RU2016106336A - Противотуберкулезная композиция, содержащая рифампицин, изониазид, этамбутол и пиразинамид, и способ ее получения - Google Patents
Противотуберкулезная композиция, содержащая рифампицин, изониазид, этамбутол и пиразинамид, и способ ее получения Download PDFInfo
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- 239000000203 mixture Substances 0.000 title claims 9
- AEUTYOVWOVBAKS-UWVGGRQHSA-N ethambutol Chemical compound CC[C@@H](CO)NCCN[C@@H](CC)CO AEUTYOVWOVBAKS-UWVGGRQHSA-N 0.000 title claims 6
- 229960003350 isoniazid Drugs 0.000 title claims 5
- QRXWMOHMRWLFEY-UHFFFAOYSA-N isoniazide Chemical compound NNC(=O)C1=CC=NC=C1 QRXWMOHMRWLFEY-UHFFFAOYSA-N 0.000 title claims 4
- 229960005206 pyrazinamide Drugs 0.000 title claims 4
- IPEHBUMCGVEMRF-UHFFFAOYSA-N pyrazinecarboxamide Chemical compound NC(=O)C1=CN=CC=N1 IPEHBUMCGVEMRF-UHFFFAOYSA-N 0.000 title claims 4
- 229960000285 ethambutol Drugs 0.000 title claims 3
- 229960001225 rifampicin Drugs 0.000 title claims 3
- JQXXHWHPUNPDRT-WLSIYKJHSA-N rifampicin Chemical compound O([C@](C1=O)(C)O/C=C/[C@@H]([C@H]([C@@H](OC(C)=O)[C@H](C)[C@H](O)[C@H](C)[C@@H](O)[C@@H](C)\C=C\C=C(C)/C(=O)NC=2C(O)=C3C([O-])=C4C)C)OC)C4=C1C3=C(O)C=2\C=N\N1CC[NH+](C)CC1 JQXXHWHPUNPDRT-WLSIYKJHSA-N 0.000 title claims 2
- 230000002365 anti-tubercular Effects 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000008187 granular material Substances 0.000 claims 5
- 229920002261 Corn starch Polymers 0.000 claims 3
- 235000019759 Maize starch Nutrition 0.000 claims 3
- 229920000881 Modified starch Polymers 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 3
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 2
- 230000003078 antioxidant effect Effects 0.000 claims 2
- 235000006708 antioxidants Nutrition 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 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 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 239000000783 alginic acid Substances 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 229960001126 alginic acid Drugs 0.000 claims 1
- 150000004781 alginic acids Chemical class 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000001506 calcium phosphate Substances 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
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 229960004106 citric acid Drugs 0.000 claims 1
- 235000015165 citric acid Nutrition 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims 1
- 229940038472 dicalcium phosphate Drugs 0.000 claims 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- AUAHHJJRFHRVPV-BZDVOYDHSA-N ethambutol dihydrochloride Chemical compound [Cl-].[Cl-].CC[C@@H](CO)[NH2+]CC[NH2+][C@@H](CC)CO AUAHHJJRFHRVPV-BZDVOYDHSA-N 0.000 claims 1
- 229960001618 ethambutol hydrochloride Drugs 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000013355 food flavoring agent Nutrition 0.000 claims 1
- 125000003976 glyceryl group Chemical group [H]C([*])([H])C(O[H])([H])C(O[H])([H])[H] 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 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
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000002356 single layer Substances 0.000 claims 1
- 235000010378 sodium ascorbate Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims 1
- 229960005055 sodium ascorbate Drugs 0.000 claims 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims 1
- 229940001584 sodium metabisulfite Drugs 0.000 claims 1
- 235000010262 sodium metabisulphite Nutrition 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 235000010384 tocopherol Nutrition 0.000 claims 1
- 239000011732 tocopherol Substances 0.000 claims 1
- 229960001295 tocopherol Drugs 0.000 claims 1
- 229930003799 tocopherol Natural products 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 claims 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims 1
Classifications
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- 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
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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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
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
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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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
- A61P31/06—Antibacterial agents for tuberculosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Pulmonology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (22)
1. Однослойная таблетка, содержащая смесь:
- гранул, содержащих изониазид, пиразинамид, этамбутол или их фармацевтически приемлемую соль и связующее средство для грануляции, которое выбрано из повидона, поливинилового спирта, маисового крахмала, прежелатинизированного крахмала или их смесей;
- рифампицина в порошкообразной форме,
- экстрагранулярных вспомогательных средств, содержащих разрыхлитель, выбранный из кроскармеллозы натрия, кросповидона, маисового крахмала, гидроксипропилцеллюлозы с низкой степенью замещения, альгиновой кислоты или их смесей,
где все гранулы имеют размер частиц, который составляет менее 0,599 мм.
2. Таблетка по п. 1, где все гранулы имеют размер частиц, который составляет менее 0,5 мм.
3. Таблетка по п. 1, где все гранулы имеют размер частиц, который составляет менее 0,422 мм.
4. Таблетка по п. 1, которая характеризуется массой, составляющей менее 1100 мг.
5. Таблетка по любому из пп. 1-4, содержащая 75 мг изониазида, 400 мг пиразинамида, 275 мг этамбутола гидрохлорида и 150 мг рифампицина.
6. Таблетка по любому из пп. 1-4, содержащая от 0,1 до 2% вес/вес связующего средства для грануляции.
7. Таблетка по любому из пп. 1-4, где экстрагранулярные вспомогательные средства дополнительно содержат разбавитель, выбранный из микрокристаллической целлюлозы, прежелатинизированного крахмала, фосфата дикальция или их смесей; антиоксидант, выбранный из аскорбата натрия, 2,6-ди-трет-бутил-4-гидрокситолуола (BHT), лимонной кислоты, токоферола, метабисульфита натрия или их смесей; смазывающее средство, выбранное из стеарата магния, стеарилфумарата натрия, стеарата кальция, стеариновой кислоты, стеарата цинка, глицерилбеганата или их смесей; средство для придания вкуса; краситель или их смеси.
8. Таблетка по любому из пп. 1-4, отличающаяся тем, что она содержит от 10 до 17% вес/вес экстрагранулярных вспомогательных средств.
9. Таблетка по п. 7, отличающаяся тем, что она содержит от 0,1 до 2% вес/вес смазывающего средства.
10. Таблетка по п. 7, отличающаяся тем, что она содержит от 0,1 до 2% вес/вес антиоксиданта.
11. Таблетка по п. 7, отличающаяся тем, что она содержит от 6 до 12% вес/вес разбавителя.
12. Таблетка по любому из пп. 1-3, отличающаяся тем, что она содержит от 2 до 6% вес/вес разрыхлителя.
13. Таблетка по любому из пп. 1-3, отличающаяся тем, что таблетка не содержит поверхностно-активное средство.
14. Таблетка по любому из пп. 1-3, отличающаяся тем, что таблетка дополнительно содержит пленочное покрытие.
15. Таблетка по любому из пп. 1-3, которая дополнительно содержит пленочное покрытие и характеризуется массой, составляющей менее 1150 мг.
16. Таблетка по п. 14, отличающаяся тем, что таблетка содержит менее 5% по весу всех примесей по отношению к весу таблетки, покрытой оболочкой, после ее выдерживания в течение 2 месяцев при 40°C и 75% относительной влажности.
17. Таблетка по п. 14, отличающаяся тем, что таблетка содержит менее 1% по весу аддукта 3-формил-рифампицин-изониазида, соответствующего общей формуле (I), по отношению к весу таблетки, покрытой оболочкой, после ее выдерживания в течение 2 месяцев при 40°C и 75% относительной влажности.
18. Способ получения таблетки по любому из пп. 1-4, отличающийся тем, что он включает стадию a) влажной грануляции изониазида, пиразинамида и этамбутола с водным раствором связующего средства для грануляции, выбранного из из повидона, поливинилового спирта, маисового крахмала, прежелатинизированного крахмала или их смесей, с получением гранул.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN3343CH2013 | 2013-07-26 | ||
| IN3343/CHE/2013 | 2013-07-26 | ||
| PCT/EP2014/065763 WO2015011163A1 (en) | 2013-07-26 | 2014-07-22 | Antitubercular composition comprising rifampicin, isoniazid, ethambutol and pyrazinamide and its process of preparation. |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2016106336A true RU2016106336A (ru) | 2017-08-31 |
| RU2016106336A3 RU2016106336A3 (ru) | 2018-05-17 |
| RU2672879C2 RU2672879C2 (ru) | 2018-11-20 |
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| RU2016106336A RU2672879C2 (ru) | 2013-07-26 | 2014-07-22 | Противотуберкулезная композиция, содержащая рифампицин, изониазид, этамбутол и пиразинамид, и способ ее получения |
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| US (1) | US9814711B2 (ru) |
| EP (1) | EP3024445B1 (ru) |
| JP (1) | JP2017501117A (ru) |
| CN (1) | CN105407874A (ru) |
| AU (1) | AU2014295100B2 (ru) |
| CA (1) | CA2918828A1 (ru) |
| CL (1) | CL2016000180A1 (ru) |
| HK (1) | HK1218721A1 (ru) |
| IL (1) | IL243370A0 (ru) |
| MX (1) | MX2016001156A (ru) |
| MY (1) | MY174007A (ru) |
| PE (1) | PE20160238A1 (ru) |
| PH (1) | PH12016500118A1 (ru) |
| RU (1) | RU2672879C2 (ru) |
| SG (1) | SG11201510699WA (ru) |
| TW (1) | TW201601716A (ru) |
| WO (1) | WO2015011163A1 (ru) |
| ZA (1) | ZA201600108B (ru) |
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| CN105407876B (zh) | 2013-07-26 | 2019-08-30 | 赛诺菲 | 抗结核病的稳定的包含异烟肼颗粒和利福喷汀颗粒的可分散的片剂及其制备方法 |
| ES2870230T3 (es) * | 2016-04-08 | 2021-10-26 | Quretech Bio Ab | Tiazolin-2-piridonas de anillo condensado, métodos para la preparación de las mismas y su uso en el tratamiento y/o la prevención de la tuberculosis |
| WO2019068910A1 (en) * | 2017-10-05 | 2019-04-11 | Quretech Bio Ab | THIAZOLINO 2-PYRIDONES WITH A FUSED CYCLE IN COMBINATION WITH A MEDICINE AGAINST TUBERCULOSIS |
| WO2019162964A1 (en) * | 2018-02-23 | 2019-08-29 | Indian Institute Of Science | Anti-tubercular composition, and combinatorial implementations thereof |
| CN108186638A (zh) * | 2018-03-08 | 2018-06-22 | 重庆华邦制药有限公司 | 异烟肼的药物组合物 |
| WO2023107923A1 (en) * | 2021-12-07 | 2023-06-15 | An2 Therapeutics, Inc. | Combinations |
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| CN1217912A (zh) | 1997-11-26 | 1999-06-02 | 岑冠新 | 复方利福喷丁制剂及制备方法 |
| YU26102A (sh) | 2000-08-09 | 2004-12-31 | Panacea Biotec Limited | Nove farmaceutske smese antituberkuloznih lekova i postupak za njihovo dobijanje |
| WO2002087547A1 (en) * | 2001-04-27 | 2002-11-07 | Lupin Limited | An improved process for preparation of four-drug anti-tubercular fixed dose combination |
| RU2195937C1 (ru) * | 2002-02-06 | 2003-01-10 | НИИ молекулярной медицины ММА им. И.М.Сеченова | Комбинированный противотуберкулезный препарат (ризобутол) |
| US20050059719A1 (en) | 2003-09-16 | 2005-03-17 | Badawy Sherif Ibrahim Farag | Solid dosage formulation containing a Factor Xa inhibitor and method |
| BRPI0415338A (pt) * | 2004-02-04 | 2006-12-05 | Vinay Ramakant Sapte | complexos de ciclodextrina oral de droga anti-tuberculose |
| TWI368509B (en) | 2005-10-05 | 2012-07-21 | Otsuka Pharma Co Ltd | Antituberculous therapeutic drugs and kit containing the same |
| CN1989966B (zh) | 2005-12-30 | 2011-06-08 | 重庆华邦制药股份有限公司 | 含利福平和异烟肼的药物组合物 |
| CN1857280A (zh) | 2006-04-11 | 2006-11-08 | 济南帅华医药科技有限公司 | 一种复方抗结核药物缓释制剂 |
| KR101197277B1 (ko) | 2009-02-05 | 2012-11-05 | (주) 벡스코아 | 경구용 결핵의 치료용 또는 예방용 고형 제형 |
| AP2012006119A0 (en) | 2009-07-31 | 2012-02-29 | Cadila Pharmaceuticals Ltd | Pharmaceutical composition of isoniazid. |
| WO2012013756A2 (fr) * | 2010-07-28 | 2012-02-02 | Laboratoires Pharma 5 | Procédé de préparation de comprimés contenant en association la rifampicine, l'isoniazide, la pyrazinamide, et éventuellement l'ethambutol |
| US8470365B2 (en) * | 2010-07-29 | 2013-06-25 | Taiwan Biotech Co., Ltd. | Process for preparation of anti-tubercular combination and pharmaceutical composition prepared therefrom |
| CN105407876B (zh) | 2013-07-26 | 2019-08-30 | 赛诺菲 | 抗结核病的稳定的包含异烟肼颗粒和利福喷汀颗粒的可分散的片剂及其制备方法 |
| WO2015011161A1 (en) | 2013-07-26 | 2015-01-29 | Sanofi | Anti-tuberculosis stable pharmaceutical composition in a form of a coated tablet comprising granules of isoniazid and granules of rifapentine and its process of preparation |
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2014
- 2014-07-22 EP EP14741897.4A patent/EP3024445B1/en not_active Not-in-force
- 2014-07-22 MY MYPI2015704808A patent/MY174007A/en unknown
- 2014-07-22 SG SG11201510699WA patent/SG11201510699WA/en unknown
- 2014-07-22 CN CN201480041951.1A patent/CN105407874A/zh active Pending
- 2014-07-22 PE PE2016000091A patent/PE20160238A1/es unknown
- 2014-07-22 RU RU2016106336A patent/RU2672879C2/ru not_active IP Right Cessation
- 2014-07-22 US US14/906,870 patent/US9814711B2/en not_active Expired - Fee Related
- 2014-07-22 CA CA2918828A patent/CA2918828A1/en not_active Abandoned
- 2014-07-22 AU AU2014295100A patent/AU2014295100B2/en not_active Expired - Fee Related
- 2014-07-22 JP JP2016528511A patent/JP2017501117A/ja not_active Ceased
- 2014-07-22 WO PCT/EP2014/065763 patent/WO2015011163A1/en active Application Filing
- 2014-07-22 MX MX2016001156A patent/MX2016001156A/es unknown
- 2014-07-25 TW TW103125583A patent/TW201601716A/zh unknown
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2015
- 2015-12-28 IL IL243370A patent/IL243370A0/en unknown
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2016
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- 2016-01-19 PH PH12016500118A patent/PH12016500118A1/en unknown
- 2016-01-22 CL CL2016000180A patent/CL2016000180A1/es unknown
- 2016-06-14 HK HK16106815.2A patent/HK1218721A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015011163A1 (en) | 2015-01-29 |
| CN105407874A (zh) | 2016-03-16 |
| EP3024445A1 (en) | 2016-06-01 |
| JP2017501117A (ja) | 2017-01-12 |
| EP3024445B1 (en) | 2019-01-09 |
| AU2014295100A1 (en) | 2016-02-11 |
| ZA201600108B (en) | 2017-04-26 |
| US20160158226A1 (en) | 2016-06-09 |
| MY174007A (en) | 2020-03-03 |
| AU2014295100B2 (en) | 2019-01-03 |
| US9814711B2 (en) | 2017-11-14 |
| IL243370A0 (en) | 2016-02-29 |
| TW201601716A (zh) | 2016-01-16 |
| CL2016000180A1 (es) | 2016-06-24 |
| RU2016106336A3 (ru) | 2018-05-17 |
| HK1218721A1 (zh) | 2017-03-10 |
| PH12016500118A1 (en) | 2016-04-25 |
| RU2672879C2 (ru) | 2018-11-20 |
| PE20160238A1 (es) | 2016-05-05 |
| CA2918828A1 (en) | 2015-01-29 |
| MX2016001156A (es) | 2016-04-29 |
| SG11201510699WA (en) | 2016-01-28 |
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| MM4A | The patent is invalid due to non-payment of fees |
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