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Measurement uncertainty for Dissolution tests using Monte Carlo methods - Uncertainties arising from sampling and
Maisa Torres Martins1, Felipe Rebello Lourenço1
1Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Av. Prof. Lineu Prestes, 580, CEP 05508-000, São Paulo, SP, Brazil.
Analytica Chimica Acta
|November 3, 2024
Summary
Measurement uncertainty in pharmaceutical dissolution testing can lead to incorrect quality decisions. This study quantifies these uncertainties, finding sampling to be the largest contributor, and proposes improved criteria to minimize false conformity risks.
Area of Science:
- Pharmaceutical Quality Control
- Analytical Chemistry
- Measurement Science
Background:
- The dissolution test is crucial for pharmaceutical quality control, assessing drug bioavailability and batch consistency.
- Measurement uncertainty in dissolution testing can lead to inaccurate conformity decisions.
- Existing methods may not adequately account for the risks associated with measurement uncertainty.
Purpose of the Study:
- To quantify measurement uncertainties in dissolution, sampling, and quantification stages of the dissolution test.
- To estimate the risk of false conformity decisions in tablet dissolution testing.
- To introduce novel, improved criteria for dissolution testing that mitigate risks from measurement uncertainty.
Main Methods:
- Comprehensive uncertainty evaluation across dissolution, sampling, and quantification.
- Application of the Monte Carlo method (MCM) for overall measurement uncertainty assessment.
- Development of an MS Excel tool for calculating risk values and classifying producer/consumer risk.
Main Results:
- Overall measurement uncertainty was approximately 5.2%, with sampling contributing 92% of this uncertainty.
- Quantification contributed 7% and dissolution steps 1% to the total uncertainty.
- The developed MS Excel tool effectively evaluated uncertainty and managed consumer risk.
Conclusions:
- Novel criteria for dissolution testing were introduced, significantly enhancing the reliability of drug quality assessments.
- The study provides a robust framework for minimizing false conformity decisions in pharmaceutical quality control.
- The developed practical tool supports reliable dissolution test result assessment, ensuring higher drug safety and efficacy standards.
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