title: Rapid intradermal delivery of liquid formulations using a hollow microstructured array.
abstract: OBJECTIVE
  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.
authors.affiliation: 3M Drug Delivery Systems Division, Building 260-03-A-05, St. Paul, Minnesota 55114, USA.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Burton
authors.forename: Chin-Yee
authors.initials: CY
authors.lastname: Ng
authors.forename: Ryan
authors.initials: R
authors.lastname: Simmers
authors.forename: Craig
authors.initials: C
authors.lastname: Moeckly
authors.forename: David
authors.initials: D
authors.lastname: Brandwein
authors.forename: Tom
authors.initials: T
authors.lastname: Gilbert
authors.forename: Nathan
authors.initials: N
authors.lastname: Johnson
authors.forename: Ken
authors.initials: K
authors.lastname: Brown
authors.forename: Tesha
authors.initials: T
authors.lastname: Alston
authors.forename: Gayatri
authors.initials: G
authors.lastname: Prochnow
authors.forename: Kris
authors.initials: K
authors.lastname: Siebenaler
authors.forename: Kris
authors.initials: K
authors.lastname: Hansen
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000276:immunology; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay; D004867:Equipment Design; D005260:Female; D006168:Guinea Pigs; D007271:Injections, Intradermal; D008297:Male; D008845:Microinjections / Q000295:instrumentation* / Q000379:methods; D009339:Needles; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000097:blood / Q000737:chemistry; D012867:Skin / Q000187:drug effects / Q000378:metabolism*; D013552:Swine; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D004364:Pharmaceutical Preparations