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Combinations of preservatives for ophthalmic compositions

A composition and antiseptic technology, which is applied in the direction of drug combination, animal repellent, plant growth regulator, etc., can solve the problems of reducing the concentration of preservatives and failing to pass through

Inactive Publication Date: 2013-01-16
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in some cases, reduced preservative concentrations can produce compositions that fail certain standards, such as the US Pharmacopoeia APET standard and the European Pharmacopoeia EP-A and / or EP-B standards for preservative effectiveness

Method used

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  • Combinations of preservatives for ophthalmic compositions
  • Combinations of preservatives for ophthalmic compositions
  • Combinations of preservatives for ophthalmic compositions

Examples

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Embodiment Construction

[0020] It has been surprisingly found that the combination of benzalkonium chloride (BAK) and polyhexamethylene biguanide (PHMB) using respective sub-effective concentrations provides effective protection against microbial contamination, meets Microbial Preservative Effectiveness Test (APET) protocol criteria, and Any ocular toxicity that may result from the use of higher concentrations of a single preservative is minimized. The present invention is of particular importance for ophthalmic products, where corneal and ocular toxicity can interfere with the commercial success of the product.

[0021] It was surprisingly found that 3 ppm polyhexamethylene biguanide (PHMB) alone could not meet the Ph Eur-B&A criteria due to poor antimicrobial effect against fungi. However, the combination of 10 ppm polyhexamethylene biguanide (PHMB) and 10 or 20 ppm BAK passed Ph Eur-B&A criteria. It was also found that 20 ppm of BAK resulted in a composition that did not meet the Ph Eur-B&A crite...

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Abstract

The present invention provides a preservative composition for protecting ophthalmic solutions from microbial attack comprising a combination of benzalkonium ion and polyhexamethylene biguanide (PHMB) wherein the combined concentrations of benzalkonium ion and polyhexamethylene biguanide (PHMB) in said composition is sufficient to provide protection against microbial attack when said composition is added to an ophtalmic solution as compared to said ophthalmic soulution having the same concentration of benzalkonium ion and polyhexamethylene biguanide (PHMB), alone.

Description

[0001] cross reference [0002] This application claims the benefit of US Provisional Application Serial No. 61 / 321,701, filed April 7, 2010, which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to the field of preservatives for ophthalmic solutions, especially aqueous ophthalmic solutions, which are prone to spoilage by exposure to the environment. More particularly, the present invention relates to ophthalmic compositions, including those used for drug delivery to the eye, those used for the treatment of dry eye and for eye care, contact lens care compositions, and the like, which may benefit from preservation. Background technique [0004] Ophthalmic compositions often utilize at least one preservative, depending on the type of composition. Certain therapeutic agents included in these compositions are often irritating to the eyes. This side effect may be reduced or eliminated in some cases if reduced concentra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00
CPCA61L12/142A61K9/0048A61K9/08A01N47/44A61K47/18A61L12/143A61P27/02A61P27/04A01N2300/00A01N33/12A61K31/275C07C279/28
Inventor W·L·提恩R·S·格雷厄姆R·斯瑞库马
Owner ALLERGAN INC
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