Intracutaneous Microneedle System
What is the intracutaneous microneedle system?
The system is a single-entity combination product, which comprises a reusable applicator and a microneedle array containing patch, for intracutaneous drug delivery allowing rapid absorption into the bloodstream. The microneedle array patch is applied to the skin using a ready to use and reusable handheld applicator.
Each microneedle array patch is individually packaged and stored at room temperature.
How does it work?
An array of close to two thousand drug-coated titanium microneedles is mounted on the skin-facing surface of a backing that resembles an adhesive bandage. The length of each individual microneedle is about 3 times the width of a human hair.
When the microneedle patch is applied, the microneedles penetrate the outermost layer of the epidermis (stratum corneum). The shallow depth of penetration limits the likelihood of stimulating sensory nerve endings and causing pain. Interstitial fluid in the skin reconstitutes the drug and makes it available for rapid absorption into the bloodstream.
What are the advantages of intracutaneous delivery?
Rapid Systemic Delivery without the Needle
There are instances where a drug cannot or should not be administered orally. For example, some drugs have poor oral bioavailability. In other cases, patients may not be able to tolerate an orally administered drug. In addition, intestinal absorption following oral delivery can be slow, delaying the beneficial effects of a drug.
Intracutaneous delivery allows systemic drug delivery without the use of a hypodermic needle. In clinical studies, less than 10% of patients reported any pain at the application site. Pharmacokinetic analysis demonstrated ~ 3-times faster absorption of zolmitriptan using our system compared with orally administered zolmitriptan.