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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
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.
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.
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.