SBIR Phase I: Closed Loop Drug Delivery System

This Small Business Innovation Research (SBIR) Phase I project is to develop a device to deliver therapeutic drugs in a controlled and monitored manner. This device will be used to control delivery of therapeutic doses of drugs, and to monitor blood levels of such drugs continuously, with on-demand administration, in order to minimize the dosage fluctuation that occurs through oral and injection administration. As an example, many patients with biphasic psychological disorders benefit from the use of lithium, including those that suffer from acute manic and hypomanic episodes in bipolar disorder, and for maintenance therapy to help diminish the intensity and frequency of subsequent manic episodes. The therapeutic window of effectiveness of lithium carbonate is very narrow. Due to the potential toxicity of lithium at blood levels close to therapeutic concentrations, monitoring lithium levels is absolutely essential. This Phase I project will develop a needleless lithium carbonate delivery/monitoring system (LDMS) capable of injecting sufficient quantities of this therapeutic agent, non-invasively through transdermal delivery mechanisms, to maintain optimal blood levels of lithium carbonate over extended periods of time. The initial commercial application of this project will be in the delivery of lithium carbonate medication to patients with bipolar disorder. Bipolar disorder affects approximately 2.3 million American every year. The most recognized treatment for this disease involves the delivery of psychotropic medications to affected individuals. Many of these and other drugs have very narrow therapeutic windows that are often at or near toxic levels. A closed loop drug delivery system can efficiently deliver and monitor these medications in a controlled manner.