HRP20170904T1 - Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću - Google Patents
Formulacije tableta (4'-trifluormetilfenil)-amida (z)-2-cijano-3-hidroksi-but-2-enske kiseline s poboljšanom stabilnošću Download PDFInfo
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- HRP20170904T1 HRP20170904T1 HRP20170904TT HRP20170904T HRP20170904T1 HR P20170904 T1 HRP20170904 T1 HR P20170904T1 HR P20170904T T HRP20170904T T HR P20170904TT HR P20170904 T HRP20170904 T HR P20170904T HR P20170904 T1 HRP20170904 T1 HR P20170904T1
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- Prior art keywords
- weight
- solid pharmaceutical
- pharmaceutical preparation
- preparation according
- starch
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- UTNUDOFZCWSZMS-YFHOEESVSA-N teriflunomide Chemical compound C\C(O)=C(/C#N)C(=O)NC1=CC=C(C(F)(F)F)C=C1 UTNUDOFZCWSZMS-YFHOEESVSA-N 0.000 title claims 3
- 239000007916 tablet composition Substances 0.000 title 1
- 239000007787 solid Substances 0.000 claims 14
- 239000000825 pharmaceutical preparation Substances 0.000 claims 13
- 239000000203 mixture Substances 0.000 claims 8
- 239000011230 binding agent Substances 0.000 claims 6
- 239000007884 disintegrant Substances 0.000 claims 6
- 239000000314 lubricant Substances 0.000 claims 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 6
- 239000003085 diluting agent Substances 0.000 claims 5
- 229920002472 Starch Polymers 0.000 claims 4
- 239000008107 starch Substances 0.000 claims 4
- 229940032147 starch Drugs 0.000 claims 4
- 235000019698 starch Nutrition 0.000 claims 4
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 3
- 229920002261 Corn starch Polymers 0.000 claims 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 229920000881 Modified starch Polymers 0.000 claims 3
- 239000001913 cellulose Substances 0.000 claims 3
- 239000008120 corn starch Substances 0.000 claims 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 229960001021 lactose monohydrate Drugs 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008109 sodium starch glycolate Substances 0.000 claims 3
- 229920003109 sodium starch glycolate Polymers 0.000 claims 3
- 229940079832 sodium starch glycolate Drugs 0.000 claims 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 229920001353 Dextrin Polymers 0.000 claims 2
- 239000004375 Dextrin Substances 0.000 claims 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- 239000005913 Maltodextrin Substances 0.000 claims 2
- 229920002774 Maltodextrin Polymers 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 2
- 235000013339 cereals Nutrition 0.000 claims 2
- 229960001681 croscarmellose sodium Drugs 0.000 claims 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 2
- 235000019425 dextrin Nutrition 0.000 claims 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 2
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims 2
- 229940046813 glyceryl palmitostearate Drugs 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 229960001375 lactose Drugs 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
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- 239000000594 mannitol Substances 0.000 claims 2
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- 229960001855 mannitol Drugs 0.000 claims 2
- 229920000609 methyl cellulose Polymers 0.000 claims 2
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- 235000010981 methylcellulose Nutrition 0.000 claims 2
- 229920001592 potato starch Polymers 0.000 claims 2
- 229920003124 powdered cellulose Polymers 0.000 claims 2
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- 235000010413 sodium alginate Nutrition 0.000 claims 2
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- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 2
- 239000000454 talc Substances 0.000 claims 2
- 229910052623 talc Inorganic materials 0.000 claims 2
- 229940033134 talc Drugs 0.000 claims 2
- 229960000331 teriflunomide Drugs 0.000 claims 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- 239000005995 Aluminium silicate Substances 0.000 claims 1
- 208000003174 Brain Neoplasms Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 229930091371 Fructose Natural products 0.000 claims 1
- 239000005715 Fructose Substances 0.000 claims 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 229920002907 Guar gum Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 208000007766 Kaposi sarcoma Diseases 0.000 claims 1
- 240000007472 Leucaena leucocephala Species 0.000 claims 1
- 235000010643 Leucaena leucocephala Nutrition 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 206010039491 Sarcoma Diseases 0.000 claims 1
- 206010040047 Sepsis Diseases 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 208000000453 Skin Neoplasms Diseases 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 208000024780 Urticaria Diseases 0.000 claims 1
- 206010046851 Uveitis Diseases 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- 229920002494 Zein Polymers 0.000 claims 1
- 230000007815 allergy Effects 0.000 claims 1
- 235000012211 aluminium silicate Nutrition 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
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- 235000010439 isomalt Nutrition 0.000 claims 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims 1
- 229960000829 kaolin Drugs 0.000 claims 1
- 239000000832 lactitol Substances 0.000 claims 1
- 235000010448 lactitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 1
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- 208000032839 leukemia Diseases 0.000 claims 1
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- 239000000845 maltitol Substances 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
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- 206010027191 meningioma Diseases 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
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- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 201000002528 pancreatic cancer Diseases 0.000 claims 1
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000006187 pill Substances 0.000 claims 1
- 239000011591 potassium Substances 0.000 claims 1
- 229910052700 potassium Inorganic materials 0.000 claims 1
- 229960003975 potassium Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
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- 150000003839 salts Chemical class 0.000 claims 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims 1
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- 239000008117 stearic acid Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C255/00—Carboxylic acid nitriles
- C07C255/01—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms
- C07C255/32—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring
- C07C255/42—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring the carbon skeleton being further substituted by singly-bound nitrogen atoms, not being further bound to other hetero atoms
- C07C255/44—Carboxylic acid nitriles having cyano groups bound to acyclic carbon atoms having cyano groups bound to acyclic carbon atoms of a carbon skeleton containing at least one six-membered aromatic ring the carbon skeleton being further substituted by singly-bound nitrogen atoms, not being further bound to other hetero atoms at least one of the singly-bound nitrogen atoms being acylated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K31/275—Nitriles; Isonitriles
- A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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Claims (13)
1. Kruti farmaceutski pripravak naznačen time da u osnovi sadrži
a) 1 % do 30 % težinski: težinski Teriflunomida, ili njegove farmaceutski prihvatljive bazične adicijske soli,
b) 5 % do 20 % težinski: težinski sredstva za raspadanje,
c) 0 % do 40 % težinski: težinski veziva,
d) 0.1 % do 2 % težinski: težinski sredstva za podmazivanje i
e) preostali postotak obuhvaća sredstva za razrjeđivanje,
pod uvjetom da navedeni kruti farmaceutski pripravak na sadrži koloidni silicijev dioksid.
2. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno sredstvo za raspadanje odabrano iz skupine koju čine karboksimetilceluloza, nisko supstituirana hidroksipropilceluloza, mikrokristalna celuloza, celuloza u prahu, kroskarmeloza natrij, metilceluloza, polakrilin kalij, natrijev alginat, natrijev škrobni glikolat ili smjesa jednog ili više od navedenih sredstava za raspadanje.
3. Kruti farmaceutski pripravak prema zahtjevu 2 naznačen time da je navedeno sredstvo za raspadanje odabrano iz skupine koju čine nisko supstituirana hidroksipropilceluloza, mikrokristalna celuloza, celuloza u prahu, kroskarmeloza natrij, natrijev škrobni glikolat ili smjesa jednog ili više od navedenih sredstava za raspadanje.
4. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno vezivo odabrano iz skupine koju čine akacija, karboksimetilceluloza, hidroksietilceluloza, hidroksipropilceluloza, dekstrin, želatina, guar guma, hidroksipropil metilceluloza, maltodekstrin, metilceluloza, natrijev alginat, preželatinirani škrob, krumpirov škrob, kukuruzni škrob ili škrob od žitarica i zein ili smjesa jednog ili više od navedenih veziva.
5. Kruti farmaceutski pripravak prema zahtjevu 4 naznačen time da je navedeno vezivo odabrano iz skupine koju čine hidroksipropilceluloza, hidroksipropil metilceluloza, preželatinirani škrob, krumpirov škrob, kukuruzni škrob ili škrob od žitarica ili smjesa jednog ili više od navedenih veziva.
6. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da je navedeno sredstvo za podmazivanje odabrano iz skupine koju čine kalcijev stearat, gliceril palmitostearat, natrijev benzoat, natrijev lauril sulfat, natrijev stearil fumarat, stearinska kiselina, talk, cinkov stearat i magnezijev stearat ili smjesa jednog ili više od navedenih sredstava za podmazivanje.
7. Kruti farmaceutski pripravak prema zahtjevu 6 naznačen time da je navedeno sredstvo za podmazivanje odabrano iz skupine koju čine natrijev stearil fumarate i magnezijev stearat ili smjesa jednog ili više od navedenih sredstava za podmazivanje.
8. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da navedeno sredstvo za razrjeđivanje je odabrano iz skupine koju čine celuloza, celuloza acetat, dekstrati, dekstrin, dekstroza, fruktoza, 1-O-α-D-glukopiranozil-D-manitol, gliceril palmitostearat, hidrogenizirano biljno ulje, kaolin, laktitol, laktoza, laktoza mono-hidrat, maltitol, manitol, maltodekstrin, maltoza, preželatinirani škrob, natrijev klorid, sorbitol, škrob, sukroza, talk i ksilitol ili smjesa jednog ili više od navedenih sredstava za razrjeđivanje.
9. Kruti farmaceutski pripravak prema zahtjevu 8 naznačen time navedeno sredstvo za razrjeđivanje je odabrano iz skupine koju čine laktoza, laktoza monohidrat, manitol i škrob ili smjesa jednog ili više od navedenih sredstava za razrjeđivanje.
10. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da navedeni pripravak je prevučen.
11. Kruti farmaceutski pripravak prema zahtjevu 10, naznačen time da je tableta ili pilula s prevlakom na bazi hipromeloze.
12. Kruti farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da u osnovi sadrži:
(a) 2 % do 15 % težinski: težinski Teriflunomida,
(b) 7 % do 15 % težinski: težinski sredstva za raspadanje odabranog od jednog ili više od mikrokristalne celuloze ili natrijevog škrobnog glikolata,
(c) 15 % do 35 % težinski: težinski veziva odabranog od jednog ili više od hidroksipropilceluloze ili kukuruznog škroba,
(d) 0.1 % do 1.0 % težinski: težinski sredstva za podmazivanje odabranog od magnezijevog stearata, te
(e) preostali postotak obuhvaća sredstva za razrjeđivanje odabrana od laktoza mono-hidrata.
13. Kruti farmaceutski pripravak prema zahtjevima 1 do 12 naznačen time da je za uporabu u liječenju sepse, alergije, reakcija presadak-protiv-domaćina, reakcija domaćin-protiv-presatka, reumatoidnog artritisa, sistemskog lupusa, multiple skleroze, psorijaze, astme, urtikarije, rinitisa, uveitisa, raka pluća, leukemije, raka jajnika, sarkoma, Kaposijevog sarkoma, meningioma, raka crijeva, raka limfnih čvorova, tumora mozga, raka dojke, raka gušterače, raka prostate ili raka kože.
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PCT/EP2010/063439 WO2011032929A1 (en) | 2009-09-18 | 2010-09-14 | (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
EP10752585.9A EP2477611B1 (en) | 2009-09-18 | 2010-09-14 | (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
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EP (1) | EP2477611B1 (hr) |
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AU (2) | AU2010297357B2 (hr) |
BR (1) | BR112012006184B1 (hr) |
CA (1) | CA2772275A1 (hr) |
CL (1) | CL2015000047A1 (hr) |
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HK (2) | HK1206245A1 (hr) |
HN (1) | HN2012000576A (hr) |
HR (1) | HRP20170904T1 (hr) |
HU (1) | HUE032963T2 (hr) |
IL (3) | IL218492A (hr) |
JO (1) | JO3327B1 (hr) |
LT (1) | LT2477611T (hr) |
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ME (1) | ME02765B (hr) |
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MY (1) | MY155613A (hr) |
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PE (2) | PE20121478A1 (hr) |
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PT (1) | PT2477611T (hr) |
RS (1) | RS56074B1 (hr) |
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SI (1) | SI2477611T1 (hr) |
TN (1) | TN2012000061A1 (hr) |
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UA (2) | UA107582C2 (hr) |
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WO (1) | WO2011032929A1 (hr) |
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PE20121478A1 (es) * | 2009-09-18 | 2012-11-12 | Sanofi Sa | Formulaciones en comprimido de teriflunomida: "(4'-trifluorometilfenil) amida del acido (z)-2-ciano-3-hidroxibut-2-enoico con estabilidad mejorada |
RU2493845C1 (ru) * | 2012-06-07 | 2013-09-27 | Общество с ограниченной ответственностью "ВАЛЕНТА ИНТЕЛЛЕКТ" | Композиция для лечения рассеянного склероза (варианты) |
CN105916522A (zh) * | 2013-11-22 | 2016-08-31 | 建新公司 | 用于治疗神经变性疾病的新方法 |
CN103656657A (zh) * | 2013-12-18 | 2014-03-26 | 北京科源创欣科技有限公司 | 特立氟胺药物组合物及制备方法 |
AU2015238301B2 (en) | 2014-03-26 | 2020-06-25 | Astex Therapeutics Ltd | Combinations |
US20160058730A1 (en) * | 2014-08-29 | 2016-03-03 | Cadila Healthcare Limited | Pharmaceutical compositions of teriflunomide |
WO2016079687A1 (en) * | 2014-11-18 | 2016-05-26 | Lupin Limited | Oral pharmaceutical composition of teriflunomide |
JOP20200201A1 (ar) | 2015-02-10 | 2017-06-16 | Astex Therapeutics Ltd | تركيبات صيدلانية تشتمل على n-(3.5- ثنائي ميثوكسي فينيل)-n'-(1-ميثيل إيثيل)-n-[3-(ميثيل-1h-بيرازول-4-يل) كينوكسالين-6-يل]إيثان-1.2-ثنائي الأمين |
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WO2017037645A1 (en) * | 2015-09-02 | 2017-03-09 | Leiutis Pharmaceuticals Pvt Ltd | Stable pharmaceutical formulations of teriflunomide |
WO2017056104A1 (en) * | 2015-09-28 | 2017-04-06 | Natco Pharma Limited | Stable pharmaceutical compositions of teriflunomide |
WO2017125841A1 (en) * | 2016-01-20 | 2017-07-27 | Emcure Pharmaceuticals Limited | Pharmaceutical compositions of teriflunomide |
JOP20190207A1 (ar) | 2017-03-14 | 2019-09-10 | Actelion Pharmaceuticals Ltd | تركيبة صيدلانية تشتمل على بونيسيمود |
HRP20240200T1 (hr) * | 2019-07-17 | 2024-04-26 | Cytokinetics, Inc. | Oralne formulacije inhibitora kardijskih sarkomera |
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TR202022336A2 (tr) * | 2020-12-30 | 2022-07-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A film coated tablet comprising teriflunomide |
EP4382097A1 (en) | 2022-11-25 | 2024-06-12 | Sanovel Ilac Sanayi Ve Ticaret A.S. | A tablet comprising teriflunomide |
WO2024112298A1 (en) * | 2022-11-25 | 2024-05-30 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A tablet comprising teriflunomide |
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