-1,500 µL of liquid formulations of small molecules salts and proteins, compounds not typically compatible with passive transdermal delivery.</abstract><cop>Boston</cop><pub>Boston : Springer US</pub><pmid>20582455</pmid><doi>10.1007/s11095-010-0177-8</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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subjects Animals
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - immunology
Bioavailability
Biochemistry
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Drug Delivery Systems - instrumentation
Drug Delivery Systems - methods
Enzyme-Linked Immunosorbent Assay
Equipment Design
Female
Guinea Pigs
Hogs
hollow microstructures
Injections, Intradermal
intradermal
Male
Medical Law
Microinjections - instrumentation
Microinjections - methods
microneedles
Microstructure
MTS
Needles
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - blood
Pharmaceutical Preparations - chemistry
Pharmaceutical sciences
Pharmacology/Toxicology
Pharmacy
Research Paper
Skin - drug effects
Skin - metabolism
Swine
Time Factors
transdermal drug delivery
Transdermal medication
title Rapid Intradermal Delivery of Liquid Formulations Using a Hollow Microstructured Array
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