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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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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Dissolution Profile Similarity Assessment-Best Practices, Decision Trees and Global Harmonization.

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Summary

This document provides best practices for assessing dissolution profiles to support biowaiver and postapproval change applications. It introduces decision trees incorporating equivalence testing and the dissolution safe space concept for regulatory clarity.

Keywords:
clinically relevant dissolution specificationsdecision treedissolution profile similaritysafe spaceunknown clinical relevance approaches

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • Current challenges in dissolution profile studies create ambiguity in regulatory assessments.
  • Previous reports highlighted issues in comparing dissolution profiles for biowaivers and postapproval changes.

Purpose of the Study:

  • To develop a "best-practice" document for assessing dissolution profiles.
  • To provide clear steps for evaluating dissolution data in regulatory submissions.
  • To address ambiguity in dissolution profile comparison for regulatory decision-making.

Main Methods:

  • Development of two decision trees outlining steps for dissolution profile assessment.
  • Inclusion of recommendations for equivalence procedures between reference and test products.
  • Description of common approaches for establishing the dissolution safe space concept.

Main Results:

  • The presented decision trees offer a structured approach to dissolution profile analysis.
  • The document integrates equivalence testing and the dissolution safe space concept.
  • Guidelines are provided for preparing clear testing protocols with defined pass/fail criteria.

Conclusions:

  • The proposed framework offers a solution to current ambiguities in dissolution profile comparison.
  • Implementation of these principles can lead to global regulatory alignment.
  • This work supports consistent quality assessment for manufacturing changes and biowaiver requests.