Four Points of Attack
Each PAD consists of a library of chemical tests that use one or more of the following stragtegies to help screen for possible counterfeit pharmaceuticals.
Qualitative colorimetric tests indicate major components of the pharmaceutical’s active ingredient. Some colorimetric tests may be used to semi-quantitatively indicate the active ingredient, thus ensuring proper pharmaceutical dosage.
Qualitative, and sometimes semi-quantitative, analysis is performed using colorimetric reagents. These tests help to verify the authenticity of the pharmaceutical by identifying the expected fillers, binders and/or counter-ions.
Qualitative colorimetric tests indicate the presence of excess by-products of the degraded active ingredient. These tests screen for expired pharmaceuticals and may be used in concert with semi-quantitative tests of the active ingredient to ensure product quality.
A library of qualitative colorimetric tests are used on every PAD to indicate the presence of common counterfeiting agents. These tests are used as “red flags” to immediately indicate to the user that the drug is suspect.
This PAD strategy can be adopted to fit most any pharmaceutical or delivery method. They can also be adapted for screening fortified dietary supplements and vitamins. PADs for antibiotics, anti-tuberculosis, anti-malarials, pain relievers and others are currently in various stages of development.
Areas of Study
The list below includes some (but not necessarily all) of the drugs currently under investigation by The PADs Project. If you would like more information on a specific project you can contact Dr. Toni Barstis at firstname.lastname@example.org or Dr. Marya Lieberman at email@example.com
Erythromycin – The first antibiotic PAD, the erythromycin PAD was first developed during the 2011-2012 school year. It was recently presented at the undergraduate poster session at the Fall 2012 ACS in Philadelphia. This PAD has recently gone through a small field test and the design is being optimized based on that data. This improved design will then undergo a 150 PAD field test. Primary researcher: Mary Bevilacqua (Saint Mary’s College)
Ciprofloxacin – This PAD has recently undergone a small-scale field test. The data from this is being used to improve and finalize the design. Once this design has been developed the PAD will undergo a 150 piece field test. Primary researcher: Elizabeth Robbins (Saint Mary’s College)
Beta Lactams – Certain of the beta lactam antibiotics are under investigation both for the counterfeiting that they frequently undergo and their common use as counterfeiting agents in other drugs. The beta lactam PAD distinguishes between ampicillin and amoxycillin. It has recently gone through basic field testing. Another general beta-lactam test is used to determine if any of these are present as counterfeiting agents in other drug analytes. Primary researchers: Dr. Marya Lieberman (University of Notre Dame), Mary Bevilacqua (Saint Mary’s College)
Chloramphenicol – A PAD for the antibiotic chloramphenicol is currently in the early lab development stage. Primary researcher: Mary Bevilacqua (Saint Mary’s College)
A PAD(s) for the testing of certain anti-diabetic drugs is currently in early lab development. Primary researcher: Tam Nguyen (University of Notre Dame)
A series of tests for antimalarial drugs such as amodiaquine and artemisinin derivatives have been compiled into an antimalarial drug PAD. This is currently in the field testing stage. Primary researchers: Elizabeth Bajema (Saint Mary’s College graduate), Meghann Mouratides (Saint Mary’s College)
Substandard antituberculosis medications can lead to emergence of drug resistance, increasing mortality and morbidity, and creating a larger threat to public health. The anti-tuberculosis PAD currently in lab development will be able to detect the “first line of defense” anti-tuberculosis drugs rifampicin, pyrazinamide, isoniazid, and ethambutol both in single and combination therapy tablets. Primary Researcher: Hannah Reiser (University of Notre Dame)
A general excipients PAD was created to test any suspicious drug (whether a specific PAD for it exists or not) for common counterfeiting agents. Some of these are relatively inert such as chalk and others can be biologically harmful such as heavy metals and free cyanide. Primary researcher: Haley Gordon (Saint Mary’s College)
A PAD was developed to test the iodate and diethylcarbamazine content of treated salt. This PAD has recently gone through a large scale (500 PAD) field test. Primary researchers: Nick Myers (University of Notre Dame), Evan Graham (University of Notre Dame), Sean McGee (University of Notre Dame)
Viagra® and Levitra® – PADs for the qualitative and semi-quantitative assesment of the PDE-5 inhibitors Viagra® and Levitra® are currently in the lab devlopment phase. Primary researcher: Haley Gordon (Saint Mary’s College)
Cialis® – A PAD for testing the content of a Cialis® pill has recently undergone a small-scale field test. After a few minor readjustments to the design it will undergo a 150 PAD field test. Primary researcher: Mary Bevilacqua (Saint Mary’s College)
A pandol PAD (one of the first to be created as a part of the PADs project) has recently gone through a 500 PAD large scale field test. The results of this were presented at the Fall 2012 American Chemical Association national meeting in Philadelphia. A publication describing these results and the chemical behavior of the PAD is currently being written. Primary researcher: Diana Vega Pantoja (Saint Mary’s College)
A PAD for the assesment of a suspicious Tamiflu® pill is in the field testing stage. Primary researchers: Benjamin Seasly (Saint Mary’s College high school intern), Victoria Darling (former Saint Mary’s College researcher)