title: [Galenic and analytic development of tacrolimus 0.06% eye drops].
abstract: OBJECTIVE
  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.affiliation: Service d'ophtalmologie, CHU Jean-Minjoz, 2, boulevard Fleming, 25030 Besançon, France. asophiegauthier@yahoo.fr
authors.forename: A-S
authors.initials: AS
authors.lastname: Gauthier
authors.forename: B
authors.initials: B
authors.lastname: Rival
authors.forename: J
authors.initials: J
authors.lastname: Sahler
authors.forename: C
authors.initials: C
authors.lastname: Fagnoni-Legat
authors.forename: S
authors.initials: S
authors.lastname: Limat
authors.forename: Y
authors.initials: Y
authors.lastname: Guillaume
authors.forename: B
authors.initials: B
authors.lastname: Delbosc
mesh_terms: D002368:Castor Oil / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D003316:Corneal Diseases / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000737:chemistry; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000737:chemistry; D009994:Osmolar Concentration; D011208:Powders; D016559:Tacrolimus / Q000008:administration & dosage* / Q000737:chemistry
chemical_list: D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D011208:Powders; D002368:Castor Oil; D016559:Tacrolimus