The DermXTM MegasphereTM Delivery System is a passive, topical technology platform that enhances the rate, volume, and depth of penetration of water- and oil-soluble cosmetic actives and Active Pharmaceutical Ingredients (APIs) into and through human skin. A water-thin, liquid solution created by JRX Biotech and protected by six issued U.S. patents, DermXTM MegasphereTM is a novel system capable of:
- Delivering small and large molecules ("macro-molecules") up to 460,000 Daltons in size.
- Delivering large volumes of actives (a "large payload") into the skin.
- Stabilizing large volumes (a "high load factor") of actives in a finished formulation.
- Delivering compounds deep into the dermis (the third layer of skin).
- Delivering active ingredients into and through the skin within minutes, not days.
Large Molecules Large Payloads High Loading Deep Delivery Fast Delivery
Large Molecules: Traditional delivery system technologies can deliver only small molecules to the skin, thus severely limiting their efficacy and dosage range and flexibility. The DermXTM MegasphereTM System, however, can deliver both small molecules (like extracts) and large molecules (like proteins). DermXTM MegasphereTM's unique value is its ability to deliver compounds that are potentially 10,000 times larger than those found in other non-invasive, passive systems.
Large Payloads: Unlike other technologies, DermXTM MegasphereTM has been proven to deliver large volumes (or a "large payload") of active ingredients into and through the skin. Currently, traditional technologies allow only 0.1 to 0.2% of an applied dose to be absorbed. However, DermXTM MegasphereTM employs "megasphere technology", a mechanism that does not require a separate carrier and penetration enhancer. As a result, up to 2 to 4% of an applied dose has been clinically proven to penetrate the skin, delivering 10 to 40 times more at one time than before.
High Loading: Efficient delivery starts with the formulation itself. The DermXTM MegasphereTM system has the ability to encapsulate, stabilize and solubilize—long-term—a high concentration (up to 70%) of an active ingredient in a finished formulation. This means that 35 to 70 times more of an active ingredient is being "delivered" or applied to the skin with each application.
Deep Delivery: Human skin is made up of three main layers: the stratum corneum, the viable epidermis and the dermis. Traditional delivery system technologies can deliver agents to only the top layer, the stratum corneum. DermXTM MegasphereTM however, has been proven to deliver these same agents deep into the third layer of skin, the dermis.
Fast Delivery: Competing skin delivery technologies are "time release" or "controlled release" technologies that release their payload of active ingredients into the skin over a matter of hours or days. This is not the case with the DermXTM MegasphereTM system. Studies have shown that large payloads of large molecules (over 5kD in size) are delivered into the deep layers of skin (the dermis) in 1 hour.
DermXTM MegasphereTM has been proven in a number of world renowned, independent laboratories using today's most sophisticated testing methods, including:
- In the clinic (in vivo) testing for irritation, wrinkles, hydration, age spots and pain,
- The in vitro Franz Diffusion Cell test,
- Chromatography analysis, and
- Controlled stability conditions (temperature and humidity).
All Franz Diffusion Cell tests were conducted using human cadaver skin and 14C radiolabeled compounds, and were performed at PRACS Institute - one of the leading dermatological and percutaneous (skin) absorption Contract Research Organizations (CROs).
Franz Diffusion Cell Chamber
"Even after 3 decades, this elegant [Franz] diffusion cell is still regarded as the single most powerful in vitro model for advancing dermatologic and transdermal product development."
-Drug Delivery Technology, July/August 2008