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Related Concept Videos

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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Crystal forms of naproxen.

Jung-Soon Song1, Young-Taek Sohn

  • 1College of Pharmacy, Duksung Women's University, Seoul, Korea.

Archives of Pharmacal Research
|April 7, 2011
PubMed
Summary

This study identified four crystal forms of naproxen. Forms 2 and 4 converted to Form 1 under specific storage conditions, indicating Form 1 has superior physical stability.

Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Naproxen is a widely used nonsteroidal anti-inflammatory drug (NSAID).
  • Understanding its solid-state properties, including polymorphism, is crucial for drug formulation and efficacy.
  • Polymorphs can exhibit different physical and chemical characteristics, impacting bioavailability.

Purpose of the Study:

  • To investigate the existence and characterization of naproxen polymorphs and pseudopolymorphs.
  • To examine the transformation behavior between different crystal forms of naproxen.
  • To assess the physical stability of naproxen crystal forms under various humidity conditions.

Main Methods:

  • Isolation of four naproxen crystal forms via recrystallization.
  • Characterization using differential scanning calorimetry (DSC), powder X-ray diffractometry (PXRD), and thermogravimetric analysis (TGA).

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  • Dissolution studies in a pH 6.8 buffer at 37°C.
  • Stability assessment after storage at 0%, 52%, and 95% relative humidity (RH) for one month.

    • Main Results:

    • Four distinct crystal forms of naproxen were successfully isolated and characterized.
    • DSC and PXRD patterns confirmed the differences between the four crystal forms.
    • Solubility profiles for all four forms were found to be similar in the tested buffer.
    • Naproxen Forms 2 and 4 transformed into Form 1 after one month of storage at various RH levels.
    • Naproxen Forms 1 and 3 demonstrated good physical stability and did not undergo transformation.

    Conclusions:

    • Naproxen exhibits polymorphism, with at least four distinct crystal forms identified.
    • Naproxen Forms 2 and 4 are less stable and can convert to the more stable Form 1.
    • Naproxen Form 1 is identified as a physically stable crystal form under ambient conditions and varying humidity, making it suitable for pharmaceutical development.