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Reliability and accuracy of intradermal injection by Mantoux technique, hypodermic needle adapter, and hollow microneedle in pigs

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Abstract

We compared the ability of three intradermal delivery devices to administer an intended dose to pig skin in vivo and target that dose to the dermal rather than subcutaneous layers. The three devices were a standard hypodermic needle and syringe for the Mantoux technique, an adapter designed to facilitate proper hypodermic needle and syringe use, and a hollow microneedle. Reliability was determined as the percentage of the administered dose that entered the skin, as opposed to remaining in the device or on the skin surface. The intradermal adapter (97.6 ± 1.5 % delivered, mean ± standard deviation), Mantoux technique (95.4 ± 4.9 %), and hollow microneedle (94.9 ± 0.3 %) exhibited similar reliability. Accuracy was determined as the percentage of the dose that entered the skin that localized in the dermis. All three devices achieved similar accuracy: hollow microneedle (99 ± 12 % delivered to the dermis, median ± standard deviation), Mantoux technique (97 ± 16 %), and intradermal adapter (92 ± 21 %). We conclude that intradermal injection by all three methods studied provided reliable delivery to the skin and provided accurate localization of delivery within the dermis. Next-generation designs of these devices have now received clearance from the FDA and are used as medical products and/or in clinical trials.

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Acknowledgments

Donna Bondy provided administrative assistance. Brian Bondy assisted with histological analysis. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH.

Conflict of interest

Mark Prausnitz is an inventor of patents that have been licensed to companies developing microneedle-based products, is a paid advisor to companies developing microneedle-based products, and is a founder/shareholder of companies developing microneedle-based products. This potential conflict of interest has been disclosed and is managed by Georgia Tech and Emory University. Samir Patel is the director of research and new product development for a company developing microneedle products for ocular drug delivery. The remaining authors declare no conflict of interest.

Declaration for animal studies

All institutional and national guidelines for the care and use of laboratory animals were followed.

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Authors and Affiliations

  1. School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332, USA

    James J. Norman, Jyoti Gupta, Samirkumar R. Patel, Sara Park & Mark R. Prausnitz

  2. PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, 98121, USA

    Courtney Jarrahian & Darin Zehrung

Authors
  1. James J. Norman
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  2. Jyoti Gupta
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  3. Samirkumar R. Patel
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  4. Sara Park
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  5. Courtney Jarrahian
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  6. Darin Zehrung
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  7. Mark R. Prausnitz
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Corresponding author

Correspondence to Mark R. Prausnitz.

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Norman, J.J., Gupta, J., Patel, S.R. et al. Reliability and accuracy of intradermal injection by Mantoux technique, hypodermic needle adapter, and hollow microneedle in pigs. Drug Deliv. and Transl. Res. 4, 126–130 (2014). https://doi.org/10.1007/s13346-013-0184-5

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