[Galenic and analytic development of tacrolimus 0.06% eye drops].

Abstract

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.

• Authors: A-S Gauthier, B Rival, J Sahler, C Fagnoni-Legat, S Limat, Y Guillaume, B Delbosc
• Journal: Journal francais d'ophtalmologie (J Fr Ophtalmol) Vol. 36 Issue 5 Pg. 408-13 (May 2013) ISSN: 1773-0597 [Electronic] France
• Vernacular Title: Développement galénique et analytique d'un collyre à base de tacrolimus 0,06 %
• PMID: 23218600 (Publication Type: English Abstract, Journal Article)
• Copyright: Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Chemical References

• Immunosuppressive Agents
• Ophthalmic Solutions
• Powders
• Castor Oil
• Tacrolimus

Topics

• Castor Oil (chemistry)
• Chromatography, High Pressure Liquid
• Corneal Diseases (drug therapy, immunology)
• Humans
• Immunosuppressive Agents (administration & dosage, chemistry)
• Ophthalmic Solutions (administration & dosage, chemistry)
• Osmolar Concentration
• Powders
• Tacrolimus (administration & dosage, chemistry)