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Compositions for treating hyperemia

a hyperemia and composition technology, applied in the field of compositions for treating hyperemia, can solve the problems of insufficient treatment, substantial discomfort, and ingredients which may be quite harmful to the eye, and achieve the effect of easy and cost-effective manufacturing, no added irritation to the eye, and no side effects

Inactive Publication Date: 2005-12-08
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides new ophthalmic compositions that can treat hyperemia (eye redness) without causing additional irritation to the eye. These compositions are easy to use, cost-effective, and can be used for both the treatment of hyperemia and the simultaneous treatment of dry eye. The compositions contain a carrier component, a vasoconstrictor component, and a demulcent component. The vasoconstrictor component helps to treat hyperemia, while the demulcent component provides lubrication to the eye. The compositions can be in the form of solutions or can be administered as eye drops. The invention also provides methods for making and using these compositions.

Problems solved by technology

These treatments have not been entirely satisfactory, however.
For example, many commercially available eye drops include preservatives, an ingredient which may be quite harmful to the eye.
Furthermore, many of the commercially available eye drops include ethylenediaminetetraacetic acid and / or salts thereof (EDTA), which may produce substantial discomfort when the eye drops are administered to the eye.
Also, these commercially available products often have pHs which are relatively acidic and can result in ocular irritation and / or discomfort.

Method used

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  • Compositions for treating hyperemia
  • Compositions for treating hyperemia

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0092] A composition is prepared by blending the various materials together and has a make-up as shown in Table 1.

TABLE 1Ingredients% w / vTetrahydrozoline HC1, USP0.05Sodium Carboxymethylcellulose, USP10.5Sodium Chloride, PhEur / USP0.39Boric Acid, NF / PhEur0.60Sodium Borate Decahydrate, NF0.035Potassium Chloride, USP0.14Calcium Chloride Dihydrate, USP0.006Magnesium Chloride Hexahydrate, USP0.006Purite ®20.0055Sodium Hydroxide 1N, NFAdjust pH to 7.2Hydrochloric Acid 1 N, NFAdjust pH to 7.2Purified Water, UPSq.s. ad

1Low Viscosity.

2Purite ® is a registered trademark of Allergan, Inc. for stabilized chlorine dioxide.

[0093] The stability of this composition is evaluated at several different temperatures and humidity conditions, according to standard procedures. This tetrahydrozoline hydrochloride-containing composition is found to be sufficiently stable to have at least an 18-month shelf life. Thus, this composition would be entitled to be labeled with at least an 18 month expiration da...

example 2

[0094] A second composition is prepared and tested for stability substantially as set forth in Example 1. The second composition has an identical make-up to the composition of Example 1 with the exception that the Purite® concentration in the second composition is 0.0050% (w / v).

[0095] The stability testing of this second composition demonstrates that this composition has stability similar to that of the composition of Example 1.

example 4

Vasoconstrictor Efficacy Comparison in New Zealand Albino Rabbits

[0098] The composition of Example 2, Visine® Original composition and Visine® L.R. composition are tested in an animal model for their abilities to treat red eye (hyperemia) and irritability effects.

[0099] Visine® Original composition includes the following: tetrahydrozoline hydrochloride 0.05% (w / v), benzalkonium chloride 0.01% (w / v), boric acid, edetate disodium 0.1% (w / v), sodium borate, sodium chloride and purified water. The pH is determined to be 6.38. The osmolality is measured and found to be 289 mOsm / kg.

[0100] Visine® L.R. composition includes the following: oxymetazoline hydrochloride 0.03% (w / v), benzalkonium chloride 0.01% (w / v), boric acid, edetate disodium 0.1%, sodium borate, sodium chloride and purified water. The pH is determined to be 6.34. The osmolality is measured and found to be 286 mOsm / kg.

[0101] Red eye, or ocular hyperemia, is scored on a 4 grade scale: 0 (no redness); +1 (some redness); +2...

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Abstract

The present compositions advantageously treat hyperemia with substantially no added irritation to the eye. In one embodiment, the compositions include an ophthalmically acceptable carrier component, a vasoconstrictor component in an amount effective to treat hyperemia when the composition is administered to an eye, and a polyanionic component in an amount effective to provide lubrication to an eye when the compositions are administered to the eye.

Description

BACKGROUND OF THE INVENTION [0001] The present invention relates to compositions including vasoconstrictor components for treating ocular hyperemia, preferably without resulting in significant eye irritation, and to methods for making and using such compositions. In one embodiment, the present invention relate to compositions effective to provide dual treatments for eye conditions, for example a dual treatment of hyperemia and dry eye. [0002] Reddening or inflammation of the superficial tissues of the eye is a relatively common affliction since it usually accompanies various allergic reactions, such as hay fever allergies and the like, foreign body irritation in the eye, or eye fatigue. Such superficial conjunctival redness, often referred to as hyperemia or ocular hyperemia, can be the result of ciliary flush, dilation of the deep straight vessels of the episclera, and / or dilation of the superficial vessels of the conjunctiva. [0003] Various types of palliative treatments have been...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/137A61P27/14A61K31/717A61K47/38
CPCA61K9/0048A61K31/137A61K31/717A61K47/38A61P27/14
Inventor HUTH, STANLEY W.
Owner ALLERGAN INC