HRP20120957T1 - Stabilni farmaceutski sastav koji sadrži pirimidin-sulfamid - Google Patents
Stabilni farmaceutski sastav koji sadrži pirimidin-sulfamid Download PDFInfo
- Publication number
- HRP20120957T1 HRP20120957T1 HRP20120957TT HRP20120957T HRP20120957T1 HR P20120957 T1 HRP20120957 T1 HR P20120957T1 HR P20120957T T HRP20120957T T HR P20120957TT HR P20120957 T HRP20120957 T HR P20120957T HR P20120957 T1 HRP20120957 T1 HR P20120957T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical composition
- sulfamide
- pyrimidine
- stable pharmaceutical
- surfactant
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- GZRPWFCHDLJSDX-UHFFFAOYSA-N pyrimidine;sulfamide Chemical compound NS(N)(=O)=O.C1=CN=CN=C1 GZRPWFCHDLJSDX-UHFFFAOYSA-N 0.000 title 1
- 239000004094 surface-active agent Substances 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 1
- 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 1
- 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 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 239000000314 lubricant Substances 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
- 230000000877 morphologic effect Effects 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
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
- A61K31/33—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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Pulmonology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (1)
1. Farmaceutski sastav, naznačen time, da obuhvaća:
a) spoj formule I
[image]
I
ili njegovu farmaceutski prihvatljivu sol, njegov solvat, hidrat ili njegov morfološki oblik,
b) laktozu ili monohidrat laktoze,
c) mikrokristaličnu celulozu,
d) polivinilpirolidon,
e) natrijev škrobni glikolat,
f) surfaktant, pri čemu surfaktant je polisorbat, i
g) lubrikant.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP2005009775 | 2005-09-12 | ||
PCT/IB2006/053210 WO2007031933A2 (en) | 2005-09-12 | 2006-09-11 | Stable pharmaceutical composition comprising a pyrimidine-sulfamide |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20120957T1 true HRP20120957T1 (hr) | 2012-12-31 |
Family
ID=37865339
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20120957TT HRP20120957T1 (hr) | 2005-09-12 | 2012-11-23 | Stabilni farmaceutski sastav koji sadrži pirimidin-sulfamid |
Country Status (24)
Country | Link |
---|---|
US (6) | US20080233188A1 (hr) |
EP (2) | EP1928409B1 (hr) |
JP (2) | JP4955685B2 (hr) |
KR (1) | KR101313395B1 (hr) |
CN (1) | CN101262847B (hr) |
AU (1) | AU2006290309B2 (hr) |
BR (1) | BRPI0615898B8 (hr) |
CA (1) | CA2621273C (hr) |
CY (1) | CY1113395T1 (hr) |
DK (1) | DK1928409T3 (hr) |
ES (1) | ES2393117T3 (hr) |
HK (1) | HK1121950A1 (hr) |
HR (1) | HRP20120957T1 (hr) |
IL (1) | IL190072A (hr) |
MY (1) | MY151003A (hr) |
NO (1) | NO341325B1 (hr) |
NZ (1) | NZ567188A (hr) |
PL (1) | PL1928409T3 (hr) |
PT (1) | PT1928409E (hr) |
RU (1) | RU2424805C2 (hr) |
SI (1) | SI1928409T1 (hr) |
TW (1) | TWI323661B (hr) |
WO (1) | WO2007031933A2 (hr) |
ZA (1) | ZA200802947B (hr) |
Families Citing this family (26)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1928409B1 (en) | 2005-09-12 | 2012-09-12 | Actelion Pharmaceuticals Ltd. | Stable pharmaceutical composition comprising a pyrimidine-sulfamide |
AR062501A1 (es) | 2006-08-29 | 2008-11-12 | Actelion Pharmaceuticals Ltd | Composiciones terapeuticas |
TWI399223B (zh) * | 2006-09-15 | 2013-06-21 | Daiichi Sankyo Co Ltd | 奧美沙坦酯及氨氯地平之固體劑型 |
MX2010001837A (es) | 2007-08-17 | 2010-03-10 | Actelion Pharmaceuticals Ltd | Derivados de 4-pirimidinasulfamida. |
DK2254570T3 (da) | 2008-02-20 | 2014-02-03 | Actelion Pharmaceuticals Ltd | Kombination omfattende paclitaxel til behandling af ovariecancer |
NO2315587T3 (hr) * | 2008-08-13 | 2018-03-24 | ||
IN2012DN01261A (hr) * | 2009-08-10 | 2015-05-15 | Univ Texas | |
US10071059B2 (en) | 2009-12-18 | 2018-09-11 | Frieslandcampina Nederland Holding B.V. | Co-processed tablet excipient composition its preparation and use |
IT1403248B1 (it) * | 2010-11-12 | 2013-10-17 | Scharper Therapeutics Srl | Composizione per il trattamento di disfunzioni degli apparati fonatorio ed olfattorio |
BR112013019680A2 (pt) | 2011-02-04 | 2016-10-11 | Actelion Pharmaceuticals Ltd | combinações compreendendo macitentana para o tratamento de glioblastoma multiforme |
DE14721256T1 (de) * | 2013-04-22 | 2017-03-16 | Sandoz Ag | Pharmazeutische zusammensetzungen mit kristallinem macitentan |
CN114404414A (zh) | 2013-06-13 | 2022-04-29 | 阿克比治疗有限公司 | 用于治疗贫血症的组合物和方法 |
CN104411691B (zh) * | 2013-06-14 | 2016-05-25 | 杭州普晒医药科技有限公司 | 马西替坦晶体及其制备方法、其药物组合物和用途 |
WO2016009322A1 (en) * | 2014-07-15 | 2016-01-21 | Sifavitor S.R.L. | Amorphous form and new crystalline forms of macitentan |
SG10201900648SA (en) | 2014-07-25 | 2019-02-27 | Novartis Ag | Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide |
CN105388244B (zh) * | 2015-12-10 | 2017-03-08 | 合肥久诺医药科技有限公司 | 一种马西替坦有关物质的高效液相色谱分析方法 |
WO2018153925A1 (en) | 2017-02-22 | 2018-08-30 | Amneal Pharmaceuticals Company Gmbh | Stable pharmaceutical compositions comprising macitentan |
SG11202105098VA (en) * | 2018-12-21 | 2021-06-29 | Actelion Pharmaceuticals Ltd | Pharmaceutical composition for the treatment of pulmonary arterial hypertension |
TW202042818A (zh) * | 2019-01-25 | 2020-12-01 | 瑞士商艾克泰聯製藥有限公司 | 用於治療慢性血栓性肺高血壓之醫藥組成物 |
US20220249381A1 (en) | 2019-07-05 | 2022-08-11 | TECNIMEDE - Sociedade Técnico-medicinal, SA | Compressed macitentan compositions, methods and uses thereof |
CR20220305A (es) | 2019-11-29 | 2022-07-28 | Actelion Pharmaceuticals Ltd | Métodos de tratamiento de hipertensión de la arteria pulmonar |
WO2022238375A1 (en) | 2021-05-11 | 2022-11-17 | Actelion Pharmaceuticals Ltd | Methods of treating pulmonary hypertension |
TW202317119A (zh) * | 2021-06-11 | 2023-05-01 | 瑞士商艾克泰聯製藥有限公司 | 用於口服投予之分散錠 |
CN117835971A (zh) | 2021-08-25 | 2024-04-05 | 巴斯夫欧洲公司 | 直接压片用辅料组合物 |
WO2023038600A1 (en) * | 2021-09-07 | 2023-03-16 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A capsule formulation comprising macitentan |
EP4154873A1 (en) | 2021-09-22 | 2023-03-29 | Sanovel Ilac Sanayi Ve Ticaret A.S. | The tablet comprising macitentan |
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EP1928409B1 (en) | 2005-09-12 | 2012-09-12 | Actelion Pharmaceuticals Ltd. | Stable pharmaceutical composition comprising a pyrimidine-sulfamide |
AR062501A1 (es) | 2006-08-29 | 2008-11-12 | Actelion Pharmaceuticals Ltd | Composiciones terapeuticas |
DK2254570T3 (da) | 2008-02-20 | 2014-02-03 | Actelion Pharmaceuticals Ltd | Kombination omfattende paclitaxel til behandling af ovariecancer |
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-
2006
- 2006-09-11 EP EP06809280A patent/EP1928409B1/en active Active
- 2006-09-11 AU AU2006290309A patent/AU2006290309B2/en active Active
- 2006-09-11 ES ES06809280T patent/ES2393117T3/es active Active
- 2006-09-11 CN CN2006800333751A patent/CN101262847B/zh active Active
- 2006-09-11 SI SI200631471T patent/SI1928409T1/sl unknown
- 2006-09-11 US US12/066,448 patent/US20080233188A1/en not_active Abandoned
- 2006-09-11 DK DK06809280.8T patent/DK1928409T3/da active
- 2006-09-11 CA CA2621273A patent/CA2621273C/en active Active
- 2006-09-11 JP JP2008529767A patent/JP4955685B2/ja active Active
- 2006-09-11 WO PCT/IB2006/053210 patent/WO2007031933A2/en active Application Filing
- 2006-09-11 PT PT06809280T patent/PT1928409E/pt unknown
- 2006-09-11 KR KR1020087008450A patent/KR101313395B1/ko active IP Right Review Request
- 2006-09-11 EP EP10009910A patent/EP2292209A3/en not_active Withdrawn
- 2006-09-11 BR BRPI0615898A patent/BRPI0615898B8/pt active IP Right Grant
- 2006-09-11 RU RU2008113869/15A patent/RU2424805C2/ru active
- 2006-09-11 NZ NZ567188A patent/NZ567188A/en unknown
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2008
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2009
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2012
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2013
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2016
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