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
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/716—Glucans
  • A61K31/722—Chitin, chitosan
• • 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
  • A61P3/04—Anorexiants; Antiobesity agents
• • 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
  • A61P9/00—Drugs for disorders of the cardiovascular system
  • A61P9/12—Antihypertensives
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
  • C08L5/08—Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Definitions

• the present invention relates to compositions comprising chitosan, in the form of a drug or food supplement, suitable for the comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome.
• syndrome X Various names have been proposed for the new syndrome, such as syndrome X,
• Reaven's syndrome (the first person to identify insulin resistance), metabolic, multiple metabolic, plurimetabolic, dysmetabolic, cardiovascular dysmetabolic and cardiometabolic syndrome, or, without the term syndrome, naming it "H phenomenon” or even "deadly quartet". Differences in its name still exist.
• a tentative therapy has been proposed for MS using oral hypoglycemics (thiazolidenediones or metformin), the activities of which are awaiting confirmation. They are, however, targeted at alterations in glycemia and insulin sensitivity alone, these being pathologies which represent only a part of MS. Therefore, the problem is of comprehensively treating the pathologies involved in the metabolic syndrome with a single therapy.
• the present invention relates to compositions comprising chitosan, in the form of a drug or food supplement, which are suitable for comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome. Also described is their preparation.
• the invention concerns the use of chitosan for comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome.
• the metabolic syndrome (MS) an association of pathologies, which are diagnosed together according to the ATP III 2005 classification, and possibly attributable to a single aetiological cause.
• To be classified as MS at least three of the following parameters must be positively assessed in the patient: a) Waist circumference greater than 102 cm in men and greater than 88 cm in women b) Triglyceride level over 150 mg/dL c) HDL cholesterol level less than 40 mg/dL in men and less than 50 mg/dL in women d) Arterial blood pressure equal to or greater than 130/85 mm Hg e) High basal fasting glucose (over 1 10 mg/dL), or altered glucose load curve.
• the present invention relates to compositions, comprising chitosan, in the form of a drug or food supplement, suitable for comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome (MS).
• compositions or food supplements can be prepared which are suitable for comprehensive therapeutic treatment or comprehensive prevention of MS pathologies, classified in accordance with ATP III 2005 criteria.
• chitosan has been found to induce a reduction in basal glucose levels to less than 1 10 mg/dL, as well as a reduction in arterial blood pressure to less than 130/85 mm Hg.
• compositions can also contain, in addition to chitosan, lubricants, such as magnesium stearate, and other excipients such as tartaric acid and/or adjuvants and/or flavourings.
• lubricants such as magnesium stearate
• other excipients such as tartaric acid and/or adjuvants and/or flavourings.
• the compositions can also contain other antioxidants.
• compositions of the present invention also preferably comprise ascorbic acid in a quantity between 1 % and 10% by weight on the chitosan present, and even more preferably between 4% and 8% by weight.
• compositions can be prepared in any pharmaceutically acceptable form, of which the tablet form is preferred, but any administration means is possible and can be considered.
• the quantity of chitosan in the compositions is variable and depends on dosage: preferably the unit doses contain chitosan in quantities between 0.1 g and 1.5 g, more preferably between 0.25 g and 1 g and even more preferably between 400 and 600 mg.
• a further aspect of the present invention is a process for preparing a pharmaceutical composition or a food supplement, suitable for comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome, by means of blending chitosan with suitable excipients or diluents or with suitable substances having complementary activity. All known methods for preparing the various compounds in drugs or food supplements by means of blending can be used. Methods for preparing tablets, in particular tablets containing ascorbic acid and magnesium stearate, are preferred.
• a further aspect of this invention concerns the use of chitosan for preparing a drug or a food supplement suitable for comprehensive therapeutic treatment or comprehensive prevention of the metabolic syndrome.
• the use of chitosan enables basal glucose levels to be reduced to less than 110 mg/dL and arterial blood pressure to be reduced to less than 130/85 mm Hg, as well as body weight and cholesterol levels to be reduced.
• Example 1 Clinical studies to evaluate the effect of a tablet containing chitosan on the pathologies that making up the metabolic syndrome
• BMI body mass index
• Table 1 describes the general characteristics of the enrolled patients who completed the treatment.
• MS the metabolic syndrome according to ATP III 2005 criteria
• Mn BP Minimum arterial blood pressure
• Each tablet of the product contained 500 mg of a mixture composed of 91 % chitosan (characteristics given in table 3), 6% ascorbic acid and
• this composition was called polyglucosamine, or PG (a term used in all experimental trials on body weight and dyslipidemia under study and/or in print).
• PG a term used in all experimental trials on body weight and dyslipidemia under study and/or in print.
• the tablets were consumed to the extent of 2 tbts/meal with half a glass of water 30 minutes before main meals. Therefore the daily dosage was 2g/day.
• Table 4 Comparison of parameters and differences between patients with and

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medicinal Chemistry (AREA)
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• General Health & Medical Sciences (AREA)
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• Animal Behavior & Ethology (AREA)
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• Pharmacology & Pharmacy (AREA)
• Diabetes (AREA)
• General Chemical & Material Sciences (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Obesity (AREA)
• Polymers & Plastics (AREA)
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• Child & Adolescent Psychology (AREA)
• Endocrinology (AREA)
• Emergency Medicine (AREA)
• Cardiology (AREA)
• Heart & Thoracic Surgery (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Coloring Foods And Improving Nutritive Qualities (AREA)
• Medicinal Preparation (AREA)

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• 2006
  • 2006-03-03 IT IT000384A patent/ITMI20060384A1/it unknown
• 2007
  • 2007-03-02 EP EP07726617A patent/EP1996207B1/en active Active
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