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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Sarah's J. Chem. Ed. paper is accepted!

Author: Marya Lieberman

Paper Millifluidics Lab: Using a Library of Color Tests to Find Adulterated Antibiotics

A two to three period analytical chemistry experiment has been developed which allows second year students to explore chemical color tests used to detect adulterated pharmaceuticals. Students prepare several paper analytical devices (PADs) to generate positive and negative controls antibiotics, along with cutting agents such as starch and chalk. These PADs are used to identify the active ingredients and excipients in mystery tablets prepared by their classmates. In the second part of the lab, the students select an individual color test and design an experiment to quantify their mystery pill’s active pharmaceutical ingredient (API). Nearly all the student groups were able to successfully identify adulterants present in their mystery tablets.  The quantification of the mystery tablets was also successful with all but one group calculating the correct concentration within 6%. In a post-lab assessment, the students identified their largest gains in their ability to analyze data and other information, skill in science writing, and learning of laboratory techniques.…

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Oxford Statement published in Lancet Global Health

Author: Marya Lieberman

Every person has the right to receive safe, quality medical products – but all too often, this isn’t the case.

  • Poor-quality medical products (including medicines, vaccines, biologics and diagnostics) fall into two categories: substandard or falsified. Both negate the benefits of modern health care and put patients at risk.

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Ceftriaxone paper accepted

Author: Marya Lieberman

Congratulations to Sarah Bliese, whose paper on analysis of ceftriaxone via the 12-lane PAD was just accepted in Analytical Methods.  Sarah used principal component analysis (PCA) to differentiate good and bad products and even to figure out why a given product was bad quality.  

Graphical Abstract CeftriaxoneColor "bar codes" classify the products as good or bad.…

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No HPLC? No problem!

Author: Marya Lieberman

Nick Meyers' paper on quantitative analysis of beta lactams on a paper card was just accepted by Analytical Methods.  Congratulations Nick! The aPAD accuracy is about 5%, not quite as good as an HPLC, but then again, the aPAD doesn't cost $40,000.  

Apad Toc Jpg Full SizeThe more blue dots appear, the smaller the antibiotic content.…

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Madeline Smith won an outstanding poster award at the Gordon Conference

Author: Marya Lieberman

Madeline's poster was titled, "The chemoPAD: A Paper Analytical Device for Detection of Four Chemotherapy Drugs," and Ayenew Ashenef from Addis Ababa University is a co-author.  Congratulations to Madeline!  

 

2019 Madeline Smith Grc Poster Award

The 2019 Gordon Research Conference on Preclinical Form and Formulation for Drug Discovery focused on cutting edge research on the development, characterization and manufacture of formulations that span multiple modalities., such as …

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Kat Hayes and Vincent Schmitz awarded $30,000 in pitch competition

Author: Marya Lieberman

The Disease Diagnostic INventors Challenge provides funding to focus measurement science and engineering creativity at Purdue, IU, IBRI and Notre Dame on innovations with the potential to address unmet biomedical needs. Kathleen Hayes and Vincent Schmitz brought together the research strengths of the Whalen and Lieberman groups at Notre Dame to tackle the difficult task of detecting bad quality or fake oxytocin.  There is currently no field test available for oxytocin quality, and studies show that about 1 in 4 vials dispensed to women in Africa do not meet quality standards.  Good luck to these energetic first year grad students!…

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Heather DiLallo honored by St Mary's College

Author: Marya Lieberman

The 2019 Lumen Christi award was presented to Heather DiLallo, who has worked for many years with the PAD project at Saint Mary's. Heather is a Chemistry major who has worked to detect falsified medicines in Nepal and China through Toni Barstis's IRES program.  She is in the 5-year dual degree program, and will be continuing her engineering coursework next academic year at Notre Dame.  We look forward to seeing her around campus! …

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Good Guy Tom's

Author: Marya Lieberman

I'm at the icddr,b site in Bandarban, and sharing the facility with about 800 boxes of shoes donated by shoe company Tom's.  They promise that for every pair they sell in the US, they'll donate a pair of shoes to children in need.  Looks like they are following through.  The community health workers distribute the shoes when they're doing their other duties.  Photo coming later. …

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PADs in Bangladesh

Author: Marya Lieberman

Marya Lieberman gave a workshop about post-market surveillance for 40 staff members from the Directorate General of Drug Administration in Dhaka, Bangladesh, the National Control Lab, and WHO-PQM. 

The workshop included a fun project to evaluate the supply chain of a medicine which involved 28 neophytes analyzing samples from a fictional country.  The PAD reader box also made its first debut outside Notre Dame.  This smart PAD reader will be sited in Bandarban at the icddr,b field office, where a small sampling project will be based in 2019.    …

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Policy actions against falsified and substandard medicine

Author: Marya Lieberman

ASTMH Journal has a good review of policy options for combatting  falsified and substandard medicines--link here. 

Abstract:  Falsified and substandard medicines are associated with tens of thousands of deaths, mainly in young children in poor countries. Poor-quality drugs exact an annual economic toll of up to US$200 billion and contribute to the increasing peril of antimicrobial resistance. The WHO has emerged recently as the global leader in the battle against poor-quality drugs, and pharmaceutical companies have increased their roles in assuring the integrity of drug supply chains. Despite advances in drug quality surveillance and detection technology, more efforts are urgently required in research, policy, and field monitoring to halt the pandemic of bad drugs. In addition to strengthening international and national pharmaceutical governance, in part by national implementation of the Model Law on Medicines and Crime, a quantifiable Sustainable Development Goal target and an international convention to insure drug quality and safety are urgent priorities.…

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Thank you to USP!

Author: Marya Lieberman

In analytical chemistry, everything depends on access to high quality reference materials. The US Pharmacopeia donated over $5,000 worth of reference standards to the PAD project in 2019.  Thanks for this contribution to our work! 

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Oxford conference on Medicine Quality and Public Health

Author: Marya Lieberman

The Medicine Quality and Public Health conference at Oxford University had 200 participants from over 50 countries, including the Directors General of the Tanzanian and Nigerian drug regulatory agencies and academics, NGOs, WHO, and pharmaceutical companies.

Marya Lieberman and Philip Coyne attended and gave several presentations.  …

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Cartoon version of PAD project at MQPH meeting

Author: Marya Lieberman

At the Oxford MQPH conference, Marya Lieberman presented in a session titled Screening Technologies:  Will they Save the Day?  The talk was captured by the sketch artist.  Here we see a summary of how the PAD works and the results of the supply chain exercise that the 20 students in the short course obtained the previous week.  …

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