University of Washington researchers have developed a lipid-based CHARM™ (complex high axial ratio microstructure) drug delivery technology. This technology can be customized for delivery of a wide variety of compounds, including drugs, peptides, proteins, DNA, and steroids.

Washington Research Foundation is licensing the rights to produce CHARM™ drug delivery devices using methods and compositions claimed in U.S. Patent No. 5,851,536, entitled "Therapeutic Delivery Using Compounds Self-Assembled into High Axial Ratio Microstructures". Additional patents covering this technology are pending in the U.S. and abroad.

MARKET NEED

Human and animal health care companies seek novel methods to deliver drugs, vaccines, and cosmeceuticals to the patient at a controlled rate in order to:

• increase the time during which the medicine stays in the therapeutic range

• reduce the number of doses needed

• reduce toxicity and side effects

• improve patient compliance and treatment outcome

ADVANTAGES OF CHARM™ DRUG DELIVERY DEVICES

• Continuous, prolonged release of therapeutic agents from microscopic drug depots

• No removal required as biodegradable, non-toxic, components dissolve completely

• No migration from the injection site

• Allows for delivery of a wide range of therapeutic agents, including peptides and DNA

• Rate of drug release can be controlled based on the lipid selected and the method of self-assembly of the CHARM™ drug delivery device

BACKGROUND

University of Washington researchers in Bioengineering, Chemistry and Medicine collaborated to produce a microscopic device that would release constant levels of drug over a prolonged period and would be suitable for many classes of drugs.The result was the CHARM™ drug delivery device.

The CHARM™ devices are composed of millions of individual lipid molecules that are i) bound to a therapeutic agent such as a peptide or DNA, directly or via a cleavable linker, and then ii) caused to self-assemble into the microstructures by thermo-cycling or by precipitation from water-miscible organic solvents.(Fig. 1).

Figure 1

Fat-soluble drugs, such as steroids, need not be bound to the CHARM-forming lipid molecules. Instead, steroids and other hydrophobic drugs can be incorporated into the lipid bilayers (Fig. 2A.) Charged therapeutic agents, such as nucleic acids, can be immobilized on the surface and/or between the lipid bilayers utilizing electrostatic interactions with the CHARM™-forming lipids (Fig. 2B.)