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Parenteral formulation of zopiclone
P V Swamy1, P Sushma, G Chirag
1Department of Pharmaceutics, HKES' College of Pharmacy, Sedam Road, Gulbarga - 585105, India.
Indian Journal of Pharmaceutical Sciences
|April 15, 2010
Summary
This study developed a stable zopiclone hydrochloride injection by creating a thermostable salt to overcome poor water solubility. Accelerated testing predicted the parenteral formulation
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Medicinal Chemistry
Background:
- Zopiclone is a water-insoluble drug, posing challenges for parenteral formulation.
- Conventional solubility enhancement techniques (co-solvency, pH control, hydrotrophy) were insufficient for zopiclone.
Purpose of the Study:
- To develop a stable and effective parenteral formulation of zopiclone.
- To enhance the solubility and stability of zopiclone for injection.
Main Methods:
- Preparation of a zopiclone hydrochloride salt to improve solubility and thermostability.
- Formulation of zopiclone hydrochloride injection batches.
- Assessment of stability under various conditions (light, oxygen, antioxidants).
- Accelerated stability testing for shelf-life prediction.
Main Results:
- Zopiclone hydrochloride salt exhibited thermostability.
- The hydrochloride salt significantly enhanced zopiclone solubility.
- Stability studies indicated the influence of light, oxygen, and antioxidants on the formulation.
Conclusions:
- Zopiclone hydrochloride salt formation is a viable strategy for developing stable parenteral formulations.
- The developed injection formulation shows promise for clinical use, with shelf-life determined through accelerated stability studies.
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