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Project Updates

Congratulations to Olatunde Awosiji Awotunde, Nicholas Roseboom, and Jin Cai!

Author: Marya Lieberman

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.  …

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Congratulations to Heather Whitehead, whose paper on instrument-free detection of DNA with Nile Blue was just accepted by Analytical Methods!

Author: Marya Lieberman

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.  …

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Health systems model shows cost-effectiveness of screening amoxicillin quality

Author: Marya Lieberman

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. …

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Oopsy!

Author: Marya Lieberman

A US pharmaceutical company just announced a recall of two lots of drugs which were "inadvertently mixed up" by the manufacturer.…

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PhD defense

Author: Marya Lieberman

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. …

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US Pharmacopiea evaluates PADs as pharmaceutical screening technology

Author: Marya Lieberman

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.

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DPAL project is published in J. Chem. Ed, congratulations to Sarah Bliese!

Author: Marya Lieberman

Sarah Bliese and Margaret Berta's paper on the distributed pharmaceutical analysis lab (DPAL) was just published in J. Chem. Ed. 

The distributed pharmaceutical analysis laboratory (DPAL) is a collaboration between 30 academic institutions around the world, whose goal is to determine the quality of medicines collected from partner organizations in low- and middle-income countries (LMICs).  The distributed pharmaceutical analysis lab project aims to make analytical capacity at colleges and universities around the world available to carry out preliminary HPLC tests of medicines purchased in LMICs.Over a thousand samples have been analyzed through DPAL in the last three years, and 168 samples with quality problems have been discovered, including falsified acetaminophen, adulterated amoxicillin-clavulanate and doxycycline, and substandard losartan.…

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Lancet Global Health Comment on risks to global pharma supply chain from COVID-19

Author: Marya Lieberman

A comment just published in Lancet Global Health expresses concern for the whole global supply chain due to the COVID-19 pandemic.  M. Lieberman is one of the 53 co-authors.  The comment urges the global community not to loose track of the need to provide access to good quality medical products for all the other illnesses out there.  Already, the epidemic is limiting mass gatherings for medical treatments such as vaccination, creating intense demand for drugs without a good evidence base for use in COVID-19, and curtailing regulatory efforts such as post-market surveillance. …

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