Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
Abstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2021-06-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-021-91443-5 |
| _version_ | 1818572933729091584 |
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| author | Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura |
| author_facet | Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura |
| author_sort | Mohammad Sofiqur Rahman |
| collection | DOAJ |
| description | Abstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more. |
| first_indexed | 2024-12-15T00:04:16Z |
| format | Article |
| id | doaj.art-67724864f4df43e1b2edbb663fe02b6a |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-15T00:04:16Z |
| publishDate | 2021-06-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-67724864f4df43e1b2edbb663fe02b6a2022-12-21T22:42:47ZengNature PortfolioScientific Reports2045-23222021-06-011111910.1038/s41598-021-91443-5Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysisMohammad Sofiqur Rahman0Naoko Yoshida1Hirohito Tsuboi2Yuichiro Ishii3Yoshio Akimoto4Kazuko Kimura5Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa UniversityAI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa UniversityDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa UniversityDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa UniversityMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa UniversityMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa UniversityAbstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more.https://doi.org/10.1038/s41598-021-91443-5 |
| spellingShingle | Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis Scientific Reports |
| title | Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis |
| title_full | Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis |
| title_fullStr | Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis |
| title_full_unstemmed | Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis |
| title_short | Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis |
| title_sort | small scale dissolution test screening tool to select potentially substandard and falsified sf medicines requiring full pharmacopoeial analysis |
| url | https://doi.org/10.1038/s41598-021-91443-5 |
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