Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis.

Scientific Reports
Mohammad Sofiqur RahmanKazuko Kimura

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 criter...Continue Reading

References

Oct 5, 2010·Pharmaceutical Research·Mohiuddin Hussain KhanKazuko Kimura
Apr 21, 2011·Pharmaceutical Statistics·Chieh ChiangJen-Pei Liu
Mar 7, 2014·BMC Pharmacology & Toxicology·Naoko YoshidaKazuko Kimura
May 31, 2015·AAPS PharmSciTech·Daniel AlsmeyerPradeep Sanghvi
May 5, 2017·BMC Pharmacology & Toxicology·Mohammad Sofiqur RahmanKazuko Kimura
Jan 10, 2018·Tropical Medicine & International Health : TM & IH·Mohammad Sofiqur RahmanKazuko Kimura
Sep 12, 2018·Pharmacy : Journal of Pharmacy, Education and Practice·Md Rafiqul IslamHirohito Tsuboi
Sep 21, 2018·BMJ Global Health·Serena VickersCéline Caillet
May 3, 2019·The Journal of Antimicrobial Chemotherapy·Patricia TaberneroPaul N Newton
Mar 25, 2020·Pharmacy : Journal of Pharmacy, Education and Practice·Mirai SakudaHirohito Tsuboi

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