Microneedle-based insulin transdermal delivery system: current status and translation challenges

Area of Science:

• Biomedical Engineering
• Materials Science
• Endocrinology

Background:

• Diabetes mellitus requires insulin therapy, commonly via subcutaneous injection.
• Non-invasive insulin delivery methods like transdermal systems are sought to improve patient experience.
• Microneedle (MN) technology presents a promising minimally invasive approach for transdermal insulin delivery.

Purpose of the Study:

• To review research progress in microneedle (MN) technologies for transdermal insulin delivery.
• To summarize clinical studies on MN-based insulin delivery devices.
• To discuss challenges hindering the clinical translation of MN-based insulin therapy.

Main Methods:

• Review of scientific literature on various MN types for insulin delivery (hollow, dissolving, hydrogel, glucose-responsive).
• Analysis and categorization of clinical studies based on their phase.
• Identification and discussion of key challenges in MN technology translation.

Main Results:

• Several MN designs (hollow, dissolving, hydrogel, glucose-responsive) show potential for controlled insulin delivery.
• Clinical studies demonstrate varying stages of development and efficacy for MN insulin delivery devices.
• Significant challenges remain in safety, efficacy, patient acceptance, manufacturing, and regulatory approval.

Conclusions:

• Microneedle technology is a rapidly advancing field for painless, transdermal insulin delivery in diabetes.
• Further research and development are crucial to overcome existing hurdles for clinical application.
• Successful translation requires addressing safety, efficacy, scalability, and regulatory considerations.