June 22, 2023--After defending her dissertation, "Methods for Pharmaceutical and Illicit Drug Analysis," Kathleen Hayes is now a PhD and will move on to Abbvie as a medical writer. Good luck Kat, we will miss you!
Joanne Cogdell, CEO of harm reduction organization Naxos Neighbors, and her collaborator Marya Lieberman, University of Notre Dame, were awarded the 2023 Next Changemaker Award from the Lucy Institute for Data and Society. The award of $51,000 will support our efforts to find emerging hazards in street drugs such as fentanyl and fentanyl analogs, xylazine, benzodiazepines, and nitazines. These superpotent opioids are associated with over 100 fatal overdose per year in this county and cause many other types of harm to people who use drugs, their families and friends, and the entire community. …
The goal of the ChemoPAD project is to use paper analytical devices to screen the quality of chemotherapy drugs in sub-Saharan Africa. The team includes collaborators from seven institutions and five countries.
Olatunde Awosiji Awotunde presented a poster on "Combining orthogonal analytical techniques to identify substandard or falsified formulations of pharmaceuticals " at the 2023 NOBCChE meeting. Congratulations to Ola on representing Notre Dame at this national event!
…Ola and Ornella were admitted as PhD candidates in May of 2023, congratulations! …
Congratulations to Heather and Kat--their manuscript, "Development and validation of a liquid chromatography tandem mass spectrometry method for the analysis of 53 benzodiazepines in illicit drug samples," was just accepted by Forensic Chemistry! This manuscript follows the earlier method for analysis of common drugs and drug metabolites published in 2022. …
Heather Whitehead defended her PhD thesis March 30, 2023. Congratulations to Dr. Whitehead as she moves on to take EPA by storm as an ORISE EPA Fellow! …
Interview in Chemical and Engineering News highlights our group's work to detect substandard and falsified pharmaceuticals.
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The Scott test has been used for over 50 years as a presumptive test for cocaine. It involves a series of reagent additions and color changes...and if it's not done and interpreted correctly, it can send innocent people to jail. This crystal structure now published in Acta Cryst E gives insight into what's going on in the test.
Bis(N,N-diethyl-4-methyl-4-piperazine-1-carboxamide) tetrakis(isothiocyanato-κN)cobalt(II), a model compound for the blue color developed in the Scott test. Oliver, A. G., Lockwood, T.-L. E., Zinna, J. & Lieberman, M. (2023). Acta Cryst. E79, 163-166
This paper shares a tandem mass spectroscopy method for quantitative analysis of 22 drugs and drug metabolites. The samples were harvested from used idPADs; we used this method, along with fentanyl and benzo test strips, to analyze 124 samples of illicit drugs collected from the Chicago area in 2021-2022. …
This commentary article, "Considerations for the design and implementation of point-of-care technology for use in low- and middle-income countries," uses the PAD project to reflect on why some technologies can be implemented in low-resource settings, and others never make it out of the lab. …
Turkey Run Analytical Conference 2022 was held at Turkey Run State Park in Indiana, and attracted researchers from Indiana, Ohio, and Illinois. In addition to Heather, Kat, Alyssa, Rachel, and Ornella, undergraduates Devena and Sarah presented posters, and Yukun from the Peaslee group also gave a poster. Congratulations to Heather Whitehead and Kathleen Hayes for organizing a great scientific meeting! …
Alyssa signed up for an early ARP time and passed with flying colors! Congratulations, Alyssa. …
Discrimination of Substandard and Falsified Formulations from Genuine Pharmaceuticals Using NIR Spectra and Machine Learning
Near-infrared (NIR) spectroscopy is a low-cost analytical tool for rapid characterization of pharmaceuticals. Usually, it's necessary to build up a "library" of NIR spectra from authentic products in order to identify real and fake formulations. In this paper, we developed a simple training method that uses binary mixtures of a pharmaceutical (acetaminophen) with two different cutting agents, and used several different data analysis models to extrapolate the training samples to real and fake samples of popular brands of acetaminophen tablets. While none of the models was able to correctly classify all the samples, a simple voting algorithm was able to compensate for the weaknesses of the models and classify 93% of the samples correctly. …
Working with the ARTiFACT Verify team, we are developing a system to monitor every stage of post-market surveillance, from sample collection to assay reports and dashboarding. The pilot of the Verify system…
Using Paper Microfluidics as a Platform for Increasing Inquiry in the Analytical Laboratory
K. Frederick, A.L. Van Wyk, R.S. Cole, M. Lieberman, R. Roller
Rachel Roller makes the case that paper labware can change the nature of laboratory instruction so it's closer to authentic scientific practice.
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Many nucleic acid tests (NATs) rely on a DNA amplification step as the detection mechanism for pathogens, viral load, and so on. Usually, DNA concentration is measured using a spectrophotometric instrument that costs tens of thousands of dollars. In this paper, Heather Whitehead used an inexpensive dye that binds to DNA and a cell phone to measure the concentration of double stranded DNA in the same concentration range commonly used to analyze NAT results. The color of Nile Blue dye shifts from blue to blue-purple to blue as it binds to DNA. While it's been known for many years that Nile Blue dye changes color when it binds to DNA, and that property has been used to develop instrumental assays, Heather figured out that by using different concentrations of the Nile Blue dye and monitoring the red, green, and blue channel intensities, the concentration of double stranded DNA can be measured with an error of less than 10 ug/ml. …
C&E News hosted this great webinar about HPLC troubleshooting--I hope it's accessible from this link.…
Kat Hayes was selected as the People's Choice winner of the 2021 Shaheen 3-minute Thesis contest. Using one static slide, no jargon, and 3 minutes of time, contestants had to explain their graduate research to a general university audience. …
Heather is the first author on this manuscript with Graham Peaslee, which has been accessed over 66,000 times--it's one of EST's most highly accessed articles in 2021!
Environ. Sci. Technol. Lett. 2021, 8, 7, 538-544
Ola is working on data analytics for pharmaceutical analysis, but is happy to help out with other projects when there's need.
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Sarah Bliese's paper with the Ozawa group at NC State is now published! Sachiko Ozawa's group developed an agent-based model, ESTEEM (Examining Screening Technologies with Economic Evaluations for Medicines), to estimate the effectiveness and cost savings of incorporating PADs and aPADs in amoxicillin quality surveillance in Kenya. We compared the current testing scenario (batches of entire samples tested by HPLC) with an expedited HPLC scenario (testing smaller batches at a time), as well as a screening scenario using PADs/aPADs to identify poor-quality amoxicillin followed by confirmatory analysis with HPLC. The PADs/aPADs screening scenario identified and removed poor-quality antibiotics faster than the expedited or regular HPLC scenarios, and reduced costs significantly. The model estimates that use of early screening tests could avert 360-870 pneumonia deaths per year in children under age 5 while reducing the number of HPLC tests required. …
Undergraduate Kyle Moon was selected as a recipient for a $300 undergraduate research grant from the Eck Insitute of Global Health. Kyle is working on a rapid and instrument-free test for childhood lead exposure. Good luck on this project, Kyle! …
Congratulations to Dr. Sarah Bliese on her successful defense of her PhD thesis, entitled "DEVELOPING SCREENING TECHNOLOGIES FOR LOW RESOURCE SETTINGS". Sarah is headed to Virginia. …
USP's Technology Review report on the PAD is now published.
Executive Summary
The paper analytical device (PAD) was developed as a cost-effective tool for field screening of a wide variety of pharmaceutical dosage forms in low-resource settings. The PAD is produced by wax printing on Ahlstrom 319 paper, which is a fast chromatography paper that creates separate reaction lanes and contains trace quantities of chemical reagents to create color changes in response to different pharmaceutical articles. Due to the COVID-19 pandemic, there has been continued upsurge of substandard and falsified (SF) medical products, especially those that claimed to be a possible treatment for the disease (e.g., azithromycin, chloroquine, and hydroxychloroquine), and which the PAD can be used to screen the products for quality. With the help of appropriate analytical techniques and methodologies, a preliminary laboratory study was conducted on all the samples used in the performance validation of the PAD to ascertain the quality status of each sample prior to the validation study on the PAD. The validation study was performed on the PAD by three different scientists using three different brands each of seven finished dosage forms (FDFs), their respective active pharmaceutical ingredients (APIs), SF formulations, and selected fillers (pharmaceuticals excipients). Upon evaluation of all data generated by the three scientists at the end of the validation study, the PAD was determined to be effective in identifying the active ingredients in all the samples collected for evaluation. The technology was also able to detect fillers such as corn starch present in some of the FDFs and formulations labeled to contain them. Results of the laboratory identification tests performed were consistent with those obtained with PAD by all three scientists. All SF formulations were prepared as per the study protocol, and all falsified formulations were correctly identified as falsified by the PAD. However, the PAD was incapable of distinguishing between substandard or degraded formulations (even those with 50% APIs) and good quality products and formulations and their respective pure APIs, making it impossible for the technology to be used to screen substandard products. Only falsified products were able to be identified correctly.
