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Related Concept Videos

Solubility03:00

Solubility

Solution, Solubility, and Solubility Equilibrium
A solution is a homogeneous mixture composed of a solvent, the major component, and a solute, the minor component. The physical state of a solution—solid, liquid, or gas—is typically the same as that of the solvent. Solute concentrations are often described with qualitative terms such as dilute (of relatively low concentration) and concentrated (of relatively high concentration).
In a solution, the solute particles (molecules, atoms, and/or ions)...
Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

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.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model01:09

Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model

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 concentration...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients, maintaining...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

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Dissolution Profile Similarity Assessment-Best Practices, Decision Trees and Global Harmonization.

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DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

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Author response to the Letter to the Editor "Equivalence analyses of dissolution profiles with the Mahalanobis distance: A regulatory perspective and a comparison with a parametric maximum deviation-based approach".

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Equivalence analyses of dissolution profiles with the Mahalanobis distance.

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Dissolution Dynamic Nuclear Polarization Instrumentation for Real-time Enzymatic Reaction Rate Measurements by NMR
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Comparison of Dissolution Profiles: A Statistician's Perspective.

Thomas Hoffelder1

  • 11 Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany.

Therapeutic Innovation & Regulatory Science
|May 2, 2018
PubMed
Summary

Statistical analysis of dissolution profiles for post-approval changes needs updates. The T² test for equivalence is recommended for highly variable dissolution profiles, enhancing pharmaceutical quality decisions.

Keywords:
T2 test for equivalencemultivariate equivalencepairwise batch comparisonssample sizesimilarity factor f2variability criterion

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Area of Science:

  • Pharmaceutical Sciences
  • Biostatistics
  • Drug Quality Assurance

Background:

  • Dissolution profile comparisons are crucial for post-approval changes, ensuring product quality.
  • Current guidelines and statistical practices often conflict, leading to lengthy discussions.
  • Existing statistical methods for highly variable dissolution profiles may require updates.

Purpose of the Study:

  • To address statistical interpretation conflicts in dissolution profile comparisons for post-approval changes.
  • To propose statistical improvements for analyzing and interpreting dissolution data.
  • To advocate for updated regulatory guidance on statistical equivalence testing.

Main Methods:

  • Review of current statistical principles and guideline interpretations.
  • Analysis of existing methods for dissolution profile comparison, including the similarity factor and multivariate equivalence procedures.
  • Evaluation of the T² test for equivalence as a suitable method for highly variable dissolution profiles.

Main Results:

  • Current practices often misinterpret sample size recommendations and lack clear variability criteria.
  • Pooled comparisons are preferred over batch-to-batch comparisons for multiple batches.
  • The T² test is identified as an appropriate and reliable method for comparing highly variable dissolution profiles, with available software implementations.

Conclusions:

  • Statistical interpretation of dissolution profile comparisons requires clearer guidelines and updated methodologies.
  • Implementing the T² test for equivalence can improve the reliability of decisions for highly variable drug products.
  • Updating FDA guidelines on multivariate equivalence procedures is necessary to reflect current statistical knowledge.