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Development of an ophthalmic formulation containing ciprofloxacin-hydroxypropyl-b-cyclodextrin complex
1Department of Pharmaceutics, Jamia Hamdard (Hamdard University), Hamdard Nagar, New Delhi, India.
Bollettino Chimico Farmaceutico
|October 7, 2003
Summary
This study developed improved ophthalmic solutions using ciprofloxacin hydrochloride (CFLX HCl) complexed with hydroxypropyl-beta-cyclodextrin (HP-beta-CD). These novel formulations demonstrated enhanced stability, efficacy, and ocular tolerance compared to conventional ones.
Area of Science:
- Pharmaceutical Sciences
- Ophthalmology
- Drug Delivery Systems
Background:
- Ciprofloxacin hydrochloride (CFLX HCl) is a widely used antibiotic for ophthalmic infections.
- Traditional ophthalmic formulations may face challenges with drug stability, solubility, and ocular tolerance.
- Cyclodextrins, like hydroxypropyl-beta-cyclodextrin (HP-beta-CD), are known excipients for improving drug properties.
Purpose of the Study:
- To formulate and evaluate ophthalmic solutions of ciprofloxacin HCl using inclusion complexes with HP-beta-CD.
- To enhance the stability, biological activity, and ocular tolerance of ciprofloxacin HCl ophthalmic formulations.
- To compare the performance of complexed ciprofloxacin formulations against uncomplexed drug formulations and a marketed product.
Main Methods:
- Preparation of ciprofloxacin HCl-HP-beta-CD inclusion complexes via freeze-drying.
- Characterization of complexes using phase solubility studies, DSC, PXRD, FTIR, and SEM.
- Formulation of ophthalmic solutions containing complexed and uncomplexed ciprofloxacin HCl.
- Evaluation of ophthalmic solutions for stability, biological activity, and ocular tolerance.
Main Results:
- Successful formation of ciprofloxacin HCl-HP-beta-CD inclusion complexes confirmed by characterization techniques.
- Ophthalmic solutions formulated with complexed ciprofloxacin HCl showed significantly improved stability.
- These formulations exhibited enhanced biological activity and superior ocular tolerance compared to uncomplexed drug formulations and the marketed preparation.
Conclusions:
- Complexation of ciprofloxacin HCl with HP-beta-CD is an effective strategy for developing advanced ophthalmic formulations.
- The freeze-drying method yielded inclusion complexes that improve drug performance in ophthalmic solutions.
- The developed formulations offer a promising alternative for treating ocular infections with better patient outcomes.