DE202005005094U1 - Composition, useful for the treatment of diseases or conditions of eye, comprises extract and/or tincture obtained from plant and/or plant parts of Euphrasia officinalis, and sodium chloride - Google Patents

Abstract

An ophthalmic composition (I) comprises an extract and/or tincture obtained from plant and/or plant parts of Euphrasia officinalis (a) (0.02-2 wt.%), and sodium chloride (b) (0.2-2 wt.%). An independent claim is also included for a single dose of Ophtiole comprising (I). ACTIVITY : Ophthalmological. MECHANISM OF ACTION : None given.

Description

The The present invention relates to an ophthalmic composition. The ophthalmic composition can be used for treatment, for example of diseases or conditions of the eye or of the eye surrounding or related to the eye Organs or tissues are used.

It It is well known that the eye is constantly exposed to high levels of stress is. In particular, wearing contact lenses or a strained Eyesight like long-lasting work in front of the screen can cause over-exertion and Irritation of the eye.

to Administration in irritated, dry or inflamed eyes usually becomes Compositions used in the form of eye drops. The compositions typically include solutions in which the active ingredients, such as herbal extracts, ethereal Ole or zinc compounds are introduced.

this solutions are often other ingredients, preservatives and antimicrobial substances added that cause allergies, cause irritation or sensitizations to the Can produce ingredients and therefore not for a permanent application are suitable. A disadvantage arises continue from that the solutions intolerances can generate.

From the EP 1 417 970 A2 A solution is known which discloses the use of dilute seawater as a basis for avoiding incompatibilities. A disadvantage of this type of preparation, however, is that the salt composition of the sea does not correspond to that of the eye. A significant disadvantage also results from the fact that even such solutions themselves can frequently produce itching, burning or other unpleasant side effects on contact with the eye.

It the object of the present invention is a composition to disposal to provide at least one of the aforementioned disadvantages of The state of the art overcomes. In particular, it is the object of the present invention to provide a Composition available For use with irritated, dry or inflamed eyes suitable is.

• – Extrakt(e) und/oder Tinktur(en) erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis im Bereich von ≥ 0,02 Gew.-% bis ≤ 2 Gew.-%, und
• – Natriumchlorid im Bereich von ≥ 0,2 Gew.-% bis ≤ 2 Gew.-%.

The object is achieved by an ophthalmic composition, the composition comprising, based on the total weight of the composition, the following substances:

• Extract (s) and / or tincture (s) obtainable from the plant and / or parts of plants of Euphrasia officinalis in the range of ≥ 0.02 wt .-% to ≤ 2 wt .-%, and
• - Sodium chloride in the range of ≥ 0.2 wt .-% to ≤ 2 wt .-%.

advantageous Embodiments of the ophthalmic composition of the invention are in the subclaims specified.

It has been surprising shown that an administration of the ophthalmic invention Composition on or in the eyes. Diseases or conditions of the Eye or the surrounding or related to the eye Tissues or organs, such as redness, Swelling, injuries, inflammation such as conjunctival and lidar inflammations, Over-exertion or dry eyes can positively influence.

Favorable Way are the ophthalmic invention Compositions particularly well tolerated. Another advantage is that the ophthalmic invention Compositions to no or very little irritation or discomfort when using on the eye.

Under The term "extract" is used in the sense of this Invention extracts from liquid or dry nature of plants or parts thereof for example, using water, understood. Preferred are dry-type extracts, which are preferably from the fresh or dried aerial parts of Euphrasia officinalis like leaves, Flowers and / or stalk available are.

Especially preferred are extracts of the whole herb of Euphrasia officinalis, also referred to as Herba Euphrasiae.

Under the name "Euphrasia officinalis "(eyebright) For the purposes of this invention, they are all commonly used under this term designated species of the genus Euphrasia understood, for example Euphrasia stricta, Euphrasia montana and / or Euphrasia rostkoviana.

Under The term "tincture" is used in the sense of this Invention extracts of plants or parts thereof using solvents such as water and / or alcohols such as ethanol, vegetable Press juices or solutions of dried plants in a solvent mixture such as an alcohol-water mixture Understood.

For the purposes of this invention, the term "substance" is to be understood as meaning the substances which comprise the composition, in particular extract (s) and / or tincture (s) obtainable from the plant and / or from plant parts of Euphrasia officinalis, sodium chloride, boric acid, caustic soda, polyvinylpyrrolidone (s), polysobate (s), preservatives such as cetrimide and / or benzododecinium chloride.

• – Extrakt(e) und/oder Tinktur(en) erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis im Bereich von ≥ 0,03 Gew.-% bis ≤ 0,5 Gew.-%, vorzugsweise ≥ 0,04 Gew.-% bis ≤ 0,2 Gew.-%, bevorzugt ≥ 0,05 Gew.-% bis < 0,1 Gew.-%, und/oder
• – Natriumchlorid im Bereich von ≥ 0,4 Gew.-% bis ≤ 1,5 Gew.-%, vorzugsweise ≥ 0,5 Gew.-% bis ≤ 1 Gew.-%, bevorzugt > 0,7 Gew.-% bis ≤ 0,8 Gew.-%.

In preferred embodiments, the ophthalmic composition comprises, based on the total weight of the composition, the following substances:

• Extract (s) and / or tincture (s) obtainable from the plant and / or from plant parts of Euphrasia officinalis in the range of ≥ 0.03% by weight to ≤ 0.5% by weight, preferably ≥ 0.04 Wt .-% to ≦ 0.2 wt .-%, preferably ≥ 0.05 wt .-% to <0.1 wt .-%, and / or
• Sodium chloride in the range from ≥ 0.4% to ≤ 1.5% by weight, preferably ≥ 0.5% to ≤ 1% by weight, preferably ≥ 0.7% by weight to ≦ 0.8% by weight.

If Unless stated otherwise, the weight contents of the respective Fabrics chosen that the total weight of the respective substances 100 wt .-%, based on the overall composition, does not exceed.

Especially enable the selection and weight content of the substances contained in particular that the ophthalmic composition is harmless also over a longer one Period, is applicable.

Especially can also the preferred concentration of sodium chloride to an improved compatibility contribute to the composition. In preferred embodiments the composition of the invention the sodium chloride content is based on the salinity of the tear fluid tuned in the eye. Of particular advantage is that the content the composition of the invention of sodium chloride on the content of the composition to further Salts matched, so the compatibility of the composition not by exceeding physiological saline concentrations of the eye Salinity is reduced.

The Composition according to the invention can also include other components, for example preservatives, preferably selected from the group comprising cetrimide and / or benzododecinium chloride. "Cetrimid" is the usual name for N-cetyl-N, N, N-trimethyl-ammonium bromide, "benzododecinium chloride" the usual name for N-benzyl-N-dodecyl-N, N-dimethyl-ammonium chloride. It is preferable that the ophthalmic composition is related on the total weight of the composition, preservative in the range of ≥ 0% by weight to ≤ 0.05 Wt .-%, preferably in the range of ≥ 0 Weight% to ≤ 0.01 Wt .-%, preferably in the range of ≥ 0 wt .-% to ≤ 0.005 wt .-%, includes. In preferred embodiments the composition comprises less than 0.01% by weight, based on the total weight of the composition, cetrimide and / or benzododecinium chloride. In particularly preferred embodiments the composition is free from preservatives.

In advantageous embodiments the composition has a pH in the range of 6.8 to 7.6, preferably in the range of 7.0 to 7.4. Preferably, the pH of the ophthalmic Composition with acids and / or bases, preferably with boric acid and / or sodium hydroxide, wherein 1 N sodium hydroxide solution is particularly advantageous adjusted. In preferred embodiments the composition comprises boric acid in the range of ≥ 0.2 Wt .-% to ≤ 0.4 Wt .-%, preferably in the range of ≥ 0.3 wt .-% to ≤ 0.35 wt .-%, preferably 0.31% by weight, based on the total weight of the composition. In further preferred embodiments the composition comprises 1N sodium hydroxide in the range of ≥ 0,1% w / w to ≤ 0.4% by weight, preferably in the range of ≥ 0.17% by weight to ≤ 0.28 Wt .-%, based on the total weight of the composition.

One Advantage of the ophthalmic invention Composition is realized by the composition in the application to no or very little irritation leads. Farther could cause irritation in contact with the eye, advantageously completely or almost completely be avoided. This means a very big advantage, since it at the Application of solutions on Eye often comes to a very unpleasant sensation of "burning" on the eye.

The ophthalmic composition may be solid, liquid and / or gel. The composition of the invention is especially for a topical ophthalmic application suitable, for example for an application on the surface of the eye or on the areas immediately surrounding the eye.

Preferably the composition is in the form of an aqueous solution. In particularly preferred embodiments if the composition is suitable, selected in dosage forms the group comprising eye drops and / or eye baths to be applied to the eye.

Conveniently, the ophthalmic composition boric acid, sodium hydroxide and / or auxiliaries, preferably selected from the group comprising viscosity-increasing additives, preferably polyvinylpyrrolidone (s), preferably povidone 25 , and / or solubilizers, preferably Polysorbate (e), more preferably polyoxyethylene sorbitan monooleate (polysorbate 80 ), on.

In preferred embodiments includes the ophthalmic composition extracts) and / or tinctures) available from the plant and / or from plant parts of Euphrasia officinalis, Sodium chloride, boric acid, Sodium hydroxide, polyvinylpyrrolidone, polysorbate, cetrimide and / or Benzododecinium.

Preferably the composition usually has no further in ophthalmic preparations contained salts, in particular no zinc sulfate. Favorable Way you can For example, hypersensitivity, the often through Zinc sulfate caused to be avoided.

• a. 0,05 Gew.-% Extrakt erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis;
• b. 0,73 Gew.-% Natriumchlorid.

In preferred embodiments, the ophthalmic composition comprises, based on the total weight of the composition, the following substances:

• a. 0.05% by weight of extract obtainable from the plant and / or from plant parts of Euphrasia officinalis;
• b. 0.73 wt .-% sodium chloride.

• a. 0,1 Gew.-% Extrakt erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis;
• b. 0,73 Gew.-% Natriumchlorid.

In particularly preferred embodiments, the ophthalmic composition comprises, based on the total weight of the composition, the following substances:

• a. 0.1% by weight of extract obtainable from the plant and / or from plant parts of Euphrasia officinalis;
• b. 0.73 wt .-% sodium chloride.

• a. 0,05 Gew.-% Extrakt erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis;
• b. 0,73 Gew.-% Natriumchlorid;
• c. 0,001 Gew.-% bis 0,01 Gew.-% Cetrimid.

In further preferred embodiments, the ophthalmic composition comprises, based on the total weight of the composition, the following substances:

• a. 0.05% by weight of extract obtainable from the plant and / or from plant parts of Euphrasia officinalis;
• b. 0.73% by weight of sodium chloride;
• c. From 0.001% to 0.01% by weight of cetrimide.

• a. 0,05 Gew.-% Extrakt erhältlich aus der Pflanze und/oder aus Pflanzenteilen von Euphrasia officinalis;
• b. 0,73 Gew.-% Natriumchlorid;
• c. 0,001 Gew.-% bis 0,01 Gew.-% Benzododeciniumchlorid.

In further preferred embodiments, the ophthalmic composition comprises, based on the total weight of the composition, the following substances:

• a. 0.05% by weight of extract obtainable from the plant and / or from plant parts of Euphrasia officinalis;
• b. 0.73% by weight of sodium chloride;
• c. 0.001% to 0.01% by weight of benzododecinium chloride.

In preferred embodiments if the ophthalmic composition is free of chamomile extract (s), Chamomile tincture (s) and / or essential oils such as Lavender oil, Orange blossom oil and / or Rose oil. This realizes a further advantage of the composition according to the invention compared to usual Preparations, as chamomile in particular can cause allergies. In addition, essential oils have a harmful effect Potential to lead often Allergies, sensitization or irritation and can also photoallergic reactions trigger.

From It is particularly advantageous that the ophthalmic composition of the invention for Preparation of a cosmetic and / or pharmaceutical agent for the treatment of diseases or conditions of the eye or the Eye-surrounding or related organs or tissues, especially redness, swelling, Injuries, inflammation like conjunctival and lidar inflammations, overexertion, dry eyes, and / or for the prevention of eye catarrh and / or Eye mucus flow usable is.

Preferably is the ophthalmic composition as a medical device in the sense of § 3 para. 1 Medical Devices Act.

The Ophthalmic according to the invention Composition is particularly advantageous in long-term use in diseases or conditions of the eye or of the eye surrounding or related to the eye Organs or tissues, in particular redness, swelling, injuries, inflammation like conjunctival and lidar inflammations, overexertion, dry eyes, and / or for the prevention of eye catarrh and / or Eye mucus flow usable. Due to the beneficial substances of ophthalmic composition is the ophthalmic composition safe for use in the preventive prevention of reddened or irritated eyes, as well as existing redness or dry eyes.

It was surprising found that within a few hours a significant improvement the complaints like redness, Swelling, injury or inflammation can be effected.

By the beneficial substances of the ophthalmic preparation can this as a means of treating diseases or conditions of the Eye or the surrounding or related to the eye Organs or tissues, in particular in the form of eye drops and / or Eye bath, to be used.

Preferably, the ophthalmic Zuberei administration in the form of drops for eyes or usable in the form of an eye bath for rinsing.

For the application becomes the composition according to the invention preferably in suitable containers bottled, which are preferably designed so that the content on the eye can be applied, for example, eye drop bottles preferably based on polyethylene, preferably LDPE (polyethylene lower Density, low density polyethylene), or HDPE (high density polyethylene, high density polyethylene). The filling volume The eye drop bottles are preferably in the range of 5 ml to 10 ml. In further preferred embodiments of the ophthalmic This composition is preferably for use as eye bath in containers based on LDPE, included.

In preferred embodiments the ophthalmic composition is in the form of eye drops in a one-dose ophthalmols, preferably based on LDPE. In particularly preferred embodiments the ophthalmic composition is in the form of eye drops in a single-dose ophthalmic free of preservatives.

It It goes without saying that the ophthalmic composition is preferably sterile for use. Preference is given to sterile substances used under sterile conditions, or the composition becomes sterilized after incorporation of the substances or the ophthalmic Composition is produced under so-called aseptic conditions, which lead to a sterile product.

The following embodiments are only for explanation of the invention and are not limiting.

example 1

• – 0,05 Gew.-% Trockenextrakt aus Euphrasia officinalis;
• – 0,73 Gew.-% Natriumchlorid;
• – 2,0 Gew.-% Povidon 25.

Eye drops comprising 100% by weight:

• - 0.05% by weight of dry extract from Euphrasia officinalis;
• 0.73% by weight of sodium chloride;
• 2.0% by weight of povidone 25.

The Eye drops were sterilized and filled into single dose ophthalmos.

Example 2

• – 0,1 Gew.-% Trockenextrakt aus Euphrasia officinalis;
• – 0,73 Gew.-% Natriumchlorid;
• – 2,0 Gew.-% Povidon 25.

Eye drops comprising 100% by weight:

• 0.1% w / w dry extract from Euphrasia officinalis;
• 0.73% by weight of sodium chloride;
• 2.0% by weight of povidone 25.

The Eye drops were sterilized and filled into single dose ophthalmos.

Claims (17)

Ophthalmic composition, characterized in that the composition, based on the total weight of the composition, comprises the following substances: extracts and / or tinctures) obtainable from the plant and / or from plant parts of Euphrasia officinalis in the range of ≥ 0.02 wt % to <2% by weight, and sodium chloride in the range of from ≥ 0.2% by weight to ≦ 2% by weight. Ophthalmic composition according to claim 1, characterized characterized in that the composition, based on the total weight the composition comprising the following substances: - extracts) and / or tinctures) from the plant and / or from plant parts of Euphrasia officinalis in the range of ≥ 0.03 Wt% to ≤ 0.5 wt%, preferably ≥ 0.04 % By weight to ≦ 0.2% by weight, preferably ≥ 0.05 Wt .-% to ≤ 0.1 Wt .-%, and / or - Sodium chloride in the range of ≥ 0.4 Wt .-% to ≤ 1.5 Wt .-%, preferably ≥ 0.5 Wt% to ≤ 1 wt%, preferably ≥ 0.7 Wt .-% to ≤ 0.8 Wt .-%. An ophthalmic composition according to claim 1 or 2, characterized in that the composition preservative, preferably selected from the group comprising cetrimide and / or benzododecinium chloride. Ophthalmic composition according to one of the previous Claims, characterized in that the composition, based on the Total weight of the composition, preservative in the range of ≥ 0% by weight to ≦ 0.05 wt .-%, preferably in the range of ≥ 0 Weight% to ≤ 0.01 Wt .-%, preferably in the range of ≥ 0 wt .-% to ≤ 0.005 wt .-%, includes. Ophthalmic composition according to one of the previous Claims, characterized in that the composition has a pH in the Range from 6.8 to 7.6, preferably in the range of 7.0 to 7, 4 has. Ophthalmic composition according to one of the previous Claims, characterized in that the composition solid, liquid and / or gel is present. Ophthalmic composition according to one of the previous Claims, characterized in that the composition is in the form of an aqueous solution is present. Ophthalmic composition according to one of the previous Claims, characterized in that the composition boric acid, caustic soda and / or auxiliaries, preferably selected from the group comprising Viscosity-enhancing additives, preferably Polyvinylpyrrolidone (s), and / or solubilizers, preferably Polysorbate (s). Ophthalmic composition according to one of the previous Claims, characterized in that the composition extracts) and / or Tinctures) from the plant and / or from plant parts of Euphrasia officinalis, Sodium chloride, boric acid, Sodium hydroxide solution, polyvinylpyrrolidone (s), polysorbate (s), cetrimide and / or Benzododeciniumchlorid includes. Ophthalmic composition according to one of the previous Claims, characterized in that the composition, based on the Total weight of the composition comprising the following substances: a. 0.05 wt .-% extract available from the plant and / or from plant parts of Euphrasia officinalis; b. 0.73 wt .-% sodium chloride. Ophthalmic composition according to one of the preceding claims, characterized characterized in that the composition, based on the total weight the composition comprising the following substances: a. 0.1 Wt .-% extract available from the plant and / or from plant parts of Euphrasia officinalis; b. 0.73 wt .-% sodium chloride. Ophthalmic composition according to one of the preceding claims, characterized characterized in that the composition, based on the total weight the composition comprising the following substances: a. 0.05 Wt .-% extract available from the plant and / or from plant parts of Euphrasia officinalis; b. 0.73% by weight of sodium chloride; c. 0.001% by weight to 0.01% by weight Cetrimide. Ophthalmic composition according to one of the preceding claims, characterized characterized in that the composition, based on the total weight the composition comprising the following substances: a. 0.05 Wt .-% extract available from the plant and / or from plant parts of Euphrasia officinalis; b. 0.73% by weight of sodium chloride; c. 0.001% by weight to 0.01% by weight Benzododecinium. Ophthalmic composition according to one of the previous Claims, characterized in that the composition is free of chamomile extract (s), Chamomile tincture (s) and / or essential oils such as Lavender oil, Orange blossom oil and / or Rose oil is. Agent for the treatment of diseases or conditions of the Eye or the surrounding or related to the eye Organs or tissues, in particular in the form of eye drops and / or Eye bath, comprising substances according to one of previous claims. One-dose ophthalmols containing an ophthalmic Composition according to one of the preceding claims. Single-dose ophthalmols according to claim 17, characterized in that that the ophthalmic composition is free of preservatives is.