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:2/8/2017)... 7, 2017 Report Highlights ... The global synthetic-biology market reached ... by 2021, growing at a compound annual growth rate (CAGR) ... of the global markets for synthetic biology. - Analyses of ... and projections of compound annual growth rates (CAGRs) through 2021. ...
(Date:2/7/2017)... 7, 2017   MedNet Solutions , an innovative ... of clinical research, is pleased to announce that the ... innovative, highly flexible and award winning eClinical solution, is ... iMedNet is a proven Software-as-a-Service (SaaS) clinical research ... (EDC), but also delivers an entire suite of eClinical ...
(Date:2/6/2017)... , Feb. 6, 2017 According to ... are driving border authorities to continue to embrace ... there are 2143 Automated Border Control (ABC) eGates ... deployed at more than 163 ports of entry ... to 2016 achieving a combined CAGR of 37%. ...
Breaking Biology News(10 mins):
(Date:2/22/2017)... ... 22, 2017 , ... ProMIS Neurosciences (“ProMIS” or the “Company”), ... today announced it has issued a scientific white paper entitled “Results from recent ... of commentaries from ProMIS’s scientific team offering insight into the Company’s product portfolio ...
(Date:2/22/2017)... Feb. 22, 2017 Origin (Origin Agritech, LLC, a subsidiary ... seed provider, and Arcadia (Arcadia Biosciences, Inc., ... and commercializes agricultural productivity traits and nutritional products, today announced their ... product developed in China to ... ...
(Date:2/22/2017)... SAN DIEGO , Feb. 22, 2017 ... announced today expansion of its translational research program ... through establishment of laboratory facilities in San Diego.  ... San Diego BioLabs facility, a biotechnology incubator sponsored ... Sanofi. In November 2016, the Company ...
(Date:2/21/2017)... ... 2017 , ... During HIMSS 2017, CloudMine, a secure, cloud-based ... partnership with Redox, a leader in cloud-based healthcare integration and API services. The ... data secure in the cloud. , The digital health developers, and various healthcare ...
Breaking Biology Technology: