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Stability study of flutamide in solid state and in aqueous solution.

A Miranda1, I Caraballo, M Millán

  • 1Departamento de Farmacia y Tecnología Farmaceútica, Facultad de Farmacia, Universidad de Sevilla, Spain.

Drug Development and Industrial Pharmacy
|June 12, 2002
PubMed
Summary

Flutamide exhibits excellent solid-state stability but degrades in aqueous solutions, particularly at higher temperatures and acidic pH. Sodium chloride addition enhances flutamide stability in solution.

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Area of Science:

  • Pharmaceutical Chemistry
  • Analytical Chemistry

Background:

  • Flutamide is a nonsteroidal antiandrogen used in prostate cancer treatment.
  • Understanding flutamide's stability is crucial for its formulation and therapeutic efficacy.

Purpose of the Study:

  • To develop a high-performance liquid chromatography (HPLC) assay for flutamide and its degradation products.
  • To investigate the influence of formulation factors on flutamide stability in solid-state and aqueous solutions.

Main Methods:

  • Development and application of a high-performance liquid chromatography (HPLC) assay.
  • Stability studies conducted under various temperature, humidity, pH, and ionic strength conditions.
  • Kinetic analysis using a second-order kinetics model for degraded solutions.

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Main Results:

  • Flutamide demonstrated high stability in solid-state form, showing minimal degradation after four months under adverse conditions.
  • In aqueous solutions, flutamide exhibited significant degradation at 22°C and 37°C, especially under acidic pH (1.1).
  • The presence of sodium chloride was found to inhibit the degradation of flutamide in aqueous solutions.

Conclusions:

  • Flutamide is stable in its solid form but susceptible to degradation in aqueous environments.
  • Formulation strategies should consider pH and ionic strength to ensure flutamide stability in liquid preparations.
  • The developed HPLC method is suitable for monitoring flutamide stability and quantifying degradation products.