Lubricious germicidal ophthalmic solutions

Inactive Publication Date: 2005-11-03
MACKLES LEONARD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008] The most suitable quaternary germicide is benzalkonium chloride, preferably used at a concentration of 0.10 to 0.010%. Heretofore this germicide could not be used with CMC as their reaction caused precipitate formation. It is the surprising finding of this invention that the presence of a polysorbate surfactant in the solution prior to the addition of the germicide prevents such precipitation. In addition to preventing the precipitation of the cationic quaternary germicide, the polysorbate acts as an ameliorating agent to lessen the irritation potential of the cationic quaternary germicide.

Problems solved by technology

Heretofore this germicide could not be used with CMC as their reaction caused precipitate formation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example # 1

[0024]

Eye Care Lubricant%1. CMC, USP1.002. Polysorbate 200.503. Benzalkonium Chloride0.014. Disodium EDTA0.105. Boric Acid0.306. Sodium Borate0.207. PEG 4001.008. Deionized Water96.89100.00

[0025] Adjust the pH to 7.4 with hydrochloric acid or sodium hydroxide.

Procedure:

[0026] 1.) Mix #1 and #8 and heat to 70° C. until dissolved. [0027] 2.) Add #2 to the batch and mix. [0028] 3.) Add #'s 4, 5, 6 and 7 to the batch and mix. [0029] 4.) Cool the batch to 50° C.; add #3 and cool the batch to room temperature. [0030] 5.) Adjust the pH to 7.4 with sodium hydroxide or hydrochloric acid.

example # 2

Example #2

[0031]

Eye Care Lubricant withTetrahydrozoline HCl%1. CMC, USP0.502. Polysorbate 200.503. Benzalkonium chloride0.014. Disodium EDTA0.105. Boric Acid0.306. Sodium Borate0.207. PEG 4001.008. Tetrahydrozoline HCl0.059. Deionized Water97.34100.00

[0032] Adjust the pH to 7.4 with hydrochloric acid or sodium hydroxide.

Procedure:

[0033] 1.) Mix #1 and #9 and heat to 70° C. until dissolved. [0034] 2.) Add #2 to the batch and mix. [0035] 3.) Add #'s 4, 5, 6 and 7 to the batch and mix. [0036] 4.) Cool the batch to 50° C.; add #8 and mix until dissolved. [0037] 5.) Add #3 to the batch and cool the batch to room temperature. [0038] 6.) Adjust the pH to 7.4 with sodium hydroxide or hydrochloric acid.

example # 3

Example #3

[0039]

Eye Care Lubricant withOxymetazoline HCl%1. CMC, USP0.502. Polysorbate 800.503. Benzalkonium chloride0.014. Disodium EDTA0.105. Boric Acid0.306. Sodium Borate0.207. PEG 4001.008. Oxymetazoline HCl0.059. Deionized Water97.34100.00

[0040] Adjust the pH to 7.4 with hydrochloric acid or sodium hydroxide.

Procedure:

[0041] See the procedure used in Example #2.

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Abstract

A novel class of lubricious ophthalmic solutions is formulated to permit the use of a recognized class of demulcents; namely, anionic polymeric demulcents in the presence of a cationic quaternary germicide wherein no precipitation of said germicide occurs.

Description

RELATED APPLICATIONS [0001] This application is a continuation in part of applicant's application Ser. No. 10 / 835,449 filed Apr. 29, 2004FIELD OF THE INVENTION [0002] Discussion of the Prior Art [0003] The use of ophthalmic solutions for the relief of many eye conditions is well known in the art. The problem with many of these solutions is that while they are pH compatible with tears, their level of lubricity or slipperiness is less than would be desirable. Thus many advantages of such solutions and the pharmacologically active substances which they may carry are not optimized. A further legal issue which must be met, at least in the United States of America is that the Food and Drug administration has set forth a list of substances which can be used in such non-prescription solutions and no others are permissible. Thus any invention in this art must be limited to the use of “monographed” components. [0004] In order to provide lubricity to ophthalmic solutions, a demulcent must be a...

Claims

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Application Information

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IPC IPC(8): A61K31/14A61K31/716A61K31/74A61K33/22A61P27/02
CPCA61K31/716A61K31/14A61P27/02
Inventor MACKLES, LEONARD
Owner MACKLES LEONARD
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