US Patent Office Issues Patent for Oral Insulin Delivery

The US Patent Office has issued a patent to Massachusetts-based Aphios Corporation for the oral delivery of insulin.

Patent No. 8,440,614, “Polymer Microspheres/Nanospheres and Encapsulating Therapeutic Proteins Therein,” covers the design of an insulin delivery system that would eliminate the need for injections.

Calling an oral delivery system “one of the Holy Grails of biotechnology and drug development,” Aphios says its patent gets around the greatest roadblock oral insulin developers have always faced: How to get insulin intact into the bloodstream before the digestive system’s powerful enzymes can tear apart the hormone’s delicate protein molecules.

The company’s oral insulin product now under development, APH-0907, encapsulates insulin in biodegradable, hydrophobic polymer nanospheres. In layman’s terms, hydrophobic polymers are tough, water-repellant materials whose molecular bonds are numerous and strong. Nanospheres are microscopic drug-bearing orbs made from the polymers.

The polymer, which is resistant to stomach acids, protects insulin from enzymatic degradation during its passage through the stomach. When nanoparticles reach the gut, they stick to the cell wall lining because of their ability to repel water and are then transported across the lining into the bloodstream. The nanoparticles are rapidly transported into the circulatory system, and as their biodegradable polymer shells degrade, their insulin cargo is released into the blood stream.

A patent is just a first step toward a workable oral insulin delivery system. However, taking the step to gain government recognition and protection of its approach to the problem says that Aphios is confident that it may have found the answer to an old problem.

The use of nanotechnology, which we touched on October 23 in article 8030 on this website (“Life With Type 2: Nano, Nano, as Mork Almost Said”), is unfolding as a major breakthrough in the treatment of disease. The ability to deliver drug doses via microscopic carriers to incredibly precise targets is opening up great new therapeutic possibilities for doctors and patients.

More information on the Aphios patent is available at

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