Abstract
Lidocaine is a local anesthetic agent used in the form of injection and topical cream. However, these formulation types have limitations of being either painful or slow-acting, thereby hindering effective and complete clinical performance of lidocaine. Dissolving microneedles (DMNs) are used to overcome these limitations owing to their fast onset time and minimally invasive administration methods. Using hyaluronic acid and lidocaine to produce the drug solution, a lidocaine HCl encapsulated DMN (Li-DMN) was fabricated by centrifugal lithography. The drug delivery rate and local anesthetic quality of Li-DMNs were evaluated using the pig cadaver insertion test and Von Frey behavior test. Results showed that Li-DMNs could deliver sufficient lidocaine for anesthesia that is required to be utilized for clinical level. Results from the von Frey test showed that the anesthetic effect of Li-DMNs was observed within 10 min after administration, thus confirming fast onset time. A toxicity test for appropriate clinical application standard was conducted with a microbial limit test and an animal skin irritation test, showing absence of skin irritation and irritation-related microorganisms. Overall, Li-DMN is a possible alternative drug delivery method for local anesthesia, meeting the requirements for clinical conditions and overcoming the drawbacks of other conventional lidocaine administration methods.
Highlights
Several clinical procedures, including venipuncture and dermatological procedures, are associated with pain, which causes anxiety and stress to the patient [1]
We demonstrated that the Li-Dissolving microneedles (DMNs) patch was biocompatible, could deliver local anesthetic more rapidly compared to conventional topical local anesthetics, and was suitable for practical use; and providing practical guidelines for the use of lidocaine HCl encapsulated DMN (Li-DMN) for further human-targeted applications
The results showed that the delivery of lidocaine the delivery efficiency of Li-DMN patches, loaded with 2.11 mg of Li-HCl (Figure 3D)
Summary
Several clinical procedures, including venipuncture and dermatological procedures, are associated with pain, which causes anxiety and stress to the patient [1]. While delivery of lidocaine using DMN has a rapid onset time compared with conventional local anesthetics, studies on the clinical application of lidocaine encapsulated DMNs, such as mechanical strength evaluation, assessment of insertion success rate, quantitative analysis of lidocaine content, and skin irritation test have not been conducted. We propose a lidocaine HCl-encapsulated DMN (Li-DMN) that can reach the nerve cells of the dermis This Li-DMN could provide a rapid onset time of 10 min compared with the widely used conventional topical anesthetics, including EMLA cream. We demonstrated that the Li-DMN patch was biocompatible, could deliver local anesthetic more rapidly compared to conventional topical local anesthetics, and was suitable for practical use; and providing practical guidelines for the use of Li-DMNs for further human-targeted applications This novel type of local anesthetic drug delivery system has the potential to deliver local anesthesia conveniently and efficiently, which will further facilitate access to the anesthetic market
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