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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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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Polymorphism of flucloxacillin sodium.

Xiao-Yin Zhou1, Zheng Liu, Miao-Miao Wang

  • 1College of Chemical and Biological Engineering, Guilin University of Technology, Guilin, China.

Die Pharmazie
|February 9, 2012
PubMed
Summary

Polymorphism in flucloxacillin sodium was investigated, revealing amorphism and three distinct crystal forms. Form III exhibited superior solubility, but further research is required for industrial application.

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Polymorphism significantly impacts drug properties, including solubility and bioavailability.
  • Limited research exists on the solid-state forms of flucloxacillin sodium.

Purpose of the Study:

  • To investigate and characterize the polymorphic forms of flucloxacillin sodium.
  • To evaluate the solubility of different flucloxacillin sodium forms.

Main Methods:

  • Crystallization using various solvents.
  • Infra-red (IR) spectroscopy.
  • Thermogravimetry (TG).
  • X-ray diffraction analysis (XRD).
  • Equilibrium solubility studies.

Main Results:

  • Flucloxacillin sodium was found to exist in amorphous and three crystalline forms (I, II, III).
  • Form III demonstrated high solubility in phosphate buffer solution (0.86 g) between 20-40°C.
  • Analytical techniques confirmed the distinct nature of each form.

Conclusions:

  • The study identified novel polymorphic forms of flucloxacillin sodium.
  • Form III shows potential for improved drug formulation due to its solubility.
  • Further investigation is necessary to assess the industrial viability of Form III.