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  • 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
• • A—HUMAN NECESSITIES
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  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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• • A—HUMAN NECESSITIES
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  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/16—Inorganic salts, minerals or trace elements
  • A23L33/165—Complexes or chelates
• • 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
  • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• • 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
  • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
• • 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
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
  • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
  • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• • 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
  • A61P25/06—Antimigraine agents
• • 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
  • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• • 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
  • A61P25/20—Hypnotics; Sedatives
• • 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
  • A61P25/22—Anxiolytics
• • 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
  • A61P25/24—Antidepressants
• • 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
  • A61P3/04—Anorexiants; Antiobesity agents
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
  • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

• the present invention relates generally to a method for increasing serotonin levels in a person.
• the present invention also relates to compositions that, when administered to a person, increase serotonin levels in the person.
• Serotonin (or 5-hyckoxytryptarnine, 5HT) is a neurotransmitter believed to be involved a wide range of mental and physical functions in the body, including sleep, mood, and eating behavior. Serotonin deficiency has been implicated in a variety of conditions, including depression, low energy, anxiety, affective disorder, obsessive-compulsive behavior, overeating, insomnia, schizophrenia, migraine headaches and bulimia. It is well established that serotonin and peptides such as neuropeptide Y are involved in the regulation of eating behavior. Increased brain levels of serotonin have been linked with appetite suppression in preclmical experiments in animals and in clinical studies with human patients. These conditions can be resolved or improved dramatically when serotonin levels of the affected person are increased.
• serotonin selective re-uptake inhibitors e.g., fluoxetine
• compounds promoting production of serotonin e.g., St. John's Wort
• compounds inhibiting the degradation of serotonin e.g., monoamine oxidase inhibitor antidepressants.
• Figure 1 is a graphical representation of the effect of exposure to (-)- hydroxycitric acid (HCA) on the release of radiolabeled serotonin from isolated, superfused, rat brain cortex slices. Stimuli were applied as follows: potassium chloride (K+, 50 mM) standard response at fractions 5 and 6 (Sj) and HCA at fractions 13 and 14 (S 2 ). Fractions of the superfusate were collected at 6-minute intervals and analyzed for radioactivity as described herein.
• K+, 50 mM potassium chloride
• Sj standard response at fractions 5 and 6
• S 2 Fractions of the superfusate were collected at 6-minute intervals and analyzed for radioactivity as described herein.
• Figure 2 is a graphical representation of the effect of exposure to (-)- hydroxycitric acid (HCA) on radiolabeled serotonin release from isolated, superfused rat brain cortex: control (K+) and in the presence of HCA (10 ⁇ M - 1 mM). Vertical bars represent means ⁇ S.E.M. The number of observations is in parenthesis.
• HCA hydroxycitric acid
• Figure 3 is a graphical representation of the increase in serum serotonin level, increase in loss of body weight, and increase in unconsumed food observed in persons treated using methods of the present invention: control (placebo), (-)-hydroxycitric acid (HCA), and HCA plus chromium and gymnemic acid (HCA+).
• the present invention resides in a method for increasing serotonin levels in a person, comprising identifying a person having or at risk for having a deficient serum serotonin levels, and administering to the person a composition incorporating an amount of (-)-hydroxycitric acid effective to increase the serotonin levels of the person.
• the amount of (-)-hydroxycitric acid administered is effective in increasing the serotonin levels in the person sufficient to suppress the appetite of or alleviate mood disorders in the person.
• mood disorders preferably alleviated include depression, anxiety, affective disorders, premenstrual dysphoria, insomnia, sleep-wake disturbances, binge eating, bulemia and obsessive- compulsive disorders.
• the amount of (-)-hydroxycitric acid administered also may preferably be effective to increase serotonin levels in the person sufficient to increase energy expenditure by the person, or to promote decrease of the person's body weight.
• the method preferably incorporates administration of an extract of Garcinia cambogia as a source of the (-)-hydroxycitric acid.
• the amount administered preferably is between about 2,700 and about 2,800 mg of (-)- hydroxycitric acid per day, in three approximately equal increments, preferably between about 45 and 60 minutes prior to comsumption of a meal.
• Preferred methods also incorporate administering an amount of chromium sufficient, in combination with the (-)-hydroxycitric acid, to increase serum serotonin level in the person, in a preferred daily dose of 400 meg.
• This chromium preferably is in the form of an niacin-bound, and more preferably oxygen-coordinated, niacin-bound, chromium.
• Preferred methods also incorporate administering an amount gymnemic acid sufficient, in combination with the (-)-hydroxycitric acid, to increase serum serotonin level, in a preferred daily dose of 100 mg.
• the preferred source of gymnemic acid is an extract of Gymnema sylvestre.
• the present invention also resides in a composition incorporating hydroxycitric acid, niacin-bound chromium, and gymnemic acid, in the preferred individual dosages discussed above (i.e., between about 900 and 930 mg (-)- hydroxycitric acid, about 133 meg chromium, and about 33 mg gymnemic acid).
• Preferred compositions consist essentially of an extract of Garcinia cambogia, an extract of Gymnema sylvestre, and niacin-bound chromium, preferably in amounts to provide the amounts of hydroxycitric acid, niacin-bound chromium, and gymnemic acid discussed above (i.e., between about 1,500 and 1,550 mg of
• the composition may be in the form of a pill, tablet, capsule, powder, lozenge, or gum, or liquid.
• the composition also may be in the form of a food or beverage, such as a food bar or shake.
• the present invention resides in a method for increasing serotonin levels in persons and alleviating various conditions linked to serotonin deficiency in those persons.
• the method includes identifying a person who is or is at risk for having deficient serotonin levels and administering to the person a composition comprising a salt of (-)hydroxycitric acid (HCA) in an amount effective to alleviate the deficiency.
• HCA salt of (-)hydroxycitric acid
• the present invention also resides in a composition comprising HCA, chromium, and gymnemic acid, preferably as a composition consisting essentially of preferred sources of HCA, chromium, and gymnemic acid. Ingestion of a salt of ( ⁇ )hydroxycitric acid is known to suppress appetite, inhibit fat production and decreases body weight in animals and persons.
• HCA has been shown to reduce food intake in experimental animals, suggesting a role for this agent in the treatment of obesity.
• HCA is a competitive inhibitor of ATP-citrate lyase, an extra-mitochondrial enzyme involved in the initial steps of de novo lipogenesis. Consequently, HCA reduces the transformation of citrate into acetyl coenzyme A, a step necessary for the formation of fatty acids in the liver.
• HCA In the presence of HCA, there is increased production of hepatic glucogen, which has been believed to activate glucoreceptors leading to a sensation of fullness and reduced appetite. This mechanism of appetite suppression, however, has never been proven. It also has been shown that HCA-induced increases in energy expenditure may account, at least in part, for the observed inhibitory effect of this anorectic agent on body weight gain in rats.
• a preferred known composition incorporating HCA for use in the methods of the present invention is an extract of the Garcinia cambogia fruit containing approximately 60% calcium/potassium salt of (-)hydroxycitric acid, marketed under the name Super CitriMaxTM by InterHealth Nutraceuticals of Benicia, California.
• This extract is highly soluble in water, and it is readily absorbed and retained by persons. Studies have shown that blood levels of the extract increase for at least 2 hours and remained in the blood for more than 4 to 9 hours after ingestion. Studies also show that eating a full meal shortly after consuming the extract reduced its absorption by about 60%. Thus, it is recommended that compositions containing the extract be taken at least 30 to 60 minutes before meals to provide maximum efficacy.
• compositions comprising chromium, gymnemic acid, or both of these. It has been surprisingly determined that consumption by persons of HCA in combination with these compounds provides for even greater increases in serotonin levels than consumption of HCA alone.
• Chromium incorporated into the compositions used in the method of the present invention preferably is in an oxygen-coordinated, niacin-bound form.
• This form of chromium is known to be more bioavailable and biologically active that other known forms.
• a preferred source of this chromium is described in U.S.
• Patent Nos. 4,934,855, 4,954,492, and 5,194,615 and is supplied by InterHealth Nutraceuticals, marketed under the name ChromeMate®. ChromeMate® has been shown to promote weight loss and loss of body fat in persons ingesting it, with no adverse effects observed from this ingestion. No prior studies on chromium, however, have determined or suggested increases in serotonin levels from ingestion of chromium, either alone or in combination with other compounds.
• Gymnemic acid has been shown to increase the production of insulin by stimulating the production of new insulin-promoting "beta-cells" cells in the pancreas. Gymnemic acid also facilitates insulin release from the beta-cells into the blood stream by increasing beta-cell membrane permeability, and inhibits the absorption of sugar molecules in the intestines during digestion, thus reducing increases in blood sugar levels.
• a preferred source of gymnemic acid in compositions used with the method of the present invention is Gymnema sylvestre extract supplied by InterHealth Nutraceuticals of Benicia, California. Gymnema sylvestre is a traditional Ayurvedic herb that is known to play a role in weight control by helping to promote normal blood sugar levels and reduce sugar cravings. Gymnema sylvestre also has also been shown to lower cholesterol in animal models. Despite its known properties, gymnemic acid or the Gymnema sylvestre previously have not been determined to affect serotonin levels in persons ingesting them.
• composition 2,800 mg of HCA daily.
• Preferred administration of the composition is orally, in three daily doses roughly 30 to 60 minutes before meals.
• Additional preferred methods include administration of a composition further incorporating approximately 100 mg of gymnemic acid, or approximately 400 meg of chromium, or both of these. As discussed above, the preferred source of gymnemic acid is
• Gymnema sylvestre extract Approximately 400 mg of Gymnema sylvestre extract serves as a source of 100 mg of gymnemic acid.
• the preferred source of chromium is ChromeMateTM, the oxygen-coordinated, niacin-bound chromium previously discussed. Approximately 4 mg of ChromeMateTM serves as a source of 400 meg of chromium.
• Methods of the present invention also include administration of compositions incorporating inert ingredients or diluents, such as sugar or other inert ingredients commonly used in food products.
• the composition administered may be in various forms commonly used for dietary supplements, including pill, tablet, capsule, powder, lozenge, gum, or liquid.
• the step of adn ⁇ tistering can include administering the compositions as part of functional foods and beverages, including bars, shakes, drinks, and other processed or prepared foods or beverages.
• HCA HCA
• Super CitriMaxTM Radiolabeled serotonin was purchased from NEN Life Sciences, Boston, MA.
• the Krebs solution used had the following composition (millimolar): potassium chloride, 4.8; sodium chloride 118; calcium chloride, 1.3; potassium dihydrogen phosphate, 1.2; sodium bicarbonate, 25; magnesium sulfate, 2.0; and dextrose, 10 (pH 7.4).
• tissue were rinsed, mounted between nylon mesh-cloth and placed in thermostatically-controlled superfusion chambers. Tissues were superfused at a rate of 0.5ml/min with oxygenated Krebs solution containing clontipramine (10 ⁇ M), a serotonin reuptake inhibitor. Fractions of the superfusate were collected at 6-minute intervals, and 3 -ml aliquots of each fraction was combined with 12 ml of aqueous scintillation cocktail marketed under the name Ecolume, by ICN Radiochemicals of California) and analyzed for radioactivity by liquid scintillation spectrometry.
• aqueous scintillation cocktail marketed under the name Ecolume, by ICN Radiochemicals of California
• Both K+ and HCA-induced radiolabeled serotonin release were estimated by subtraction of the extrapolated basal tritium efflux from total tritium release in the 20-minute period after the onset of stimulation. Basal (unstimulated) tritium efflux was assumed to decline linearly between pre-stimulation and post- stimulation fractions. Stimulation-evoked radiolabeled serotonin release during S x and S 2 was determined graphically, and the ratio of the two peaks (SJS ⁇ was calculated and compared with untreated control preparations.
• Results obtained were expressed as absolute S ⁇ /S 2 ratios. Data from different experiments (control and test) were pooled and then subjected to statistical analysis. Except where indicated otherwise, values given are arithmetic means ⁇ SEM. Significance of difference between control and test values was evaluated using analysis of variance (ANOVA) followed by Dunnett's test . Differences with ANOVA.
• HCA hypoxia-sensitive serotonin
• concentration-related increase in basal efflux of radiolabeled serotonin reaching a maximum at 300 ⁇ M ( Figure 2).
• the overflow of radiolabeled serotonin induced by the maximal concentration of HCA (300 ⁇ M) was equivalent to the release induced by the standard concentration of K+ (50 mM).
• HCA alters the release and/or availability of serotonin in the brain slices, specifically by increasing the release of serotonin from neuronal stores in the brain cortex in a concentration-dependent fashion.
• Exposure of the rat brain cortex slices to different concentrations of HCA had no significant effect on K+-depolarization evoked release of radiolabeled serotonin.
• HCA increased the basal release of tritium-labeled 5-HT in a concentration-dependent fashion.
• the maximal effect caused by HCA on radiolabeled serotonin release was equivalent to responses elicited by the K+ depolarizing stimuli.
• HCA may act via a "reserpine-like" or "t ramine-like” action to increase the efflux of radiolabeled pools of 5-HT in the brain cortex.
• a reserpine-like action may involve HCA induced interference with the storage of radiolabeled serotonin in vesicles whereas, a tyramine-like effect could involve vesicular release of radiolabeled serotonin in a non-exocytoxic manner.
• HCA may act to prevent the reuptake of released radiolabeled serotonin, resulting in an increased efflux of this amine into the superfusate.
• compositions within the scope of the present invention were tested.
• a double-blind, placebo-controlled human clinical trial was conducted using a composition incorporating: the HCA extract described above, or the HCA extract in combination with an oxygen-coordinated niacin-bound chromium (ChromeMate®, supplied by InterHealth), and a standardized Gymnema sylvestre extract (also supplied by InterHealth).
• ChromeMate® oxygen-coordinated niacin-bound chromium
• Gymnema sylvestre extract also supplied by InterHealth
• the subjects were randomly divided into three groups. The first group was given a placebo. The second group was given a daily dose of 4,667 mg of garcinia cambogia extract (providing 2,800 mg HCA per day). The third group was given a daily dose of 4,667 mg of a combination of garcinia cambogia (2,800 mg HCA), 4 mg of niacin-bound chromium (providing 400 meg of elemental chromium), and 400 mg of Gymnema sylvestre extract (providing 100 mg gymnemic acid). The subjects received their respective compositions in three equally-divided doses 30 to 60 minutes before breakfast, lunch and dinner for eight weeks. These dosage levels of HCA were determined by extrapolation of successful earlier animal trials, as well as review of optimal micromolar concentrations of HCA in ex vivo brain tissue resulting in maximum serotonin release.
• combining consumption of HCA with oxygen-coordinated niacin-bound chromium (incorporating elemental chromium), and Gymnema sylvestre extract (incorporating gymnemic acid), provides for increased efficacy of the method, increasing serum serotonin levels greater than consumption of HCA alone, further improving alleviation of the negative conditions discussed above.
• Administration of the three compounds works synergistically to substantially increase serotonin levels in persons consuming the compounds.

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