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Abnormal intraocular pressure treatment

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Title: Abnormal intraocular pressure treatment.
Abstract: Methods and compositions for reducing intraocular pressure in a patient, particularly a human patient, are described. In particular, compositions are disclosed that contain an anthocyanoside or an extract comprising it, a proanthocyanidin or an extract comprising it and combinations thereof. The compositions are useful for lowering intraocular pressure. ...


Browse recent Hoffmann & Baron, LLP patents - Syosset, NY, US
Inventors: Victor Ferrari, Salvatore Malandrino, Carolina Burki, Frank Schoenlau
USPTO Applicaton #: #20110046215 - Class: 514456 (USPTO) - 02/24/11 - Class 514 
Drug, Bio-affecting And Body Treating Compositions > Designated Organic Active Ingredient Containing (doai) >Heterocyclic Carbon Compounds Containing A Hetero Ring Having Chalcogen (i.e., O,s,se Or Te) Or Nitrogen As The Only Ring Hetero Atoms Doai >Oxygen Containing Hetero Ring >The Hetero Ring Is Six-membered >Polycyclo Ring System Having The Hetero Ring As One Of The Cyclos >Bicyclo Ring System Having The Hetero Ring As One Of The Cyclos (e.g., Chromones, Etc.)

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The Patent Description & Claims data below is from USPTO Patent Application 20110046215, Abnormal intraocular pressure treatment.

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RELATED APPLICATIONS

This application claims the benefit of priority to U.S. application 61/011,561 filed Jan. 18, 2008, which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to methods and compositions for treating or reducing high or abnormal intraocular pressure.

BACKGROUND

Intraocular pressure is the pressure, generally measured in millimeters of mercury (mm Hg), of the fluid in the eye. Intraocular pressure is measured with an instrument called a tonometer. The most accurate of which is generally considered to be the applanation tonometer, which measures the force required to flatten a small area of central cornea after the eyes have been numbed.

Normal intraocular pressure is generally considered to range from 10 mm Hg to 21 mm Hg, with the average being about 16 mm Hg. According to the National Eye Institute of the U.S. National Institutes of Health, elevated intraocular pressure affects between three and six million people in the United States. Elevated intraocular pressure is thought to be the leading risk factor for glaucoma which affects approximately two million people in the United States. Glaucoma is the leading cause of blindness in the United States and other industrialized countries.

Ocular hypertension occurs when a person has elevated intraocular pressure which has not affected vision or damaged the structure of the eye. Because approximately 1.5 million people in the United States were being treated with costly ocular hypotensive medications that carry the potential for serious and even life-threatening side effects, the National Eye Institute funded a study to determine whether lowering intraocular pressure in ocular hypertensive patients prevents or delays the onset of glaucoma. This study, the Ocular Hypertension Treatment Study (OHTS), was a five year randomized, controlled multicenter clinical trial. The study concluded that lowering intraocular pressure using commercially available topical antiglaucoma agents lowered the risk of developing glaucoma in five years from 9.5% to 4.4%.

Accordingly, there is a need for compositions, particularly natural compositions which can achieve their therapeutic effect with few or no side effects, that can be used to reduce high or abnormal intraocular pressure.

SUMMARY

OF THE INVENTION

One aspect of the present invention provides methods for reducing intraocular pressure in a patient comprising administering to the patient a therapeutically effective amount of at least one of an anthocyanoside, a proanthocyanidin or a combination thereof (e.g., therapeutically effective amounts of at least one anthocyanoside and at least one proanthocyanidin) until intraocular pressure is reduced. According to some embodiments, the at least one anthocyanoside and/or at least one proanthocyanidin is one or more extracts comprising one or more anthocyanosides and/or one or more proanthocyanidins, respectively.

In another aspect, the present invention provides pharmaceutical compositions for the treatment or prevention of high or abnormal intraocular pressure comprising (1) a therapeutically effective amount of at least one of an anthocyanoside, a proanthocyanidin or a combination thereof (e.g., therapeutically effective amounts of at least one anthocyanoside and at least one proanthocyanidin), and (2) a pharmaceutically acceptable excipient. According to some embodiments, the at least one anthocyanoside and/or at least one proanthocyanidin is one or more extracts comprising one or more anthocyanosides and/or one or more proanthocyanidins, respectively.

DETAILED DESCRIPTION

Proanthocyanidins designate a group of flavonoids that includes the subgroups procyanidins, prodelphinidins and propelargonidins. Proanthocyanidins are homogeneous or heterogeneous polymers consisting of the monomer units catechin or epicatechin, which are connected either by 4-8 or 4-6 linkages, to the effect that a great number of isomer proanthocyanidins exist. Typically, the proanthocyanidins oligomers have a chain length of 2-12 monomer units. Proanthocyanidins may be synthesized or extracted from a plant material. Proanthocyanidins are extracted from plant material by conventional methods using solvents like water, ethanol or acetone or fluid carbon dioxide. The extracts are purified by solvent/solvent extraction, ultra filtration or chromatographic procedures. The purified extracts are concentrated by solvent evaporation, freeze drying or spray drying. Nonlimiting examples of plant material sources of proanthocyanidins include grape seeds, grape skin, pine barks, ginkgo leaves, peanuts, cocoa beans, tamarind, tomato, almond, apple, cranberry, blueberry, and tea leaves.

A well-known product containing proanthocyanidins, which is available in trade as a preparation of a food supplement under the name Pycnogenol®, is an extract of the maritime pine bark (Pinus pinaster). Pycnogenol®, the extract from French maritime pine bark (Pinus pinaster), is a registered trademark belonging to Horphag Research, Ltd. Pycnogenol® is a standardized bark extract of the French maritime pine Pinus pinaster, Aiton, subspecies Atlantica des Villar (Pycnogenol®, Horphag Research Ltd., UK). The quality of this extract is specified in the United States Pharmacopeia (USP 28) (Maritime Pine Extract. In: United States Pharmacopeia. Rockville: United States Pharmacopeial Convention, Inc.; 2005. pp. 2115-2116.). Between 65-75% of Pycnogenol® are procyanidins comprised of catechin and epicatechin subunits with varying chain lengths (Rohdewald P. A review of the French maritime pine bark extract (Pycnogenol), an herbal medication with a diverse clinical pharmacology (Int J Clin Pharmacol Ther 2002; 40: 158-168.). Other constituents are polyphenolic monomers, phenolic or cinnamic acids and their glycosides (Id.).

Pinus pinaster (P. pinaster) and Pinus maritima (P. maritime), are understood to refer to the same organism. Hence, these terms, as used herein, are interchangeable.

Another group of naturally occurring flavonoids is the anthocyanins or anthocyanosides. Anthocyanins are colored substances that are responsible for the red, purple and blue colors of many fruits and flowers. They are prevalent in and responsible for the colors of fruits that include blueberries, bilberries, blackberries, cherries, plums, currant, chokeberries, grapes, strawberries, raspberries, boysenberries, marionberries, cranberries and elderberries. Anthocyanins may be synthesized or extracted from a plant material. Anthocyanins are extracted from plant material by conventional methods using solvents like water, ethanol or acetone or fluid carbon dioxide. The extracts are purified by solvent/solvent extraction, ultra filtration or chromatographic procedures.

A well-known product containing anthocyanins, which is available in trade as a preparation of a food supplement under the name Mirtoselect®, is an extract of bilberry fruit (Vaccinium myrtillus L.). Mirtoselect®, the extract from fresh bilberry fruits (Vaccinium myrtillus L.), is a registered trademark belonging to Indena S.p.A. Mirtoselect® is a standardized fruit extract of the bilberry Vaccinium myrtillus L. (Mirtoselect®, Indena S.p.A., Milan, Italy). This extract contains anthocyanins and is characterized by a specific and reproducible HPLC profile.

The terms “anthocyanins” and “anthocyanosides” are understood to refer to the same compounds. Hence, these terms, as used herein, are interchangeable.

By an “effective” amount or a “therapeutically effective amount” of a drug or pharmacologically active agent is meant a nontoxic but sufficient amount of the drug or agent to provide the desired effect, i.e., reduction of intraocular pressure.

An appropriate “effective” amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation.

The term “extract”, as used herein includes any preparation obtained from plants, fruits or vegetables using an extraction method.

According to one aspect of the present invention, methods are provided for reducing intraocular pressure in a patient, preferably a human patient, comprising administering to the patient a therapeutically effective amount of at least one of an anthocyanoside, a proanthocyanidin or a combination thereof (e.g., therapeutically effective amounts of at least one anthocyanoside and at least one proanthocyanidin) until intraocular pressure is reduced. According to certain preferred embodiments, the at least one anthocyanoside and/or at least one proanthocyanidin is one or more extracts comprising one or more anthocyanosides and/or one or more proanthocyanidins, respectively.

According to some embodiments, the patient has an intraocular pressure, in at least one eye, of between 15 mm Hg to 18 mm Hg, between 18 mm Hg to 21 mm Hg, between 21 mm Hg to 25 mm Hg, or between 25 mm Hg to 30 mm Hg. According to some embodiments, the patient has an intraocular pressure, in at least one eye, of greater than 15 mm Hg, greater than 21 mm Hg, greater than 25 mm Hg, or greater than 30 mm Hg.



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stats Patent Info
Application #
US 20110046215 A1
Publish Date
02/24/2011
Document #
12863073
File Date
01/16/2009
USPTO Class
514456
Other USPTO Classes
International Class
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Drawings
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Intraocular Pressure
Proanthocyanidin
Reducing Intraocular Pressure


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