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Related Experiment Videos

Devitrification of amorphous celecoxib.

Piyush Gupta1, Arvind K Bansal

  • 1Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Punjab 160 062, India.

AAPS Pharmscitech
|December 16, 2005
PubMed
Summary
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Amorphous celecoxib (CEL) devitrification is accelerated by temperature and humidity, leading to loss of solubility. Protecting CEL during preparation enhances stability, but environmental factors cause crystallization, impacting solid dosage forms.

Area of Science:

  • Materials Science
  • Pharmaceutical Science
  • Solid-State Chemistry

Background:

  • Amorphous solid dispersions are crucial for enhancing the solubility and bioavailability of poorly soluble drugs.
  • Celecoxib (CEL) is a nonsteroidal anti-inflammatory drug (NSAID) often formulated in amorphous forms to improve its therapeutic efficacy.
  • Understanding the physical stability of amorphous drugs is critical for successful pharmaceutical development and manufacturing.

Purpose of the Study:

  • To investigate the devitrification behavior of amorphous celecoxib (CEL) under various stress conditions relevant to solid dosage form processing.
  • To identify the key environmental factors (temperature, pressure, humidity) that induce crystallization of amorphous CEL.
  • To analyze the impact of preparation methods on the initial physical state and subsequent stability of amorphous CEL.

Related Experiment Videos

Main Methods:

  • Amorphous CEL was prepared using in situ methods within analytical instruments and via laboratory quench-cooling.
  • Characterization techniques included dynamic mechanical thermal analysis, differential scanning calorimetry, microscopy, and Fourier-transform infrared spectroscopy.
  • Samples were subjected to controlled temperature, pressure, and humidity conditions, including accelerated stability testing (40°C/75% RH).

Main Results:

  • In situ prepared amorphous CEL showed resistance to crystallization under temperature/pressure due to environmental protection, but underwent structural relaxation.
  • Laboratory-prepared amorphous CEL was partially crystalline due to environmental exposure, indicating incomplete vitrification.
  • Thermal stress and humidity were identified as primary drivers of devitrification, favoring metastable polymorphic forms.
  • Complete devitrification of amorphous CEL occurred within 15 days under accelerated stability conditions (40°C/75% RH).

Conclusions:

  • Temperature and humidity significantly promote the devitrification of amorphous celecoxib, compromising its solubility advantage.
  • The method of preparation critically influences the initial stability of amorphous CEL, with in situ methods offering better protection.
  • Devitrification propensity is linked to the molecular interactions between amorphous and crystalline states, highlighting the importance of controlled processing and storage conditions for amorphous pharmaceuticals.