Cyclosporines are immunosuppressant drugs which are often delivered for ophthalmic indications in the form of microemulsions, offering thermodynamic stability, phase transition to a liquid-crystal state, very low surface tension and small droplet size. These features assist ocular absorption and retention of the drug, parameters upon which its efficacy and duration of action depends.
The formulation of ophthalmic emulsions (eye drops) with long shelf life is complicated by the tendency of emulsion droplets to aggregate, particularly in the presence of the polymers that are used to increase formulation stability.
This application note describes a comprehensive multi-parameter strategy for the characterization of microemulsions, designed to improve the efficiency of the approval process for both innovator and generic ophthalmic emulsions.
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