Premium
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(s) -
Okumura J.,
Taga M.,
Tey S.,
Kataoka Y.,
Nam N.,
Kimura K.
Publication year - 2010
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2010.02627.x
Subject(s) - dissolution testing , test (biology) , dissolution , medicine , amoxicillin , mathematics , pharmacology , chemistry , biology , antibiotics , microbiology and biotechnology , drug , paleontology , biopharmaceutics classification system
Summary 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.