SBIR-STTR Award

PharmChem Laboratories has developed a new sweat patch product, the FastPatch(TM), which reduces minimum wear times to detect cocaine and most other drugs of abuse from the full day typically required with standard sweat patches to 20 or 30 minutes through mild heating. Additionally, there is an increasing need and growing market for the detection of crack use distinct from other cocaine use. Recent research has identified unique pyrolytic metabolites of crack, anhydroecgonine methylester (AEME) and ecgonidine (ECD). These metabolites are detected through GC/MS. However, a low-cost EIA procedure is likely within a year increasing the market potential for detection with a FastPatch(TM). This application proposes a non-controlled field trial (N=360) of the FastPatch(TM) in an arrestee sample with high incidence of crack and other cocaine use. This trial will examine the feasibility of using the FastPatch(TM) in criminal justice settings while evaluating the effectiveness of detecting crack analytes and other cocaine in FastPatch(TM) sweat eluate. The FastPatch avoids typical problems with urinalysis such as violations of privacy, dilution or substitution of specimens, possibility of disease transmission, and transport of noxious fluids. Advantages over the standard sweat patch include longer window of detection (2-3 weeks versus 2-3 days) and short minimum period of wear needed to detect most drugs (20-30 minutes versus 24 hours). There is a growing market and a need for the FastPatchTM in criminal justice, drug treatment, and workplace settings. PROPOSED COMMERCIAL APPLICATIONS: As a commercial product FastPatches offer several advantages to urine testing: l) noninvasive sampling, 2) longer period of detection for monitoring, 3) difficult to adulterate or beat, and 4) ease of sample transport. FastPatches are superior to standard patches requiring shorter wear times to detect drugs, and longer window of detection. FastPatches may eventually replace urine as the method of choice in the drug treatment, criminal justice, military, and workplace drug testing markets.

Thesaurus Terms:
cocaine, crack cocaine, drug abuse, drug testing, technology /technique development drug metabolism, noninvasive diagnosis, sample collection (physical), sweat gas chromatography mass spectrometry, human subject

PharmChem Inc. has developed a new sweat patch product, the FastPatch TM, which reduces minimum wear times to detect cocaine and most other drugs of abuse from the full day typically required with standard sweat patches (Liberty et al., 1999a) to 20 or 30 minutes through mild heating (Liberty, 2003). Additionally, there is an increasing need and growing market for the detection of crack use distinct from other cocaine. Recent research (Martin et al., 1989) has identified unique pyrolytic metabolites of crack, anhydroecgo-nine methylester (AEME) and ecgonidine (ECD) through GC/MS. It is likely that a low-cost EIA procedure for detection of crack use will be available within a year, increasing the market potential for detection using a Fastpatch (tm). During Phase I, 180 subjects wore two FastPatch prototypes (one on each hand) and only one patch per subject was needed to obtain sufficient sweat eluate for GC/MS. This finding has positive market potential. Cocaine use was detected in sweat of 92.4 percent of subjects, comparable to 91 percent with EMIT urinalysis in a high prevalence sample. Crack metabolites were successfully detected in 54 percent of subjects. While there were no significant differences in detection rates between 15, 20, and 30 min. wear periods, all wear periods successfully detected substantial cocaine/crack use, and a shorter 10 min. condition will be tested. This finding has positive market potential. During Phase II, these changes will occur: Fast patches will be worn in moderate and low prevalence samples, a shorter wear period will be added, more biological tests will be included (e.g., standard sweat patches and GC/MS of urine), testing for more drugs (heroin and marijuana), data collection will expand to include both a residential drug treatment program and a workplace, low-prevalence sample, the latter a venue with positive market potential. The FastPatch avoids problems with urinalysis such as violations of privacy, dilution or substitution of specimens, possibility of disease transmission, and transport of noxious fluids. Advantages over the standard sweat patch include a longer window of detection (2-3 wks. versus 2-3 days) and a shorter minimum period of wear needed to detect most drugs (10-20 m n. versus 24 hrs.).

Thesaurus Terms:
biosensor, cocaine, crack cocaine, diagnosis design /evaluation, drug abuse, drug detection, rapid diagnosis, skin, sweat, technology /technique development diagnosis quality /standard, drug addiction, marijuana abuse, opiate alkaloid, substance abuse biotechnology, clinical research, data collection methodology /evaluation, gas chromatography mass spectrometry, human subject, patient oriented research, urinalysis