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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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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The formation of a colloidal system is exemplified by an aqueous solution containing Cl− ions is introduced to another containing Ag+ ions, resulting in the precipitation of solid AgCl as extremely tiny crystals. Instead of settling out as a filterable precipitate, these crystals remain suspended in the liquid, showcasing a colloidal system.A colloidal system involves colloidal particles within the approximate range of 1 to 1000 nm in at least one dimension, dispersed in a medium called...
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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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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Phase separation kinetics in amorphous solid dispersions upon exposure to water.

Hitesh S Purohit1, Lynne S Taylor1

  • 1Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, United States.

Molecular Pharmaceutics
|April 9, 2015
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Summary

A novel fluorescence technique effectively monitors phase separation in amorphous solid dispersions (ASDs). This method provides rapid insights into ASD stability and dissolution, crucial for drug formulation development.

Keywords:
amorphous solid dispersionsfluorescencephase separationwater

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
  • Understanding phase separation kinetics in ASDs is vital for predicting drug product stability and performance.
  • Current methods for studying ASD phase separation can be time-consuming or lack sensitivity.

Purpose of the Study:

  • To develop and validate a novel fluorescence spectroscopy technique for studying phase separation kinetics in hydrated ASDs.
  • To employ environment-sensitive fluorescent probes to monitor amorphous-amorphous phase separation (AAPS) during storage and dissolution.
  • To establish fluorescence spectroscopy as a primary, independent method for ASD characterization.

Main Methods:

  • Utilized environment-sensitive fluorescent probes to monitor changes in emission characteristics.
  • Confirmed initial miscibility using infrared (IR) spectroscopy and differential scanning calorimetry (DSC).
  • Employed fluorescence spectroscopy alongside DSC, X-ray diffraction (XRD), fluorescence microscopy, and IR spectroscopy for comprehensive analysis.

Main Results:

  • Successfully monitored AAPS kinetics in probucol-poly(vinylpyrrolidone) (PVP) and ritonavir-PVP ASDs upon hydration.
  • Demonstrated the fluorescence method's ability to differentiate between systems exhibiting AAPS and those that do not (e.g., ritonavir-HPMCAS ASD).
  • Achieved good agreement between fluorescence spectroscopy results and conventional analytical techniques.

Conclusions:

  • Fluorescence spectroscopy is a fast, efficient tool for detecting and monitoring phase transformations in ASDs during hydration.
  • The developed technique offers mechanistic insights into the stability and dissolution behavior of ASDs.
  • This method enhances the understanding of ASD behavior, aiding in the development of more stable and effective drug formulations.