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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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Solid-state forms of zoledronic acid: polymorphism in hydrates.

Romina Ruscica1, Micaela Bianchi, Mariano Quintero

  • 1Grupo Materia Condensada, GIyA, GAIyANN, CAC, Comisión Nacional de Energía Atómica, Av. Gral. Paz 1499, (1650) San Martín, Buenos Aires, Argentina.

Journal of Pharmaceutical Sciences
|June 10, 2010
PubMed
Summary
This summary is machine-generated.

This study investigates solid-state forms of zoledronic acid, revealing distinct hydrated and anhydrous crystalline structures. Different dehydration rates yield unique amorphous and crystalline phases with varying thermal properties.

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Area of Science:

  • Solid-state chemistry
  • Materials science
  • Pharmaceutical sciences

Background:

  • Zoledronic acid is a nitrogen-containing bisphosphonate crucial for treating bone diseases.
  • Understanding its solid-state properties is vital for drug formulation and stability.
  • Polymorphism and hydration states significantly impact drug efficacy and delivery.

Purpose of the Study:

  • To characterize the different solid-state forms of zoledronic acid.
  • To investigate the impact of hydration and dehydration on its crystalline structure.
  • To analyze the thermal behavior and stability of various zoledronic acid forms.

Main Methods:

  • Differential Scanning Calorimetry (DSC) for thermal analysis.
  • Thermogravimetric analysis (TG) for mass change during heating.
  • X-ray Diffraction (XRD) for crystal structure determination.

Main Results:

  • Two distinct hydrated forms were identified: monohydrate and trihydrate.
  • The crystal structure of the trihydrate was elucidated.
  • Heating hydrated forms yielded two different anhydrous forms.
  • Dehydration rate influenced the formation of a metastable amorphous phase.
  • High humidity exposure resulted in a new trihydrate crystalline form, distinct from the initial one.

Conclusions:

  • Zoledronic acid exhibits complex polymorphism with varying hydration states.
  • The dehydration process can generate amorphous phases and multiple crystalline forms.
  • The same degree of hydration (trihydrate) can exist in different crystalline structures with distinct thermal properties.
  • Solid-state characterization is essential for understanding zoledronic acid's behavior and optimizing its use.