Abstract
The purpose of this study was to compare generic versus brand name formulations of both prescription and over-the-counter (OTC) medications. FDA regulations require a bioequivalence of generic prescription drugs within 20% of the brand name product. OTC drugs are not subjected to the same criteria; the FDA has a list of approximately 800 approved ingredients that are combined in numerous ways to create over 100,000 OTC medications. To assess the level of variation between prescription and OTC generic formulas and their brand name counterparts, drug samples of each category were analyzed using gas chromatography-mass spectrometry (GC-MS). The brand name prescription drug, DarvocetN, was compared with its generic counterpart; the brand name OTC acetaminophen medication, Tylenol, was compared with two different store brand generic formulations. The resulting GC-MS data indicated greater variance between OTC formulas than the prescription medications sampled.
Faculty Sponsors
Dr. Reza Razeghifard, Dr. Deanne Roopnarine
Project Type
Event
Location
Alvin Sherman Library
Start Date
2010 12:00 PM
End Date
2010 5:00 PM
How Profound: No Difference in the Compound
Alvin Sherman Library
The purpose of this study was to compare generic versus brand name formulations of both prescription and over-the-counter (OTC) medications. FDA regulations require a bioequivalence of generic prescription drugs within 20% of the brand name product. OTC drugs are not subjected to the same criteria; the FDA has a list of approximately 800 approved ingredients that are combined in numerous ways to create over 100,000 OTC medications. To assess the level of variation between prescription and OTC generic formulas and their brand name counterparts, drug samples of each category were analyzed using gas chromatography-mass spectrometry (GC-MS). The brand name prescription drug, DarvocetN, was compared with its generic counterpart; the brand name OTC acetaminophen medication, Tylenol, was compared with two different store brand generic formulations. The resulting GC-MS data indicated greater variance between OTC formulas than the prescription medications sampled.
