Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
  • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
  • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/06—Antihyperlipidemics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
  • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/12—Antihypertensives

Definitions

• the invention relates generally to methods for increasing endogenous plasmalogen levels in animals and particularly to methods for increasing endogenous plasmalogen levels in animals by administering long chain polyunsaturated fatty acids (LCPUFAs) to the animals.
• LCPUFAs long chain polyunsaturated fatty acids
• Plasmalogens and their structure and use are known to skilled artisans.
• Plasmalogens are glycerol ether phospholipids wherein a glycerol moiety is bound to a 1- alkenyl ether group or a 1-alkyl ether group.
• Three major classes of plasmalogens have been identified and designated choline, ethanolamine, and serine plasmalogens.
• the chemical structure on one group of plasmalogens is shown in Figure 1 , which illustrates the ether linkage at Cl on the glycerol backbone.
• R is a hydrocarbon chain of varying length and X is choline, ethanolamine, or serine. 1 5 CH 3
• Plasmalogens are known to be associated with various diseases and conditions in animals, particularly in animals with low endogenous plasmalogen levels. Similarly, endogenous plasmalogen levels are known to decrease as an animal ages, possibly resulting in the onset of diseases and conditions adverse to the animal's health.
• US5759585 discloses the use of plasmalogens for treating neurodegenerative diseases.
• US6177476 discloses methods for replenishing plasmalogens in mammals using monoethers of glycerols and their carboxylic acid ester derivatives.
• WO08124916A1 discloses methods for the diagnosis and risk assessment of plasmalogen deficiency mediated diseases of aging, particularly colon cancer, prostate cancer, lung cancer, breast cancer, ovarian cancer, kidney cancer, cognitive impairment, and dementia.
• LCPUFAs are administered to the animal in amounts of from about 1 to about 1000 milligrams per kilogram of body weight per day (mg/kg/day), preferably from about 5 to about 500 mg/kg/day, most preferably from about 10 to about 300 mg/kg/day.
• the methods are useful for preventing or treating diseases or conditions such as metabolic syndrome, neurodegenerative disease, dementia, Alzheimer's disease, cognitive impairment, colon cancer, prostate cancer, lung cancer, breast cancer, ovarian cancer, and kidney cancer, particularly in aging animals and more particularly in aging animals that are experiencing a decrease in endogenous plasmalogen levels.
• animal means any animal that could benefit from an increase in endogenous plasmalogen levels, including avian, bovine, canine, equine, feline, hicrine, murine, ovine, and porcine animals.
• LCPUFA long chain polyunsaturated fatty acid
• plasmalogen agent means any compound, composition, or drug other than LCPUFAs useful for increasing or decreasing endogenous plasmalogen levels in animals.
• conjunction means that one or more LCPUFAs, plasmalogen agents, or other compounds or compositions are administered to an animal (1) together in a food composition or (2) separately at the same or different frequency using the same or different administration routes at about the same time or periodically.
• Periodically means that the plasmalogen agent is administered on a dosage schedule acceptable for a specific plasmalogen agent and that the LCPUFAs are administered to an animal routinely as appropriate for the particular animal.
• “About the same time” generally means that the LCPUFAs and plasmalogen agent are administered at the same time or within about 72 hours of each other.
• “In conjunction” specifically includes administration schemes wherein plasmalogen agent is administered for a prescribed period and the LCPUFAs are administered indefinitely, particularly as part of a complete and balanced food composition.
• extending the prime means extending the number of years an animal lives a healthy life and not just extending the number of years an animal lives, e.g., an animal would be healthy in the prime of its life for a relatively longer time.
• health and/or wellness of an animal means the complete physical, mental, and social well being of the animal, not merely the absence of disease or infirmity.
• the term “aging” means being of advanced age such that the animal has exceeded 50% of the average lifespan for its particular species and/or breed within a species.
• single package means that the components of a kit are physically associated in or with one or more containers and considered a unit for manufacture, distribution, sale, or use.
• Containers include, but are not limited to, bags, boxes, cartons, bottles, packages of any type or design or material, over-wrap, shrink-wrap, affixed components (e.g., stapled, adhered, or the like), or combinations thereof.
• a single package may be containers of individual plasmalogen agents and LCPUFAs or compositions containing LCPUFAs physically associated such that they are considered a unit for manufacture, distribution, sale, or use.
• kits means that the components of a kit are associated by directions on one or more physical or virtual kit components instructing the user how to obtain the other components, e.g., in a bag or other container containing one component and directions instructing the user to go to a website, contact a recorded message or a fax-back service, view a visual message, or contact a caregiver or instructor to obtain instructions on how to use the kit or safety or technical information about one or more components of a kit.
• ranges are used herein in shorthand, so as to avoid having to list and describe each and every value within the range. Any appropriate value within the range can be selected, where appropriate, as the upper value, lower value, or the terminus of the range.
• the present invention provides methods for increasing endogenous plasmalogen levels in an animal.
• the methods comprise administering to the animal an endogenous plasmalogen level increasing amount of one or more long chain polyunsaturated fatty acids (LCPUFAs).
• LCPUFAs long chain polyunsaturated fatty acids
• the invention provides methods for preventing or treating a disease or condition in an animal caused or affected by decreased plasmalogen levels.
• the methods comprise administering an endogenous plasmalogen level increasing amount of one or more LCPUFAs to an animal susceptible to or suffering from the disease or condition.
• the methods are useful for preventing or treating any disease caused or affected by decreased plasmalogen levels, as known to skilled artisans.
• the methods are useful for preventing metabolic syndrome, neurodegenerative disease, dementia, Alzheimer's disease, cognitive impairment, colon cancer, prostate cancer, lung cancer, breast cancer, ovarian cancer, and kidney cancer.
• Endogenous plasmalogen levels are decreased when they are below the average level known for an animal or species of animals. Average levels are known to skilled artisans.
• the present invention provides methods for extending the prime years of an animal's life.
• the methods comprise administering to the animal an endogenous plasmalogen level increasing amount of one or more LCPUFAs.
• the invention provides methods for promoting the health or wellness of an animal.
• the methods comprise administering to the animal an endogenous plasmalogen level increasing amount of one or more LCPUFAs.
• the methods are useful for promoting health or wellness of animals of any age or classification, including adult animals and senior animals.
• the LCPUFAs can be any LCPUFA known to skilled artisans.
• the LCPUFAs are one or more monocarboxylic acids having at least 18 carbon atoms and at least two double bonds.
• the LCPUFAs are one or more monocarboxylic acids having at least 20 carbon atoms and at least two double bonds.
• LCPUFAs include omega fatty acids such as linoleic acid 18:2 (n-6) all-cis-9,12-octadecadienoic acid; gamma-linolenic acid (GLA) 18:3 (n-6) all-cis-6,9,12- octadecatrienoic acid; eicosadienoic acid 20:2 (n-6) all-cis-l l,14-eicosadienoic acid; dihomo-gamma-linolenic acid (DGLA) 20:3 (n-6) all-cis-8,l l,14-eicosatrienoic acid; arachidonic acid (AA) 20:4 (n-6) all-cis-5,8,l l,14-eicosatetraenoic acid; docosadienoic acid 22:2 (n-6) all-cis-13,16-docosadienoic acid; adrenic acid 22:4 (n-l
• LCPUFAs can be provided as free compounds or as esters such as acylglycerols (monoacylglycerol, diacylglycerol and triacylglycerol) or glycerophospholipids (phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol or phosphatidylserine).
• acylglycerols monoacylglycerol, diacylglycerol and triacylglycerol
• glycerophospholipids phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol or phosphatidylserine.
• the LCPUFAs are administered to the animal as triacylglycerols or phospholipids derivatives.
• the LCPUFAs can be administered using any suitable method.
• the LCPUFAs are administered to an animal orally.
• the LCPUFAs are administered orally using any suitable form for oral administration, e.g., tablets, pills, suspensions, solutions (possibly admixed with drinking water), emulsions, capsules, powders, syrups, and food compositions (a confectionery for a human, a pet food composition, or a treat or flavored treat for an animal).
• the LCPUFAs are administered to the animal as part of a food composition.
• the LCPUFAs are administered as part of a complete and balanced diet.
• the LCPUFAs can be administered to an animal in any amount useful for increasing endogenous plasmalogen levels.
• LCPUFAs are administered to the animal in amounts of from about 1 to about 1000 milligrams per kilogram of body weight per day (mg/kg/day), preferably from about 5 to about 500 mg/kg/day, most preferably from about 10 to about 300 mg/kg/day.
• LCPUFAs can be administered in the diet, preferably a complete and balanced diet, in amounts of from about 1 to about 1000 grams per kilogram of diet (g/kg/diet), preferably from about 5 to about 500 g/kg/diet, most preferably from about 10 to about 300 g/kg/diet.
• plasmalogen levels are increased in various tissues and organs, as known to skilled artisans.
• plasmalogen levels are increased in brain glial cells of the animal, particularly adult and aging animals.
• plasmalogen levels are increased in plasma lipids, lipoproteins, kidney, lung, testes, skeletal muscle, heart, brain, lymphocytes, spleen, macrophages, polymorphonuclear leukocytes, retina, and erythrocytes.
• kits suitable for increasing endogenous plasmalogen levels in an animal comprise in separate containers in a single package or in separate containers in a virtual package, as appropriate for the kit component, one or more LCPUFAs and at least one of (1) one or more comestible ingredients suitable for consumption by an animal; (2) one or more plasmalogen agents; (3) instructions for how to combine two or more of the LCPUFAs, plasmalogen agents, and comestible ingredients to produce a composition suitable for consumption by an animal, particularly to produce a composition useful for increasing endogenous plasmalogen levels, preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels, extending the healthy prime years of an animal's life, or promoting the health or wellness of an animal; (4) instructions for how to administer LCPUFAs and plasmalogen agents in conjunction, particularly to produce a composition useful for increasing endogenous plasmalogen levels, preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels, extending the healthy prime
• the kit comprises a virtual package
• the kit is limited to instructions in a virtual environment in combination with one or more physical kit components.
• the kit contains LCPUFAs and other components such as plasmalogen agents in amounts sufficient for increasing endogenous plasmalogen levels in an animal.
• the kits may contain the kit components in any of various combinations and/or mixtures.
• the kit contains a packet containing one or more LCPUFAs and a container of food for consumption by an animal, e.g., a dog or cat food or an animal treat.
• the kit contains a packet containing one or more LCPUFAs and a plasmalogen agent.
• the kit contains a packet containing one or more LCPUFAs, a plasmalogen agent, and a container of food for consumption by an animal.
• the foods, plasmalogen agents, and LCPUFAS are admixed just prior to consumption.
• the kit may contain additional items such as a device for mixing LCPUFAs, plasmalogen agents, or comestible ingredients or a device for containing the admixture, e.g., a spoon and a food bowl.
• the invention provides a means for communicating information about or instructions for one or more of (1) using LCPUFAs for increasing endogenous plasmalogen levels in an animal; (2) using LCPUFAs for preventing or treating a disease or condition in an animal caused or affected by decreased plasmalogen levels, e.g.
• metabolic syndrome neurodegenerative disease, dementia, Alzheimer's disease, cognitive impairment, colon cancer, prostate cancer, lung cancer, breast cancer, ovarian cancer, and kidney cancer; (3) using LCPUFAs for extending the prime years of an animal's life; (4) using LCPUFAs for promoting the health or wellness of an animal; (5) admixing LCPUFAs with one or more comestible ingredients, particularly to produce a composition useful for increasing endogenous plasmalogen levels, preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels, extending the healthy prime years of an animal's life, or promoting the health or wellness of an animal; and (6) using LCPUFAs in conjunction with one or more plasmalogen agents for increasing endogenous plasmalogen levels, preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels, extending the healthy prime years of an animal's life, or promoting the health or wellness of an animal.
• the means comprises one or more of a physical or electronic document, digital storage media, optical storage media, audio presentation, audiovisual display, or visual display containing the information or instructions.
• the means is selected from the group consisting of a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a handout, a public announcement, an audiotape, a videotape, a DVD, a CD- ROM, a computer readable chip, a computer readable card, a computer readable disk, a USB device, a Fire Wire device, a computer memory, and any combination thereof.
• Useful information includes one or more of (1) methods and techniques for combining and administering LCPUFAs, plasmalogen agents, comestible ingredients, and other kit components and (2) contact information for animals or their caregivers to use if they have a question about the invention and its use.
• Useful instructions include amounts for mixing and administration amounts and frequency, e.g., dosages.
• the communication means is useful for instructing on the benefits of using the present invention and communicating the approved methods for administering the invention to an animal.
• the present invention provides packages comprising one or more LCPUFAs or a material suitable for containing one or more LCPUFAs and a label affixed to the package containing a word or words, picture, design, acronym, slogan, phrase, or other device, or combination thereof, that indicates that the contents of the package contains compounds that are useful for increasing endogenous plasmalogen levels, preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels, extending the healthy prime years of an animal's life, or promoting the health or wellness of an animal.
• such device comprises the words “increases endogenous plasmalogen levels” or “useful for preventing or treating diseases or conditions in an animal caused or affected by decreased plasmalogen levels” or an equivalent expression printed on the package.
• Any package or packaging material suitable for containing dog food is useful in the invention, e.g., a bag, box, bottle, can, pouch, and the like manufactured from paper, plastic, foil, metal, and the like.
• the package further comprises one or more plasmalogen agents.
• the package contains a food composition comprising LCPUFAs and a plasmalogen agent, preferably for administration to a companion animal.
• the invention provides compositions useful for increasing endogenous plasmalogen levels in an animal comprising one or more LCPUFAs in amounts sufficient for increasing endogenous plasmalogen levels in an animal.
• the composition comprises LCPUFAs in amounts sufficient to administer LCPUFAs to the animal in amounts of from about 1 to about 1000 mg/kg/day, preferably from about 5 to about 500 mg/kg/day, most preferably from about 10 to about 300 mg/kg/day.
• the animal is a human or companion animal.
• the companion animal is a canine such as a dog or a feline such as a cat.
• the animal is an aging animal, particularly an aging animal suffering from or susceptible to diseases or conditions that are characteristic of aging.
• DHA means docosahexaenoic acid
• DHA-TG means docosahexaenoic containing triacylglycerols
• DHA-PL means docosahexaenoic containing phospholipids
• DMA means dimethylacetate
• PE means phosphatidylethanolamine.
• the control diet did not contain DHA or other LCPUFAs while the DHA-TG and DHA-PL groups contained the same level of DHA added in these diets as triacylglycerols (fish oil) or phospholipids (Krill Oil). After a weaning period (21 days after birth), all the neonates were fed a DHA free diet.
• DMA Dimethylacetate
• PE Phosphatidylethanolamine
• DMA Dimethylacetate
• DMA Dimethylacetate

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• Health & Medical Sciences (AREA)
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• Public Health (AREA)
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• Medicinal Chemistry (AREA)
• Veterinary Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Diabetes (AREA)
• Epidemiology (AREA)
• Neurosurgery (AREA)
• Neurology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Obesity (AREA)
• Emergency Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Cardiology (AREA)
• Urology & Nephrology (AREA)
• Hospice & Palliative Care (AREA)
• Vascular Medicine (AREA)
• Psychiatry (AREA)
• Endocrinology (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Fodder In General (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Feed For Specific Animals (AREA)
• Coloring Foods And Improving Nutritive Qualities (AREA)

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• 2009
  • 2009-12-30 EP EP09836535A patent/EP2373161A4/en not_active Withdrawn
  • 2009-12-30 US US13/138,066 patent/US20110275600A1/en not_active Abandoned
  • 2009-12-30 RU RU2011132386/13A patent/RU2011132386A/ru not_active Application Discontinuation
  • 2009-12-30 WO PCT/US2009/006749 patent/WO2010077358A1/en not_active Ceased
  • 2009-12-30 MX MX2011007188A patent/MX2011007188A/es not_active Application Discontinuation
  • 2009-12-30 CN CN2009801536386A patent/CN102271502A/zh active Pending
  • 2009-12-30 JP JP2011544414A patent/JP2012514597A/ja active Pending
  • 2009-12-30 AU AU2009333809A patent/AU2009333809A1/en not_active Abandoned
  • 2009-12-30 CA CA2747582A patent/CA2747582A1/en not_active Abandoned
• 2011
  • 2011-08-01 ZA ZA2011/05665A patent/ZA201105665B/en unknown

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