RU2001116566A - APPLICATION OF DIALKYLFUMARATES FOR THE TREATMENT OF REASONS "OWNERS AGAINST THE TRANSPLANT" AND AUTOIMMUNE DISEASES - Google Patents

APPLICATION OF DIALKYLFUMARATES FOR THE TREATMENT OF REASONS "OWNERS AGAINST THE TRANSPLANT" AND AUTOIMMUNE DISEASES

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RU2001116566A
RU2001116566A RU2001116566/14A RU2001116566A RU2001116566A RU 2001116566 A RU2001116566 A RU 2001116566A RU 2001116566/14 A RU2001116566/14 A RU 2001116566/14A RU 2001116566 A RU2001116566 A RU 2001116566A RU 2001116566 A RU2001116566 A RU 2001116566A
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disease
graves
use according
group
autoimmune diseases
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RU2001116566/14A
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RU2215524C2 (en
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Раджендра К. ДЖОШИ
Ханс-Петер ШТРЕБЕЛЬ
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Фумафарм Аг
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1. Применение одного или более диалкилфумаратов для получения фармацевтической композиции для лечения реакций "хозяин против трансплантата" и реакций "трансплантат против хозяина" при трансплантациях органов и клеток, и для лечения аутоиммунных заболеваний, выбранных из группы, состоящей из юношеского диабета, тиреодита Хашимото, диффузного токсического зоба (болезни Грейвса или базедовой болезни), системной красной волчанки (SLE), ксеродерматоза (синдрома Шегрена), пернициозной анемии и хронического активного (люпоидного) гепатита.1. The use of one or more dialkyl fumarates for the preparation of a pharmaceutical composition for treating host versus transplant and transplant versus host reactions in organ and cell transplants, and for treating autoimmune diseases selected from the group consisting of juvenile diabetes, Hashimoto thyroiditis, diffuse toxic goiter (Graves' disease or Grave's disease), systemic lupus erythematosus (SLE), xerodermatosis (Sjogren's syndrome), pernicious anemia and chronic active (lupoid) hepatitis. 2. Применение по п. 1 одного или более диалкилфумаратов формулы
Figure 00000001

в которой R1 и R2 могут быть одинаковыми или разными, независимо друг от друга линейными, разветвленными или циклическими, насыщенными или ненасыщенными C1-20-алкильными остатками, которые в случае необходимости могут быть замещены галогеном (хлор, фтор, йод, бром), гидроксигруппой, C1-4-алкоксигруппой, нитрогруппой или цианогруппой, пригодных для получения фармацевтической композиции для применения в трансплантационной медицине или для терапии аутоиммунных заболеваний, выбранных из группы, состоящей из юношеского диабета, тиреоидита Хашимото, диффузного токсического зоба (болезни Грейвса или базедовой болезни), системной красной волчанки (SLE), ксеродерматоза (синдрома Шегрена), пернициозной анемии и хронического активного (люпоидного) гепатита.2. The use according to claim 1 of one or more dialkyl fumarates of the formula
Figure 00000001

in which R 1 and R 2 can be the same or different, independently from each other linear, branched or cyclic, saturated or unsaturated C 1-20 -alkyl residues, which, if necessary, can be replaced by halogen (chlorine, fluorine, iodine, bromine ), a hydroxy group, a C 1-4 alkoxy group, a nitro group or a cyano group, suitable for preparing a pharmaceutical composition for use in transplant medicine or for treating autoimmune diseases selected from the group consisting of juvenile diabetes, Hashi thyroiditis moto, diffuse toxic goiter (Graves 'disease or Graves' disease), systemic lupus erythematosus (SLE), xerodermatosis (Sjogren's syndrome), pernicious anemia and chronic active (lupoid) hepatitis. 3. Применение по п. 2, в котором остатки R1 и R2 обозначают метил, этил, н-пропил, изопропил, н-бутил, втор. -бутил, трет. -бутил, пентил, циклопентил, 2-этилгексил, гексил, циклогексил, гептил, циклогептил, октил, винил, аллил, 2-гидроксиэтил, 2- и/или 3-гидроксипропил, 2-метоксиэтил, метоксиэтил или 2- или 3-метоксипропил.3. The use of claim 2, wherein R 1 and R 2 are methyl, ethyl, n-propyl, isopropyl, n-butyl, sec. -butyl, tert. -butyl, pentyl, cyclopentyl, 2-ethylhexyl, hexyl, cyclohexyl, heptyl, cycloheptyl, octyl, vinyl, allyl, 2-hydroxyethyl, 2- and / or 3-hydroxypropyl, 2-methoxyethyl, methoxyethyl or 2- or 3-methoxypropyl . 4. Применение по п. 3, в котором R1 и R2 идентичны и представляют собой метил или этил.4. The use of claim 3, wherein R 1 and R 2 are identical and are methyl or ethyl. 5. Применение по пп. 1-4, в котором из биологически активных веществ готовятся оральные композиции в форме таблеток, микротаблеток, пилюль или гранулятов, в случае необходимости в капсулах или пакетиках. 5. The use of PP. 1-4, in which from the biologically active substances are prepared oral compositions in the form of tablets, microtablets, pills or granules, if necessary, in capsules or sachets. 6. Применение по п. 5, в котором размер или средний диаметр пилюль или микротаблеток находится в области от 300 до 2000 мкм. 6. The use according to claim 5, in which the size or average diameter of the pills or microtablets is in the range from 300 to 2000 microns. 7. Применение по пп. 1-6, в котором композиция находится в виде мягко- или твердожелатиновых капсул. 7. The use of PP. 1-6, in which the composition is in the form of soft or hard gelatin capsules. 8. Применение по одному из пп. 1-7, в котором композиция содержит биологически активное вещество в количестве, соответствующем от 10 до 300 мг фумаровой кислоты. 8. The use according to one of paragraphs. 1-7, in which the composition contains a biologically active substance in an amount corresponding to from 10 to 300 mg of fumaric acid. 9. Применение по пп. 5-8, в котором дозированные единицы лекарственных средств снабжены оболочкой, устойчивой к желудочному соку. 9. The use of PP. 5-8, in which dosage units of drugs are provided with a membrane resistant to gastric juice. 10. Применение по одному из пп. 1-4, в котором лекарственные средства используются форме препаратов для кожного и чрескожного применения, препаратов для парентерального применения и препаратов для ректального применения. 10. The use according to one of paragraphs. 1-4, in which the drugs are used in the form of preparations for skin and percutaneous use, preparations for parenteral administration and preparations for rectal administration. 11. Фармацевтическая композиция в форме микротаблеток или пилюль, содержащая один или более диалкилфумаратов формулы
Figure 00000002

в которой R1 и R2 могут быть одинаковыми или разными, независимо друг от друга линейными, разветвленными или циклическими, насыщенными или ненасыщенными С1-20-алкильными остатками, которые в случае необходимости могут быть замещены галогеном (хлор, фтор, иод, бром), гидроксигруппой, C1-4-алкоксигруппой, нитрогруппой или цианогруппой, и, в случае необходимости, содержащая пригодные носители и вспомогательные вещества, для применения в трансплантационной медицине или для терапии аутоиммунных заболеваний, как полиартрит, рассеянный склероз, юношеский диабет, тиреоидит Хашимото, диффузный токсический зоб (болезнь Грейвса или базедова болезнь), системная красная волчанка (SLE), ксеродерматоз (синдром Шегрена), пернициозная анемия и хронический активный (люпоидный) гепатит, псориаз, псориатический артрит, нейродермит и региональный энтерит Крона.11. A pharmaceutical composition in the form of microtablets or pills containing one or more dialkyl fumarates of the formula
Figure 00000002

in which R 1 and R 2 can be the same or different, independently from each other linear, branched or cyclic, saturated or unsaturated C 1-20 -alkyl residues, which, if necessary, can be replaced by halogen (chlorine, fluorine, iodine, bromine ), hydroxy, C 1-4 alkoxy, nitro or cyano, and, if necessary, contain suitable carriers and adjuvants for use in transplantation medicine or for the therapy of autoimmune diseases such as polyarthritis, multiple sclerosis, w diabetes mellitus, Hashimoto's thyroiditis, diffuse toxic goiter (Graves disease or Bazedova disease), systemic lupus erythematosus (SLE), xerodermatosis (Sjogren's syndrome), pernicious anemia and chronic active (lupoid) hepatitis, psoriasis, psoriatic arthritis and neurodermatitis, neurodermatitis, neurodermatitis . 12. Композиция по п. 11, содержащая диметилфумарат, диэтилфумарат или метилэтилфумарат. 12. The composition according to p. 11, containing dimethyl fumarate, diethyl fumarate or methyl ethyl fumarate. 13. Композиция по п. 11 или 12, содержащая биологически активное вещество в количестве, соответствующем от 10 до 300 мг фумаровой кислоты. 13. The composition according to p. 11 or 12, containing a biologically active substance in an amount corresponding to from 10 to 300 mg of fumaric acid. 14. Применение одного или более диалкилфумаратов для получения фармацевтической композиции в форме микротаблеток или пилюль для терапии аутоиммунных заболеваний выбранных из группы, состоящей из полиартрита, рассеянного склероза, юношеского диабета, тиреодита Хашимото, диффузного токсического зоба (болезни Грейвса или базедовой болезни), системной красной волчанки (SLE), ксеродерматоза (синдрома Шегрена), пернициозной анемии и хронического активного (люпоидного) гепатита. 14. The use of one or more dialkyl fumarates for the preparation of a pharmaceutical composition in the form of microtablets or pills for the treatment of autoimmune diseases selected from the group consisting of polyarthritis, multiple sclerosis, juvenile diabetes, Hashimoto thyroiditis, diffuse toxic goiter (Graves' disease or basic disease), systemic red lupus erythematosus (SLE), xerodermatosis (Sjögren’s syndrome), pernicious anemia, and chronic active (lupoid) hepatitis. 15. Применение по п. 14 одного или более диалкилфумаратов формулы
Figure 00000003

в которой R1 и R2 могут быть одинаковыми или разными, независимо друг от друга линейными, разветвленными или циклическими, насыщенными или ненасыщенными C1-20-алкильными остатками, которые в случае необходимости могут быть замещены галогеном (хлор, фтор, иод, бром), гидроксигруппой, C1-4-алкоксигруппой, нитрогруппой или цианогруппой, для получения фармацевтической композиции для терапии аутоиммунных заболеваний, выбранных из группы, состоящей из полиартрита, рассеянного склероза, юношеского диабета, тиреоидита Хашимото, диффузного токсического зоба (болезни Грейвса или базедовой болезни), системной красной волчанки (SLE), ксеродерматоза (синдрома Шегрена), пернициозной анемии и хронического активного (люпоидного) гепатита.15. The use according to claim 14 of one or more dialkyl fumarates of the formula
Figure 00000003

in which R 1 and R 2 can be the same or different, independently from each other linear, branched or cyclic, saturated or unsaturated C 1-20 -alkyl residues, which, if necessary, can be replaced by halogen (chlorine, fluorine, iodine, bromine ), hydroxy, C 1-4 alkoxy, nitro or cyano for preparing a pharmaceutical composition for the therapy of autoimmune diseases selected from the group consisting of polyarthritis, multiple sclerosis, juvenile diabetes, Hashimoto's thyroiditis, diffuse toxic one goiter (Graves 'disease or Graves' disease), systemic lupus erythematosus (SLE), Sjögren's syndrome (Sjögren's syndrome), pernicious anemia and chronic active (lupoid) hepatitis. 16. Применение по п. 15, в котором остатки R1 и R2 обозначают метил, этил, н-пропил, изопропил, н-бутил, втор. -бутил, трет. -бутил, пентил, циклопентил, 2-этилгексил, гексил, циклогексил, гептил, циклогептил, октил, винил, аллил, 2-гидроксиэтил, 2- и/или 3-гидроксипропил, 2-метоксиэтил, метоксиэтил или 2- или 3-метоксипропил.16. The use of claim 15, wherein R 1 and R 2 are methyl, ethyl, n-propyl, isopropyl, n-butyl, sec. -butyl, tert. -butyl, pentyl, cyclopentyl, 2-ethylhexyl, hexyl, cyclohexyl, heptyl, cycloheptyl, octyl, vinyl, allyl, 2-hydroxyethyl, 2- and / or 3-hydroxypropyl, 2-methoxyethyl, methoxyethyl or 2- or 3-methoxypropyl . 17. Применение по п. 14 или 15, в котором R1 и R2 идентичны и представляют собой метил или этил.17. The use of claim 14 or 15, wherein R 1 and R 2 are identical and are methyl or ethyl. 18. Применение по одному из пп. 14-17, в котором из биологически активного вещества готовятся оральные композиции в форме таблеток, микротаблеток или пилюль в капсулах или пакетиках. 18. The use according to one of paragraphs. 14-17, in which oral compositions in the form of tablets, microtablets or pills in capsules or sachets are prepared from a biologically active substance. 19. Применение по одному из пп. 14-18, отличающееся тем, что размер или средний диаметр пилюль или микротаблеток находится в области от 300 до 2000 мкм. 19. The use according to one of paragraphs. 14-18, characterized in that the size or average diameter of the pills or microtablets is in the range from 300 to 2000 microns. 20. Применение по п. 18, отличающееся тем, что композиция находится в виде мягко- или твердожелатиновых капсул. 20. The use of claim 18, wherein the composition is in the form of soft or hard gelatin capsules. 21. Применение по одному из пп. 14-20, в котором композиция содержит биологически активное вещество в количестве, соответствующем от 10 до 300 мг фумаровой кислоты. 21. The use according to one of paragraphs. 14-20, in which the composition contains a biologically active substance in an amount corresponding to from 10 to 300 mg of fumaric acid. 22. Применение по одному из пп. 18-21, отличающееся тем, что дозированные единицы лекарственных средств снабжены оболочкой, устойчивой к желудочному соку. 22. The use according to one of paragraphs. 18-21, characterized in that the dosage units of drugs are provided with a membrane resistant to gastric juice.
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