HRP20100348T1 - Stabilne farmaceustke formulacije montelukast natrija - Google Patents
Stabilne farmaceustke formulacije montelukast natrija Download PDFInfo
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- HRP20100348T1 HRP20100348T1 HR20100348T HRP20100348T HRP20100348T1 HR P20100348 T1 HRP20100348 T1 HR P20100348T1 HR 20100348 T HR20100348 T HR 20100348T HR P20100348 T HRP20100348 T HR P20100348T HR P20100348 T1 HRP20100348 T1 HR P20100348T1
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- pharmaceutical composition
- montelukast
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 23
- LBFBRXGCXUHRJY-HKHDRNBDSA-M montelukast sodium Chemical compound [Na+].CC(C)(O)C1=CC=CC=C1CC[C@H](C=1C=C(\C=C\C=2N=C3C=C(Cl)C=CC3=CC=2)C=CC=1)SCC1(CC([O-])=O)CC1 LBFBRXGCXUHRJY-HKHDRNBDSA-M 0.000 title claims 7
- 229960001951 montelukast sodium Drugs 0.000 title claims 7
- UCHDWCPVSPXUMX-TZIWLTJVSA-N Montelukast Chemical compound CC(C)(O)C1=CC=CC=C1CC[C@H](C=1C=C(\C=C\C=2N=C3C=C(Cl)C=CC3=CC=2)C=CC=1)SCC1(CC(O)=O)CC1 UCHDWCPVSPXUMX-TZIWLTJVSA-N 0.000 claims abstract 11
- 229960005127 montelukast Drugs 0.000 claims abstract 11
- 150000003839 salts Chemical class 0.000 claims abstract 7
- 239000000203 mixture Substances 0.000 claims abstract 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract 5
- 239000007941 film coated tablet Substances 0.000 claims abstract 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract 5
- 239000000080 wetting agent Substances 0.000 claims abstract 4
- 239000003085 diluting agent Substances 0.000 claims abstract 3
- 239000000314 lubricant Substances 0.000 claims abstract 3
- 239000011230 binding agent Substances 0.000 claims abstract 2
- 239000007884 disintegrant Substances 0.000 claims abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 8
- 150000003462 sulfoxides Chemical class 0.000 claims 8
- 239000000945 filler Substances 0.000 claims 7
- 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 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 4
- 229920002472 Starch Polymers 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 4
- 229960001021 lactose monohydrate Drugs 0.000 claims 4
- 235000019359 magnesium stearate Nutrition 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 229920003109 sodium starch glycolate Polymers 0.000 claims 4
- 229940079832 sodium starch glycolate Drugs 0.000 claims 4
- 239000008109 sodium starch glycolate Substances 0.000 claims 4
- 229940032147 starch Drugs 0.000 claims 4
- 239000008107 starch Substances 0.000 claims 4
- 235000019698 starch Nutrition 0.000 claims 4
- QFTNWCBEAVHLQA-XNHCCDLUSA-N 2-[1-[[(1r)-1-[3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfinylmethyl]cyclopropyl]acetic acid Chemical compound CC(C)(O)C1=CC=CC=C1CC[C@@H](S(=O)CC1(CC(O)=O)CC1)C1=CC=CC(\C=C\C=2N=C3C=C(Cl)C=CC3=CC=2)=C1 QFTNWCBEAVHLQA-XNHCCDLUSA-N 0.000 claims 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 229940071676 hydroxypropylcellulose Drugs 0.000 claims 3
- 229940057948 magnesium stearate Drugs 0.000 claims 3
- 238000003825 pressing Methods 0.000 claims 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 3
- 239000003826 tablet Substances 0.000 claims 2
- 238000007580 dry-mixing Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000009736 wetting Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 238000007907 direct compression Methods 0.000 abstract 1
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- 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
- A61K31/47—Quinolines; Isoquinolines
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- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- 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
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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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- 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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Abstract
Stabilna farmaceutska kompozicija u obliku tablete obložene filmom, naznačena time što sadrži montelukast ili njegovu sol i farmaceutski prihvatljiv inertni punitelj izabran od najmanje jednog od razblaživača, vezivnog sredstva, sredstva za raspadanje, sredstva za vlaženje, lubrikanta ili klizajućeg sredstva, uz uvjet da farmaceutski prihvatljivi inertni punitelj nije mikrokristalna celuloza, pri čemu je farmaceutska kompozicija pripremljena direktnim prešanjem iz suhe mješavine. Patent sadrži još 17 patentnih zahtjeva.
Claims (18)
1. Stabilna farmaceutska kompozicija u obliku tablete obložene filmom, naznačena time što sadrži montelukast ili njegovu sol i farmaceutski prihvatljiv inertni punitelj izabran od najmanje jednog od razblaživača, vezivnog sredstva, sredstva za raspadanje, sredstva za vlaženje, lubrikanta ili klizajućeg sredstva, uz uvjet da farmaceutski prihvatljivi inertni punitelj nije mikrokristalna celuloza, pri čemu je farmaceutska kompozicija pripremljena direktnim prešanjem iz suhe mješavine.
2. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što kompozicija sadrži odgovarajući montelukast sulfoksid, pri čemu se odgovarajući montelukast sulfoksid u kompoziciji ne povećava za više od 1 težinski % od početne količine montelukasta poslije čuvanja na oko i oko 75% relativne vlažnosti u trajanju od 3 mjeseca.
3. Farmaceutska kompozicija prema patentnom zahtjevu 2, naznačena time što je sol montelukast natrij i odgovarajući sulfoksid je sulfoksid formule (I):
[image]
4. Farmaceutska kompozicija prema patentnom zahtjevu 2 ili 3, naznačena time što se količina odgovarajućeg sulfoksida ne povećava za više od 0.5 težinskih % od početne količine montelukasta poslije čuvanja na oko i oko 75% relativne vlažnosti u trajanju od 3 mjeseca.
5. Farmaceutska kompozicija prema patentnom zahtjevu 4, naznačena time što se količina odgovarajućeg sulfoksida ne povećava za više od 0.3 težinskih % od početne količine montelukasta poslije čuvanja na oko i oko 75% relativne vlažnosti u trajanju od 3 mjeseca.
6. Farmaceutska kompozicija prema patentnom zahtjevu 5, naznačena time što se količina odgovarajućeg sulfoksida ne povećava za više od 0.1 težinskih % od početne količine montelukasta poslije čuvanja na oko i oko 75% relativne vlažnosti u trajanju od 3 mjeseca.
7. Farmaceutska kompozicija u obliku tablete obložene filmom, naznačena time što sadrži montelukast ili njegovu sol i farmaceutski prihvatljiv inertni punitelj, uz uvjet da farmaceutski prihvatljiv inertni punitelj nije mikrokristalna celuloza, pri čemu je odgovarajući montelukast sulfoksid prisutan u količine od ne više od 0.2 težinska % montelukasta ili njegove soli neposredno poslije pripreme, pri čemu je farmaceutska kompozicija pripremljena direktnim prešanjem iz suhe mješavine.
8. Farmaceutska kompozicija prema patentnom zahtjevu 7, naznačena time što je odgovarajući sulfoksid prisutan u količini od ne više od 0.1 težinski % montelukasta neposredno poslije pripreme.
9. Farmaceutska kompozicija prema patentnom zahtjevu 7 ili 8, naznačena time što je sol montelukast natrij i odgovarajući sulfoksid je sulfoksid formule (I):
[image]
10. Farmaceutska kompozicija prema bilo kojem od prethodno navedenih patentnih zahtjeva, naznačena time što kompozicija sadrži sredstvo za vlaženje.
11. Farmaceutska kompozicija prema patentnom zahtjevu 10, naznačena time što je sredstvo za vlaženje natrijev lauril sulfat.
12. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time što je tableta – tableta obložena filmom koja dodatno sadrži sredstvo za oblaganje, uz uvjet da sredstvo za oblaganje nije mikrokristalna celuloza.
13. Farmaceutska kompozicija prema patentnom zahtjevu 12, naznačena time što sadrži montelukast natrij, laktoza monohidrat, hidroksipropilcelulozu, škrob, natrijev škrob glikolat i magnezijev stearat.
14. Farmaceutska kompozicija prema patentnom zahtjevu 13, naznačena time što je montelukast natrij prisutan u količini od oko 5 težinskih %, laktoza monohidrat je prisutna u količini od oko 62 težinska %, hidroksipropilceluloza je prisutna u količini od oko 2 težinska %, škrob je prisutan u količini od oko 18 težinskih %, natrijev škrob glikolat je prisutan u količini od oko 9 težinskih %, magnezijev stearat je prisutan u količini od oko 1 težinski % i sredstvo za oblaganje je prisutno u količini od oko 3 težinska %.
15. Farmaceutska kompozicija prema patentnom zahtjevu 12, naznačena time što sadrži montelukast natrij, laktoza monohidrat, hidroksipropilcelulozu, škrob, natrijev lauril sulfat, natrijev škrob glikolat i magnezijev stearat.
16. Postupak za pripremu farmaceutske kompozicije u obliku tablete obložene filmom prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što sadrži spajanje montelukasta ili njegove farmaceutski prihvatljive soli sa farmaceutski prihvatljivim inertnim puniteljem koji je izabran od najmanje jednog od razblaživača, sredstva za raspadanje, sredstva za vlaženje, lubrikanta ili klizajućeg sredstva uz uvjet da farmaceutski prihvatljivi inertni punitelj nije mikrokristalna celuloza.
17. Postupak prema patentnom zahtjevu 16, naznačen time što je svaki od farmaceutski prihvatljivih inertnih punitelja prvo testiran u cilju procjene njegove pogodnosti u stabilnoj farmaceutskoj kompoziciji montelukasta.
18. Postupak prema patentnom zahtjevu 16 za pripremu farmaceutske kompozicije prema patentnom zahtjevu 15, naznačen time što sadrži miješanje montelukast natrija, laktoza monohidrata, hidroksipropilceluloze, škroba, natrijevog lauril sulfata, natrijevog škrob glikolata i magnezijeva stearata u postupku suhog miješanja i prešanja izmješanih komponenti u obliku tablete.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US77225806P | 2006-02-09 | 2006-02-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20100348T1 true HRP20100348T1 (hr) | 2010-09-30 |
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ID=36910917
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100348T HRP20100348T1 (hr) | 2006-02-09 | 2010-06-21 | Stabilne farmaceustke formulacije montelukast natrija |
Country Status (18)
| Country | Link |
|---|---|
| US (3) | US20070184108A1 (hr) |
| EP (2) | EP1818057B1 (hr) |
| JP (2) | JP2009526047A (hr) |
| CN (1) | CN101365450A (hr) |
| AT (1) | ATE464902T1 (hr) |
| AU (1) | AU2006337648A1 (hr) |
| CA (1) | CA2635841A1 (hr) |
| CY (1) | CY1110221T1 (hr) |
| DE (1) | DE602006013781D1 (hr) |
| DK (1) | DK1818057T3 (hr) |
| ES (1) | ES2342727T3 (hr) |
| HR (1) | HRP20100348T1 (hr) |
| IL (1) | IL193074A0 (hr) |
| PL (1) | PL1818057T3 (hr) |
| PT (1) | PT1818057E (hr) |
| RS (1) | RS51330B (hr) |
| SI (1) | SI1818057T1 (hr) |
| WO (1) | WO2007092031A1 (hr) |
Families Citing this family (41)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3216445A1 (en) * | 2004-05-28 | 2017-09-13 | Imaginot Pty Ltd. | Oral therapeutic compound delivery system |
| EP3449928A1 (en) | 2005-11-28 | 2019-03-06 | Imaginot Pty Ltd. | Oral therapeutic compound delivery system |
| AU2006337648A1 (en) * | 2006-02-09 | 2007-08-16 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical formulations of montelukast sodium |
| CN103349659A (zh) * | 2006-09-26 | 2013-10-16 | 塔罗制药北美有限公司 | 液体药物组合物以及应用 |
| US20100292251A1 (en) * | 2008-01-07 | 2010-11-18 | Torrent Pharmaceuticals Limited | Montelukast benzhydryl piperazine salts and process for preparation thereof |
| CA2719246A1 (en) * | 2008-03-26 | 2009-10-01 | Taro Pharmaceuticals North America, Inc. | Stabilizing lipid compositions for oral pharmaceutical agents |
| TR200806298A2 (tr) | 2008-08-22 | 2010-03-22 | Bi̇lgi̇ç Mahmut | Farmasötik formülasyon |
| WO2010107404A1 (en) | 2009-03-16 | 2010-09-23 | Mahmut Bilgic | Stable pharmaceutical combinations |
| CN101773481B (zh) * | 2010-01-09 | 2013-01-16 | 鲁南制药集团股份有限公司 | 一种含有孟鲁司特钠的咀嚼片 |
| WO2011105539A1 (ja) * | 2010-02-26 | 2011-09-01 | 東レ株式会社 | 被覆固形製剤 |
| TR201009398A2 (tr) | 2010-11-11 | 2012-05-21 | Bi̇lgi̇ç Mahmut | Fiziksel özellikleri geliştirilmiş tablet formülasyonları |
| TR201009394A2 (tr) | 2010-11-11 | 2012-06-21 | Bi̇lgi̇ç Mahmut | Geliştirilmiş montelukast formülasyonları. |
| EP2640355A1 (en) * | 2010-11-16 | 2013-09-25 | Lupin Limited | Stable oral pharmaceutical compositions of montelukast |
| CN102085187B (zh) * | 2011-01-27 | 2012-01-11 | 海南美大制药有限公司 | 孟鲁司特钠脂质体固体制剂 |
| KR101077468B1 (ko) * | 2011-03-04 | 2011-11-07 | (주)차바이오앤디오스텍 | 안정한 경구용 속용 필름 제제 |
| KR101278572B1 (ko) * | 2011-10-18 | 2013-06-25 | 주식회사 네비팜 | 류코트리엔 길항제와 에피나스틴의 복합제제 |
| WO2013077829A1 (en) | 2011-11-21 | 2013-05-30 | Mahmut Bilgic | Water-soluble pharmaceutical granules |
| JP6200432B2 (ja) * | 2011-12-26 | 2017-09-20 | エスケー ケミカルズ カンパニー リミテッド | モンテルカストまたはその薬学的に許容可能な塩を含む経口投与用フィルム |
| CN103239450B (zh) * | 2012-02-07 | 2014-11-26 | 齐鲁制药有限公司 | 一种能快速溶出、稳定的孟鲁司特钠口服固体制剂及其制备方法 |
| EP2716279A1 (en) | 2012-10-04 | 2014-04-09 | Lamda UK Ltd. | Oral solutions containing leukotriene antagonists |
| CN103040784A (zh) * | 2012-12-26 | 2013-04-17 | 深圳致君制药有限公司 | 一种孟鲁司特钠片组合物及其制备方法 |
| KR20220164069A (ko) * | 2013-06-06 | 2022-12-12 | 피브로겐, 인크. | Hif 하이드록실라제 억제자의 약학적 제형 |
| CN103494781B (zh) * | 2013-08-30 | 2014-10-29 | 哈药集团技术中心 | 一种孟鲁司特钠咀嚼片处方及其制备工艺 |
| CN104644605A (zh) * | 2013-11-25 | 2015-05-27 | 天津汉瑞药业有限公司 | 一种含孟鲁司特钠的稳定的胶囊制剂及其制备方法 |
| CN104649968B (zh) * | 2013-11-25 | 2017-03-15 | 天津汉瑞药业有限公司 | 一种孟鲁司特钠倍半水合物化合物 |
| CN103720672B (zh) * | 2014-01-26 | 2016-03-16 | 新疆特丰药业股份有限公司 | 孟鲁司特钠咀嚼片及其粉末直接压片制备方法 |
| JP6488003B2 (ja) * | 2014-04-25 | 2019-03-20 | アールピー シーラー テクノロジーズ リミテッド ライアビリティ カンパニー | 安定なモンテルカスト溶液 |
| CN104666266B (zh) * | 2015-03-23 | 2017-09-22 | 曲素欣 | 一种含有孟鲁司特钠的固体口服制剂及其制备方法 |
| JP6489435B2 (ja) * | 2015-04-20 | 2019-03-27 | 高田製薬株式会社 | モンテルカストナトリウム顆粒製剤 |
| JP2017001989A (ja) * | 2015-06-11 | 2017-01-05 | ニプロ株式会社 | 医薬組成物の製造方法及び医薬組成物 |
| CN105616368B (zh) * | 2016-01-22 | 2017-02-22 | 山东新时代药业有限公司 | 一种孟鲁司特钠片剂及其制备方法 |
| CN106474080A (zh) * | 2016-09-24 | 2017-03-08 | 万特制药(海南)有限公司 | 一种孟鲁斯特纳口崩片及其制备方法 |
| CN106491556A (zh) * | 2016-10-21 | 2017-03-15 | 江苏阿尔法药业有限公司 | 一种稳定的孟鲁司特钠肠溶微丸 |
| CN109833302A (zh) * | 2017-11-29 | 2019-06-04 | 扬子江药业集团有限公司 | 一种稳定的孟鲁司特钠咀嚼片及其制备方法 |
| CN110045049B (zh) * | 2018-01-17 | 2021-07-09 | 天津药物研究院有限公司 | 一种同时测定孟鲁司特钠及其制剂多种有关物质的方法 |
| CN110721166A (zh) * | 2018-07-16 | 2020-01-24 | 北京万全德众医药生物技术有限公司 | 一种孟鲁司特钠片剂及其制备方法 |
| CN110731947A (zh) * | 2018-07-18 | 2020-01-31 | 北京万全德众医药生物技术有限公司 | 孟鲁司特钠口崩片的制备方法 |
| CN110787139A (zh) * | 2018-08-01 | 2020-02-14 | 北京万全德众医药生物技术有限公司 | 一种孟鲁司特钠药物组合物 |
| CN111110679A (zh) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | 一种含有孟鲁司特钠的药物组合物 |
| CN111249238A (zh) * | 2020-01-19 | 2020-06-09 | 安徽省先锋制药有限公司 | 一种孟鲁司特钠颗粒制剂方法 |
| KR20230025062A (ko) | 2021-08-13 | 2023-02-21 | 단국대학교 천안캠퍼스 산학협력단 | 결정형 몬테루카스트를 포함하는 지속성 현탁 주사제 및 이의 제조방법 |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2548675B1 (fr) * | 1983-07-06 | 1987-01-09 | Seppic Sa | Compositions filmogenes pour enrobage des formes solides de produits pharmaceutiques ou alimentaires et produits obtenus revetus desdites compositions |
| US4851409A (en) * | 1986-02-14 | 1989-07-25 | Merck Frosst Canada Inc. | 2-substituted quinoline dioic acids and pharmaceutical compositions |
| CA1297035C (en) * | 1987-12-29 | 1992-03-10 | Warner-Lambert Canada Inc. | Chewable, non-gritty calcium citrate tablet |
| US5856322A (en) * | 1990-10-12 | 1999-01-05 | Merck Frosst Canada, Inc. | Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists |
| US5565473A (en) | 1990-10-12 | 1996-10-15 | Merck Frosst Canada, Inc. | Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists |
| TW448160B (en) * | 1993-12-28 | 2001-08-01 | Merck & Co Inc | Novel dicyclohexylamine salt and process for the preparation of leukotriene antagonists |
| US5427933A (en) * | 1994-07-20 | 1995-06-27 | Merck & Co., Inc. | Reduction of phenylalkyl ketones to the corresponding (S)-hydroxy derivatives using mucor hiemalis IFO 5834 |
| US5491077A (en) * | 1994-07-20 | 1996-02-13 | Merck & Co., Inc. | Microbial method |
| US5750539A (en) * | 1995-06-07 | 1998-05-12 | Merck Frosst Canada | Heteroaryl diol acids as leukotriene antagonists |
| US5952347A (en) * | 1997-03-13 | 1999-09-14 | Merck & Co., Inc. | Quinoline leukotriene antagonists |
| US6224907B1 (en) * | 1998-03-06 | 2001-05-01 | Alza Corporation | Anti-asthma therapy |
| FR2781152B1 (fr) * | 1998-07-20 | 2001-07-06 | Permatec Tech Ag | Utilisation d'un polymere de type acrylique en tant qu'agent de desagregation |
| US20020006433A1 (en) * | 1999-04-29 | 2002-01-17 | Nigel P. Davidson | Pharmaceutical formulations |
| MY148466A (en) * | 2001-10-26 | 2013-04-30 | Merck Frosst Canada Ltd | Granule formulation |
| US20050107612A1 (en) * | 2002-12-30 | 2005-05-19 | Dr. Reddy's Laboratories Limited | Process for preparation of montelukast and its salts |
| US7553853B2 (en) * | 2003-10-10 | 2009-06-30 | Synthon Bv | Solid-state montelukast |
| GB2407498B (en) * | 2003-10-30 | 2008-06-11 | Cipla Ltd | Oral formulations for 5-HT receptor agonists with reduced degradation of active ingredient |
| US20050096840A1 (en) * | 2003-11-03 | 2005-05-05 | Simske Steven J. | Navigation routing system and method |
| WO2005075427A2 (en) * | 2004-01-30 | 2005-08-18 | Teva Pharmaceutical Industries Ltd. | Montelukast sodium polymorphs |
| KR20060117356A (ko) * | 2004-01-30 | 2006-11-16 | 테바 파마슈티컬 인더스트리즈 리미티드 | 몬테루카스트 유리산 다형체 |
| CA2554927A1 (en) * | 2004-02-03 | 2005-08-18 | Chemagis Ltd. | Stable amorphous forms of montelukast sodium |
| WO2005089761A1 (en) * | 2004-03-17 | 2005-09-29 | Pfizer Limited | Combination for treating inflammatory diseases |
| CA2562009A1 (en) * | 2004-04-05 | 2005-10-20 | Sepracor Inc. | (r,r)-formoterol in combination with other pharmacological agents |
| US7189853B2 (en) * | 2004-04-15 | 2007-03-13 | Dr. Reddy's Laboratories Limited | Process for the preparation of [R-(E)-1-[[[1-[3-[2-[7-chloro-2-quinolinyl]ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid (Montelukast) and its pharmaceutically acceptable salts |
| TWI354569B (en) * | 2004-05-28 | 2011-12-21 | Bristol Myers Squibb Co | Coated tablet formulation and method |
| CN1287792C (zh) * | 2004-08-30 | 2006-12-06 | 鲁南制药集团股份有限公司 | 孟鲁司特钠的分散片剂型 |
| EP1803457A1 (en) * | 2005-12-30 | 2007-07-04 | Krka Tovarna Zdravil, D.D., Novo Mesto | Pharmaceutical composition containing montelukast |
| AU2006337648A1 (en) * | 2006-02-09 | 2007-08-16 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical formulations of montelukast sodium |
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- 2006-05-09 EP EP06252449A patent/EP1818057B1/en active Active
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- 2006-05-09 AT AT06252449T patent/ATE464902T1/de active
- 2006-05-09 US US11/431,177 patent/US20070184108A1/en not_active Abandoned
- 2006-05-09 PT PT06252449T patent/PT1818057E/pt unknown
- 2006-05-09 SI SI200630685T patent/SI1818057T1/sl unknown
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- 2006-05-09 PL PL06252449T patent/PL1818057T3/pl unknown
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- 2006-05-09 RS RSP-2010/0329A patent/RS51330B/en unknown
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| US20070184101A1 (en) | 2007-08-09 |
| PL1818057T3 (pl) | 2010-09-30 |
| EP1818057A1 (en) | 2007-08-15 |
| RS51330B (en) | 2011-02-28 |
| AU2006337648A1 (en) | 2007-08-16 |
| EP1818057B1 (en) | 2010-04-21 |
| EP2158911A1 (en) | 2010-03-03 |
| SI1818057T1 (sl) | 2010-08-31 |
| IL193074A0 (en) | 2009-02-11 |
| ES2342727T3 (es) | 2010-07-13 |
| JP2013049709A (ja) | 2013-03-14 |
| JP2009526047A (ja) | 2009-07-16 |
| US20070184108A1 (en) | 2007-08-09 |
| CY1110221T1 (el) | 2015-01-14 |
| DK1818057T3 (da) | 2010-07-19 |
| CN101365450A (zh) | 2009-02-11 |
| WO2007092031A1 (en) | 2007-08-16 |
| CA2635841A1 (en) | 2007-08-16 |
| ATE464902T1 (de) | 2010-05-15 |
| PT1818057E (pt) | 2010-06-18 |
| US20100120848A1 (en) | 2010-05-13 |
| DE602006013781D1 (de) | 2010-06-02 |
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