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Published on: January 26, 2018
[Cyclosporine 2% eye drops preparation]
F Chast1, F Lemare, J-M Legeais
1Service de Pharmacie, Pharmacologie et Toxicologie, Hôtel-Dieu, Paris. francois.chast@htd.ap-hop-paris.fr
Journal Francais D'Ophtalmologie
|September 3, 2004
Summary
This study details the preparation and stability of 2% cyclosporine eye drops, finding them stable for 12 months with minimal systemic absorption, making them suitable for ophthalmic use.
Area of Science:
- Ophthalmology
- Immunology
- Pharmaceutical Sciences
Context:
- Immunological diseases of the eye (cornea, conjunctiva, uvea) often require effective treatments.
- High-risk corneal transplantation frequently necessitates immunosuppressive therapy to prevent rejection.
- Standard ophthalmic formulations may not always provide optimal cyclosporine delivery.
Purpose:
- To present a stable and effective preparation of 2% cyclosporine eye drops.
- To evaluate the manufacturing process ensuring sterility and quality control.
- To assess the systemic bioavailability and toxicity of the prepared eye drops.
Summary:
- A 2% cyclosporine eye drop formulation was prepared by diluting a commercial oral solution in sterile castor oil under strict aseptic conditions.
- Chemical analysis confirmed stability for up to 12 months, with minimal statistical difference in concentration over time.
- Pharmacokinetic analysis revealed very low systemic bioavailability, with blood concentrations below detection limits, indicating an absence of systemic toxicity.
Impact:
- The developed 2% cyclosporine eye drops offer a stable, long-lasting (12 months) ophthalmic formulation.
- The preparation demonstrates a favorable safety profile with negligible systemic absorption and no noted local adverse effects.
- This formulation can be a valuable addition to hospital pharmacies for treating various ocular inflammatory and post-transplant conditions.
