Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• • C—CHEMISTRY; METALLURGY
  • C07—ORGANIC CHEMISTRY
  • C07K—PEPTIDES
  • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
  • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
  • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
  • C07K16/2869—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
  • A61K41/0004—Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
• • 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
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
• • 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
  • A61P5/00—Drugs for disorders of the endocrine system
  • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
  • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies

Definitions

• the invention relates to medicine and can be used for the effective treatment and prevention of obesity, diabetes and other diseases accompanied by impaired glucose tolerance.
• a medicament is known from the prior art for the treatment of obesity, diabetes mellitus and other diseases accompanied by impaired glucose tolerance (see, for example, the Russian Drugs Register "Drug Encyclopedia", 14th edition, Moscow, Radar Station, 2006, p.223-226 , c. 329-332, p. 510, p. 731).
• the invention is aimed at creating an effective drug based on antibodies for the oral treatment of obesity, diabetes and other diseases accompanied by impaired glucose tolerance, without side effects, and a method for producing it in solid dosage form.
• the drug for the oral treatment of diabetes mellitus and other diseases accompanied by impaired glucose tolerance contains antibodies to the beta subunit of the insulin receptor in an activated form obtained by repeated serial dilution and external exposure according to homeopathic technology.
• the drug contains monoclonal, polyclonal, recombinant, immune or natural antibodies to the beta subunit of the insulin receptor in an activated form.
• the drug contains a mixture of various homeopathic dilutions of the antibody to the beta subunit of the insulin receptor in an activated form.
• the method of obtaining a solid dosage form for oral therapy of diabetes mellitus and other diseases accompanied by impaired glucose tolerance involves mixing an effective amount of a carrier irrigated in pseudo- fluidized bed by water-alcohol dilution of antibodies in the activated form to the beta subunit of the insulin receptor, prepared by combining multiple sequential dilutions - reducing the concentration of antibodies and external effects according to homeopathic technology, and dried at a temperature not exceeding 35 ° C, with pharmaceutically acceptable additives and the subsequent tableting the mixture by direct dry pressing.
• lactose with a particle size of from 150 to 250 is used as a carrier
• the drug prepared in accordance with the invention is a new pharmacological preparation based on antibodies, which is characterized by the presence of specific pharmacological activity, high efficiency; lack of side effects; environmental friendliness and low cost.
• the drug is prepared as follows.
• the isolated antibodies are subsequently diluted repeatedly - they reduce the concentration and are subjected to an external, usually mechanical, effect, for example, according to the homeopathic potentiation technology (see Homeopathic medicines. Description and manufacture manual, V. Schwabe, Moscow, 1967, pp. 12-38 or G. Keller, Homeopathy, M. "Medicine” 2000, part 1, pp. 37 - 40).
• a uniform decrease in concentration is made by sequentially diluting 1 volume part of the starting substance (antibodies) in 9 volume parts (for decimal dilution D) or in 99 volume parts (for hundredth dilution C) or in 999 volume parts (for sychal dilution) of a neutral solvent - distilled water and / or 70% ethyl alcohol with multiple vertical shaking of each dilution obtained and the use of mainly separate containers for each subsequent dilution until the desired dilution is obtained.
• External processing in the process of reducing the concentration can also be performed by ultrasound, electromagnetic or other physical effects.
• a mixture of various homeopathic dilutions can be used.
• the resulting dilution in the form of an aqueous or alcoholic solution can be used as a liquid dosage form for oral administration into the body (in the form of drops), or for subsequent preparation of a solid oral form.
• the granules of a neutral substance — lactose (milk sugar) introduced into the fluidized bed — are irrigated with a particle size of 150–250 ⁇ m prepared by the above-described technology, water-alcohol dilution (preferably hundred) of the activated form of antibodies to the beta subunit of the insulin receptor with simultaneous drying at a temperature not exceeding 35 0 C.
• the estimated amount of prepared "saturated” lactose is loaded into the mixer and mixed with microcrystalline cellulose, introduced in an amount of 10.0 ⁇ 15.0 mass. % of the total mass of the load. Then, “unsaturated” lactose is added to the mixture (if necessary, to reduce cost and some simplification and acceleration a technological process without reducing the effectiveness of the therapeutic effect by reducing the content of a pharmaceutical substance in a tablet: water-alcohol dilution of the activated form of antibodies) in an amount of 30–80 mass% of the total load and magnesium stearate in an amount of 0.8–1.2 mass. % of the total mass of the load, and evenly mixed.
• the obtained dry homogeneous mixture is sent to a tabletting machine, for example, tablet - Korsh press - XL 400, to form round tablets by direct dry pressing weighing 150 ⁇ 500 mg.
• the antidiabetic activity of an aqueous solution of an activated form of a rabbit polyclonal antibody to the beta subunit of the insulin receptor was studied in a model of streptozotocin-induced diabetes in outbred male rats.
• the drug was administered intragastrically at a dose of 2.5 ml / kg per rat for 50 days.
• Insulin Actrapid HM subcutaneous dose of 12 units / kg per day
• glibenclamide MP Biomedisal at a dose of 8 mg / kg per day
• Patient M 15 years old, diagnosed with type 1 diabetes mellitus, disease duration 7 years. Due to the decrease in the effectiveness of insulin therapy (prodrug insulin preparations), the following are prescribed: the activated form of monoclonal mouse antibodies to the beta subunit of the human insulin receptor (a mixture of homeopathic dilutions C12 + C30 + C200) - 1 tablet for resorption in the mouth 2 times a day . After 2 weeks of treatment, the effectiveness of insulin therapy significantly increased, as a result of which the dose of insulin was reduced from 0.5 units / kg / day to 0.3 units / kg / day. Later (after 3 months), the dose of insulin administered was reduced to 0.1 units / kg / day.
• the activated form of monoclonal mouse antibodies to the beta subunit of the human insulin receptor a mixture of homeopathic dilutions C12 + C30 + C200
• Patient D 8 years old, from 5 years old is sick with type I diabetes. The course of diabetes is rapidly progressive.
• glycemia 20 mmol / l
• human recombinant insulin at a dose of 30 units per day.
• the administration of polyclonal rabbit antibodies to the C-terminal fragment of the beta subunit of the insulin receptor (a mixture of homeopathic dilutions C12 + C30 + C200) for 2 tablets for resorption in the mouth 2 times a day was proposed, the administration of insulin was continued at a constant dose.
• glycemia decreased to 15.5 mmol / L; after 2 weeks of treatment, blood glucose levels returned to normal and remained stable.
• Example 10 Patient A., 51 years old, has been observed for a long time by an endocrinologist regarding decompensated type I diabetes mellitus with manifestations of diabetic nephropathy, neuropathy, skin lesions, and retinopathy.
• the administration of ultra-low doses of goat polyclonal antibodies to the beta subunit of the human insulin receptor (a mixture of homeopathic dilutions C12 + C30 + C200) for 1 tablet for resorption in the mouth 3 times a day is prescribed.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Organic Chemistry (AREA)
• Diabetes (AREA)
• Immunology (AREA)
• Engineering & Computer Science (AREA)
• Pharmacology & Pharmacy (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Endocrinology (AREA)
• Hematology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Epidemiology (AREA)
• Obesity (AREA)
• Biomedical Technology (AREA)
• Molecular Biology (AREA)
• Proteomics, Peptides & Aminoacids (AREA)
• Genetics & Genomics (AREA)
• Biophysics (AREA)
• Neurology (AREA)
• Biochemistry (AREA)
• Alternative & Traditional Medicine (AREA)
• Emergency Medicine (AREA)
• Microbiology (AREA)
• Mycology (AREA)
• Child & Adolescent Psychology (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Peptides Or Proteins (AREA)

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• 2007
  • 2007-05-31 EP EP07794025A patent/EP2036574A4/en not_active Withdrawn
  • 2007-05-31 MX MX2008015621A patent/MX2008015621A/es not_active Application Discontinuation
  • 2007-05-31 EA EA200802440A patent/EA200802440A1/ru unknown
  • 2007-05-31 CA CA2654408A patent/CA2654408C/en not_active Expired - Fee Related
  • 2007-05-31 EP EP11007331A patent/EP2395021A1/en not_active Withdrawn
  • 2007-05-31 BR BRPI0712540-2A patent/BRPI0712540A2/pt not_active Application Discontinuation
  • 2007-05-31 AU AU2007261782A patent/AU2007261782A1/en not_active Abandoned
  • 2007-05-31 US US12/303,648 patent/US9308259B2/en not_active Expired - Fee Related
  • 2007-05-31 KR KR1020097000197A patent/KR20090024241A/ko not_active Withdrawn
  • 2007-05-31 WO PCT/RU2007/000288 patent/WO2007149010A1/ru not_active Ceased
  • 2007-05-31 JP JP2009514226A patent/JP5687425B2/ja not_active Expired - Fee Related
• 2008
  • 2008-12-07 IL IL195755A patent/IL195755A/en active IP Right Grant
• 2016
  • 2016-02-11 US US15/041,582 patent/US20160159916A1/en not_active Abandoned
  • 2016-06-22 IL IL246402A patent/IL246402A/en active IP Right Grant

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