HRP20200046T1 - Formulacije apiksabana - Google Patents
Formulacije apiksabana Download PDFInfo
- Publication number
- HRP20200046T1 HRP20200046T1 HRP20200046TT HRP20200046T HRP20200046T1 HR P20200046 T1 HRP20200046 T1 HR P20200046T1 HR P20200046T T HRP20200046T T HR P20200046TT HR P20200046 T HRP20200046 T HR P20200046T HR P20200046 T1 HRP20200046 T1 HR P20200046T1
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- Prior art keywords
- tablet
- apixaban
- tablets
- mixing
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- Prior art date
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 claims 12
- 229960003886 apixaban Drugs 0.000 title claims 12
- 239000000203 mixture Substances 0.000 title claims 10
- 238000009472 formulation Methods 0.000 title claims 3
- 239000002245 particle Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 5
- 238000002356 laser light scattering Methods 0.000 claims 4
- 239000002994 raw material Substances 0.000 claims 4
- 238000004090 dissolution Methods 0.000 claims 3
- 238000007922 dissolution test Methods 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 239000012736 aqueous medium Substances 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 238000007908 dry granulation Methods 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 230000009424 thromboembolic effect Effects 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 1
- 239000012738 dissolution medium Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
-
- 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
- A61K9/20—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
- A61K9/2013—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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- 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
- 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
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
- A61K31/4162—1,2-Diazoles condensed with heterocyclic ring systems
-
- 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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
-
- 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
- A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
Claims (10)
1. Tableta koja sadrži do 5 mg kristalnih čestica apiksabana koje imaju D90 manji od 89 µm, kao što je mjereno rasipanjem laserske svjetlosti, i farmaceutski prihvatljiv razblaživač ili nosač, gdje formulacija pokazuje svojstva otapanja takva da se količina lijeka koja je ekvivalentna sa najmanje 77% otapa u roku od 30 minuta, pri čemu se test otapanja izvodi u vodenom mediju puferiranom na pH opseg 1 do 7.4 i kontroliran je na 37° C.
2. Tableta kao što je definirano u patentnom zahtjevu 1, gdje
(a) rezultat je utvrđen kao prosjek od 6 tableta; i/ili
(b) test otapanja je izveden u 900 mL medija za otapanje koji sadrži 0.05 M natrij fosfata pri pH 6.8 sa 0.05% SDS na 37 °C upotrebom USP aparata 2 (lopatice) pri brzini rotacije od 75 o/min i uzorci su analizirani za apiksaban pomoću HPLC na 280 nm.
3. Tableta kao što je definirano u patentnom zahtjevu 1 ili 2, gdje navedena kompozicija sadrži oblik N-1 apiksabana.
4. Tableta kao što je definirano u bilo kojem od patentnih zahtjeva 1 do 3, gdje je apiksaban u obliku kristalnih čestica koje imaju D90 manji od 50 µm, D90 manji od 30 µm ili D90 manji od 25 µm kao što je mjereno rasipanjem laserske svjetlosti.
5. Tableta kao što je definirano u bilo kojem od patentnih zahtjeva 1 do 4, gdje je apiksaban u obliku kristalnih čestica koje imaju srednju vrijednost veličine čestice manju od 89 µm kao što je mjereno rasipanjem laserske svjetlosti.
6. Tableta za upotrebu u liječenju tromboembolijskog poremećaja, gdje tableta je tableta kao što je definirano u jednom od patentnih zahtjeva 1 do 5.
7. Tableta za upotrebu u liječenju tromboembolijskog poremećaja kao što je definirano u patentnom zahtjevu 6, gdje je tableta administrirana oralno dva puta dnevno.
8. Postupak proizvodnje tableta apiksabana, gdje svaka tableta ima kompoziciju koja sadrži do 5 mg kristalnih čestica apiksabana i farmaceutski prihvatljiv razblaživač ili nosač, koji obuhvaća korake:
(1) miješanja sirovih materijala potrebno prije granulacije;
(2) granulacija sirovih materijala iz koraka (1) primjenom procesa suhe granulacije, pri čemu čestice apiksabana imaju D90 manji od 89 µm kao što je mjereno sa rasipanjem laserske svjetlosti;
(3) miješanja granula određene veličine iz koraka (2) sa ekstragranularnim sirovim materijalima;
(4) komprimiranja smjese iz koraka (3) u tablete; i
(5) oblaganja filmom tableta iz koraka (4),
gdje formulacija pokazuje svojstva otapanja takva da se količina lijeka koja je ekvivalentna sa najmanje 77% otapa u roku od 30 minuta, pri čemu se test otapanja izvodi u vodenom mediju puferiranom na pH opseg 1 do 7.4 i kontroliran je na 37° C.
9. Postupak proizvodnje tableta apiksabana kao što je definirano u patentnom zahtjevu 8, pri čemu su svojstva otapanja utvrđena kao prosjek od 6 tableta.
10. Postupak proizvodnje tableta apiksabana kao što je definirano u patentnom zahtjevu 8 ili 9 koji obuhvaća korake:
(1) miješanja sirovih materijala, sa apiksabanom kontrolirane veličine čestica;
(2) uključivanja intragranularnih dijelova vezujućeg sredstva, sredstva za raspadanje i drugih punilaca u smjesu iz koraka (1);
(3) granulacije materijala iz koraka (2) korištenjem postupka suhe granulacije koji obuhvaća:
(a) uklanjanje grudica iz intragranularnog lubrikanta upotrebom pogodnog sita ili mlina;
(b) dodavanje lubrikanta smjesi iz koraka (2) i miješanje;
(c) sabijanje ovlažene smjese u trake gustoće u opsegu od 1.1 do 1.2 g/cm3 i formiranje do dane veličine sabijenih traka upotrebom valjak kompaktora;
(4) miješanja granula određene veličine iz koraka (3) i ekstragranularnog sredstva za raspadanje u odgovarajućoj mješalici;
(5) uklanjanja grudica iz ekstragranularnog lubrikanta upotrebom pogodnog sita/mlina i miješanje sa granulama iz koraka (4);
(6) komprimiranja smjese iz (5) u tablete;
(7) oblaganja filmom tableta iz koraka (6).
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US30805610P | 2010-02-25 | 2010-02-25 | |
EP17175864.2A EP3246021B1 (en) | 2010-02-25 | 2011-02-24 | Apixaban formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20200046T1 true HRP20200046T1 (hr) | 2020-03-20 |
Family
ID=43901603
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160179TT HRP20160179T1 (hr) | 2010-02-25 | 2016-02-19 | Formulacije apiksabana |
HRP20190430TT HRP20190430T8 (hr) | 2010-02-25 | 2019-03-05 | Formulacije apiksabana |
HRP20192064TT HRP20192064T1 (hr) | 2010-02-25 | 2019-11-15 | Formulacije apiksabana |
HRP20192069TT HRP20192069T1 (hr) | 2010-02-25 | 2019-11-18 | Formulacije apiksabana |
HRP20200046TT HRP20200046T1 (hr) | 2010-02-25 | 2020-01-13 | Formulacije apiksabana |
Family Applications Before (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160179TT HRP20160179T1 (hr) | 2010-02-25 | 2016-02-19 | Formulacije apiksabana |
HRP20190430TT HRP20190430T8 (hr) | 2010-02-25 | 2019-03-05 | Formulacije apiksabana |
HRP20192064TT HRP20192064T1 (hr) | 2010-02-25 | 2019-11-15 | Formulacije apiksabana |
HRP20192069TT HRP20192069T1 (hr) | 2010-02-25 | 2019-11-18 | Formulacije apiksabana |
Country Status (31)
Country | Link |
---|---|
US (5) | US9326945B2 (hr) |
EP (7) | EP3662899A1 (hr) |
JP (4) | JP5846647B2 (hr) |
KR (4) | KR20210124532A (hr) |
CN (3) | CN109602716A (hr) |
AU (1) | AU2011220775B2 (hr) |
BR (1) | BR112012021337A8 (hr) |
CA (1) | CA2791171C (hr) |
CO (1) | CO6640207A2 (hr) |
CY (5) | CY1117434T1 (hr) |
DK (5) | DK2538925T3 (hr) |
ES (5) | ES2757603T3 (hr) |
HK (5) | HK1180248A1 (hr) |
HR (5) | HRP20160179T1 (hr) |
HU (4) | HUE047140T2 (hr) |
IL (3) | IL309564A (hr) |
IN (1) | IN2012DN06587A (hr) |
LT (4) | LT3251660T (hr) |
MX (3) | MX353145B (hr) |
NZ (1) | NZ601738A (hr) |
PE (3) | PE20160042A1 (hr) |
PL (5) | PL3017811T3 (hr) |
PT (5) | PT3257500T (hr) |
RS (5) | RS59810B1 (hr) |
RU (1) | RU2685724C2 (hr) |
SG (2) | SG10201501349VA (hr) |
SI (5) | SI2538925T1 (hr) |
SM (1) | SMT201600049B (hr) |
TR (1) | TR201903195T4 (hr) |
WO (1) | WO2011106478A2 (hr) |
ZA (1) | ZA201205807B (hr) |
Families Citing this family (42)
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ES2757603T3 (es) | 2010-02-25 | 2020-04-29 | Bristol Myers Squibb Holdings Ireland | Formulaciones de apixabán |
WO2013164839A2 (en) * | 2012-03-06 | 2013-11-07 | Cadila Healthcare Limited | Amorphous form of apixaban, process of preparation and compositions thereof |
EP2854759B1 (en) * | 2012-05-24 | 2019-12-18 | ratiopharm GmbH | Dosage forms comprising apixaban and matrix former |
WO2014052678A1 (en) | 2012-09-26 | 2014-04-03 | Bristol-Myers Squibb Company | Apixaban liquid formulations |
CN102908324A (zh) * | 2012-10-31 | 2013-02-06 | 南京正科制药有限公司 | 一种阿哌沙班片 |
EP2752414A1 (en) | 2013-01-04 | 2014-07-09 | Sandoz AG | Crystalline form of apixaban |
CZ2013305A3 (cs) | 2013-04-23 | 2014-11-05 | Zentiva, K.S. | Nové krystalické formy APIXABANU a způsob jejich přípravy |
US20160113912A1 (en) * | 2013-06-18 | 2016-04-28 | Cadila Healthcare Limited | An improved process for the preparation of apixaban and intermediates thereof |
EP2907507A1 (en) * | 2014-02-17 | 2015-08-19 | Sandoz Ag | Pharmaceutical composition comprising apixaban |
CN103830199A (zh) * | 2014-03-24 | 2014-06-04 | 重庆东得医药科技有限公司 | 含阿哌沙班的药用制剂及其制备方法 |
CN104316637B (zh) * | 2014-10-30 | 2016-08-17 | 江苏宝众宝达药业有限公司 | 高效液相色谱法测定阿哌沙班清洗残留量 |
US9603846B2 (en) | 2014-11-25 | 2017-03-28 | Cadila Healthcare Limited | Process for the preparation of apixaban |
WO2016181276A1 (en) * | 2015-05-08 | 2016-11-17 | Wockhardt Limited | Stable pharmaceutical compositions comprising antibacterial agent |
EP3380083A1 (en) | 2015-11-26 | 2018-10-03 | Zentiva, K.S. | Preparation of a drug form containing amorphous apixaban |
CN106913528A (zh) * | 2015-12-25 | 2017-07-04 | 中美华世通生物医药科技(武汉)有限公司 | 阿哌沙班微丸及其制备方法 |
CN108472261B (zh) * | 2016-01-12 | 2021-12-03 | 广东东阳光药业有限公司 | 阿哌沙班固体组合物及其制备方法 |
EP3195860A1 (de) * | 2016-01-22 | 2017-07-26 | STADA Arzneimittel AG | Verfahren zur herstellung eines apixaban-granulates |
WO2017163170A1 (en) * | 2016-03-21 | 2017-09-28 | Sun Pharmaceutical Industries Limited | Pharmaceutical composition comprising apixaban |
WO2017182908A1 (en) * | 2016-04-18 | 2017-10-26 | Emcure Pharmaceuticals Limited | Pharmaceutical compositions of apixaban |
EP3243505A1 (en) | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | A pharmaceutical composition comprising amorphous apixaban |
CN106822006B (zh) * | 2016-06-08 | 2020-08-28 | 北京普德康利医药科技发展有限公司 | 一种阿哌沙班片及其制备方法 |
WO2017221209A1 (en) | 2016-06-23 | 2017-12-28 | Lupin Limited | Pharmaceutical formulations of apixaban |
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