Premium
Galenic and analytic development of Tacrolimus 0.06% eye drops
Author(s) -
GAUTHIER AS,
RIVAL B,
SAHLER J,
FAGILEGAT C,
GUILLAUME YVES,
LIMAT S,
DELBOSC B
Publication year - 2012
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2012.f116.x
Subject(s) - tacrolimus , medicine , eye drop , chromatography , ophthalmology , chemistry , surgery , transplantation
Purpose The administration of topical tacrolimus (FK506) eye drops or ointment is used in treating corneal immune pathologies and in the prevention of the high‐risk corneal graft rejection. The purpose of this study is to develop a new well‐tolerated formulation of tacrolimus 0,06% eye drops. Procedure and the preparation are presented and discussed. Methods Tacrolimus monohydrate powder and virgin castor oil are used in this new formulation. The manufacturing process guarantees the product sterility. Analytical validation of the assay by high‐performance liquid chromatography allows precise control of the concentration of tacrolimus. Results The manufacturing and packaging of these eye drops provide good product stability. The concentration of tacrolimus 0.06% was maintained for 28 days, and no mycological or bacteriological contamination was found. Eye drop can be conserved close and exposed to the light during three months after production. Conclusion Tolerance studies are currently being carried out.