Pharmaceutical compositions with phosphonium antimicrobial agents

Abstract

The present invention is related to pharmaceutical compositions that include a phosphonium antimicrobial agent. In a preferred embodiment, the present invention relates to an otic, nasal or ophthalmic composition (e.g., an aqueous ophthalmic solution) that includes a phosphonium salt compound as an antimicrobial agent. The compositions typically possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements and / or similar preservative standards (e.g., EP and JP).

Description

CROSS REFERENCE TO RELATED APPLICATION [0001]This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Ser. No. 61 / 328,815, filed Apr. 28, 2010, the entire contents of which are incorporated herein by reference.TECHNICAL FIELD OF THE INVENTION [0002]The present invention is related to pharmaceutical compositions that include a phosphonium antimicrobial agent. In a preferred embodiment, the present invention relates to an otic, nasal or ophthalmic composition (e.g., an aqueous ophthalmic solution) that includes a phosphonium salt compound as an antimicrobial agent.BACKGROUND OF THE INVENTION[0003]Pharmaceutical compositions, particularly ophthalmic, otic and nasal compositions, that are utilized multiple times by a patient are often referred to as being of a “multi-dose” nature. Such compositions can be manufactured under sterile conditions via procedures that are well known to those skilled in the art. However, once the packaging for a product is o...

AI Technical Summary

Benefits of technology

"The present invention is about a pharmaceutical composition that contains a phosphonium antimicrobial agent. This agent has a specific formula and can be used in the treatment of ophthalmic infections. The composition can be applied through various routes such as injection, oral or eye drop. The phosphonium antimicrobial agent is present in the composition in a certain amount and can be effective in treating infections caused by bacteria and other microorganisms."

Problems solved by technology

However, once the packaging for a product is opened, such that the composition contained therein is exposed to the atmosphere and other sources of potential microbial contamination (e.g., the hands of a human patient), the sterility of the product may be compromised.

While such preservatives are typically needed to provide required preservation efficacy, those same preservatives can exhibit variable degrees of discomfort and / or toxicity to bodily tissue.

A desired balance between anti-microbial efficacy and potential toxicological effects of anti-microbial preservatives is often difficult to achieve.

More specifically, the concentration of an antimicrobial agent necessary for the preservation of multi-dose pharmaceutical formulations from microbial contamination may create the potential for toxicological effects on the cornea and / or other bodily tissues.

Using lower concentrations of the anti-microbial agents generally helps to reduce the potential for such toxicological effects, but the lower concentrations may be insufficient to achieve the required level of biocidal efficacy (i.e., antimicrobial preservation).

Images