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Cefoxitin sodium: solution and solid-state chemical stability studies.

E R Oberholtzer, G S Brenner

    Journal of Pharmaceutical Sciences
    |July 1, 1979
    PubMed
    Summary
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    Cefoxitin sodium stability was studied for parenteral formulations. Optimal stability occurs at pH 5-7 in solution, with crystalline forms being more stable than amorphous ones.

    Area of Science:

    • Pharmaceutical Sciences
    • Drug Formulation
    • Chemical Stability

    Background:

    • Parenteral formulations require thorough physicochemical characterization.
    • Cefoxitin sodium is an antibiotic requiring specific formulation considerations.

    Purpose of the Study:

    • To determine essential physicochemical properties of cefoxitin sodium for parenteral formulation.
    • To evaluate the stability of cefoxitin sodium in solution and solid states.

    Main Methods:

    • Investigated cefoxitin sodium solubility and decomposition kinetics in aqueous solutions across a pH range.
    • Assessed thermal decomposition rates of amorphous and crystalline cefoxitin sodium.
    • Correlated solid-state decomposition with water content.

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    Main Results:

    • Cefoxitin sodium is highly soluble in water, with decomposition following apparent first-order kinetics (pH 3-9).
    • Maximum aqueous stability is observed between pH 5-7, with ~10% activity loss in 2 days at 25°C.
    • Crystalline cefoxitin sodium demonstrates significantly greater stability than amorphous forms.
    • Solid-state decomposition is biphasic and linked to water content.

    Conclusions:

    • Understanding cefoxitin sodium's solution and solid-state stability is crucial for developing effective parenteral formulations.
    • pH control (5-7) and use of crystalline forms enhance cefoxitin sodium stability.