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Ketorolac tromethamine compositions for treating or preventing ocular pain

a technology of ketorolac and compositions, applied in the field of pharmaceutical compositions, can solve the problems of ocular irritation, 5% ketorolac formulation is ocular irritation, primarily burning and stinging, and is associated with some adverse effects, so as to reduce the required daily dosage and prolong the effect of ketorola

Inactive Publication Date: 2013-01-31
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides an eye drop solution containing 0.4% of ketorolac tromethamine, which is better for absorption by the eye and minimizes the need for preservatives, chelating agents, and surfactants. This solution reduces the occurrence of adverse events while maintaining clinical efficacy. It has been found to be effective in treating ocular pain, including postoperative photorefractive keratectomy surgery patients. Ketorolac tromethamine solution also reduces prostaglandin E2 levels in the eye. The solution has been found to have enhanced ketorolac bioavailability, allowing for a reduction in dosing frequency.

Problems solved by technology

All drugs are associated with some adverse effects.
The most common adverse event associated with the use of the 0.5% ketorolac formulation is ocular irritation, primarily burning and stinging upon instillation.

Method used

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  • Ketorolac tromethamine compositions for treating or preventing ocular pain
  • Ketorolac tromethamine compositions for treating or preventing ocular pain
  • Ketorolac tromethamine compositions for treating or preventing ocular pain

Examples

Experimental program
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example 1

[0041]Unless otherwise specified, all steps in this procedure were carried out at room temperature. The following procedure was followed in accordance with the amounts listed in Table 1 below. Purified water was charged into the main batch vessel. Mixing was initiated to produce a vortex sufficient to disperse and / or dissolve all product ingredients without excessive aeration or foam formation. The following components were added directly into the vortex in order, allowing each to dissolve before adding the next: sodium chloride, calcium chloride, dihydrate magnesium chloride, hexahydrate, boric acid, sodium borate, sodium carboxymethyl cellulose as a an percent aqueous solution comprising including a mixture of 65% medium molecular weight and 35% high molecular weight carboxymethyl cellulose. The solution was mixed for no longer than 15 minutes. A specified amount of 1N sodium hydroxide, was then added. The pH was checked and, if needed, was adjusted to 7.3 with 1N sodium hydroxide...

example 2

[0042]Unless otherwise specified, all steps in this procedure were carried out at room temperature. The following procedure was followed in accordance with the amounts listed in Table 2 below. Purified water at 90% of batch size was charged into the main batch vessel. Mixing was initiated to produce a vortex sufficient to disperse and / or dissolve all product ingredients without excessive aeration or foam formation. The following components were added directly into the vortex in order, allowing each to dissolve before adding the next: sodium chloride, edetate disodium, octoxynol-40 (as a 70% stock solution) and benzalkoniurn chloride (as a 10% stock solution). The amount of benzalkonium chloride added took into account the assay of the stock solution used. The solution was mixed for no longer than 15 minutes. A specified amount of 1N sodium hydroxide, 1.85 mL per liter of final bulk product, was then added. The pH was checked and if needed was adjusted to 10.7-11.0 with 1N sodium hyd...

example 3

[0043]This example was prepared according to the procedure of Example 1, except that hydroxypropyl cellulose was used in place of the sodium carboxymethyl cellulose in an amount sufficient to provide a viscosity equivalent to the viscosity of the composition of Example 1.

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Abstract

The present invention provides an aqueous ophthalmic solution comprising an effective amount of ketorolac which comprises carboxymethyl cellulose in an aqueous solution which provides increased visual acuity in users and wherein said concentration of carboxymethyl cellulose is selected to provide an increased absorption of ketorolac in the eye of a patient which is at least 130% greater than the absorption of a comparative aqueous ketorolac ophthalmic solution having the same concentration of ketorolac.

Description

RELATED APPLICATION[0001]This application claims the benefit of U.S. patent application Ser. No. 12 / 552,057 filed on Sep. 1, 2009 pursuant to 35 USC 120 which application claims the benefit of Ser. No. 12 / 396,131 filed on Mar. 2, 2009 which application claims the benefit of and priority to U.S. provisional application Ser. No. 61 / 067,925 filed Mar. 3, 2008, No. 61 / 096,096 filed Sep. 11, 2008, and No. 61 / 111,919 filed Nov. 6, 2008, and to Australian Patent Application No. 2009202969 filed on Jul. 23, 2009 pursuant to 35 USC 119, all of which prior applications are incorporated herein by reference in their entireties.FIELD OF THE INVENTION[0002]This invention relates to pharmaceutical compositions. More particularly, this invention relates to topical ophthalmic solutions comprising 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, otherwise known as ketorolac, and the use of ketorolac for treating or preventing ocular pain.DESCRIPTION OF THE RELATED ART[0003]Topical nonsteroidal...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/407A61P29/00A61P27/02
CPCA61K9/0048A61K9/08A61K31/14A61K31/407A61K47/38A61K47/10A61K47/12A61K47/186A61K47/02A61P27/02A61P27/10A61P29/00
Inventor FARNES, ELDON Q.ATTAR, MAYSSASCHIFFMAN, RHETT M.CHANG, CHIN-MINGGRAHAM, RICHARD S.WELTY, DEVIN F.
Owner ALLERGAN INC
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