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Pharmaceutical ophthalmological liquid compositions containing propionic acid derivatives as a preservative

A technology of composition and preservative components, which is applied in the directions of drug combination, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of preservatives of ophthalmic compositions that are not commonly used

Inactive Publication Date: 2012-06-13
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these compounds have not heretofore been commonly used for the preservation of ophthalmic compositions

Method used

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  • Pharmaceutical ophthalmological liquid compositions containing propionic acid derivatives as a preservative
  • Pharmaceutical ophthalmological liquid compositions containing propionic acid derivatives as a preservative
  • Pharmaceutical ophthalmological liquid compositions containing propionic acid derivatives as a preservative

Examples

Experimental program
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Effect test

Embodiment

[0032] A preservative efficacy study was conducted to determine whether the addition of cellulose acetate increased the efficacy of the purite preservative in Optive. For this study, two concentrations of cellulose acetate (0.1% and 0.5%) were added to Optive samples and analyzed relative to Optive alone.

[0033] The standard APET test USP / EP5.1.3 was performed on five standard microorganisms defined in the Pharmacopoeia to compare three different samples. For these three bacteria (Staphylococcus aureus (S.aureus), Pseudomonas aeruginosa (P.aeruginosa) and Escherichia coli (E.coli)), at the time point of 6 hours, add 0.5% Cellulose acetate had a greater log reduction, 0.80 and 1.3 log reductions greater than Optive alone. (Refer to the attached table). All time points met the criteria stated in the USP and EU Pharmacopoeias.

[0034] For yeast and mold microorganisms, cellulose acetate 0.5% also showed a 1.55 log reduction for C. albicans and a 0.48 log reduction for A. br...

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PUM

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Abstract

The invention provides ophthalmic compositions preserved using propionic preservative components alone or in combination with at least one additional preservative. In particular, an improvement in anti-microbial activity against bacteria is seen in addition to activity specific to fungal organisms and / or mold.

Description

[0001] cross reference [0002] This application claims priority to US Provisional Patent Application Serial No. 61 / 221,578, filed June 30, 2009, the entire disclosure of which is incorporated herein by this specific reference. technical field [0003] The present invention generally relates to pharmaceutical compositions. In particular, the present invention relates to ophthalmic compositions comprising an active drug and at least one propionic acid preservative component. Background technique [0004] Preservatives are used in multi-use ophthalmic compositions to prevent microbial contamination of the composition after the package has been opened. Many preservatives have been developed, including quaternary ammonium salts such as benzalkonium chloride; mercury compounds such as phenylmercuric acetate and thimerosal; alcohols such as chlorobutanol and benzyl alcohol; etc. [0005] Propionic acid and its salts are known antifungal agents and have been used in the baking i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/08
CPCA61K9/08A61K9/0048A61P27/02A61P27/06A61P29/00A61P3/02A61P31/04A61P37/08A61P43/00A61K31/196A61K31/19A61K31/192
Inventor O·奥勒尼克
Owner ALLERGAN INC
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