1. Ocular Tolerability and Safety of Ketotifen Fumarate Ophthalmic Solution
Mark B. Abelson, Matthew J. Chapin, Barry M. Kapik, Naveed B. K. Shams. Advances In Therapy. Volume 19 No. 4 July/August 2002
Ketotifen fumarate (Zaditor™/Zaditen®), a benzocycloheptathiophene derivative for the treatment of allergic conjunctivitis, demonstrates multiple mechanisms of action. A relatively selective antagonist of the histamine H1 receptor and a mast cell stabilizer, ketotifen is also reportedly an eosinophil inhibitor (decreasing chemotaxis and activation). Eosinophils have been found in the late phase of allergic conjunctivitis. This 6-week placebo-controlled study evaluated the ocular tolerability and safety of ketotifen fumarate .025% ophthalmic solution administered four times daily (at twice the recommended daily dose) to volunteers, including children, with normal ocular health.
2. The Sorption of Ketotifen Fumarate by Chitosan
Khouloud A. Alkhamis, Mutaz S. Salem, and Mai S. Khanfar. AAPS PharmSciTech, Vol. 9, No. 3, September 2008
The ketotifen fumarate concentrations both before and after the attainment of equilibrium were determined with the aid of a reversed-phase HPLC system. A 5μm Spherosorb C18 column (3.9× 100 mm) was used for this separation. The wavelength for detection of ketotifen fumarate was set at 300 nm. The detector sensitivity was set at 0.01 AUFS. The flow rate was 1.0 ml/min and the injection volume was 10μl. The HPLC system included the following equipment: liquid pump (model L7150, LaChrom), variable wavelength detector (Diode array L 7455), autosampler model (L7200) and interface model (D 7000) and the software (all Merck, Hitachi, Japan). The mobile phase consisted of 70% acetonitrile and 30% phosphate buffer (0.05 M and pH=3.4).