Navigation Links
Prednisone tablets less variable than marketed drugs
Date:4/1/2008

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 tests 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.


'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

Related biology news :

1. Variable light illuminates the distribution of picophytoplankton
2. Ant guts could pave the way for better drugs
3. Simplifying manufacture of drugs, plastics earns UH chemist top honor
4. Pharmaceutical breakthrough may make a range of drugs cheaper and more available
5. Northwestern Memorial trial may wean kidney transplant patients off antirejection drugs
6. Physician-scientist urges improved drug regulation to ensure heart safety of non-heart drugs
7. Cheaper drugs now closer to realization with new DropArray technology
8. Club drugs inflict damage similar to traumatic brain injury
9. MIT: Remote-control nanoparticles deliver drugs directly into tumors
10. Market testing of dietary supplements and drugs underscores value of USPs public health programs
11. Scientists unveil structure of molecular target of many drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/21/2016)... Columbia , June 21, 2016 ... to the new role of principal product architect ... named the director of customer development. Both will ... chief technical officer. The moves reflect NuData,s strategic ... in response to high customer demand and customer ...
(Date:6/16/2016)... 16, 2016 The global ... to reach USD 1.83 billion by 2024, according ... Inc. Technological proliferation and increasing demand in commercial ... to drive the market growth.      ... The development of advanced multimodal techniques for biometric ...
(Date:6/9/2016)... leader in attendance control systems is proud to announce the introduction of fingerprint attendance ... the right employees are actually signing in, and to even control the opening of ... ... ... Photo - ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... DIEGO , June 24, 2016 ... more sensitively detects cancers susceptible to PARP inhibitors ... circulating tumor cells (CTCs). The new test has ... HRD-targeted therapeutics in multiple cancer types. ... targeting DNA damage response pathways, including PARP, ATM, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica delle ... people with peritoneal or pleural mesothelioma. Their findings are the subject of a new ... , Diagnostic biomarkers are signposts in the blood, lung fluid or tissue of mesothelioma ...
(Date:6/23/2016)... ... 23, 2016 , ... UAS LifeSciences, one of the leading ... UP4™ Probiotics, into Target stores nationwide. The company, which has been manufacturing high ... its list of well-respected retailers. This list includes such fine stores as Whole ...
(Date:6/23/2016)... 23, 2016 /PRNewswire/ - FACIT has announced the ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" or ... of a portfolio of first-in-class WDR5 inhibitors for ... as WDR5 represent an exciting class of therapies, ... medicine for cancer patients. Substantial advances have been ...
Breaking Biology Technology: