WaferiX Sublingual Technology

The WaferiX® technology consists of a small wafer prepared by proprietary formulation using the freeze-drying process. The wafer is intended to be placed under the tongue, which subsequently dissolves within one minute, releasing the active compounds for rapid absorption in a time sensitive manner. The wafer administration is well-tolerated with no after-taste, leaving behind no residue or grittiness under the tongue hence preventing the urge to swallow.

The WaferiX® technology provides a simple drug carrier matrix with millions of tiny amorphous holes to house (encapsulate) the active drug molecules in a cost-effective manner of delivering drugs which otherwise cannot be administered orally due to their poor oral absorption and/or extensive loss to the first pass hepatic metabolism. The only way to administer these drugs is by intravenous (“IV”) administration but sometimes the IV route may be impractical (e.g. in traumatic conditions like severe burns). The rapid and superior absorption characteristics provide higher bioavailability and a potential to lower the administered dose and reduce the concurrent side effects. There is also the issue of phobia of injections especially in children and some elderly in which case, the sublingual oral delivery of a pharmaceutical drug is more desirable. For health care workers, it will help prevent needle-stick injuries in compliance to occupational, health and safety practices. These benefits allow for the application of WaferiX® in conditions where instantaneous therapeutic effect is desired, like acute or breakthrough pain as well as male erectile dysfunction.

WaferiX® is a multiple platform drug carrier technology that was used to develop the world's first sublingual ketamine oral wafer, Wafermine®. We have also used WaferiX® in our pharmaceutical products, to deliver active compounds like sildenafil citrate (Wafesil®) and buprenorphine (BnoX®). In our nutraceuticals range, we have also applied WaferiX® to Waferest® to deliver melatonin, and to RadianiX® to deliver glutathione. Our technology is easily adaptable to a vast number of other FDA approved drugs that require a faster delivery or reduction in the loss of drugs due to hepatic and gastrointestinal metabolism.

Patent

Visit www.ixbiopharma.com/patent for our list of patents.

Our products are patented in all key markets, including Australia, China, India, Japan, South Korea, Hong Kong SAR, Macau SAR, European Union (Germany, France, United Kingdom, Italy, Spain, Netherlands, Turkey, Switzerland, Sweden, Poland, Belgium, Austria, Norway, Denmark, Ireland and Finland), Canada, South Africa, New Zealand, Singapore, Malaysia, Vietnam and Indonesia, and have been allowed in USA and Israel.

The claims of the patents cover a fast-dissolving oral dosage form for the release of a biologically active material in the oral cavity. Additionally, the particular dosage form may contain and deliver a wide range of biologically active materials and is not limited to a specific biologically active material. Methods for the production of the fast dissolving oral dosage form are also provided.

Our patents strategy includes the use of the Patent Cooperation Treaty system with a view to obtain broad protection for our patent portfolio, which covers the WaferiX® technology, our products as well as potential new formulations. We aim to secure intellectual property protection for our invention and products in all relevant jurisdictions, as and when necessary. In most countries, the term awarded for a granted patent is 20 years from the date of application.