1. High failure rate of the dissolution tests for 500-mg amoxicillin capsules sold in Cambodia: is it because of the product or the test method?
- Author
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Okumura J, Taga M, Tey S, Kataoka Y, Nam N, and Kimura K
- Subjects
- Amoxicillin chemistry, Anti-Bacterial Agents chemistry, Cambodia, Capsules chemistry, Capsules standards, Chemistry, Physical, Developing Countries, Humans, Pharmacopoeias as Topic, Quality Assurance, Health Care, Solubility, Amoxicillin standards, Anti-Bacterial Agents standards
- Abstract
Objectives: During the survey of substandard medicines in Cambodia in 2007, it was found that more than 90% of 500-mg amoxicillin (AMPC) capsules failed the United States Pharmacopeia (USP) 30 TEST 1 dissolution test. In the USP, several monographs provide multiple methods for performing the dissolution test. By using the 500-mg AMPC capsule as an example, we aimed to identify the problems and implications of the USP methods adopted for the dissolution test as a global standard., Methods: All AMPC samples were collected from the Cambodian market in 2007. For the quantitative test, we referred to USP 30. We performed the USP 28 and USP 30 TEST 2 dissolution tests and compared these results with those of the USP 30 TEST 1., Results: All 500-mg AMPC capsules used for the comparison passed the quantitative test. Samples that passed the USP 28 and USP 30 TEST 2 dissolution tests were identical, and the pass rate was 97.1% (34/35), whereas the pass rate with the USP 30 TEST 1 was 8.6% (3/35). The difference in the dissolution results between the three methods was significant (P<0.0001)., Conclusion: This study revealed that many users would select the most stringent method when multiple methods exist in the USP. This may lead to a high failure rate of the tests. Because USP is a global standard, we recommend that it take into consideration the developing countries and create a more detailed user-friendly manual for selection for appropriate methods., (© 2010 Blackwell Publishing Ltd.)
- Published
- 2010
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