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:4/14/2016)... TEL AVIV, Israel , April 14, 2016 /PRNewswire/ ... in Behavioral Authentication and Malware Detection, today announced the ... has already assumed the new role. Goldwerger,s ... for BioCatch, on the heels of the deployment of ... In addition, BioCatch,s behavioral biometric technology, which discerns unique ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys has ... CEO, Barrett Bready , M.D., who returned to ... the original technical leadership team, including Chief Technology Officer, ... Product Development, Steve Nurnberg and Vice President of Software ... the company. Dr. Bready served as CEO ...
(Date:3/22/2016)... , March 22, 2016 ... research report "Electronic Sensors Market for Consumer Industry by ... & Others), Application (Communication & IT, Entertainment, ... - Global Forecast to 2022", published by ... is expected to reach USD 26.76 Billion ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... 23, 2016 Houston Methodist Willowbrook Hospital ... Sports Association to serve as their official health ... Methodist Willowbrook will provide sponsorship support, athletic training ... association coaches, volunteers, athletes and families. ... Sports Association and to bring Houston Methodist quality ...
(Date:6/23/2016)... ... 23, 2016 , ... Supplyframe, the Industry Network for electronics ... Lab . Located in Pasadena, Calif., the Design Lab’s mission is to bring ... designed, built and brought to market. , The Design Lab is Supplyframe’s physical ...
(Date:6/23/2016)... Andrew D Zelenetz ... Published recently in Oncology ... touchONCOLOGY, Andrew D Zelenetz , discusses the ... is placing an increasing burden on healthcare systems ... With the patents on many biologics expiring, interest ...
(Date:6/23/2016)... 2016  Amgen (NASDAQ: AMGN ) today ... life sciences incubator to accelerate the development of ... space at QB3@953 was created to help high-potential life ... many early stage organizations - access to laboratory infrastructure. ... launched two "Amgen Golden Ticket" awards, providing each winner ...
Breaking Biology Technology: