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Related Concept Videos

Recrystallization: Solid–Solution Equilibria01:10

Recrystallization: Solid–Solution Equilibria

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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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Precipitation Processes

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The experimental conditions in a gravimetric analysis should be optimized to maximize the particle size and purity of the obtained precipitate. Ideally, the concentration of the precipitating reagent should be low with effective stirring to maintain low relative supersaturation for the growth of large crystals. In homogeneous precipitation, the precipitant is slowly generated by a chemical reaction in the solution to avoid local reagent excesses. For example, urea decomposes gradually to...
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Crystal Growth: Principles of Crystallization

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Crystallization is a phase transformation process in which crystals are precipitated from a supersaturated solution or formed from other sources. During crystallization, atoms or molecules arrange themselves into a well-defined, rigid crystal lattice to minimize energy.
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Polymer Classification: Crystallinity

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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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Colloidal precipitates

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The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...
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Updated: Jun 27, 2025

Optimizing the Growth of Endothiapepsin Crystals for Serial Crystallography Experiments
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Accelerated stability modeling of recrystallization from amorphous solid Dispersions: A Griseofulvin/HPMC-AS case

Ariana Sheng-Chu Leon1, Kenneth C Waterman2, Guanhua Wang1

  • 1Level 2, Block C3, Maple Science Park, Qixia District, Nanjing 210048 China.

International Journal of Pharmaceutics
|May 3, 2024
PubMed
Summary

Predicting recrystallization in amorphous solid dispersions (ASDs) is crucial for drug stability. This study uses an accelerated stability assessment program (ASAP) to accurately model shelf-life and prevent drug crystallization.

Keywords:
ASAPAccelerated Physical StabilityAmorphous Solid Dispersion (ASD)GriseofulvinKinetics ModelingPredictionRecrystallizationShelf-life

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance oral bioavailability of poorly water-soluble drugs.
  • Predicting ASD crystallization during storage is vital but challenging due to quantification limits and complex kinetics.
  • Current methods for predicting ASD stability are time-consuming and have limited accuracy.

Purpose of the Study:

  • To develop and validate a predictive shelf-life model for amorphous solid dispersions (ASDs) using an accelerated stability assessment program (ASAP).
  • To improve the accuracy of predicting ASD crystallization levels by employing advanced kinetic modeling techniques.
  • To establish a reliable method for assessing the long-term stability of ASDs under various stress conditions.

Main Methods:

  • Preparation of a model amorphous solid dispersion (ASD) using spray drying (griseofulvin and HPMC-AS-LF).
  • Application of the accelerated stability assessment program (ASAP) with isoconversion and modified Arrhenius approach below the glass transition temperature (Tg).
  • Development and utilization of a sensitive X-ray powder diffraction (XRPD) method for crystal content quantification in stressed ASD samples.

Main Results:

  • The ASAPprime® modeling showed good agreement with long-term (40°C/75%RH) crystallinity levels.
  • Developed XRPD method provided sensitive quantification of crystal content in stressed ASDs.
  • Accelerated stability studies demonstrated potential for improving ASD shelf-life prediction accuracy.

Conclusions:

  • The accelerated stability assessment program (ASAP) effectively predicts crystallization in amorphous solid dispersions (ASDs).
  • This approach enhances the accuracy of shelf-life predictions for ASDs, crucial for drug product development.
  • The study supports the use of ASAP for reliable and efficient stability assessment of amorphous solid dispersions.