Reduction of glycine particle size by impinging jet crystallization

Tímea Tari, Zoltán Fekete, Piroska Szabó-Révész, Zoltán Aigner

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

The parameters of crystallization processes determine the habit and particle size distribution of the products. A narrow particle size distribution and a small average particle size are crucial for the bioavailability of poorly water-soluble pharmacons. Thus, particle size reduction is often required during crystallization processes. Impinging jet crystallization is a method that results in a product with a reduced particle size due to the homogeneous and high degree of supersaturation at the impingement point. In this work, the applicability of the impinging jet technique as a new approach in crystallization was investigated for the antisolvent crystallization of glycine. A factorial design was applied to choose the relevant crystallization factors. The results were analysed by means of a statistical program. The particle size distribution of the crystallized products was investigated with a laser diffraction particle size analyser. The roundness and morphology were determined with the use of a light microscopic image analysis system and a scanning electron microscope. Polymorphism was characterized by differential scanning calorimetry and powder X-ray diffraction. Headspace gas chromatography was utilized to determine the residual solvent content. Impinging jet crystallization proved to reduce the particle size of glycine. The particle size distribution was appropriate, and the average particle size was an order of magnitude smaller (d(0.5) = 8-35 μm) than that achieved with conventional crystallization (d(0.5) = 82-680 μm). The polymorphic forms of the products were influenced by the solvent ratio. The quantity of residual solvent in the crystallized products was in compliance with the requirements of the International Conference on Harmonization.

Original languageEnglish
Pages (from-to)96-102
Number of pages7
JournalInternational Journal of Pharmaceutics
Volume478
Issue number1
DOIs
Publication statusPublished - Jan 15 2015

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Keywords

  • Crystal habit
  • Glycine
  • Impinging jet crystallization
  • Particle size
  • Polymorphism
  • Residual solvent content

ASJC Scopus subject areas

  • Pharmaceutical Science

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