التفاصيل البيبلوغرافية
| العنوان: |
The Science of USP 1 and 2 Dissolution: Present Challenges and Future Relevance. |
| المؤلفون: |
Vivian Gray, Gregg Kelly, Min Xia, Chris Butler, Saji Thomas, Stephen Mayock |
| المصدر: |
Pharmaceutical Research; Jun2009, Vol. 26 Issue 6, p1289-1302, 14p |
| مصطلحات موضوعية: |
DRUG solubility testing, BLOOD testing, SOLID dosage forms, ORAL medicine, DRUG development, DRUG stability, EXPERIMENTAL design |
| مستخلص: |
Abstract Since its inception, the dissolution test has come under increasing levels of scrutiny regarding its relevance, especially to the correlation of results to levels of drug in blood. The technique is discussed, limited to solid oral dosage forms, beginning with the scientific origins of the dissolution test, followed by a discussion of the roles of dissolution in product development, consistent batch manufacture (QC release), and stability testing. The ultimate role of dissolution testing, “to have the results correlated to in vivo results or in vivo in vitro correlation,” is reviewed. The recent debate on mechanical calibration versus performance testing using USP calibrator tablets is presented, followed by a discussion of variability and hydrodynamics of USP Apparatus 1 and Apparatus 2. Finally, the future of dissolution testing is discussed in terms of new initiatives in the industry such as quality by design (QbD), process analytical technology (PAT), and design of experiments (DOE). [ABSTRACT FROM AUTHOR] |
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Copyright of Pharmaceutical Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
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