HRP20211606T1 - Oralni farmaceutski pripravci dabigatran-eteksilata - Google Patents
Oralni farmaceutski pripravci dabigatran-eteksilata Download PDFInfo
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- HRP20211606T1 HRP20211606T1 HRP20211606TT HRP20211606T HRP20211606T1 HR P20211606 T1 HRP20211606 T1 HR P20211606T1 HR P20211606T T HRP20211606T T HR P20211606TT HR P20211606 T HRP20211606 T HR P20211606T HR P20211606 T1 HRP20211606 T1 HR P20211606T1
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- Prior art keywords
- mixture
- granules
- mixing
- pharmaceutically acceptable
- etexilate
- Prior art date
Links
- 229960000288 dabigatran etexilate Drugs 0.000 title 1
- KSGXQBZTULBEEQ-UHFFFAOYSA-N dabigatran etexilate Chemical group C1=CC(C(N)=NC(=O)OCCCCCC)=CC=C1NCC1=NC2=CC(C(=O)N(CCC(=O)OCC)C=3N=CC=CC=3)=CC=C2N1C KSGXQBZTULBEEQ-UHFFFAOYSA-N 0.000 title 1
- 239000008203 oral pharmaceutical composition Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 19
- 239000008187 granular material Substances 0.000 claims 15
- 238000002156 mixing Methods 0.000 claims 13
- 229960004951 dabigatran etexilate mesylate Drugs 0.000 claims 9
- XETBXHPXHHOLOE-UHFFFAOYSA-N dabigatran etexilate methanesulfonate Chemical compound CS(O)(=O)=O.C1=CC(C(\N)=N/C(=O)OCCCCCC)=CC=C1NCC1=NC2=CC(C(=O)N(CCC(=O)OCC)C=3N=CC=CC=3)=CC=C2N1C XETBXHPXHHOLOE-UHFFFAOYSA-N 0.000 claims 9
- 150000007524 organic acids Chemical class 0.000 claims 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims 9
- 239000002245 particle Substances 0.000 claims 8
- 239000011230 binding agent Substances 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 230000001681 protective effect Effects 0.000 claims 4
- 239000007902 hard capsule Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000008188 pellet Substances 0.000 claims 3
- 239000007931 coated granule Substances 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 1
- 150000007513 acids Chemical class 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 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
- A61K31/33—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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- 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
-
- 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
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—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
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (6)
1. Pripravak naznačen time što sadrži smjesu najmanje dva tipa čestica, gdje a) prvi tip čestica sadrži dabigatran-eteksilat-mesilat i koji ne sadrži kiseline; i b) drugi tip čestica sadrži najmanje jednu farmaceutski prihvatljivu organsku kiselinu,
gdje je najmanje jedan tip čestica obložen zaštitnim pokrovnim slojem, te
gdje pripravak sadrži od 0,01%, težinski, do 90%, težinski, dabigatran-eteksilat-mesilata, na osnovi ukupne težine pripravka.
2. Postupak priprave pripravka u skladu s patentnim zahtjevom 1, naznačen time što se sastoji u koraku miješanja navedenog prvog tipa čestica i navedenog drugog tipa čestica s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom.
3. Postupak u skladu s patentnim zahtjevom 2, naznačen time što se navedeni prvi tip čestica pripravlja granuliranjem.
4. Postupak u skladu s patentnim zahtjevom 3, naznačen time što se sastoji u koracima:
(i) miješanja dabigatran-eteksilat-mesilata s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(ii) granuliranja smjese iz koraka (i) s otopinom veziva kako bi se dobilo granule dabigatran-eteksilat-mesilata;
(iii) miješanja najmanje jedne organske kiseline s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(iv) granuliranja smjese iz koraka (iii) s otopinom veziva kako bi se dobilo granule organske kiseline;
(v) oblaganja granula organske kiseline zaštitnim pokrovnim slojem;
(vi) miješanja granula iz koraka (ii) s obloženim granulama iz koraka (v) kako bi se dobilo smjesu najmanje dva tipa granula;
(vii) izbornog miješanja smjese najmanje dva tipa granula iz koraka (vi) s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(viii) dodavanja maziva u smjesu iz koraka (vii);
(ix) punjenje podmazane smjese iz koraka (viii) u prikladne tvrde kapsule.
5. Postupak u skladu s patentnim zahtjevom 3, naznačen time što se sastoji u koracima:
(i) miješanja dabigatran-eteksilat-mesilata s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(ii) granuliranja smjese iz koraka (i) s otopinom veziva kako bi se dobilo granule dabigatran-eteksilat-mesilata;
(iii) miješanja najmanje jedne organske kiseline s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(iv) granuliranja smjese iz koraka (iii) s otopinom veziva kako bi se dobilo granule organske kiseline;
(v) oblaganja granula dabigatran-eteksilat-mesilata zaštitnim pokrovnim slojem;
(vi) miješanja granula iz koraka (iv) s obloženim granulama iz koraka (v) kako bi se dobilo smjesu najmanje dva tipa granula;
(vii) izbornog miješanja smjese najmanje dva tipa granula iz koraka (vi) s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(viii) dodavanja maziva u smjesu iz koraka (vii);
(ix) punjenje podmazane smjese iz koraka (viii) u prikladne tvrde kapsule.
6. Postupak u skladu s patentnim zahtjevom 3, naznačen time što se sastoji u koracima:
(i) miješanja dabigatran-eteksilat-mesilata s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(ii) granuliranja smjese iz koraka (i) s otopinom veziva kako bi se dobilo granule dabigatran-eteksilat-mesilata;
(iii) miješanja najmanje jedne organske kiseline s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(iv) ekstrudiranje i sferoniziranje smjese iz koraka (iii) kako bi se dobilo pelete organske kiseline;
(v) oblaganja peleta organske kiseline iz koraka (iv) zaštitnim pokrovnim slojem;
(vi) miješanja granula iz koraka (ii) s obloženim peletima iz koraka (v) kako bi se dobilo smjesu najmanje dva tipa čestica;
(vii) izbornog miješanja smjese najmanje dva tipa granula iz koraka (vi) s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
(viii) dodavanja maziva u smjesu iz koraka (vii);
(ix) punjenje podmazane smjese iz koraka (viii) u prikladne tvrde kapsule.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN461MU2012 | 2012-02-21 | ||
| EP13704974.8A EP2817000B1 (en) | 2012-02-21 | 2013-02-21 | Oral pharmaceutical compositions of dabigatran etexilate |
| PCT/EP2013/053426 WO2013124340A1 (en) | 2012-02-21 | 2013-02-21 | Oral pharmaceutical compositions of dabigatran etexilate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211606T1 true HRP20211606T1 (hr) | 2022-01-21 |
Family
ID=47739283
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20211606TT HRP20211606T1 (hr) | 2012-02-21 | 2013-02-21 | Oralni farmaceutski pripravci dabigatran-eteksilata |
Country Status (27)
| Country | Link |
|---|---|
| US (3) | US11013729B2 (hr) |
| EP (2) | EP2817000B1 (hr) |
| JP (1) | JP6215239B2 (hr) |
| KR (1) | KR102090242B1 (hr) |
| CN (2) | CN110123774A (hr) |
| AU (1) | AU2013224146B2 (hr) |
| BR (1) | BR112014020474B1 (hr) |
| CA (1) | CA2864423C (hr) |
| CY (1) | CY1124678T1 (hr) |
| DK (1) | DK2817000T3 (hr) |
| ES (1) | ES2895918T3 (hr) |
| HK (1) | HK1203832A1 (hr) |
| HR (1) | HRP20211606T1 (hr) |
| HU (1) | HUE056194T2 (hr) |
| IL (1) | IL234032B (hr) |
| IN (1) | IN2014DN06734A (hr) |
| JO (1) | JO3616B1 (hr) |
| LT (1) | LT2817000T (hr) |
| MX (1) | MX368868B (hr) |
| NZ (1) | NZ628301A (hr) |
| PL (1) | PL2817000T3 (hr) |
| PT (1) | PT2817000T (hr) |
| RS (1) | RS62566B1 (hr) |
| RU (1) | RU2633482C2 (hr) |
| SI (1) | SI2817000T1 (hr) |
| WO (1) | WO2013124340A1 (hr) |
| ZA (1) | ZA201405855B (hr) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS62566B1 (sr) | 2012-02-21 | 2021-12-31 | Towa Pharmaceutical Europe S L | Oralne farmaceutske kompozicije dabigatran eteksilata |
| CN111012756B (zh) * | 2013-06-21 | 2023-06-13 | 四川海思科制药有限公司 | 一种达比加群酯药物组合物及其制备方法 |
| CN104414995A (zh) * | 2013-09-04 | 2015-03-18 | 天津汉瑞药业有限公司 | 甲磺酸达比加群酯的药用组合物 |
| EP2853260A1 (en) * | 2013-09-27 | 2015-04-01 | ratiopharm GmbH | Pharmaceutical preparation comprising dabigatran etexilate bismesylate |
| WO2015071841A1 (en) | 2013-11-12 | 2015-05-21 | Druggability Technologies Holdings Limited | Complexes of dabigatran and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them |
| CN104784147B (zh) * | 2014-01-20 | 2018-01-23 | 成都苑东生物制药股份有限公司 | 一种甲磺酸达比加群酯胶囊药物组合物及其制备方法 |
| CN104994856A (zh) * | 2014-01-30 | 2015-10-21 | 杭州领业医药科技有限公司 | 达比加群酯及其盐的投药制剂及其制备方法 |
| CN104922092A (zh) * | 2014-03-19 | 2015-09-23 | 陕西天森药物研究开发有限公司 | 一种通过包裹法制备的达比加群酯或其盐和水合物的药物组合 |
| WO2015145462A1 (en) | 2014-03-26 | 2015-10-01 | Cadila Healthcare Limited | Pharmaceutical compositions of dabigatran |
| CN104095830A (zh) * | 2014-05-22 | 2014-10-15 | 万特制药(海南)有限公司 | 一种甲磺酸盐达比加群酯胶囊的制备方法 |
| CN104825422B (zh) * | 2014-09-29 | 2017-12-12 | 普济生物科技（台州）有限公司 | 含达比加群酯甲磺酸盐的药物组合物及其制备方法 |
| CN105560206A (zh) * | 2014-10-13 | 2016-05-11 | 重庆圣华曦药业股份有限公司 | 一种达比加群酯胶囊的制备 |
| CA3001495C (en) * | 2014-11-03 | 2021-07-20 | Solipharma Llc | Formulations of dabigatran etexilate or dabigatran etexilate salts and preparation methods thereof |
| WO2016107605A1 (zh) * | 2014-12-31 | 2016-07-07 | 昆明积大制药股份有限公司 | 药物组合物及其制备方法 |
| WO2017103945A1 (en) * | 2015-12-15 | 2017-06-22 | Strides Shasun Limited | Pharmaceutical compositions |
| CN106890148A (zh) * | 2015-12-21 | 2017-06-27 | 青岛黄海制药有限责任公司 | 一种达比加群酯片剂及其制备 |
| WO2017111637A1 (en) | 2015-12-23 | 2017-06-29 | Zaklady Farmaceutyczne Polpharma Sa | Pharmaceutical composition comprising dabigatran or a pharmaceutically acceptable salt thereof |
| JP2018184375A (ja) * | 2017-04-27 | 2018-11-22 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | ダビガトランエテキシラート又は医薬的に許容されるその塩を含む錠剤及びその製造方法 |
| TR201706848A2 (tr) * | 2017-05-10 | 2018-11-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar |
| WO2019004980A2 (en) * | 2017-05-10 | 2019-01-03 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF DABIGATRAN DEXILATE |
| TR201722353A2 (tr) * | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatran eteksi̇lat i̇çeren oral uygulama i̇çi̇n farmasöti̇k formülasyon |
| TR201722323A2 (tr) | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatranin oral farmasöti̇k kompozi̇syonlari |
| TR201722630A2 (hr) | 2017-12-28 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | |
| CN110339193B (zh) | 2018-04-04 | 2022-04-29 | 上海汉都医药科技有限公司 | 含达比加群酯的药物组合物及其制备方法 |
| WO2020032885A2 (en) | 2018-05-04 | 2020-02-13 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Capsule-in-capsule compositions of dabigatran etexilate |
| TR201905308A2 (tr) * | 2019-04-09 | 2020-10-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A capsule formulation of dabigatran etexilate |
| CN113577067B (zh) * | 2021-06-03 | 2023-08-15 | 北京福元医药股份有限公司 | 一种甲磺酸达比加群酯药物制剂 |
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