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Solution stability of ciclosidomine.

C F Carney1

  • 1Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877.

Journal of Pharmaceutical Sciences
|May 1, 1987
PubMed
Summary
This summary is machine-generated.

Ciclosidomine (N-cyclohexanecarbonyl-3-(4-morpholino)-sydnone imine hydrochloride) stability is pH-dependent, with minimal degradation near pH 6. Light exposure significantly accelerates ciclosidomine degradation, necessitating protective measures.

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Area of Science:

  • Pharmaceutical Chemistry
  • Chemical Kinetics
  • Drug Stability

Background:

  • Ciclosidomine (N-cyclohexanecarbonyl-3-(4-morpholino)-sydnone imine hydrochloride) is a compound requiring stability assessment for pharmaceutical applications.
  • Understanding degradation pathways is crucial for formulation and storage recommendations.

Purpose of the Study:

  • To investigate the solution stability of ciclosidomine under various environmental conditions.
  • To determine the influence of pH, temperature, ionic strength, and buffer species on degradation rates.

Main Methods:

  • Hydrolysis kinetics were studied across a range of pH values, temperatures, and ionic strengths.
  • Degradation rates were monitored in the presence and absence of light.
  • General acid- and base-catalyzed reactions were analyzed.

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Main Results:

  • Degradation followed apparent first-order kinetics and was subject to general acid- and base-catalysis.
  • A minimum degradation rate was observed near pH 6 at 60°C and ionic strength of 0.1 M.
  • Ionic strength changes (0.05–0.2 M) did not significantly impact degradation rates at pH 7 or pH 2.
  • Light exposure drastically increased degradation rates at pH 3, 5, and 6.

Conclusions:

  • Ciclosidomine solutions are most stable around pH 6.
  • Protection from light is essential to maintain drug integrity.
  • Projected shelf-life at 20°C and 30°C indicates moderate stability under optimal conditions (pH 6, protected from light).