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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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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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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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Image-based dissolution analysis for tracking the surface stability of amorphous powders.

Jernej Štukelj1,2, Mikael Agopov2, Jouko Yliruusi2

  • 1Division of Pharmaceutical Chemistry and Technology, University of Helsinki, Viikinkaari 5E, 00790 Helsinki, Finland.

ADMET & DMPK
|March 18, 2022
PubMed
Summary

Amorphous drugs offer improved solubility but risk recrystallization. Image-based single-particle analysis (SPA) effectively monitors drug solubility changes over time, revealing solid-state transformations crucial for pharmaceutical stability.

Keywords:
AmorphousCrystallizationSPASingle-Particle AnalysisSolubilityStability

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Area of Science:

  • Materials Science
  • Pharmaceutical Science
  • Physical Chemistry

Background:

  • Crystalline drug solubility limitations can be addressed by amorphization, creating high-energy disordered solids.
  • Amorphous drugs exhibit enhanced solubility but reduced physical stability, leading to recrystallization and loss of solubility benefits.
  • Understanding recrystallization kinetics and its impact on dissolution is vital for amorphous pharmaceutical formulations.

Purpose of the Study:

  • To demonstrate the utility of image-based single-particle analysis (SPA) for monitoring amorphous drug solubility.
  • To investigate the impact of storage conditions on the solid-state stability and solubility of amorphous indomethacin.
  • To correlate SPA solubility measurements with X-ray powder diffraction (XRPD) data.

Main Methods:

  • Amorphous indomethacin samples were stored under controlled conditions (22 °C/23% RH and 22 °C/75% RH).
  • Solubility was monitored over time using image-based single-particle analysis (SPA).
  • Solid-state form was characterized using X-ray powder diffraction (XRPD).

Main Results:

  • At 22 °C/23% RH, XRPD indicated full crystallinity by day 40, while SPA detected crystalline solubility by day 25.
  • At 22 °C/75% RH, SPA showed solubility slightly above the crystalline form by day 2, despite incomplete crystallization by day 80.
  • SPA measurements directly reflected surface solid-state changes, correlating with storage conditions and stability.

Conclusions:

  • Image-based single-particle analysis (SPA) provides a straightforward method to monitor amorphous material solubility.
  • SPA offers vital insights into storage condition effects on dissolution and solubility, requiring minimal sample amounts.
  • This technique is particularly valuable for understanding and predicting the long-term stability of amorphous pharmaceuticals.