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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Various dissolution theories provide insight into the factors that influence the dissolution rate. Danckwerts' Model suggests that turbulence, rather than a stagnant layer, characterizes the dissolution medium at the solid-liquid interface. In this model, the agitated solvent contains macroscopic packets that move to the interface via eddy currents, facilitating the absorption and delivery of the drug to the bulk solution. The regular replenishment of solvent packets maintains the...
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Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

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Summary

This workshop highlighted challenges in dissolution profile similarity assessment for drug product quality. A majority favored clinically relevant dissolution specifications over statistical methods for evaluating CMC changes.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Product Quality Assessment
  • Regulatory Science

Background:

  • The 2019 M-CERSI workshop focused on In Vitro Dissolution Similarity Assessment for drug product quality.
  • Regulatory agencies (FDA, HC, EMA, ANVISA) and industry discussed challenges with dissolution profile similarity for Chemistry, Manufacturing, and Control (CMC) changes.
  • Current methods, like the f2 equation, have scientific shortcomings, and there's a need for improved assessment strategies.

Purpose of the Study:

  • To summarize discussions on dissolution profile similarity assessment for minor/moderate CMC changes.
  • To identify scientific shortcomings and areas of debate regarding dissolution testing methodologies.
  • To explore opportunities for global harmonization in dissolution assessment strategies.

Main Methods:

  • Summary of podium presentations and breakout sessions from the M-CERSI workshop.
  • Discussion of experiences and concerns shared by regulatory agencies and the pharmaceutical industry.
  • Analysis of debates surrounding dissolution timepoint variability, pairwise batch comparisons (PBC), and statistical methods.

Main Results:

  • Dissolution profile similarity testing is part of a larger evidence-based assessment for CMC changes.
  • Debate occurred on controlling timepoint variability and using PBC; industry suggested larger sample sizes and a single mathematical method.
  • A majority favored using clinically relevant dissolution specifications (CRDS) and dissolution safe space over statistical similarity methods.

Conclusions:

  • The workshop underscored the need for global harmonization in dissolution assessment, including variability, timepoint selection, and statistical methods.
  • There is a clear preference for CRDS and dissolution safe space over traditional similarity assessment for evaluating CMC changes.
  • Addressing ambiguity in dissolution assessment is crucial for globally operating pharmaceutical companies.