HRP20180215T1 - Postupak za proizvodnju farmaceutskog proizvoda koji sadrži limunsku kiselinu, magnezijev oksid, kalijev bikarbonat i natrijev pikosulfat, farmaceutski pripravak koji sadrži granule dobivene takvim postupkom i njihovi međuproizvodi - Google Patents
Postupak za proizvodnju farmaceutskog proizvoda koji sadrži limunsku kiselinu, magnezijev oksid, kalijev bikarbonat i natrijev pikosulfat, farmaceutski pripravak koji sadrži granule dobivene takvim postupkom i njihovi međuproizvodi Download PDFInfo
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- HRP20180215T1 HRP20180215T1 HRP20180215TT HRP20180215T HRP20180215T1 HR P20180215 T1 HRP20180215 T1 HR P20180215T1 HR P20180215T T HRP20180215T T HR P20180215TT HR P20180215 T HRP20180215 T HR P20180215T HR P20180215 T1 HRP20180215 T1 HR P20180215T1
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- granules
- potassium bicarbonate
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- 239000008187 granular material Substances 0.000 title claims 18
- GOZDTZWAMGHLDY-UHFFFAOYSA-L sodium picosulfate Chemical compound [Na+].[Na+].C1=CC(OS(=O)(=O)[O-])=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OS([O-])(=O)=O)C=C1 GOZDTZWAMGHLDY-UHFFFAOYSA-L 0.000 title claims 15
- 229960005077 sodium picosulfate Drugs 0.000 title claims 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 title claims 13
- 238000000034 method Methods 0.000 title claims 13
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 title claims 13
- 229910000028 potassium bicarbonate Inorganic materials 0.000 title claims 11
- 235000015497 potassium bicarbonate Nutrition 0.000 title claims 11
- 239000011736 potassium bicarbonate Substances 0.000 title claims 11
- 239000000825 pharmaceutical preparation Substances 0.000 title claims 10
- 239000000395 magnesium oxide Substances 0.000 title claims 7
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 title claims 7
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 title claims 7
- 239000013067 intermediate product Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 229940127557 pharmaceutical product Drugs 0.000 title 1
- 239000002245 particle Substances 0.000 claims 30
- 238000002360 preparation method Methods 0.000 claims 7
- 238000005507 spraying Methods 0.000 claims 5
- 239000000243 solution Substances 0.000 claims 4
- 238000001035 drying Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 1
- 239000007864 aqueous solution Substances 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
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/009—Sachets, pouches characterised by the material or function of the envelope
-
- 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
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
-
- 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
- A61K9/1611—Inorganic compounds
-
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Pyridine Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (25)
1. Pripravak koji sadrži granule uključujući natrijev pikosulfat i kalijev bikarbonat, te granule sadrže sloj natrijevog pikosulfata obložen na jezgru od kalijevog bikarbonata.
2. Pripravak prema zahtjevu 1 naznačen time da granule imaju raspon ili raspodjelu veličine čestica (promjer) od između 100 µm i 900 µm.
3. Pripravak prema zahtjevu 1 naznačen time da granule imaju raspodjelu veličine čestica (promjer) pri čemu više od 85% čestica ima veličinu čestica (promjer) između 100 µm i 900 µm.
4. Pripravak prema zahtjevu 1 ili zahtjevu 3 naznačen time da granule imaju raspodjelu veličine čestica (promjer) pri čemu manje od 5% čestica ima veličinu čestica (promjer) veću od 900 µm; i/ili pri čemu manje od 5% čestica ima veličinu čestica (promjer) manju od 100 µm.
5. Pripravak prema bilo kojem od zahtjeva 1 do 4 naznačen time da nadalje sadrži suhu smjesu limunske kiseline i magnezijevog oksida.
6. Farmaceutski pripravak naznačen time da sadrži pripravak prema bilo kojem od zahtjeva 1 do 5.
7. Farmaceutski pripravak naznačen time da sadrži (a) granule koje obuhvaćaju limunsku kiselinu i magnezijev oksid, te granule sadrže sloj magnezijevog oksida presvučen na jezgru limunske kiseline; i (b) granule koje sadrže natrijev pikosulfat i kalijev bikarbonat, te granule sadrže sloj natrijevog pikosulfata obložen na jezgru od kalijevog bikarbonata.
8. Farmaceutski pripravak prema zahtjevu 7 naznačen time da je debljina sloja magnezijevog oksida 2 do 15 µm.
9. Farmaceutski pripravak prema zahtjevu 7 ili 8 naznačen time da je debljina sloja magnezijevog oksida 5 do 10 µm.
10. Farmaceutski pripravak prema bilo kojem od zahtjeva 7 do 9 naznačen time da su granule (a) široke između 450 i 800 µm na njihovom najširem mjestu.
11. Farmaceutski pripravak prema bilo kojem od zahtjeva 7 do 10 naznačen time da granule (a) imaju veličinu čestica (promjer) u rasponu od između 100 µm i 900 µm.
12. Farmaceutski pripravak prema bilo kojem od zahtjeva 7 do 11 naznačen time da granule (a) imaju raspodjelu veličine čestica (promjer) pri čemu više od 85% čestica ima veličinu čestica (promjer) između 100 µm i 900 µm.
13. Farmaceutski pripravak prema bilo kojem od zahtjeva 7 do 12 naznačen time da granule (a) imaju raspodjelu veličinu čestica (promjer) pri čemu manje od 5% čestica ima veličinu čestica (promjer) veću od 900 µm; i/ili pri čemu manje od 5% čestica ima veličinu čestica (promjer) manju od 100 µm.
14. Farmaceutski pripravak prema bilo kojem od zahtjeva 6 do 13 naznačen time da nadalje sadrži natrijev saharin i/ili aromu naranče.
15. Postupak za dobivanje pripravka koji sadrži kalijev bikarbonat i natrijev pikosulfat naznačen time da obuhvaća korak primjene (npr. raspršivanjem) otopine natrijevog pikosulfata na kalijev bikarbonat; i sušenje natrijevog pikosulfata i kalijevog bikarbonata.
16. Postupak prema zahtjevu 15 naznačen time da bikarbonat prethodno zagrijan prije nanošenja (npr. raspršivanjem) otopine natrijevog pikosulfata na kalijev bikarbonat.
17. Postupak prema zahtjevu 15 ili zahtjevu 16 naznačen time se natrijev pikosulfat i kalijev bikarbonat suše na temperaturi od između 30° do 100°C.
18. Postupak prema bilo kojem od zahtjeva 15 do 17 naznačen time da je sušenje tijekom nanošenja (npr. raspršivanjem), i/ili neposredno ili uglavnom neposredno nakon nanošenja (npr. raspršivanjem).
19. Postupak prema bilo kojem od zahtjeva 15 do 18 naznačen time da postoje dvije ili više primjena otopine natrijevog pikosulfata, natrijev pikosulfat i kalijev bikarbonat se suše tijekom ili neposredno ili uglavnom neposredno nakon svakog nanošenja.
20. Postupak prema bilo kojem od zahtjeva 15 do 19 naznačen time da je proizvod ili pripravak nastao primjenom (npr. raspršivanjem) otopine natrijevog pikosulfata na kalijev bikarbonat i sušenje je u obliku granula ili čestica.
21. Postupak prema zahtjevu 20 naznačen time da granule ili čestice imaju raspodjelu veličine čestica (promjer) pri čemu više od 85% čestica ima veličinu čestica (promjer) između 100 µm i 900 µm.
22. Postupak prema zahtjevu 20 ili 21 naznačen time da granule ili čestice imaju raspodjelu veličine čestica (promjer) pri čemu manje od 5% čestica ima veličinu čestica (promjer) veću od od 900 µm; i/ili pri čemu manje od 5% čestica ima veličinu čestica (promjer) manju od 100 µm.
23. Postupak prema bilo kojem od zahtjeva 15 do 22 naznačen time da je natrijev pikosulfat u vodenoj otopini.
24. Postupak prema bilo kojem od zahtjeva 1 do 23 naznačen time da kalijev bikarbonat ima veličinu čestica (promjer) u rasponu od između 100 µm i 900 µm.
25. Postupak prema bilo kojem od zahtjeva 15 do 23 naznačen time da nadalje sadrži korak miješanja granula obloženih natrijevim pikosulfatom sa suhom smjesom limunske kiseline i magnezijevog oksida i proizvoljno barem jednim od natrijevog saharina i arome naranče.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07254049 | 2007-10-12 | ||
US98054907P | 2007-10-17 | 2007-10-17 | |
CNA2007101860236A CN101406457A (zh) | 2007-10-12 | 2007-11-09 | 制备药物产品的方法 |
GB0805953A GB0805953D0 (en) | 2008-04-01 | 2008-04-01 | Process for the manufacture of a pharmaceutical product |
PCT/IB2008/003199 WO2009047633A2 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate |
EP08837670.2A EP2207526B1 (en) | 2007-10-12 | 2008-10-10 | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
Publications (1)
Publication Number | Publication Date |
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HRP20180215T1 true HRP20180215T1 (hr) | 2018-03-23 |
Family
ID=42082803
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20180215TT HRP20180215T1 (hr) | 2007-10-12 | 2018-02-05 | Postupak za proizvodnju farmaceutskog proizvoda koji sadrži limunsku kiselinu, magnezijev oksid, kalijev bikarbonat i natrijev pikosulfat, farmaceutski pripravak koji sadrži granule dobivene takvim postupkom i njihovi međuproizvodi |
Country Status (24)
Country | Link |
---|---|
US (2) | US8481083B2 (hr) |
EP (1) | EP2207526B1 (hr) |
JP (1) | JP5654873B2 (hr) |
KR (2) | KR101381263B1 (hr) |
CN (1) | CN101820859B (hr) |
AU (1) | AU2008309287B2 (hr) |
BR (1) | BRPI0818541B8 (hr) |
CA (1) | CA2702152A1 (hr) |
DK (1) | DK2207526T3 (hr) |
ES (1) | ES2659716T3 (hr) |
HR (1) | HRP20180215T1 (hr) |
HU (1) | HUE038174T2 (hr) |
IL (1) | IL204500A (hr) |
JO (1) | JO3406B1 (hr) |
LT (1) | LT2207526T (hr) |
MX (1) | MX2010003588A (hr) |
NZ (1) | NZ583899A (hr) |
PL (1) | PL2207526T3 (hr) |
PT (1) | PT2207526T (hr) |
RU (1) | RU2473332C2 (hr) |
SI (1) | SI2207526T1 (hr) |
TW (1) | TWI418352B (hr) |
WO (1) | WO2009047633A2 (hr) |
ZA (1) | ZA201002131B (hr) |
Families Citing this family (14)
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KR101381263B1 (ko) | 2007-10-12 | 2014-04-04 | 페링 인터내셔널 센터 에스 에이 | 구연산, 산화 마그네슘, 중탄산칼륨 및 피코황산나트륨을 포함하는 의약품의 제조 방법, 이러한 방법에 의해 제조된 과립을 포함하는 약제학적 조성물 및 중간체 |
KR101155099B1 (ko) * | 2012-03-29 | 2012-06-11 | 남봉길 | 장 세척용 조성물의 제조 방법 및 이에 의해 제조된 장 세척용 조성물 |
TR201904884T4 (tr) * | 2012-07-27 | 2019-05-21 | Redhill Biopharma Ltd | Koloni̇k boşaltmada kullanima yöneli̇k formülasyonlar ve formülasyonlarin üreti̇m yöntemleri̇ |
JP2014224080A (ja) * | 2013-05-17 | 2014-12-04 | 協和化学工業株式会社 | 大腸の検査または手術のための処置剤 |
KR101517520B1 (ko) | 2013-08-05 | 2015-05-04 | 이희엽 | 피코황산나트륨 함유 장 세척용 조성물의 제조방법 |
IN2013MU02911A (hr) * | 2013-09-10 | 2015-07-03 | Cadila Healthcare Ltd | |
KR101420315B1 (ko) * | 2014-03-19 | 2014-07-17 | 남봉길 | 약학적 액제 조성물 |
JP6907118B2 (ja) * | 2015-01-14 | 2021-07-21 | ピーエフ、コンシューマー、ヘルスケア、1、リミテッド、ライアビリティー、カンパニーPF Consumer Healthcare 1 LLC | 経口送達製品 |
MX2018001965A (es) | 2015-08-17 | 2018-11-09 | Ferring Bv | Formulaciones liquidas que contienen picosulfato y citrato de magnesio. |
CN105456264B (zh) * | 2015-12-03 | 2018-07-10 | 广州瑞尔医药科技有限公司 | 双效缓泻的药物组合物及其制备方法 |
US11471447B2 (en) | 2019-06-20 | 2022-10-18 | Hetero Labs Limited | Stable pharmaceutical product and vessel comprising sodium picosulfate, magnesium oxide and citric acid |
CN110638786A (zh) * | 2019-10-09 | 2020-01-03 | 杭州百诚医药科技股份有限公司 | 一种匹可硫酸钠与枸橼酸、氧化镁的药物组合物及制备方法 |
CN113648327B (zh) * | 2021-08-24 | 2023-03-28 | 山东京卫制药有限公司 | 一种药物组合物及其制备方法 |
CN115040512B (zh) * | 2022-07-28 | 2023-06-20 | 苏州中化药品工业有限公司 | 一种药物组合物及其制备方法 |
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AUPS088702A0 (en) * | 2002-03-04 | 2002-03-28 | Borody, Thomas Julius | Electrolyte purgative |
US20040115265A1 (en) | 2002-12-11 | 2004-06-17 | Loutfy Benkerrour | Multilayered tablet containing pravastatin and aspirin and method |
US7758906B2 (en) | 2006-01-20 | 2010-07-20 | Kraft Foods Global Brands Llc | Thickening system for products prepared with milk |
KR101381263B1 (ko) | 2007-10-12 | 2014-04-04 | 페링 인터내셔널 센터 에스 에이 | 구연산, 산화 마그네슘, 중탄산칼륨 및 피코황산나트륨을 포함하는 의약품의 제조 방법, 이러한 방법에 의해 제조된 과립을 포함하는 약제학적 조성물 및 중간체 |
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2008
- 2008-10-10 KR KR1020137023315A patent/KR101381263B1/ko active IP Right Grant
- 2008-10-10 US US12/677,857 patent/US8481083B2/en active Active
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- 2008-10-10 ES ES08837670.2T patent/ES2659716T3/es active Active
- 2008-10-10 DK DK08837670.2T patent/DK2207526T3/da active
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- 2008-10-10 AU AU2008309287A patent/AU2008309287B2/en active Active
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