Rockville, Md., April 1, 2008 — The U.S. Pharmacopeial (USP) Convention today announced results of a study comparing the dissolution variability of USP Prednisone Lot P Reference Standard tablets to two marketed drugs. Study results clearly show less variability in USP Prednisone Lot P tablets than in the marketed tablets. Dissolution testing of solid oral dosage forms plays a critical role in drug manufacturing because it indicates whether a drug will dissolve properly in the body. This in turn is an established criterion in quality assurance and regulation of manufactured drugs and dietary supplements.
In all analytical testing, including dissolution, the apparatus used must undergo installation, operation and performance qualification to ensure reliable results. These activities are detailed in various USP General Chapters, particularly Dissolution <711>. For dissolution testing, the performance verification test involves USP Prednisone Reference Standard tablets. The current study explored quality attributes of USP Lot P Prednisone Reference Standard tablets in comparison to two commercially available drugs that are marketed in tablet form.
The study was undertaken in response to assertions that the USP Prednisone Lot P Reference Standard tablets yielded highly variable results and led to unreliable dissolution test results. It compared the dissolution variability associated with selected commercial dosage forms to that of USP Lot P Prednisone Reference Standard tablets. The study was conducted according to metrological principles established by the International Organization for Standardization.
“I am very pleased that the results of this testing showed significantly less variability in the USP Lot P Prednisone Reference Standard tablets than in the comparator tablets,” said William Koch, Ph.D, chief reference materials officer for USP. “USP Prednisone yielded an average variability of less than five percent, while comparators averaged about 13 percent. Established metrological principles were followed to ensure the test’s objectivity, and it is clear that USP Prednisone Reference Standard tablets are not the cause of variation in dissolution test results,” Dr. Koch continued. “Manufacturers should be assured of the appropriate performance of the USP Prednisone tablets in dissolution testing.”
Details on the dissolution testing variability can be found at www.springerlink.com/content/j8246315n5404j18/?p=8a0886888caf41b4b69722da48bfb5d8&pi=0 (Part I) and www.springerlink.com/content/b3726195727184gl/?p=8a0886888caf41b4b69722da48bfb5d8&pi=1 (Part II), or in AAPS PharmSciTech at www.springerlink.com/content/6275835w64234k11/?p=75b065723c66472eac12ac7d102d985b&pi=0.
USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by helping to ensure the quality and consistency of medicines, food ingredients, and dietary supplements, promoting the safe and proper use of medications, and verifying ingredients in drugs and dietary supplements. Its standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical and food industries, and consumer organizations. For more information about USP and its public health programs, visit www.usp.org/newscenter.