Glide Pharma’s Glide SDI® Solid Dose Injector incorporates a solid drug formulation smaller than a grain of rice that is pushed under the skin, reported Charles Potter, Ph.D., CEO. “One of the challenges is making sure the dosage is sufficiently robust so it will penetrate the skin,” he added. This property is achieved by mixing the drug with excipients for the required release kinetics. A quick-dissolving formulation uses a sugar and a controlled-release version uses a polymer.
The drug is pushed via a spring-powered, re-usable actuator, which is about the size of a fountain pen. “When the user stops pushing, the drug stops moving, meaning we’re delivering it to the same depth every time. That’s very important to our technology,” Dr. Potter said.
Although the drugs have to be re-formulated, the solid dose provides better storage, safety, stability, easy transportation, accurate dosing, minimal skin response, and is cost-effective, he added.
Other drug formulations routinely use polymer microspheres for controlled release. “The difficulty is you can get clogged needles and then you are relying on the spheres to release drugs as you want them. We have a solid piece of drug going into the skin, and we should be able to get a better release profile than the spheres.”
The Solid Dose Injector is currently being evaluated in several clinical studies. A Phase I trial has been completed involving a fentanyl product for acute pain, and another one is starting using a Novartis drug to reduce human growth hormone levels. Another big application area is vaccines. The company has participated in five preclinical vaccine studies with three different antigens, Dr. Potter said.