Fabrication, evaluation and applications of dissolving microneedles.

Research progress of microneedles in the treatment of melanoma.

Diabetes mellitus is a metabolic disease manifested by hyperglycemia. For patients with type 1 and advanced type 2 diabetes mellitus, insulin therapy is essential. Subcutaneous injection remains the most common administration method. Non-invasive insulin delivery technologies are pursued because of their benefits of decreasing patients’ pain, anxiety, and stress. Transdermal delivery systems have gained extensive attention due to the ease of administration and absence of hepatic first-pass metabolism. Microneedle (MN) technology is one of the most promising tactics, which can effectively deliver insulin through skin stratum corneum in a minimally invasive and painless way. This article will review the research progress of MNs in insulin transdermal delivery, including hollow MNs, dissolving MNs, hydrogel MNs, and glucose-responsive MN patches, in which insulin dosage can be strictly controlled. The clinical studies about insulin delivery with MN devices have also been summarized and grouped based on the study phase. There are still several challenges to achieve successful translation of MNs-based insulin therapy. In this review, we also discussed these challenges including safety, efficacy, patient/prescriber acceptability, manufacturing and scale-up, and regulatory authority acceptability.

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

An update on microneedle-based systems for diabetes

Diabetes mellitus is a severe condition in which the pancreas produces inadequate insulin or the insulin generated is ineffective for utilisation by the body; as a result, insulin therapy is required for control blood sugar levels in patients having type 1 diabetes and is widely recommended in advanced type 2 diabetes patients with uncontrolled diabetes despite dual oral therapy, while subcutaneous insulin administration using hypodermic injection or pump-mediated infusion is the traditional route of insulin delivery and causes discomfort, needle phobia, reduced adherence, and risk of infection. Therefore, transdermal insulin delivery has been extensively explored as an appealing alternative to subcutaneous approaches for diabetes management which not only is non-invasive and easy, but also avoids first-pass metabolism and prevents gastrointestinal degradation. Microneedles have been commonly investigated in human subjects for transdermal insulin administration because they are minimally invasive and painless. The different types of microneedles developed for the transdermal delivery of anti-diabetic drugs are discussed in this review, including solid, dissolving, hydrogel, coated, and hollow microneedles. Numerous microneedle products have entered the market in recent years. But, before the microneedles can be effectively launched into the market, a significant amount of investigation is required to address the numerous challenges. In conclusion, the use of microneedles in the transdermal system is an area worth investigating because of its significant benefits over the oral route in the delivery of anti-diabetic medications and biosensing of blood sugar levels to assure improved clinical outcomes in diabetes management.

Emergence of microneedles as a potential therapeutics in diabetes mellitus

As a painless and minimally invasive method of self-administration, microneedle is very promising to replace subcutaneous injection of insulin for type I diabetes treatment. Since the introduction of microneedles, many scholars have paid attention to and studied this technology, which has made it developed rapidly. However, there is no product on the market or in clinical trials at present. The reason is that there are still many technical problems in microneedle drug delivery system, such as the perfect integration of stable, controllable, fast, long-lasting, safe, and other necessary conditions. Here, we review the achievements that researchers have made that contain one or more of the above factors, and put some ideas to solve the limitations of insulin delivery by microneedles for reference.

Ranran Guo

Papers

Design and development of insulin microneedles for diabetes treatment.