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Updated: May 16, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
[Galenic and analytic development of tacrolimus 0.06% eye drops]
A-S Gauthier1, B Rival, J Sahler
1Service d'ophtalmologie, CHU Jean-Minjoz, 2, boulevard Fleming, 25030 Besançon, France. asophiegauthier@yahoo.fr
Purpose:
The administration of topical tacrolimus (FK506) eye drops or ointment is effective in treating certain immunologic corneal diseases and in the prevention of rejection of high-risk corneal grafts. The purpose of this study is to determine the optimal formulation of tacrolimus 0.06% eye drops. A procedure for preparation is presented and discussed.
Methods:
Tacrolimus monohydrate powder and virgin castor oil are used in this new formulation. The manufacturing process guarantees consistency of product sterility. Measurement by high-performance liquid chromatography allows precise control of the concentration of tacrolimus.
Results:
The manufacture and packaging of tacrolimus 0.06% eye drops involve numerous controls allowing for guaranteed sterility and stability. The drops remained sterile and stabile for 28 days after opening regardless of storage conditions and can be stored for 3 months after manufacture. Tolerability studies are currently being performed.
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