Using Microfluidic Chip Technology for Assessing Drug Quality

Improving access to quality medicines is an ongoing challenge in the developing world. In addition to overcoming the challenge of bringing drugs to remote or difficult-to-reach areas, there is the problem of substandard or counterfeit drugs entering the supply chain. To help address that problem, a new platform for detecting substandard and counterfeit medicines using microfluidics was recognized earlier this year with a grant through a private–public parntership Saving Lives at Birth: A Grand Challenge through Development.

Saving Lives at Birth: A Grand Challenge through Development is an initiative to improve maternal and children’s health. It was launched in March 2011 to seek innovative prevention and treatment approaches for pregnant women and newborns in rural, low-resource settings. The project is a partnership between the US Agency for International Development (USAID), the government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the World Bank. These partners provided nearly $14 million for this grant program's first round of funding and have a commitment of investing at least $50 million in projects in multiyear funding. The first call in 2011 for innovative approaches resulted in the selection of 24 solutions for award. A second call was issued in February 2012 for innovations across three domains: science and technology, service delivery, and ways to stimulate demand for healthcare services at the time of birth. The call elicited more than 500 submissions from almost 60 countries. In July 2012, The Saving Lives at Birth partners nominated 15 innovations for award. Among the innovations recognized was PharmaCheck, a new platform for detecting substandard and counterfeit medicines.

Developed by Boston University in collaboration with the Promoting the Quality of Medicines (PQM) program, which is supported by USAID and implemented by the US Pharmacopeial Convention (USP), PharmaCheck has reached the proof of concept stage—demonstrating a quantitation linear relationship for analysis of an antimalarial medicine of interest on a microfluidic chip, according to a July 26, 2012, USP press release. The technology addresses shortcomings of current field-based, portable quality- control laboratories currently in use throughout the developing world, including the inability to precisely and accurately measure the percentage of API or other important quality attributes of medicines. The technology is expected to greatly reduce the need for confirmation of field-tested results at fully equipped quality-control laboratories.

“This technology promises to be groundbreaking in the fight against substandard and counterfeit medicines,” said Anthony Boni, pharmaceutical management specialist for USAID’s Global Health Bureau, Office of Health, Infectious Diseases and Nutrition/Health Systems Division, in the USP release. “Inexpensive, easy-to-use and effective, we expect that PharmaCheck will represent a paradigm shift in combating the scourge of poor quality medicines. One of the most exciting elements is the ability to potentially deploy this technology at point-of-use, with an ultimate vision of healthcare facilities, clinics, and hospitals using the technology to verify the quality of the medicines they receive.”

Muhammad Zaman, associate chair for undergraduate studies, biomedical engineering and professor of biomedical engineering at Boston University is leading the development for PharmaCheck. A project summary provided by Saving Lives at Birth, explained the need for such a device to improve maternal and children’s health. Malaria affects over 50% of the populace in sub-Saharan Africa and contributes to over 200,000 newborn and 10,000 maternal deaths annually worldwide. In 2008, maternal sepsis accounted for 36,000 deaths while neonatal infection caused close to a million neonatal deaths. It is estimated that between 10–30% of drug sales are counterfeit in parts of Africa, Asia, and Latin America and between 30–50% of all anti-malarials are substandard. The primary objective of the project is to develop a device to screen for substandard anti-malarials and antibiotics, thereby improving adverse maternal and neonatal health outcomes with respect to malaria and sepsis. The researchers say there is no device to test counterfeit and substandard drugs in the field thoroughly. To this end, they see PharmaCheck as a user-friendly, cost-effective, contextual and high-throughput device capable of quantitatively measuring active ingredient concentration and drug-release profiles to quickly and accurately screen for spurious medicines.

“Existing methods of counterfeit drug detection are bulky, qualitative, error-prone and do not take time-based measurements of drug-release kinetics, and thus do not provide information about whether therapeutic levels of the drug are reached and sustained,” noted the summary. “PharmaCheck addresses these shortcomings through affordable fluorescence, dissolution testing, which allows for highly specific and quantitative time-course measurements of drug release. PharmaCheck will offer an affordable, effective tool for local health authorities to better safeguard the efficacy of their pharmacopeia and significantly impact maternal and neonatal health outcomes in the developing world.”

“This technology is an important breakthrough as we strive to help ensure the quality, safety and efficacy of medicines essential to treating patients suffering from malaria, tuberculosis and HIV/AIDS in developing countries around the world,” said. Patrick Lukulay, vice-president of Global Health Impact Programs for USP and director of the PQM Program, in the USP release. “This will be a very powerful tool with broad application and impact. We are very pleased to be partnering with Boston University in advancing this technology.”