Science & Research

FDA Grand Rounds

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The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.  #FDAGrandRounds.

Thursday, January 12, 2017
12:00 p.m. -1:00 p.m., Eastern Standard Time (EST) 

Presented by

Thilak Mudalige, PhD
Research Chemist
FDA's Office of Regulatory Affairs 

Webcast Lecture

Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products

About the Presentation

Nanoparticles--the fine particles that cover a range between 1 and 1,000 nanometers--are increasingly being used in consumer and medical products because of their unique, beneficial properties.  Silver nanoparticles, for example, are used in wound dressing for their antimicrobial properties.  Titanium dioxide nanoparticles are used in sunscreen to block ultraviolet radiation.  And liposomal nanoparticles are used as drug carriers to reduce toxicity and increase circulation time in the blood.  

But as the application and use of nanoparticles in these products becomes more common, the health impacts of nanoparticles need to be better understood.  One reason for this is that nanomaterials are very susceptible to batch-to-batch variation in their physical and chemical properties during production.  Therefore, the challenge of detecting, quantifying, and characterizing nanoparticles in products is essential for their regulation.  

Characterizing inorganic nanoparticles like gold, silver, and titanium dioxide, which are used in products like dietary supplements and sun screens involves quantifying metallic content, size-based separation, and determining size and speciation, based on oxidation state.  Characterizing organic nanomaterials such as liposomes that are used in drug delivery systems for cancer treatment, for example involves determining encapsulated active ingredient content, lipid profile, size, and zeta potential.  

Dr. Mudalige’s will describe the methodology he developed for characterizing inorganic and organic nanoparticles, using various microscopic techniques, light scattering, size-based separation methodology, elemental analysis, and mass spectrometry.
 

About the Presenter 

A research chemist in FDA’s Office of Regulatory Affairs, Dr. Thilak Mudalige conducts research on method development for characterizing nanomaterials in FDA-regulated products. His work focuses largely on size-based separation of nanomaterials, using capillary electrophoresis, asymmetric field flow fractionations and determination of elemental and molecular composition of nanomaterials using mass spectrometry. 

Dr. Mudalige joined FDA in 2009, after training as a post-doctoral research associate at the Center for Functional Nanomaterials in Brookhaven National Laboratory, Upton, New York.
 

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