BME PhD Dissertation Defense - Darash Desai

10:00 am on Thursday, April 10, 2014
8 St. Mary’s Street, Photonics Center, Room 339
Dr. Muhammad Zaman (Advisor)
Dr. Mark Grinstaff (Chair)
Dr. Michael Smith
Dr. Susan Foster, Professor of International Health at BU School of Public Health
Dr. Chris Gill, Associate Professor at BU School of Public Health

Title: "PharmaChk: Robust Device for Counterfeit and Substandard Medicines Screening in Developing Regions"

Counterfeit and substandard medicines are a grave public health concern that comprises a $75B black market and claims over 100,000 lives every year. The World Health Organization estimates that 10-50% of medicines in countries around the world are adulterated, and their presence imposes serious financial and economic burdens while also contributing to the rise of drug-resistant pathogens. Although a plethora of technologies are available for field-based quality screening, none reliably quantify active pharmaceutical ingredient (API) content or kinetic release from a dissolving tablet. The United States Pharmacopeia, a global leader in medicines standards for over 150 years, indicates that these quality measures are vitally important yet remain outside the reach of existing screening tools. The current field standard relies on thin layer chromatography to only provide qualitative results that make it difficult to discern between tablets that contain 80% and 100% API. Meanwhile, international standards set the threshold for substandard medicines at 90%. This clear lack of appropriately quantitative and field-based analytical tools poses a serious problem for national and international policy-makers who are plagued with wildly variable information that prevents focused and deliberate action against the spread of these medications.

This work presents an alternative analytical technique that can specifically and accurately quantify drug API content and kinetic release. PharmaChk provides an orthogonal approach to existing technologies using a portable, inexpensive, and easy-to-use platform. We demonstrate that aptamers can provide a simple and effective way to target a wide range of APIs, while maintaining high quantitative precision and accuracy. A microfluidic, flow-through system is employed to obtain valuable drug quality information using a single step procedure. Through our research, we demonstrate the development of the PharmaChk platform from the proof-of-concept stage to beta prototyping and field-testing. By providing a portable, robust, and quantitative approach to medicines testing, PharmaChk can enable the collection of important drug quality information throughout pharmaceutical supply chains and ultimately save the lives of millions that are not afforded safe and essential medicines.