Dissolvable microneedle manufacturing methods and the application of three-dimensional printing to pharmaceuticals

Dissolvable microneedles are an intradermal drug delivery technology with exciting potential for widespread distribution of minimally invasive, self-administered medicines and vaccines. The most popular manufacturing method for medical dissolvable microneedles is micromoulding, a process which can have drawbacks of low material efficiency and high regulatory requirements. The UCC-patented “ImmuPatch” process is a micromoulding method which significantly improves on the material efficiency of traditional micromoulding. In this study, a specific method based upon the ImmuPatch process was developed for aseptic manual fabrication of two-layered dissolvable microneedles capable of incorporating at 2 μg protein dose. The developed method was not ideal, with high variability in the patches produced and significant challenges in verifying the protein dose. Fabrication of dissolvable microneedles is well positioned for the application of automation methods. One proposed option for the automation of dissolvable microneedle manufacture is additive manufacturing, which in addition to automation has the advantage of eliminating the regulatory challenges associated with micromoulding. A systematic literature review of methods applying additive manufacturing to the fabrication of solid dosage formats was conducted and identified processing parameters and format properties associated with different technologies. Additive manufacturing has been applied to micromould-free dissolvable microneedle fabrication in limited examples and should be explored further.

Grantor dc:publisher

University College Cork

Year dc:date.issued

2024

Author dc:creator

• Wilkstein, Katerina

Advisors dc:contributor.advisor

• Moore, Anne
• Vucen, Sonja

• Microneedles
• Vaccines
• Vaccine
• Three-dimensional printing
• 3d printing
• Additive manufacturing
• Process design
• Process scale up
• Ergonomic safety
• Process optimisation
• Pharmaceutical process

Statement dc:rights

• © 2024, Katerina Wilkstein.

Licence dc:rights.uri

• https://creativecommons.org/licenses/by-nc-nd/4.0/

Language dc:language.iso

en

Handle dc:identifier.uri

https://hdl.handle.net/10468/16467

OAI identifier oai:identifier

oai:cora.ucc.ie:10468/16467