Alcon Laboratories, Inc.

Alcon Research, Ltd.

Alcon Universal Ltd.

Novartis Ag

L Wayne Schneider

Masood A Chowhan

Wesley Wehsin Han

John M Yanni

Daniel A Gamache

Bhagwati P Kabra

Haresh G Bhagat

Raymond E Conrow

David W Stroman

Terri Pasquine

Alan L Weiner

Malay Ghosh

Rajan Bawa

Timothy L Kessler

Lori K Weimer

Zhongyou Wei

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).

Pharmaceutical compositions with phosphonium antimicrobial agents

The present invention is directed to the provision of multi-dose, self-preserved 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), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.

Self-preserved aqueous pharmaceutical compositions

The present invention is directed to the provision of multi-dose, self-preserved 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), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borat or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.

Self preserved aqueous pharmaceutical compositions

HETE salts, the preparation of HETE salts, the preparation of stable and efficacious HETE compositions, HETE compositions and methods of use for treating dry eye are disclosed.

Hydroxyeicosatetraenoate salts, compositions and methods of use in treating dry eye disorders

Compositions containing one or more HETE derivative(s) and an effective concentration of ethanol and methods of use for treating dry eye are disclosed.

Compositions containing hydroxyeicosatetraenoic acid derivatives and methods of use in treating dry eye disorders

The use of polyethoxylated castor oils in prostaglandin compositions enhances the prostaglandin's chemical stability.

Storage-stable prostaglandin compositions

The use of polyethoxylated castor oils in prostaglandin compositions greatly enhances the prostaglandin's chemical stability.

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Crowley, TX, United States of America

L Wayne Schneider