Stability of cyclosporine 1% in artificial tears

ABSTRACT We wished to determine the stability of frozen, refrigerated, and room temperature topical cyclosporine 1% in artificial tears (Tears Plus®). Cyclosporine 1% eye drops were made in artificial tears prior to the manufacturers recommendations of using a lipid soluble vehicle, such as olive oil. Patients preferred the artificial tears preparation over the oil based cyclosporine product. Because of the good clinical response and the reluctance of patients to change to the oil vehicle product, we determined the stability of cyclosporine 1% in artificial tears. Cyclosporine 1% was prepared in artificial tears (polyvinyl alcohol 1.4% and povidone 0.6%) by adding 1 ml of the injectable (50mg/ml) cyclosporine into 4 ml of the artificial tears solution. Each bottle was frozen at −20° C for one month and then the cyclosporine concentration was determined after thawing and refrigeration or storage at room temperature. Refrigerated stability was determined after thawing for up to 28 days and room temperature ...