HRP20110646T1 - Injektabilna suspenzija aripiprazola - Google Patents
Injektabilna suspenzija aripiprazola Download PDFInfo
- Publication number
- HRP20110646T1 HRP20110646T1 HR20110646T HRP20110646T HRP20110646T1 HR P20110646 T1 HRP20110646 T1 HR P20110646T1 HR 20110646 T HR20110646 T HR 20110646T HR P20110646 T HRP20110646 T HR P20110646T HR P20110646 T1 HRP20110646 T1 HR P20110646T1
- Authority
- HR
- Croatia
- Prior art keywords
- injection
- solution
- mixture
- aripiprazole
- agent
- Prior art date
Links
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 title claims abstract 12
- 229960004372 aripiprazole Drugs 0.000 title claims abstract 12
- 229940102213 injectable suspension Drugs 0.000 title 1
- 239000000203 mixture Substances 0.000 claims abstract 23
- 238000002347 injection Methods 0.000 claims abstract 17
- 239000007924 injection Substances 0.000 claims abstract 17
- 238000013265 extended release Methods 0.000 claims abstract 4
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 239000000243 solution Substances 0.000 claims 11
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 239000003795 chemical substances by application Substances 0.000 claims 7
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 5
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 4
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 229940068977 polysorbate 20 Drugs 0.000 claims 4
- 239000011780 sodium chloride Substances 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 3
- 230000000717 retained effect Effects 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 239000000080 wetting agent Substances 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- 229920001219 Polysorbate 40 Polymers 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 claims 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims 1
- 229940101027 polysorbate 40 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 239000002562 thickening agent Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract 2
- 239000004005 microsphere Substances 0.000 abstract 2
- 239000013543 active substance Substances 0.000 abstract 1
- 230000009286 beneficial effect Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
Injektabilna smjesa za produljeno oslobađanje aripiprazola koja sadrži suspenziju aripiprazola u otopini za injekciju u količini od najmanje 10 mg/ml i po izboru sadrži sredstvo za povećanje viskoznosti, pri čemu u smjesi nema matrica za produljeno oslobađanje. Patent sadrži još 23 patentna zahtjeva.
Claims (24)
1. Injektabilna smjesa za produljeno oslobađanje aripiprazola koja sadrži suspenziju aripiprazola u otopini za injekciju u količini od najmanje 10 mg/ml i po izboru sadrži sredstvo za povećanje viskoznosti, pri čemu u smjesi nema matrica za produljeno oslobađanje.
2. Smjesa prema zahtjevu 1, gdje je oslobađanje aripiprazola barem 7 dana.
3. Smjesa prema zahtjevima 1 ili 2, gdje sredstvo za povećanje viskoznosti sadrži karboksimetil celulozu.
4. Smjesa prema bilo kojem od zahtjeva 1 do 3, gdje otopina za injekciju sadrži barem 1%vol natrijeve karboksimetil celuloze.
5. Smjesa prema zahtjevu 4, gdje otopina za injekciju sadrži 3%vol karboksimetil celuloze.
6. Smjesa prema bilo kojem od zahtjeva 1 do 5, gdje otopina za injekciju dalje sadrži sredstvo za vlaženje.
7. Smjesa prema zahtjevu 6, pri čemu se površinski aktivno sredstvo bira iz skupine koja obuhvaća polisorbat 20, polisorbat 40 i polisorbat 80.
8. Smjesa prema zahtjevu 7, gdje otopina za injekciju sadrži 0.1%tež polisorbata 20.
9. Smjesa prema bilo kojem od zahtjeva 1 do 8, gdje otopina za injekciju sadrži sredstvo za povećanje gustoće.
10. Smjesa prema zahtjevu 9, pri čemu sredstvo za povećanje gustoće sadrži sorbitol.
11. Smjesa prema bilo kojem od zahtjeva 1 do 10, gdje otopina za injekciju sadrži sredstvo za podešavanje toničnosti.
12. Smjesa prema zahtjevu 11, pri čemu sredstvo za podešavanje toničnosti sadrži natrijev klorid.
13. Smjesa prema zahtjevu 12, gdje otopina za injekciju sadrži 1%tež natrijevog klorida.
14. Injektabilna smjesa prema zahtjevu 1 koja sadrži najmanje 10 mg aripiprazola, pri čemu je otopina za injekciju vodena otopina za injekciju koja sadrži vodu, sredstvo za povećanje viskoznosti, sredstvo za vlaženje i sredstvo za podešavanje toničnosti.
15. Injektabilna smjesa prema zahtjevu 1 koja sadrži najmanje 10 mg aripiprazola, pri čemu je otopina za injekciju vodena otopina za injekciju koja sadrži vodu, 3%vol karboksimetilceluloze, 0.1% polisorbata 20 i 1%tež natrijevog klorida.
16. Injektabilna smjesa prema zahtjevu 1 koja sadrži najmanje 10 mg aripiprazola, pri čemu je otopina za injekciju vodena otopina za injekciju koja u biti sadrži vodu, 3%vol karboksimetilceluloze, 0.1%tež polisorbata 20 i 0.9%tež natrijevog klorida.
17. Uporaba smjese kako je definirana u bilo kojem od zahtjeva 1 do 16 za proizvodnju lijeka za primjenu injekcijom.
18. Uporaba prema zahtjevu 17, gdje se smjesa primjenjuje u mišić ili potkožno.
19. Uporaba prema zahtjevu 17 ili 18 koja dalje obuhvaća drugu primjenu smjese najmanje 7 dana nakon prve primjene.
20. Uporaba prema zahtjevu 17 ili 18 koja dalje obuhvaća drugu primjenu smjese najmanje oko 14 dana nakon prve primjene.
21. Uporaba prema bilo kojem od zahtjeva 17 do 20, pri čemu je aripiprazol prisutan u količini od najmanje 20 mg/ml.
22. Uporaba prema zahtjevu 17 ili 18, gdje se terapijski učinkovita količina aripiprazola zadržava u plazmi pojedinca najmanje 7 dana.
23. Uporaba prema zahtjevu 17 ili 18, gdje se terapijski učinkovita količina aripiprazola zadržava u plazmi pojedinca najmanje 14 dana.
24. Uporaba prema zahtjevu 17 ili 18, gdje se terapijski učinkovita količina aripiprazola zadržava u plazmi pojedinca najmanje 21 dan.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/635,221 US20050032811A1 (en) | 2003-08-06 | 2003-08-06 | Methods for administering aripiprazole |
| PCT/US2004/024345 WO2005016262A2 (en) | 2003-08-06 | 2004-07-29 | Methods for administering aripiprazole |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20110646T1 true HRP20110646T1 (hr) | 2011-12-31 |
Family
ID=34116189
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20110646T HRP20110646T1 (hr) | 2003-08-06 | 2011-09-07 | Injektabilna suspenzija aripiprazola |
Country Status (22)
| Country | Link |
|---|---|
| US (9) | US20050032811A1 (hr) |
| EP (2) | EP1660037B1 (hr) |
| JP (3) | JP5300194B2 (hr) |
| CN (2) | CN102133171A (hr) |
| AT (1) | ATE522200T1 (hr) |
| AU (1) | AU2004264886C1 (hr) |
| CA (1) | CA2534997C (hr) |
| CY (1) | CY1111874T1 (hr) |
| DK (1) | DK1660037T3 (hr) |
| ES (1) | ES2369893T3 (hr) |
| HK (1) | HK1091725A1 (hr) |
| HR (1) | HRP20110646T1 (hr) |
| IL (1) | IL173441A (hr) |
| MX (1) | MXPA06001350A (hr) |
| NO (1) | NO339816B1 (hr) |
| NZ (1) | NZ545037A (hr) |
| PL (1) | PL1660037T3 (hr) |
| PT (1) | PT1660037E (hr) |
| SE (1) | SE1660037T5 (hr) |
| SI (1) | SI1660037T1 (hr) |
| WO (1) | WO2005016262A2 (hr) |
| ZA (1) | ZA200601385B (hr) |
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| US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| DK1675573T4 (da) * | 2003-10-23 | 2012-08-06 | Otsuka Pharma Co Ltd | Steril, injicerbr aripiprazol-formulering med kontrolleret frigivelse samt fremgangsmåde |
| TWI371274B (en) * | 2003-10-23 | 2012-09-01 | Bristol Myers Squibb Co | Process for making sterile aripiprazole of desired mean particle size |
| EP1933814A2 (en) * | 2005-09-15 | 2008-06-25 | Elan Pharma International Limited | Nanoparticulate aripiprazole formulations |
| ES2437581T3 (es) * | 2005-11-17 | 2014-01-13 | Zogenix, Inc. | Suministro de formulaciones viscosas por inyección sin aguja |
| US7799790B2 (en) | 2006-07-20 | 2010-09-21 | Helm Ag | Amorphous aripiprazole and process for the preparation thereof |
| EP1880714A1 (en) * | 2006-07-20 | 2008-01-23 | Helm AG | Amorphous Aripiprazole and Process for the Preparation thereof |
| GB0618879D0 (en) * | 2006-09-26 | 2006-11-01 | Zysis Ltd | Pharmaceutical compositions |
| BRPI0813274A2 (pt) * | 2007-06-25 | 2014-12-30 | Otsuka Pharma Co Ltd | Microesferas tendo estrutura de núcleo/revestimento |
| JP4879349B2 (ja) * | 2007-07-31 | 2012-02-22 | 大塚製薬株式会社 | アリピプラゾール懸濁液及び凍結乾燥製剤の製造方法 |
| CA2766033C (en) * | 2009-06-25 | 2016-09-20 | Alkermes, Inc. | Prodrugs of nh-acidic compounds |
| WO2010151689A1 (en) | 2009-06-25 | 2010-12-29 | Alkermes, Inc. | Heterocyclic compounds for the treatment of neurological and psychological disorders |
| AU2011270701B2 (en) | 2010-06-24 | 2015-05-14 | Alkermes Pharma Ireland Limited | Prodrugs of NH-acidic compounds: ester, carbonate, carbamate and phosphonate derivatives |
| CN107625728A (zh) * | 2010-10-18 | 2018-01-26 | 大日本住友制药株式会社 | 注射用缓释制剂 |
| AR083884A1 (es) * | 2010-11-16 | 2013-03-27 | Otsuka Pharma Co Ltd | Jeringa prellenable de doble camara y relleno de aripiprazol en la jeringa |
| CN102525915B (zh) * | 2010-12-14 | 2016-09-28 | 江苏豪森药业集团有限公司 | 一种持续释放的注射制剂及其制备方法和用途 |
| SI3156056T1 (sl) * | 2011-03-18 | 2024-03-29 | Alkermes Pharma Ireland Limited | Farmacevtski sestavki, ki obsegajo estre sorbitana |
| JO3410B1 (ar) | 2011-06-07 | 2019-10-20 | Otsuka Pharma Co Ltd | تركيبة أريبيبرازول مجفف بالتبريد |
| EP2790734B1 (en) | 2011-12-15 | 2019-02-20 | Alkermes Pharma Ireland Limited | Prodrugs of secondary amine compounds |
| CN103301461B (zh) * | 2012-03-08 | 2018-09-07 | 江苏豪森药业集团有限公司 | 一种长效注射制剂及其制备方法和用途 |
| NZ630643A (en) | 2012-03-19 | 2017-08-25 | Alkermes Pharma Ireland Ltd | Pharmaceutical compositions comprising fatty acid esters |
| JP6333802B2 (ja) * | 2012-03-19 | 2018-05-30 | アルカームス ファーマ アイルランド リミテッド | ベンジルアルコールを含む医薬組成物 |
| WO2013142202A1 (en) | 2012-03-19 | 2013-09-26 | Alkermes Pharma Ireland Limited | Pharmaceutical compositions comprising glycerol esters |
| JOP20200109A1 (ar) | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| AR090775A1 (es) * | 2012-04-23 | 2014-12-03 | Otsuka Pharma Co Ltd | Preparado inyectable |
| CA2885196C (en) | 2012-09-19 | 2021-06-22 | Alkermes Pharma Ireland Limited | Pharmaceutical compositions having improved storage stability |
| AR096131A1 (es) | 2013-04-30 | 2015-12-09 | Otsuka Pharma Co Ltd | Preparado oral sólido que comprende aripiprazol y un método para producir un preparado oral sólido que comprende aripiprazol |
| US10525057B2 (en) | 2013-09-24 | 2020-01-07 | Otsuka Pharmaceutical Co., Ltd. | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
| RU2688233C2 (ru) | 2014-03-20 | 2019-05-21 | Алкермес Фарма Айэленд Лимитед | Препараты арипипразола, имеющие повышенные скорости впрыска |
| CN105078898B (zh) * | 2014-05-22 | 2018-08-28 | 上海现代药物制剂工程研究中心有限公司 | 阿立哌唑长效缓释微粒注射剂及其制备方法 |
| IL292079B1 (en) * | 2014-08-18 | 2024-03-01 | Alkermes Pharma Ireland Ltd | Protropa aripiprazole preparations, and their uses |
| WO2016032950A1 (en) | 2014-08-25 | 2016-03-03 | Alkermes Pharma Ireland Limited | Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia |
| CN106474058B (zh) | 2015-08-31 | 2020-01-07 | 南京诺瑞特医药科技有限公司 | 具有延长的保质期的阿立哌唑可注射悬浮液制剂 |
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| US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| US6987111B2 (en) * | 2003-08-06 | 2006-01-17 | Alkermes Controlled Therapeutics, Ii | Aripiprazole, olanzapine and haloperidol pamoate salts |
| DK1675573T4 (da) * | 2003-10-23 | 2012-08-06 | Otsuka Pharma Co Ltd | Steril, injicerbr aripiprazol-formulering med kontrolleret frigivelse samt fremgangsmåde |
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2003
- 2003-08-06 US US10/635,221 patent/US20050032811A1/en not_active Abandoned
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2004
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