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Fabrication of a Master Mold for Microneedles with a Micron-sized Air-vent Hole
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Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects
Jaya Arya1, Sebastien Henry1, Haripriya Kalluri1
1Georgia Institute of Technology, Atlanta, GA 30332, USA.
Biomaterials
|March 13, 2017
Summary
Dissolving microneedle patches show excellent skin tolerability and ease of use in human trials. Patients found them non-painful, preferred them over injections, and were confident in self-administration, supporting clinical translation.
Area of Science:
- Dermatology
- Biomedical Engineering
- Pharmaceutics
Background:
- Microneedle patches offer a promising alternative to conventional drug delivery methods.
- Clinical translation requires understanding patient experience and product reliability.
Purpose of the Study:
- To evaluate the safety, usability, and patient acceptance of dissolving microneedle patches.
- To assess local skin reactions and self-administration reliability in human participants.
Main Methods:
- Fifteen human participants received placebo microneedle patches.
- Data collected on skin reactions, pain, swelling, and erythema.
- Investigator and self-administration delivery efficiencies were compared.
Main Results:
- Microneedle patches were well-tolerated with mild, transient erythema and no pain or swelling.
- Self-administration was reliable and comparable to investigator administration.
- Participants overwhelmingly preferred microneedle patches to needle and syringe injections.
Conclusions:
- Dissolving microneedle patches are safe, easy to use, and well-accepted by patients.
- These findings support the further clinical development of microneedle patch technology.
- The technology shows potential to facilitate drug delivery translation.
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