Our Drug Delivery Technology

Silicia monomers and drug subtance are emulsified together
Silicia monomers migrate to the oil/water interface in a well - controlled process
A silica shell is formed

Innovative drug delivery systems are often used to enhance therapeutic effects of existing drugs, giving pharmaceutical companies competitive and financial advantages and providing patients with improved medication.  Yet, only one microsphere delivery system, Microsponge, has ever been approved by the FDA for topical prescription drug products.  The dearth of topical drug microsphere delivery systems might be attributed to the nature of the dermatology market, which has not justified the extensive investments required to get the FDA’s approval for a novel delivery system.  However, our products take advantage of the fact that silica has already been approved by the FDA as a safe excipient for topical drug products (it is used as a thickener and filler in numerous products) and utilize our expertise in sol-gel encapsulation processes to expedite the approval process of drugs that are based on our delivery systems.
Encapsulation of a drug substance can be made using a variety of techniques, such as solvent evaporation, coacervation, and interfacial polymerization.  Most encapsulations involve organic polymers, such as polymethyl methacrylate, chitosan and cellulose.  The resultant encapsulated drug substance can be an aqueous dispersion of varying payload and volume fraction or a dried powder.  Control over the encapsulation process when organic polymers are used is challenging and is mainly limited to shell thickness.  Other properties of the organic polymer encapsulating material are hard to control.  In contrast, we use proprietary 'sol-gel' processes to shape silica on site to form microcapsule shells of almost any size and release rate profile.  Sol-gel is a chemical process whereby amorphous silica, or other metal oxides, are made by forming interconnections among colloidal particles (the “sol”) under increasing viscosity until a rigid silica shell (the “gel”) is formed.  The drug substance that is added during the sol-gel reaction is encapsulated, in a patented technique, by which a core-shell structure is formed.  The drug substance is in the core and the silica is the capsule shell.  At the end of the process, the microcapsules are in the shape of small beads in the range of 1-40µ.
Our silica-based delivery system improves the tolerability of topical dermatological drug products by entrapping drug substances in porous silica microcapsules. This entrapment creates a protective barrier between the drug substance and the skin and controls the release rate of the drug substance.  Our delivery system also enables highly effective novel fixed-dose combinations of two or more otherwise unstable drug substances by creating a silica protective layer around labile drug substances.  Our delivery system only contains inactive ingredients which are listed in the FDA’s inactive ingredients database (IID) and are approved for topical use, substantially simplifying and expediting the regulatory approval process.  Communications with the FDA indicate that the agency accepts our suggested in-process specification and analytical procedures for the encapsulated substances.