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Glycine crystallization during spray drying: the pH effect on salt and polymorphic forms.

Lian Yu1, Kingman Ng

  • 1Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. yu_lian@lilly.com

Journal of Pharmaceutical Sciences
|October 16, 2002
PubMed
Summary
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Spray drying glycine solutions at different pH levels significantly impacts the resulting salt and polymorphic forms. Adjusting pH controls the crystallization of glycine polymorphs and salts, influencing physical stability and particle characteristics for pharmaceutical applications.

Area of Science:

  • Materials Science
  • Chemical Engineering
  • Pharmaceutical Sciences

Background:

  • Glycine, an amino acid, exists in multiple polymorphic forms (alpha, beta, gamma).
  • The physical form of glycine impacts its stability and suitability for pharmaceutical formulations.
  • Spray drying is a common technique for producing powders with specific particle properties.

Purpose of the Study:

  • To investigate the effect of pH on the polymorphic and salt forms of glycine produced by spray drying.
  • To understand how pH influences the crystallization of glycine and its salts.
  • To assess the potential for controlling glycine's physical form for improved formulation stability.

Main Methods:

  • Aqueous solutions of glycine were spray dried across a pH range of 1.7 to 10.0 using HCl or NaOH for pH adjustment.

Related Experiment Videos

  • The resulting powders were analyzed for their polymorphic and salt composition.
  • Particle morphology and size were characterized.

    • Main Results:

    • Spray drying at neutral pH (6.2) yielded alpha-glycine, while pH adjustment to 4.0 and 8.0 favored gamma-glycine.
    • Acidic pH conditions (1.7-3.0) resulted in mixtures of glycine polymorphs and HCl salts (diglycine HCl, glycine HCl).
    • Alkaline pH conditions (9.0-10.0) produced gamma-glycine and potentially sodium glycinate.
    • HCl loss was observed during spray drying of glycine HCl solutions, influenced by inlet temperature.
    • Different pH conditions led to variations in particle morphology and size.

    Conclusions:

    • pH is a critical parameter controlling glycine's polymorphic and salt forms during spray drying.
    • The thermodynamically more stable gamma-glycine can be preferentially crystallized by pH adjustment.
    • Spray drying offers a method to produce glycine powders with tailored physical properties for pharmaceutical applications.
    • Understanding these pH-dependent transformations is crucial for developing stable glycine-containing formulations.