EP4251155A4 - Procédés améliorés de granulation par voie humide pour formulations comprenant de l'apixaban - Google Patents
Procédés améliorés de granulation par voie humide pour formulations comprenant de l'apixaban Download PDFInfo
- Publication number
- EP4251155A4 EP4251155A4 EP20963794.1A EP20963794A EP4251155A4 EP 4251155 A4 EP4251155 A4 EP 4251155A4 EP 20963794 A EP20963794 A EP 20963794A EP 4251155 A4 EP4251155 A4 EP 4251155A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- apixaban
- formulations
- wet granulation
- improved wet
- granulation processes
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- QNZCBYKSOIHPEH-UHFFFAOYSA-N Apixaban Chemical compound C1=CC(OC)=CC=C1N1C(C(=O)N(CC2)C=3C=CC(=CC=3)N3C(CCCC3)=O)=C2C(C(N)=O)=N1 QNZCBYKSOIHPEH-UHFFFAOYSA-N 0.000 title 1
- 229960003886 apixaban Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 238000005550 wet granulation Methods 0.000 title 1
Classifications
-
- 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
- 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
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
-
- 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
- A61K9/2013—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/TR2020/051185 WO2022115052A1 (fr) | 2020-11-27 | 2020-11-27 | Procédés améliorés de granulation par voie humide pour formulations comprenant de l'apixaban |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP4251155A1 EP4251155A1 (fr) | 2023-10-04 |
| EP4251155A4 true EP4251155A4 (fr) | 2024-07-31 |
Family
ID=81754730
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP20963794.1A Pending EP4251155A4 (fr) | 2020-11-27 | 2020-11-27 | Procédés améliorés de granulation par voie humide pour formulations comprenant de l'apixaban |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP4251155A4 (fr) |
| WO (1) | WO2022115052A1 (fr) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017121340A1 (fr) * | 2016-01-12 | 2017-07-20 | 广东东阳光药业有限公司 | Composition solide d'araxaban et procédé de préparation de cette composition |
| WO2018150286A1 (fr) * | 2017-02-17 | 2018-08-23 | Unichem Laboratories Ltd | Composition pharmaceutique d'apixaban |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GEP20074098B (en) | 2001-09-21 | 2007-05-10 | Bristol Myers Squibb Co | Lactam-containing compounds and derivatives thereof as factor xa inhibitors |
| PL3251660T3 (pl) * | 2010-02-25 | 2020-02-28 | Bristol-Myers Squibb Holdings Ireland Unlimited Company | Formulacje apiksabanu |
| EP2554159A1 (fr) | 2011-08-04 | 2013-02-06 | ratiopharm GmbH | Formes pharmaceutiques comportant de l'apixaban et améliorant d'uniformité de contenu |
| CN104644593A (zh) * | 2013-11-23 | 2015-05-27 | 天津市汉康医药生物技术有限公司 | 阿哌沙班组合物及其制备方法 |
| EP2907507A1 (fr) | 2014-02-17 | 2015-08-19 | Sandoz Ag | Composition pharmaceutique comprenant de l'apixaban |
| EP3195860A1 (fr) | 2016-01-22 | 2017-07-26 | STADA Arzneimittel AG | Procede de fabrication d'un granule d'apixaban |
| WO2017163170A1 (fr) | 2016-03-21 | 2017-09-28 | Sun Pharmaceutical Industries Limited | Composition pharmaceutique comprenant de l'apixaban |
| WO2017182908A1 (fr) | 2016-04-18 | 2017-10-26 | Emcure Pharmaceuticals Limited | Compositions pharmaceutiques d'apixaban |
| EP3243505A1 (fr) | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | Composition pharmaceutique comprenant de l'apixaban amorphe |
| WO2017221209A1 (fr) | 2016-06-23 | 2017-12-28 | Lupin Limited | Formulations pharmaceutiques d'apixaban |
| TR201717703A2 (tr) | 2017-11-10 | 2019-05-21 | Ali Raif Ilac Sanayi Ve Ticaret Anonim Sirketi | Api̇ksaban formülasyonlari |
| KR102128321B1 (ko) | 2018-03-13 | 2020-06-30 | 주식회사 종근당 | 아픽사반을 포함하는 가용화를 위한 약제학적 제제 및 이의 제조 방법 |
-
2020
- 2020-11-27 WO PCT/TR2020/051185 patent/WO2022115052A1/fr not_active Ceased
- 2020-11-27 EP EP20963794.1A patent/EP4251155A4/fr active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017121340A1 (fr) * | 2016-01-12 | 2017-07-20 | 广东东阳光药业有限公司 | Composition solide d'araxaban et procédé de préparation de cette composition |
| WO2018150286A1 (fr) * | 2017-02-17 | 2018-08-23 | Unichem Laboratories Ltd | Composition pharmaceutique d'apixaban |
Non-Patent Citations (1)
| Title |
|---|
| See also references of WO2022115052A1 * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2022115052A1 (fr) | 2022-06-02 |
| EP4251155A1 (fr) | 2023-10-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
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| 17P | Request for examination filed |
Effective date: 20230511 |
|
| AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
| DAV | Request for validation of the european patent (deleted) | ||
| DAX | Request for extension of the european patent (deleted) | ||
| A4 | Supplementary search report drawn up and despatched |
Effective date: 20240701 |
|
| RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61K 9/20 20060101ALI20240625BHEP Ipc: A61P 7/02 20060101ALI20240625BHEP Ipc: A61K 9/28 20060101ALI20240625BHEP Ipc: A61K 31/4545 20060101AFI20240625BHEP |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
|
| 17Q | First examination report despatched |
Effective date: 20250214 |