WO2003033020A1 - Composition et technique permettant de traiter un phenomene de cachexie apres une maladie - Google Patents

Composition et technique permettant de traiter un phenomene de cachexie apres une maladie Download PDF

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Publication number
WO2003033020A1
WO2003033020A1 PCT/US2002/033061 US0233061W WO03033020A1 WO 2003033020 A1 WO2003033020 A1 WO 2003033020A1 US 0233061 W US0233061 W US 0233061W WO 03033020 A1 WO03033020 A1 WO 03033020A1
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WO
WIPO (PCT)
Prior art keywords
weight percent
composition
applicants
amino acid
paste
Prior art date
Application number
PCT/US2002/033061
Other languages
English (en)
Inventor
Stephen E. Bachman
Michael E. Hubbert
Michael L. Galyean
Original Assignee
Ganado Research, L.L.C.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ganado Research, L.L.C. filed Critical Ganado Research, L.L.C.
Publication of WO2003033020A1 publication Critical patent/WO2003033020A1/fr

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/13—Amines
    • A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof

Definitions

  • the invention relates to an ingestible composition for oral administration to animals, including humans.
  • the ingestible composition comprises a liquid drink, drench or paste.
  • the invention further relates to a method using Applicants' composition to treat post-illness wasting phenomenon.
  • Applicants' invention comprises such an effective, easily administered, appetite-restoring, composition and method.
  • Applicants' invention includes a method to treat post-illness wasting phenomenon in animals, including humans.
  • Applicants' invention further includes a method to maintain the health of animals, including humans.
  • Applicants' methods first form an ingestible composition which includes Glutamine, Taurine, Vitamin E, Vitamin C, and Zinc. That ingestible composition is daily administered orally to the animal.
  • Applicants' ingestible composition further includes Brewers Yeast.
  • Applicants' ingestible composition further includes whey protein.
  • composition further includes an amino acid component comprising Alanine, Aspartic acid, Glutamic acid, Isoleucine, Leucine, Lysine, Phenylalanine, Serine, Threonine, Tryptophan, and Valine.
  • amino acid component further includes Arginine, Cystine / Cystine, Glycine, Histidine, Methionine, Proline, and Tyrosine.
  • Applicants' invention includes a composition and method to treat post-illness wasting phenomenon in animals, including humans.
  • Applicants' invention further includes a composition and method to maintain the health of animals, including humans.
  • Applicants' composition is prophylatically administered to animals, particularly to companion animals, to maintain an optimal level of health and well being.
  • One such embodiment for example, includes one or more gastrointestinal tract lubricants to facilitate expulsion of hair balls from feline companion animals.
  • Certain embodiments of Applicants' composition include daily required levels of vitamins and minerals, plus additional levels of zinc, vitamin E, whey, one or more nucleotides, one or more nucleosides, glutamine, taurine/taurine derivatives, and combinations thereof.
  • Alternative embodiments further include one or more flavorings at an aggregate amount of up to about ten weight percent, one or more fragrances at an aggregate amount of up to about one weight percent, one or more antibiotics at an aggregate amount of up to about fifty weight percent, one or more probiotics at an aggregate amount of up to about fifty weight percent, one or more additional vitamins at an aggregate amount of up to about twenty weight percent, one or more minerals at an aggregate amount of up to about twenty weight percent, one or more elements at an aggregate amount of up to about twenty weight percent, and combinations thereof.
  • Applicants' composition is suitable for oral administration to animals, including humans.
  • Applicants' formulation is provided in a pharmaceutically acceptable carrier with or without an inert diluent.
  • the carrier should be assimilable and edible and includes liquid, semi-solid, e.g. pastes, or solid carriers.
  • any conventional media, agent, diluent or carrier is not detrimental to the recipient animal, or to the therapeutic effectiveness of Applicants' formulation contained therein, its use in an orally administrable form for use in practicing the methods of the present invention is appropriate.
  • Examples of carriers or diluents include sugars, fats, oils, water, glycerin, saline solutions, lipids, liposomes, thickening agents, resins, binders, fillers and the like, or combinations thereof.
  • Applicants mean any compound that comprises zinc, for example zinc chloride, zinc acetate, zinc sulfate, and the like.
  • Zinc further includes polymeric compositions capable of yielding free zinc ion but which contain zinc in another form.
  • Applicants' composition contains substantially chelated zinc ion.
  • Applicants' composition includes zinc in an amount up to about two weight percent (2 wt %).
  • Vitamin E Vitamin E is known to have effects on the immune system (Coelho, 1996). Because of possible injection-site reactions, injections of vitamin E with some commercial preparations might be less desirable than dietary supplements or drenches (Galyean et al., 1991). Supplemental vitamin E in receiving diets seems to be beneficial for decreasing morbidity and improving performance. Secrist et al. (1997) pooled the results of five studies in which supplemental vitamin E was evaluated at levels of 450 to 1,600 IU/animal daily. Weighted means for daily gain tended (P ⁇ 0J4) to be increased (2.03 vs 1.76 lb/d), with no change in DMI, resulting in improved feed: gain (9 vs 12.4) with supplemental vitamin E.
  • Morbidity tended to be less (P ⁇ 0J4) with vitamin E (48 vs 55%). These five trials included steers and steers plus bulls, with initial BW ranging from 534 to 600 lb. Percentage of concentrate in diets ranged from 10 to 74. Applicants' composition includes Vitamin E in an amount up to about five weight percent (5 wt %).
  • Whey The prime difference between whey (serum lactis) and whole milk is the near absence in the former of the caseins, the casein-bound calcium and phosphate, most of the fat and the fat soluble vitamins.
  • the actual concentration in whey of "whey proteins" is usually similar to that in milk.
  • the caseins represent about eighty weight percent (80 wt %) of the total protein content of cows milk while whey proteins comprise about twenty weight percent (20 wt %).
  • the separation of the whey protein component from the caseins renders the amino acid profile and associated small peptides patterns of whey proteins unaltered by that of the caseins, once the digestive process has released free amino acids from all ingested proteins.
  • cytokines are produced by the leukocytes in response to infectious and inflammatory agents, interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor ⁇ ("TNF ⁇ ”) seem to be responsible for the effects on intermediary metabolism (Klasing, 1988).
  • IL-1 interleukin-1
  • IL-6 interleukin-6
  • TNF ⁇ tumor necrosis factor ⁇
  • PIC pro-inflammatory cytokines
  • the pathway is activated by cytokines and glucocorticoids, which might account for the lower performance of cattle treated for BRD and for the occasional wasting conditions that can occur in such cattle. Insulin inhibits the UP pathway, thereby potentially counteracting the negative effects of cytokines and glucocorticoids.
  • composition and method provide a source of carbohydrate and protein in the form of whey protein in Applicants' ingestible composition to stimulate insulin release and to decrease the negative effects of cytokines and glucocorticoids.
  • composition includes whey protein in an amount up to about sixty weight percent (60 wt %).
  • Brewer's Yeast Saccharomyces cerevisiae is a source of all the major B vitamins (except B12). It also contains other vitamins, sixteen amino acids and fourteen or more minerals.
  • Brewer's Yeast provides many B vitamins, it enhances the roles these vitamins play in the body.
  • the B-complex vitamins assist in the metabolism of carbohydrates, fats, and proteins.
  • different B vitamins play different roles, particularly in their support of the nervous system.
  • the body When under the pressures of stress or infection, the body needs greater supplies of B vitamins. The body does not store excess B vitamins, so they must be regularly consumed. B vitamins can also help relieve morning sickness.
  • Brewer's yeast is also a source of chromium. The U.S. FDA recommends 120 meg of chromium daily, but 90% of Americans are deficient in this important mineral.
  • Chromium has the ability to significantly lower blood cholesterol levels.
  • chromium is also an important supplement for those with Type II (adult onset) diabetes because it can significantly lower blood sugar levels. Without chromium, insulin is not able to work properly and blood sugar levels rise.
  • researchers have been able to lower some diabetic glucose levels to almost normal levels with daily chromium doses of 1,000 meg.
  • Applicants have found that Brewer's Yeast supplies nucleic acid moieties. Nucleotides and nucleosides in the diet seem to be important in maintenance and stimulation of cellular immunity in nonruminant species (Yamauchi et al., 1996). In ruminants, levels of nucleotides and nucleosides provided to the small intestine would typically be high because of production of microbial cells in the rumen. Cattle that succumb to BRD would have low feed intakes, potentially resulting in lower quantities of nucleotides and nucleosides being absorbed from the small intestine, thereby exacerbating the negative of low feed intake on the cellular immune system. Applicants' composition includes Brewer's Yeast in an amount up to about fifteen weight percent (15 wt %).
  • Glutamine Glutamine is currently being considered as a conditionally essential amino acid during inflammatory conditions like infection and injury of animals (Newsholme, 2001) because it seems to be required for proliferation and function of immune system cells.
  • supplemental glutamine has been beneficial for digestive tract health in young ruminants challenged by infection (Lobley et al., 2001). Muscle protein breakdown seems to be the major source of glutamine in animals under catabolic stress (Newsholme, 2001).
  • composition and method provides glutamine in an oral paste for morbid cattle to stimulate the immune system and maintain digestive tract health. Use of Applicants' composition and method is thought to decrease protein degradation and stimulate feed intake, leading to more rapid recovery from BRD.
  • composition includes glutamine in an amount up to about fifteen weight percent (15 wt %).
  • Taurine Taurine is a conditionally essential amino acid (essential in felines) that is not utilized in protein synthesis, but rather is found free or in simple peptides. Taurine has been shown to be essential in certain aspects of mammalian development, and in vitro studies in various species have demonstrated that low levels of taurine are associated with various pathological lesions, including cardiomyopathy, retinal degeneration, and growth retardation, especially if deficiency occurs during development. Metabolic actions of taurine include: bile acid conjugation, detoxification, membrane stabilization, osmoregulation, and modulation of cellular calcium levels.
  • taurine has been used with varying degrees of success in the treatment of a wide variety of conditions, including: cardiovascular diseases, hypercholesterolemia, epilepsy and other seizure disorders, macular degeneration, Alzheimer's disease, hepatic disorders, alcoholism, and cystic fibrosis. (Alt Med Rev 1998;3(2):128-136)
  • taurine was first discovered as a component of ox bile in 1827, it was not until 1975 that the significance of taurine in human nutrition was identified, when it was discovered that formula-fed, pre-term infants were not able to sustain normal plasma or urinary taurine levels. Signs of taurine deficiency have also been detected in children on long-term, total parenteral nutrition, and in patients with "blind-loop" syndrome. In vivo studies in various species have shown taurine to be essential in certain aspects of mammalian development, and have demonstrated that low levels of taurine are associated with various pathological lesions, including cardiomyopathy, retinal degeneration, and growth retardation, especially if deficiency occurs during development.
  • taurine is known to play an important role in numerous physiological functions. While conjugation of bile acids is perhaps its best-known function, this accounts for only a small proportion of the total body pool of taurine in humans. Other metabolic actions of taurine include: detoxification, membrane stabilization, osmoregulation, and modulation of cellular calcium levels. Both plasma and platelet taurine levels have been found to be depressed in insulin-dependent diabetic patients; however, these levels were raised to normal with oral taurine supplementation. In addition, the amount of arachidonic acid needed to induce platelet aggregation was lower in these patients than in healthy subjects. Taurine supplementation reversed this effect as well, reducing platelet aggregation.
  • composition includes taurine in an amount up to about six weight percent (6 wt %).
  • EXAMPLE I Table 1 summarizes the ingredients comprising one embodiment of Applicants' composition.
  • the formulation of Example I was incorporated into an oral gel.
  • the dosage used for the formulation of Example I is between about 1 to about 10 g of formulation per kilogram of body weight.
  • Applicants' method utilizes less than 1 gram of formulation per kilogram of animal body weight.
  • Applicants' method includes using more than about 10 grams of formulation per kilogram of body weight.
  • Alternative embodiments of Applicants' composition include a mixture of amino acids rather than Whey protein.
  • these embodiments of Applicants' composition have the amino acid component recited in Table 2.
  • the percentages of Table 2 comprise weight percentages of the amino acid component.
  • Applicants' composition includes the amino acid component of Table 2 in an amount up to about sixty weight percent (60 wt %).
  • Applicants' amino acid component includes Alanine, Aspartic acid, Glutamic acid, Isoleucine, Leucine, Lysine, Phenylalanine, Serine, Threonine, Tryptophan, and Valine. In certain embodiments, Applicants' amino acid component further includes Arginine. In certain embodiments, Applicants' amino acid component further includes Cystine / Cysteine. In certain embodiments, Applicants' amino acid component further includes Glycine. In certain embodiments, Applicants' amino acid component further includes Histidine. In certain embodiments, Applicants' amino acid component further includes Methionine. In certain embodiments, Applicants' amino acid component further includes Proline. In certain embodiments, Applicants' amino acid component further includes Tyrosine.
  • composition can be formed with or without binders, carriers, surfactants, buffering agents, fragrances, flavorings, dispersing agents, and the like.
  • the various components can be added in any order. Conventional mixing techniques can be used to blend the various ingredients.
  • the components are dry blended, extruded, and then formed into pellets or flakes.
  • the components of Table 1 for example, comprise ninety weight percent or more of the final composition.
  • the composition includes one or more carrier components, such as water, fats, oils, glycerin, lipids, liposomes, thickening agents, and the like.
  • the components of Table 1 for example, comprise between about fifty weight percent and about ninety weight percent of the final composition.
  • the composition comprises a paste having a bulk viscosity of about 100,000 centipoises or more.
  • the components of Table 1 for example, comprise less than about fifty weight percent of the final composition.
  • the composition comprises a paste having a bulk viscosity of less than about 100,000 centipoises.
  • Applicants' invention includes a method to maintain a healthy animal's appetite and well being.
  • Applicants' method includes feeding a healthy animal pellets or flakes formed using Applicants' composition.
  • Applicants have found it useful to include daily such pellets / flasks in an amount up to about twenty-five percent of the animal's normal daily food intake.
  • Applicants have found it efficacious to administer Applicants' composition in the form of a paste to animals recovering from, for example, an illness or surgery.
  • the viscosity of the paste can be adjusted, along with inclusion of various flavorings, to enhance the efficacy of administration.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une technique de traitement de phénomène de cachexie après une maladie chez des animaux. Cette technique consiste d'abord à former une composition comestible qui comprend de la glutamine, de la taurine, de la vitamine E, de la vitamine C et du zinc. On administre quotidiennement cette composition comestible à l'animal par voie orale. Dans certains modes de réalisation de l'invention, cette composition comestible comprend aussi des levures de bière. Dans certains modes de réalisation de l'invention, cette composition comestible comprend aussi des protéines de lactosérum. Dans certains modes de réalisation de l'invention, cette composition comestible comprend aussi un composant d'amino acides comprenant de l'alanine, de l'acide aspartique, de l'acide glutamique, de l'isoleucine, de la leicine, de la lysine, de la phénylalanine, de la sérine, de la thréonine, du tryptophan et de la valine. Dans certains modes de réalisation de l'invention, le composant d'amino acides comprend aussi de l'arginine, de la cystine/cystine, de la glycine, de l'histidine, de la méthionine, de la proline et de la tyrosine.
PCT/US2002/033061 2001-10-17 2002-10-17 Composition et technique permettant de traiter un phenomene de cachexie apres une maladie WO2003033020A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32993801P 2001-10-17 2001-10-17
US60/329,938 2001-10-17

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WO2003033020A1 true WO2003033020A1 (fr) 2003-04-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106616037A (zh) * 2016-12-20 2017-05-10 集美大学 一种石斑鱼用牛磺酸复合制剂及其应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6156355A (en) * 1998-11-02 2000-12-05 Star-Kist Foods, Inc. Breed-specific canine food formulations
US6288116B1 (en) * 1998-05-13 2001-09-11 Novartis Nutrition Ag Method of administration of a nutritional product to a person having renal failure

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6288116B1 (en) * 1998-05-13 2001-09-11 Novartis Nutrition Ag Method of administration of a nutritional product to a person having renal failure
US6156355A (en) * 1998-11-02 2000-12-05 Star-Kist Foods, Inc. Breed-specific canine food formulations

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106616037A (zh) * 2016-12-20 2017-05-10 集美大学 一种石斑鱼用牛磺酸复合制剂及其应用

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