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.
Highlights
The production and distribution of substandard and falsified medicines (SFs) are increasing throughout the world[1,2,3]
Given that the medicine stock is limited in small retail markets in local areas of Lower and middle-income countries (LMICs), it is often difficult to collect a sufficient number of samples to carry out full pharmacopoeial testing
We describe a small-scale dissolution test based on limited sampling, designed to screen samples collected in the field in order to identify potential substandard and falsified (SF) medicines that should receive full pharmacopoeial analysis
Summary
The production and distribution of substandard and falsified medicines (SFs) are increasing throughout the world[1,2,3]. In contrast, results from criminal activities, which are often enabled by inadequate regulation and g overnance[8] In this context, convenient methods to detect SF medicines are still urgently required[9,10,11,12,13]. We describe a small-scale dissolution test based on limited sampling, designed to screen samples collected in the field in order to identify potential substandard and falsified (SF) medicines that should receive full pharmacopoeial analysis. The purpose of this study is to develop a small-scale but statistically valid dissolution test that can be used both to provide an estimate of the prevalence of SF medicines based on predetermined acceptance criteria and to detect potential SFs that should receive full pharmacopoeial analysis
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