Article

Pharmaceutical Research

, Volume 19, Issue 1, pp 63-70

First online:

Macroflux® Microprojection Array Patch Technology: A New and Efficient Approach for Intracutaneous Immunization

  • James A. MatrianoAffiliated withBiological Sciences, ALZA Corporation Email author 
  • , Michel CormierAffiliated withBiological Sciences, ALZA Corporation
  • , Juanita JohnsonAffiliated withBiological Sciences, ALZA Corporation
  • , Wendy A. YoungAffiliated withTransdermal Product Research and Development, ALZA Corporation
  • , Margaret ButteryAffiliated withBiological Sciences, ALZA Corporation
  • , Kofi NyamAffiliated withBiological Sciences, ALZA Corporation
  • , Peter E. DaddonaAffiliated withBiological Sciences, ALZA Corporation

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Abstract

Purpose. We evaluated the Macroflux® microprojection array patch technology as a novel system for intracutaneous delivery of protein antigens.

Methods. Macroflux® microprojection array systems (330-μm microprojection length, 190 microprojections/cm2, 1- and 2-cm2 area) were coated with a model protein antigen, ovalbumin (OVA), to produce a dry-film coating. After system application, microprojection penetration depth, OVA delivery, and comparative immune responses were evaluated in a hairless guinea pig model.

Results. Macroflux® microprojections penetrated into hairless guinea pig skin at an average depth of 100 μm with no projections deeper than 300 μm. Doses of 1 to 80 μg of OVA were delivered via 1- or 2-cm2 systems by varying the coating solution concentration and wearing time. Delivery rates were as high as 20 μg in 5 s. In a prime and boost dose immune response study, OVA-coated Macroflux® was most comparable to equivalent doses injected intradermally. Higher antibody titers were observed when OVA was administered with the microprojection array or intradermally at low doses (1 and 5 μg). Macroflux® administration at 1- and 5-μg doses gave immune responses up to 50-fold greater than that observed after the same subcutaneous or intramuscular dose. Dry coating an adjuvant, glucosaminyl muramyl dipeptide, with OVA on the Macroflux® resulted in augmented antibody responses.

Conclusions. Macroflux® skin patch technology provides rapid and reproducible intracutaneous administration of dry-coated antigen. The depth of skin penetration targets skin immune cells; the quantity of antigen delivered can be controlled by formulation, patch wearing time, and system size. This novel needle-free patch technology may ultimately have broad applications for a wide variety of therapeutic vaccines to improve efficacy and convenience of use.

administration route dry-film coating immunization Macroflux® microprojection array vaccination