Lightweight Electronically Controlled Transdermal Patch for Enfuvirtide Delivery

DESCRIPTION (provided by applicant): This Phase I NIH SBIR, will develop a Lightweight Electronically Controlled Transdermal Patch for Enfuvirtide Delivery (LET-PED). Thirty-three million people worldwide are living with the Human Immunodeficiency Virus (HIV). Currently, patients infected with HIV receive Highly Active Antiretroviral Therapy (HAART) for the management of the infection. HAART regimens can be complex in terms of numbers of medications, number of doses per day, and adverse effects. Medication regimens for the management of HIV must be taken with near perfect compliance to maximize benefits and prevent the development of viral resistance. Enfuvirtide, approved by the Food and Drug Administration (FDA) in 2003, is an infusion inhibitor that blocks the HIV from attaching to the CD4 cell (or T-cell). It is subcutaneously injected twice daily and directed at patients not responding to other treatments. However, it has been found that 98% of patients experience injection site reactions. Piezoelectric ultrasonic transdermal drug delivery technologies have been shown to delivery insulin in animal models and human trials. The 20 kHz ultrasonic waves open 25 to 125 m micro-channels in the stratum corneum, allowing the medications to reach the blood system, but operate at low intensity levels that did not show any noticeable damage or significant skin change using histological examination. The LET-PED will be a needle-free, automatic and safe ultrasonic drug delivery device to keep HIV patients in medication regime compliance. Phase I Specific Aims are: 1. Design and build a piezoelectric lightweight transducer drug delivery patch with a replaceable/refillable drug reservoir and piezoelectric micro-pump. 2. Characterize the acoustic energy field and determine the safety limits to skin with histological and confocal microscopy studies 3. Perform acoustic experiments using human skin samples with Enfuvirtide to evaluate the penetration using the LET-PED These aims will test the hypothesis that that a piezoelectric transdermal drug delivery patch can allow Enfuviritide to pass through the skin without causing tissue damage. The long-term objective of this work is to commercialize the LET-PED. The HIV population of ~2 million patients in Western Europe and North America would be the first target market. The technology could also be licensed for specific application areas. PUBLIC HEALTH RELEVANCE: This Phase I NIH SBIR, will develop a Lightweight Electronically Controlled Transdermal Patch for Enfuvirtide Delivery. The LET-PED will be a needle- free, automatic and safe ultrasonic drug delivery device to keep HIV patients in medication regime compliance.