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Related Experiment Videos

Effect of dimethyl-beta-cyclodextrin on nitrazepam stability

S I Saleh1, A A Rahman, A E Aboutaleb

  • 1Dept. of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Egypt.

Journal De Pharmacie De Belgique
|September 1, 1993
PubMed
Summary

Nitrazepam forms an inclusion complex with heptakis; 2,6 di-O-methyl-beta-cyclodextrin (DM-beta-CD), improving its stability at 30°C. However, this complexation offered no significant stabilization at higher temperatures.

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Area of Science:

  • Pharmaceutical Chemistry
  • Physical Chemistry

Background:

  • Nitrazepam is a benzodiazepine drug with limited aqueous solubility.
  • Cyclodextrins are known to form inclusion complexes with various drugs, potentially enhancing their properties.

Purpose of the Study:

  • To investigate the formation of an inclusion complex between Nitrazepam and heptakis; 2,6 di-O-methyl-beta-cyclodextrin (DM-beta-CD).
  • To evaluate the impact of this complexation on the stability of Nitrazepam in acidic solution at different temperatures.

Main Methods:

  • Phase solubility studies were conducted to confirm complex formation.
  • Kinetic studies of Nitrazepam hydrolysis were performed spectrophotometrically at 30, 40, and 50°C in the presence of DM-beta-CD.
  • First-order reaction kinetics were used to analyze degradation data.

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Main Results:

  • An AL-type phase solubility diagram indicated successful inclusion complex formation without precipitation.
  • Nitrazepam hydrolysis followed first-order kinetics in acidic media across the studied temperatures.
  • Complexation with DM-beta-CD enhanced Nitrazepam stability at 30°C but showed no significant effect at 40°C and 50°C.

Conclusions:

  • Nitrazepam forms a stable inclusion complex with DM-beta-CD in solution.
  • DM-beta-CD can improve Nitrazepam's stability at lower temperatures, suggesting potential applications in specific formulations.