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Polymorphism of clarithromycin.

Y T Sohn1, J K Rhee, W B Im

  • 1College of Pharmacy, Duksung Women's University, Seoul, Korea. ytsohn@center.duksung.ac.kr

Archives of Pharmacal Research
|September 8, 2000
PubMed
Summary
This summary is machine-generated.

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A new recrystallization method enhances the purity of clarithromycin Form II crystals. This cost-effective approach simplifies obtaining the stable antibiotic crystalline form.

Area of Science:

  • Pharmaceutical Science
  • Crystallography
  • Drug Development

Background:

  • Drug physicochemical properties depend on polymorphic crystalline forms.
  • Clarithromycin exhibits at least three polymorphic crystalline forms.
  • Conventional methods for obtaining stable clarithromycin Form II result in low purity.

Purpose of the Study:

  • To develop a novel method for improving the purity of clarithromycin Form II.
  • To establish a cost-effective process for obtaining pure stable crystalline forms of clarithromycin.

Main Methods:

  • Recrystallization of clarithromycin in specific solvents (C5-12 alkanes or C4-10 ethers).
  • Characterization using Differential Scanning Calorimetry (DSC) and Powder X-ray Diffraction (PXRD).
  • Comparison with conventionally prepared Form II crystals.

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Main Results:

  • The novel recrystallization method yields clarithromycin crystals identical to Form II.
  • DSC analysis confirmed the absence of an exothermic peak near 110°C, indicating high purity Form II.
  • The new process is simpler and avoids purity issues associated with conventional methods.

Conclusions:

  • A novel, simple recrystallization process effectively produces high-purity clarithromycin Form II.
  • This method offers a significant cost reduction for obtaining the stable crystalline form.
  • The improved purity and cost-effectiveness make this method advantageous for pharmaceutical manufacturing.