AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES

摘要

The present invention is directed to the provision of multi-dose, ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP). The compositions include at two different polyols in conjunction with borate and a low concentration of benzalkonium chloride.

主权项

1. A multi-dose ophthalmic composition, comprising:
a first polyol, the first polyol being selected from mannitol, sorbitol or a combination thereof; a second polyol, the second polyol being selected from propylene glycol, glycerine or a combination thereof; an effective amount of borate, the effective amount being less than about 0.5 w/v % of the overall composition; BAC as an anti-microbial preservative, the concentration of BAC in the composition being greater than 0.00001 w/v % but less than 0.0035 w/v %; and water.