Stability of fumagillin in an extemporaneously prepared ophthalmic solution.
The stability of fumagillin 70 microg/mL (as the bicyclohexylammonium crystal) in an extemporaneously prepared ophthalmic solution was studied. An ophthalmic solution of fumagillin 70 microg/mL was prepared by combining 120 mg of fumagillin bicyclohexylammonium crystals with 20 mL of 0.9% Sodium Chloride Injection, USP, and 20 mL of an ophthalmic irrigating solution. The solution was stored in 12 sterile semi-opaque dropper bottles; 4 bottles were stored at 25 degrees C exposed to light, 4 were stored at 25 degrees C in the dark, and 4 were stored at 4 degrees C in the dark. Samples were taken on days 0, 7, 14, 21, and 28 and analyzed by high-performance liquid chromatography. Sterility was tested as well. In the solutions stored at 25 degrees C, 17-30% of the initial drug concentration was lost during the first week. The solution protected from light and stored at 4 degrees C lost about 12% of active drug by week 4. There was no change in color or odor in any of the solutions and only a minor change in pH over the study period. There was no evidence of microbial growth in any of the solutions tested. Fumagillin 70 microg/mL (as the bicyclohexylammonium crystal) in 0.9% sodium chloride injection and an ophthalmic irrigating solution containing benzalkonium chloride was stable in the dark for 14 days at 4 degrees C.
Abdel-Rahman
S M
SM
Pharmacy and Pediatrics, University of Missouri, Kansas City, USA.
Nahata
M C
MC
D000981:Antiprotozoal Agents / Q000737:chemistry*; D003510:Cyclohexanes; D004339:Drug Compounding; D004355:Drug Stability; D015822:Eye Infections, Parasitic / Q000188:drug therapy*; D005231:Fatty Acids, Unsaturated / Q000737:chemistry*; D006801:Humans; D009883:Ophthalmic Solutions; D012717:Sesquiterpenes; D013997:Time Factors
D000981:Antiprotozoal Agents; D003510:Cyclohexanes; D005231:Fatty Acids, Unsaturated; D009883:Ophthalmic Solutions; D012717:Sesquiterpenes; C026211:fumagillin