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Unlike ionic or small covalent molecules, polymers do not form crystalline solids due to the diffusion limitations of their long-chain structures. However, polymers contain microscopic crystalline domains separated by amorphous domains.
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Recrystallization is a purification technique used to separate impurities from solid compounds. In this technique, no chemical reactions occur. Instead, it exploits physical properties only, specifically, the solubility differences between the desired compound and impurities, either at a single temperature or at different temperatures, and under other selected conditions. The solid-solution equilibrium (solubility equilibrium) of each component in the solution represents a binary phase...
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Solids in which the atoms, ions, or molecules are arranged in a definite repeating pattern are known as crystalline solids. Metals and ionic compounds typically form ordered, crystalline solids. A crystalline solid has a precise melting temperature because each atom or molecule of the same type is held in place with the same forces or energy. Amorphous solids or non-crystalline solids (or, sometimes, glasses) which lack an ordered internal structure and are randomly arranged. Substances that...
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Methods of Ex Situ and In Situ Investigations of Structural Transformations: The Case of Crystallization of Metallic Glasses
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Crystallinity: A Complex Critical Quality Attribute of Amorphous Solid Dispersions.

Dana E Moseson1,2, Lynne S Taylor1

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Molecular Pharmaceutics
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Summary

Amorphous solid dispersions (ASDs) may not require 100% amorphous content. Specifications for crystalline content in ASD drug products depend on various factors, including drug properties and formulation, necessitating a risk-based approach.

Keywords:
amorphous solid dispersioncritical quality attributescrystallinitydissolutionphysical stabilityprocessing

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
  • The presence of crystalline content in ASDs can arise from incomplete amorphization or nucleation and crystal growth.
  • Assessing and controlling crystallinity is vital for ensuring drug product performance and stability.

Purpose of the Study:

  • To investigate the necessity of 100% amorphous content in ASD performance.
  • To define appropriate specifications for crystalline content in ASD drug products.
  • To explore the origins, detection, and impact of crystallinity on ASD performance.

Main Methods:

  • Literature review and perspective synthesis on ASD crystallinity.
  • Discussion of analytical challenges in detecting trace crystallinity.
  • Case study analysis to illustrate the impact of crystallinity on drug release and performance.

Main Results:

  • Crystallinity in ASDs can originate from manufacturing or storage-related instability.
  • Detecting low levels of crystallinity requires orthogonal analytical methods.
  • The impact of crystallinity on drug release is complex and formulation-dependent.

Conclusions:

  • A 100% amorphous content is not always required for ASD performance.
  • Specification limits for crystalline content must be individualized based on risk assessment.
  • A holistic approach considering drug properties, formulation, and stability is essential for managing crystallinity in ASDs.