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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid

Andre Hermans¹, Johanna Milsmann², Hanlin Li³

¹Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey, USA. andre_hermans@merck.com.

The AAPS Journal

|December 13, 2022

Summary

Developing amorphous solid dispersions (ASDs) for poorly soluble drugs presents unique dissolution challenges. This review offers recommendations for solubility measurements and quality control dissolution methods for ASDs.

Keywords:

Amorphous solid dispersions Crystallization Dissolution Solubility

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Area of Science:

Pharmaceutical Sciences
Drug Delivery
Physical Chemistry

Background:

Amorphous solid dispersions (ASDs) are crucial for formulating poorly soluble drugs, improving oral absorption.
ASD formulations can achieve supersaturation, posing challenges for solubility characterization and dissolution testing.
Accurate solubility and dissolution data are vital for drug absorption and product quality control.

Approach:

This review categorizes challenges in solubility measurement and dissolution method development for ASDs.
It addresses the definition of solubility, sink conditions, and non-sink dissolution applications for ASDs.
The review also evaluates the use of dissolution testing for detecting crystallinity in ASD formulations.

Key Points:

Defining solubility and sink conditions for ASD dissolution requires careful consideration.
Non-sink dissolution methods are applicable for ASD formulation screening and quality control (QC) method development.
Dissolution testing offers advantages and disadvantages for assessing ASD crystallinity.

Conclusions:

Addressing these challenges is essential for robust ASD development and control strategies.
Sharing successful dissolution experiment examples can foster scientific consensus on ASD dissolution testing.
Standardized methods will ensure the quality and efficacy of ASD-based oral dosage forms.