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WO2025071432A1 - Agent pharmaceutique pour le traitement de maladies arthrosiques - Google Patents

Agent pharmaceutique pour le traitement de maladies arthrosiques Download PDF

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Publication number
WO2025071432A1
WO2025071432A1 PCT/RU2024/050081 RU2024050081W WO2025071432A1 WO 2025071432 A1 WO2025071432 A1 WO 2025071432A1 RU 2024050081 W RU2024050081 W RU 2024050081W WO 2025071432 A1 WO2025071432 A1 WO 2025071432A1
Authority
WO
WIPO (PCT)
Prior art keywords
chondroitin sulfate
sodium chondroitin
iron
solution
treatment
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/RU2024/050081
Other languages
English (en)
Russian (ru)
Inventor
Николай Наумович Беленький-Гордонов
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Obshestvo S Ogranichennoi Otvetstvennostiu <<diamed Farma>>
Original Assignee
Obshestvo S Ogranichennoi Otvetstvennostiu <<diamed Farma>>
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
Priority claimed from RU2023124931A external-priority patent/RU2813891C1/ru
Application filed by Obshestvo S Ogranichennoi Otvetstvennostiu <<diamed Farma>> filed Critical Obshestvo S Ogranichennoi Otvetstvennostiu <<diamed Farma>>
Publication of WO2025071432A1 publication Critical patent/WO2025071432A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/295—Iron group metal compounds
    • 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
    • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • 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
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis

Definitions

  • the invention relates to the field of medicine, in particular to medicinal products for the treatment of arthrological diseases.
  • the course of treatment is 3-4 weeks (10-14 intramuscular injections every other day).
  • the medicinal product "Khonsat solution for intramuscular injection”.
  • the drug is administered intramuscularly at 1 ml (100 mg) every other day. If well tolerated the dose is increased to 2 ml (200 mg), starting with the fourth injection.
  • the course of treatment is 25-30 injections. If necessary, repeated courses can be carried out after 6 months.
  • the medicinal product "ARTRAVIR-TRIVIUM solution for intramuscular injection”. Administer intramuscularly 100 mg (1 ml) every other day. If well tolerated, the dose is increased to 200 mg (2 ml), starting with the fourth injection. The course of treatment is 25-30 injections. If necessary, repeat courses can be carried out after 6 months.
  • the disadvantages of such drugs include similar side effects - allergic reactions (skin itching, erythema, urticaria, dermatitis, edema), hemorrhages at the injection site. And since the above drugs have a long course of treatment (at least 25 injections), this inevitably leads to an increase in the number of these side effects. In addition, long courses are not convenient for patients, since it is necessary to visit treatment rooms for at least 25 days, not all medical specialists are trained to do these injections, especially intra-articular ones. This leads to the fact that patients do not undergo full courses of treatment, significantly reducing the effectiveness of the treatment. Also, for all the listed drugs, repeated courses are required at least 6 times a year, which also creates difficulties for patients or leads to reluctance to continue further treatment.
  • Iron helps support many important functions of the body, affecting the level of vital energy, concentration, gastrointestinal processes, the immune system and regulation of body temperature. Its deficiency or excess immediately affects well-being. Iron is an important component of hemoglobin, which consists of red blood cells (erythrocytes). Hemoglobin contains about two-thirds of the iron in the body. It combines with oxygen, and red blood cells carry it from the lungs throughout the body. This mineral is also a part of many elements responsible for cholesterol metabolism, the conversion of calories into energy, the fight against toxins, and is involved in the process of stopping inflammatory processes. Thanks to iron, the immune system copes with its functions better, and red blood cells use it to send carbon dioxide to the lungs for processing.
  • red blood cells use it to send carbon dioxide to the lungs for processing.
  • Iron metabolism disorders can have a variety of clinical manifestations, including anemia (a decrease in the concentration of hemoglobin and / or the number of red blood cells in the blood)) and hemochromatosis (a hereditary disease that leads to the accumulation of iron in tissues).
  • Iron in the human body is a component of many enzymes and proteins that are necessary for metabolic processes - the destruction and utilization of toxins, cholesterol metabolism, and the conversion of calories into energy. It also helps the body's immune system cope with aggressors.
  • a dose of elemental iron not exceeding 20 mg / kg of weight is non-toxic, from 20 to 60 mg / kg of weight is slightly toxic and moderately toxic, and > 60 mg / kg of weight can cause symptoms of severe poisoning.
  • iron compounds are used in medicine. For example, ferrous sulfate, ferrous fumarate, ferrous hydroxide, ferrous gluconate, ferrous pyrophosphate and others. All iron compositions are well known to specialists and are commercially available.
  • “Ferrovit” tablets Vitamin and mineral complex. Contains iron in the form of iron sulfate, folic acid and vitamin B 12. Used as a preventive measure for conditions accompanied by an increased need for vitamins and iron.
  • Feroplex dragee Contains iron in the form of iron sulfate, vitamins B 12, C and folic acid. Used to treat and prevent iron deficiency anemia.
  • “Ferroglobin” capsules Contains iron in the form of iron fumarate, folic acid and vitamins B6 and B 12. Prescribed for: iron-, folic- and B 12-deficiency anemia caused by prolonged bleeding (including blood loss due to surgical operations); diets and impaired absorption of iron from the gastrointestinal tract; to improve physical development;
  • “Maltofer” tablets Contains iron hydroxide. Used to treat anemia caused by iron deficiency, as well as to prevent iron deficiency.
  • Totema solution for oral administration Contains iron gluconate dihydrate, manganese, copper. Used for the prevention and treatment of iron deficiency anemia.
  • Standard Forte capsules Contains iron pyrophosphate. Used as a dietary supplement as prescribed by a doctor for various iron deficiency conditions.
  • Ferum Lek solution for intramuscular injection. Contains iron hydroxide. Used to treat anemia.
  • the objective of the present invention is to eliminate the disadvantages inherent in the known sodium chondroitin sulfate agents described above.
  • the objective of the present invention is to develop a product with sodium chondroitin sulfate in the form of solid, soft and liquid forms for the treatment of arthrological diseases, containing essential fatty acids and possessing high efficiency, which include the active substance - sodium chondroitin sulfate.
  • the set tasks are solved by creating a means for treating arthrological diseases, including an effective amount of sodium chondroitin sulfate and at least one auxiliary substance or carrier, characterized in that it additionally contains iron in a relative amount from 1 mg/kg to 40 mg/kg, based on the mass of the active substance - sodium chondroitin sulfate.
  • the technical result of the present invention consists in the high efficiency of the agent, high regeneration and acceleration of growth of cartilage tissue and an increase in the thickness of cartilage. It has been found that the introduction of a certain amount of iron into the compositions containing sodium chondroitin sulfate leads to a reduction in the course of treatment, an increase in the rate of cartilage tissue regeneration and a reduction in side effects.
  • the use of the agent according to the invention leads to the normalization of metabolic processes, acceleration of the removal of edema in case of injuries and/or injections and a high process of tissue regeneration in the area of injury and/or injection, and improvement of tissue blood supply.
  • iron is understood to mean elemental (atomic) iron in divalent or trivalent form as part of various chemical compounds used for the manufacture of medicines and biologically active additives.
  • the choice of a specific iron compound is determined by the specific dosage form.
  • the amount of iron compound used in the composition of the product is determined by the required amount of iron per kg of sodium chondroitin sulfate and can be calculated by a specialist.
  • the agent according to the present invention includes iron in a relative amount from 1 mg/kg to 40 mg/kg based on the weight of the active substance - sodium chondroitin sulfate.
  • the proposed iron concentrations are suitable for the tasks at hand.
  • the claimed product includes an effective amount of sodium chondroitin sulfate.
  • An effective amount is an amount that has a therapeutic effect.
  • the amount of sodium chondroitin sulfate in the product can range from 50 mg to 2500 mg.
  • the amount of sodium chondroitin sulfate in the product can range from 300 mg to 1500 mg.
  • the amount of sodium chondroitin sulfate in the product can range from 500 mg to 1200 mg.
  • the amount of sodium chondroitin sulfate in the product can range from 50 mg to 250 mg.
  • the amount of sodium chondroitin sulfate in the product can range from 50 mg to 150 mg.
  • the amount of sodium chondroitin sulfate in the product can range from 400 mg to 900 mg.
  • a product made in the form of a cream, gel or ointment may contain one or more essential oils selected from the group: dimethyl sulfoxide, propylene glycol, carbomer, trolamine, macrogol, edetate, neroli and lavender oils, lanolin, petrolatum.
  • the product made in the form of a tablet, may additionally contain glucosamine hydrochloride.
  • the mass ratio of glucosamine hydrochloride to sodium chondroitin sulfate may be 0.5 - 5: 1.
  • the tablet may be film-coated, in which case the tablet coating has the following composition, taken in relation to chondroitin sulfate sodium: hydroxypropyl methylcellulose - 1:0.07, titanium dioxide (E171) - 1:0.016, triacetin - 1:0.014 mg.
  • the product which is made in the form of a solution, contains water.
  • the finished parenteral product may contain a certain amount of preservatives such as benzyl alcohol, sodium benzoate, sodium metabisulfite, sodium bisulfite, methyl parahydroxybenzoate or similar.
  • These diseases include degenerative-dystrophic diseases of the joints and spine: osteoarthrosis of the peripheral joints, intervertebral osteochondrosis and osteoarthrosis, rheumatoid arthritis, gout, reactive arthritis, spondyloarthropathies, arthritis in systemic lupus erythematosus, dermatomyositis and other systemic diseases, psoriatic arthritis, post-traumatic injuries of articular cartilage, ligaments, menisci.
  • osteoarthrosis of the peripheral joints intervertebral osteochondrosis and osteoarthrosis
  • rheumatoid arthritis gout
  • reactive arthritis spondyloarthropathies
  • arthritis in systemic lupus erythematosus erythematosus
  • dermatomyositis and other systemic diseases
  • psoriatic arthritis post-traumatic injuries of articular cartilage, ligaments, menisci.
  • a preparation in the form of a gel including sodium chondroitin sulfate, purified water, and which additionally contains iron in a relative amount of 1 mg/kg to 40 mg/kg based on the weight of sodium chondroitin sulfate, can be obtained using various auxiliary substances.
  • solution No. 1 100 kg of the preparation in the form of a gel are obtained by first preparing solution No. 1: 1200 g of carbomer from the total mass is stirred and added to 8 l of purified water. Then solution No. 2 is prepared: dissolving 39.98 g of methyl parahydroxybenzoate in 8 l of ethanol. To obtain solution No.
  • solution No. 1 100 kg of the preparation in the form of a gel are obtained by first preparing solution No. 1: 1232.54 g of carbomer are stirred and added to 8.22 l of purified water. Then solution No. 2 is prepared: by dissolving 41.08 g of nipagin in 6.16 l of ethanol. To obtain solution No.
  • solution No. 1 is obtained by adding 749.58 g of carbomer to 35.98 l of purified water and then mixing. Then solution No. 2 is prepared by dissolving 29.98 g of methyl parahydroxybenzoate in 4497.48 ml of ethanol. Solution No.
  • 3 is obtained by stirring while heating to a temperature of 70 °C in 54.52 l of purified water, 1500 g of sodium chondroitin sulfate, 149.92 g of glucosamine hydrochloride, 299.83 g of methylsulfonylmethane, 3 g of sodium metabisulfite, 1500 g of propylene glycol, carbomer - 749.58 g, 1% solution of iron gluconate - 12.10 ml (in terms of containing 10 mg of elemental iron per 1 kg of sodium chondroitin sulfate. Manufacturer of the substance Dr. Paul Lohmann GmbH, Germany). After which the solutions are stirred for several hours until a gel mass is formed. If necessary, add a fragrance in the amount of 14.99 g.
  • a preparation in the form of an ointment including sodium chondroitin sulfate, purified water, and which additionally contains iron in a relative amount of 1 mg/kg to 40 mg/kg based on the weight of sodium chondroitin sulfate, can also be obtained using various methods.
  • Vaseline medical in the amount of 35.71 kg, anhydrous lanolin in the amount of 15.31 kg, stearic acid in the amount of 3.06 kg, pentol in the amount of 5.10 kg are melted at a temperature of (70 ⁇ 2) ° C, stirred, then cooled to a temperature of (55 ⁇ 2) ° C (ointment base).
  • Sodium chondroitin sulfate in the amount of 5.10 kg is dissolved in 20.35 l of distilled water.
  • Sodium diclofenac in the amount of 5.10 kg is dissolved in 10.20 l of dimethyl sulfoxide.
  • 61.72 ml of 1% iron gluconate solution (containing 15 mg of elemental iron per 1 kg of sodium chondroitin sulfate, manufacturer of the substance Dr. Paul Lomani GmbH, Germany) are added to solutions of sodium diclofenac in dimethyl sulfoxide and chondroitin sulfate in water with stirring. The resulting substance is added to the ointment base, brought to 100 kg with purified water, homogenized, and then transferred for packaging.
  • ointment base by adding 40.20 kg of petroleum jelly, 3.02 kg of stearic acid and 20.10 kg of lanolin to the mixer. Heat the mixture to 60-65 °C and stir until smooth. Add 15.03 g of dimethyl sulfoxide in small portions during mixing. Dissolve 1.51 kg of sodium chondroitin sulfate in 20.1 l of purified water. Add 48.63 ml of 1% ferrous gluconate solution to the solution while stirring (containing 40 mg of elemental iron per 1 kg of sodium chondroitin sulfate. Substance manufacturer Dr. Paul Lohmani GmbH, Germany). Add the resulting solution to the ointment base, bring to 100 kg with purified water and stir until completely homogenized.
  • the preparation contains 95-120 mg of lyophilized powder of Na-salt of chondroitin sulfate, which is obtained from sodium dissolved in apyrogenic injection water chondroitin sulfate salts and iron from 1 mg/kg to 40 mg/kg based on the weight of sodium chondroitin sulfate.
  • the injection solution prepared from the specified lyophilisate using apyrogenic water contains Na-salt of chondroitin sulfate in a therapeutic dosage of 9.0-11.5 wt%.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention se rapporte au domaine de la médecine, et notamment à des agents médicamenteux pour le traitement de maladies arthrosiques. Cet agent pour le traitement de maladies arthrosiques contient une quantité efficace de chondroïtine de sulfate de sodium et au moins une substance auxiliaire ou excipient, et comprend également du fer dans une quantité relative de 1 mg/kg à 40 mg/kg en termes de poids de chondroïtine de sulfate de sodium.
PCT/RU2024/050081 2023-09-28 2024-04-11 Agent pharmaceutique pour le traitement de maladies arthrosiques Pending WO2025071432A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2023124931 2023-09-28
RU2023124931A RU2813891C1 (ru) 2023-09-28 Фармацевтическое средство для лечения артрологических заболеваний

Publications (1)

Publication Number Publication Date
WO2025071432A1 true WO2025071432A1 (fr) 2025-04-03

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ID=95201773

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2024/050081 Pending WO2025071432A1 (fr) 2023-09-28 2024-04-11 Agent pharmaceutique pour le traitement de maladies arthrosiques

Country Status (1)

Country Link
WO (1) WO2025071432A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1308155A2 (fr) * 2001-10-12 2003-05-07 Nipro Corporation Solution injectable contenant un colloide de fer et chondroitine sulfate de cartilage de requin
RU2373943C1 (ru) * 2008-04-22 2009-11-27 Лариса Теодоровна Волова Материал для восстановления костной ткани
JP4992162B2 (ja) * 2000-11-27 2012-08-08 大正製薬株式会社 鉄イオン配合内服液剤
CN110432483A (zh) * 2019-07-05 2019-11-12 上海奥医高科技实业有限公司 一种类风湿关节炎专用型临床营养配方及其制备方法
RU2739746C9 (ru) * 2020-06-29 2021-02-15 Общество С Ограниченной Ответственностью «Диамед-Фарма» Фармацевтическое средство для лечения артрологических заболеваний
EA041405B1 (ru) * 2020-08-10 2022-10-20 Общество с ограниченной ответственностью "ДИАМЕД-фарма" Фармацевтическое средство для лечения артрологических заболеваний

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4992162B2 (ja) * 2000-11-27 2012-08-08 大正製薬株式会社 鉄イオン配合内服液剤
EP1308155A2 (fr) * 2001-10-12 2003-05-07 Nipro Corporation Solution injectable contenant un colloide de fer et chondroitine sulfate de cartilage de requin
RU2373943C1 (ru) * 2008-04-22 2009-11-27 Лариса Теодоровна Волова Материал для восстановления костной ткани
CN110432483A (zh) * 2019-07-05 2019-11-12 上海奥医高科技实业有限公司 一种类风湿关节炎专用型临床营养配方及其制备方法
RU2739746C9 (ru) * 2020-06-29 2021-02-15 Общество С Ограниченной Ответственностью «Диамед-Фарма» Фармацевтическое средство для лечения артрологических заболеваний
EA041405B1 (ru) * 2020-08-10 2022-10-20 Общество с ограниченной ответственностью "ДИАМЕД-фарма" Фармацевтическое средство для лечения артрологических заболеваний

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