Effect and safety of Benzalkonium chloride in an ophthalmic solution containing Ofloxacin

摘要

The study was planned to determine the safest and the most effective concentration of Benzalkonium Chloride (BAK) in an ophthalmic solution containing antibiotic ofloxacin. To determine the safe and effective concentrations of BAK, three different formulations of ophthalmic solution were prepared by using the various concentrations of BAK. The preservative efficacy test (PET) was conducted for all the formulations. PET was performed according to British Pharmacopoeia. British Pharmacopoeia states that there must be 2 log reductions at 6 Hrs and 3 log reductions at 24 Hrs with no recovery at 28th days for bacteria. For fungi there must be 2 log reductions at 7th day with no recovery at 28th days. The results showed that 0.010 v/v concentration failed for required log reductions at 6 Hrs, 24 Hrs for bacteria and at 7th day for fungi. 0.016% v/v concentration passed criteria for log reduction for bacteria but failed for log reduction of fungi. 0.020% v/v concentration passed criteria for both bacteria and fungi.