Abstract
It’s of great significance to develop insulin-loaded dissolving microneedles (MNs) which are fabricated with various methods and materials for transdermal delivery of insulin to effectively and efficiently treat diabetes. In this work, we present a kind of FITC-insulin tip-loaded dissolving MNs fabricated with the mixture of polyvinyl alcohol (PVA) and sucrose using homemade PDMS MNs mold under vacuum conditions. The uniform appearance of MN arrays contributes to controlling the drug dosage well as required. Sufficient mechanical strength for penetrating tough stratum corneum can be obtained by vacuum frozen-drying for at least 6 h after peeling MNs off the mold. About 90% of the FITC-insulin is localized in the conical MN tips and can be released into the skin within 2 min after insertion. The in vivo insulin absorption study and hypoglycemic effect in diabetic mice demonstrate that the proposed insulin-loaded MNs can efficiently deliver the insulin to the systemic circulation and exhibit a similar effect to hypodermic injection on hypoglycemic administration. Together these results suggested that the efficient MN fabrication process proposed in this work shows great potential for mass production and practical application of drug-loaded dissolving MNs in the future.
Highlights
IntroductionThe treatment for insulin-dependent diabetes mellitus patients mainly involves obtaining a normal blood glucose value (below 8.0 mmol/L prior to large meals for adult diabetes patients) by delivery of exogenous insulin via conventional injection pen or insulin pump multiple times per day (Rodger, 1991)
The treatment for insulin-dependent diabetes mellitus patients mainly involves obtaining a normal blood glucose value by delivery of exogenous insulin via conventional injection pen or insulin pump multiple times per day (Rodger, 1991)
The dissolving polymer MNs were fabricated by filling FITC-insulin crystal and polyvinyl alcohol (PVA)/sucrose MN matrix gel into MN cavities with a multi-step vacuum processing technology
Summary
The treatment for insulin-dependent diabetes mellitus patients mainly involves obtaining a normal blood glucose value (below 8.0 mmol/L prior to large meals for adult diabetes patients) by delivery of exogenous insulin via conventional injection pen or insulin pump multiple times per day (Rodger, 1991). Frequent injections using traditional hypodermic metal needles may cause physical pain, wound infection, tissue necrosis and nerve damage, which is inconvenient and leads to poor patient compliance (Chu, 2005). To address these issues, many alternative methods of insulin delivery have been investigated, including intranasal, pulmonary, oral and transdermal administration (McAllister et al, 2003; Prausnitz, 2004; Lassmann-Vague and Raccah, 2006; Chen et al, 2011; Chaturvedi et al, 2013; Mo et al, 2014). Except for the matrix material and preparation process, the geometry and mechanical structure of dissolving MNs have a significant influence on the MN performance in the process of application
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