HRP20191366T4 - Injekcijski pripravak - Google Patents
Injekcijski pripravak Download PDFInfo
- Publication number
- HRP20191366T4 HRP20191366T4 HRP20191366TT HRP20191366T HRP20191366T4 HR P20191366 T4 HRP20191366 T4 HR P20191366T4 HR P20191366T T HRP20191366T T HR P20191366TT HR P20191366 T HRP20191366 T HR P20191366T HR P20191366 T4 HRP20191366 T4 HR P20191366T4
- Authority
- HR
- Croatia
- Prior art keywords
- salt
- quinolin
- benzo
- butoxy
- preparation according
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims 39
- 150000003839 salts Chemical class 0.000 claims 43
- 238000002347 injection Methods 0.000 claims 18
- 239000007924 injection Substances 0.000 claims 18
- 239000000375 suspending agent Substances 0.000 claims 18
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 claims 17
- 229960004372 aripiprazole Drugs 0.000 claims 17
- 229940079593 drug Drugs 0.000 claims 15
- 239000003814 drug Substances 0.000 claims 15
- 239000000203 mixture Substances 0.000 claims 14
- ZKIAIYBUSXZPLP-UHFFFAOYSA-N brexpiprazole Chemical compound C1=C2NC(=O)C=CC2=CC=C1OCCCCN(CC1)CCN1C1=CC=CC2=C1C=CS2 ZKIAIYBUSXZPLP-UHFFFAOYSA-N 0.000 claims 13
- 239000007788 liquid Substances 0.000 claims 11
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 10
- 239000002202 Polyethylene glycol Substances 0.000 claims 10
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 10
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 10
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 10
- 229920001223 polyethylene glycol Polymers 0.000 claims 10
- 239000011164 primary particle Substances 0.000 claims 10
- 238000000034 method Methods 0.000 claims 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 8
- 125000004106 butoxy group Chemical group [*]OC([H])([H])C([H])([H])C(C([H])([H])[H])([H])[H] 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 229940071643 prefilled syringe Drugs 0.000 claims 3
- 208000020925 Bipolar disease Diseases 0.000 claims 2
- 239000000084 colloidal system Substances 0.000 claims 2
- 238000013265 extended release Methods 0.000 claims 2
- 208000028683 bipolar I disease Diseases 0.000 claims 1
- 208000025307 bipolar depression Diseases 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 150000004683 dihydrates Chemical group 0.000 claims 1
- 239000002270 dispersing agent Substances 0.000 claims 1
- 239000006185 dispersion Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 201000000980 schizophrenia Diseases 0.000 claims 1
- 239000011163 secondary particle Substances 0.000 claims 1
Classifications
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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 or sparfloxacin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- 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
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Psychiatry (AREA)
- Dispersion Chemistry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261636938P | 2012-04-23 | 2012-04-23 | |
| US201361792089P | 2013-03-15 | 2013-03-15 | |
| EP13728542.5A EP2841054B2 (en) | 2012-04-23 | 2013-04-23 | Injectable preparation |
| PCT/JP2013/062683 WO2013162048A1 (en) | 2012-04-23 | 2013-04-23 | Injectable preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20191366T1 HRP20191366T1 (hr) | 2019-12-27 |
| HRP20191366T4 true HRP20191366T4 (hr) | 2022-08-19 |
Family
ID=48614096
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191366TT HRP20191366T4 (hr) | 2012-04-23 | 2013-04-23 | Injekcijski pripravak |
Country Status (31)
| Country | Link |
|---|---|
| US (9) | US20150093442A1 (enExample) |
| EP (2) | EP3539534A1 (enExample) |
| JP (7) | JP6234996B2 (enExample) |
| KR (5) | KR20240068788A (enExample) |
| CN (3) | CN104470499B (enExample) |
| AR (1) | AR090776A1 (enExample) |
| AU (6) | AU2013253374B2 (enExample) |
| BR (1) | BR112014026307B1 (enExample) |
| CA (2) | CA3120297A1 (enExample) |
| CO (1) | CO7151500A2 (enExample) |
| CY (1) | CY1122252T1 (enExample) |
| DK (1) | DK2841054T4 (enExample) |
| EA (1) | EA026619B1 (enExample) |
| ES (1) | ES2743706T5 (enExample) |
| HR (1) | HRP20191366T4 (enExample) |
| HU (1) | HUE045979T2 (enExample) |
| IL (1) | IL235299B (enExample) |
| JO (2) | JOP20200109A1 (enExample) |
| LT (1) | LT2841054T (enExample) |
| MX (3) | MX387891B (enExample) |
| MY (3) | MY210484A (enExample) |
| NZ (1) | NZ630335A (enExample) |
| PH (2) | PH12014502379B1 (enExample) |
| PL (1) | PL2841054T5 (enExample) |
| PT (1) | PT2841054T (enExample) |
| SG (3) | SG11201406451SA (enExample) |
| SI (1) | SI2841054T2 (enExample) |
| TW (6) | TW202425992A (enExample) |
| UA (1) | UA115444C2 (enExample) |
| WO (1) | WO2013162048A1 (enExample) |
| ZA (1) | ZA201407335B (enExample) |
Families Citing this family (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR090775A1 (es) * | 2012-04-23 | 2014-12-03 | Otsuka Pharma Co Ltd | Preparado inyectable |
| JOP20200109A1 (ar) | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| TWI562991B (en) * | 2012-04-23 | 2016-12-21 | Otsuka Pharma Co Ltd | Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same |
| CN105461703B (zh) * | 2014-12-29 | 2019-05-17 | 深圳市泛谷药业股份有限公司 | 一种brexpiprazole的制备方法 |
| JP6513461B2 (ja) * | 2015-04-14 | 2019-05-15 | 帝國製薬株式会社 | ブレクスピプラゾールの経皮吸収製剤 |
| CN104829603A (zh) * | 2015-05-19 | 2015-08-12 | 杭州新博思生物医药有限公司 | A晶型依匹唑派盐酸盐及其制备方法 |
| US10501450B2 (en) | 2016-02-01 | 2019-12-10 | Hexal Ag | Anhydrate-free polymorphically pure micronized crystalline brexpiprazole di-hydrate for use in intramuscular injectable sustained release formulations |
| WO2018137708A1 (zh) * | 2017-01-26 | 2018-08-02 | 重庆莱美药业股份有限公司 | 一种纳米炭-铁复合体系及其组合物、制备方法和用途 |
| WO2019213286A1 (en) * | 2018-05-02 | 2019-11-07 | LifeMax Laboratories, Inc. | Extended release suspension formulation of lurasidone |
| US12409153B2 (en) | 2018-11-02 | 2025-09-09 | Amaterasu Lifesciences Llp | Liquid injectable composition |
| WO2021199076A1 (en) * | 2020-03-30 | 2021-10-07 | Cipla Limited | Injectable aripiprazole formulation |
| US20230129919A1 (en) * | 2020-04-01 | 2023-04-27 | Otsuka Pharmaceutical Co., Ltd. | Methods for dose initiation of aripiprazole treatments |
| US20230372317A1 (en) * | 2020-10-27 | 2023-11-23 | Pts Consulting, Llc | A liquid injectable composition of donepezil |
| US11229644B1 (en) * | 2020-12-31 | 2022-01-25 | Lake O'hara Llc | Methods of treating psychiatric disorders in obese patients with brexpiprazole |
| US11910794B2 (en) | 2021-03-08 | 2024-02-27 | Monsanto Technology Llc | Solutions and methods for long-term pollen storage |
| WO2023067664A1 (ja) * | 2021-10-18 | 2023-04-27 | 大塚製薬株式会社 | ベンゾチオフェン化合物の新規結晶形及びその製造方法 |
| JP7760615B2 (ja) * | 2022-06-16 | 2025-10-27 | ウィズダム・ファーマスーティカル・カンパニー・リミテッド | 薬物組成物及びブレクスピプラゾール口腔内溶解フィルム |
| JP2024016759A (ja) * | 2022-07-26 | 2024-02-07 | ニプロ株式会社 | アリピプラゾール懸濁液の製造方法 |
| CN115969785A (zh) * | 2022-12-30 | 2023-04-18 | 辰欣药业股份有限公司 | 一种阿立哌唑注射剂及其制备方法 |
| WO2024194955A1 (en) * | 2023-03-17 | 2024-09-26 | Otsuka Pharmaceutical Co., Ltd. | Methods of dispersing aripiprazole injectable preparations |
| CN120957722A (zh) | 2023-04-26 | 2025-11-14 | 大塚制药株式会社 | 用阿立哌唑治疗精神分裂症或i型双相障碍的剂量启动 |
| CN121866045A (zh) * | 2023-09-08 | 2026-04-14 | 广州玻思韬控释药业有限公司 | 注射用凝胶 |
| WO2025183016A1 (ja) * | 2024-02-26 | 2025-09-04 | 大塚製薬株式会社 | Ｑｕａｂｏｄｅｐｉｓｔａｔ含有組成物 |
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| CN105125509B (zh) | 2011-01-24 | 2019-01-11 | 大塚制药株式会社 | 以阿立哌唑作为有效成分的块状组合物 |
| TWI636784B (zh) | 2011-04-05 | 2018-10-01 | 大塚製藥股份有限公司 | 含7-〔4-(4-苯並〔b〕噻吩-4-基-哌-1-基)丁氧基〕-1H-喹啉-2-酮之醫藥組成物與套組，以及彼之用途 |
| JP2012232958A (ja) † | 2011-05-09 | 2012-11-29 | Otsuka Pharmaceut Co Ltd | 注射製剤 |
| JO3410B1 (ar) | 2011-06-07 | 2019-10-20 | Otsuka Pharma Co Ltd | تركيبة أريبيبرازول مجفف بالتبريد |
| US9241876B2 (en) | 2011-06-27 | 2016-01-26 | Shanghai Zhongxi Pharmaceutical Corporation | Aripiprazole medicament formulation and preparation method therefor |
| TW201309651A (zh) | 2011-06-29 | 2013-03-01 | Otsuka Pharma Co Ltd | 阿立哌唑（ａｒｉｐｉｐｒａｚｏｌｅ）無水物Ｂ形結晶微粒子之製造方法 |
| ES2601457T3 (es) | 2011-07-28 | 2017-02-15 | Otsuka Pharmaceutical Co., Ltd. | Método para producir compuestos de benzo[b]tiofeno |
| JO3227B1 (ar) | 2011-09-08 | 2018-03-08 | Otsuka Pharma Co Ltd | مشتقات بنزو ثيوفين بها استبدال ببرازين كعوامل مضادة للذهان |
| JO3753B1 (ar) | 2011-10-14 | 2021-01-31 | Otsuka Pharma Co Ltd | قرص يتألف من 7-[4-(4-بينزو[بي]ثيوفين-4-ايل-ببرازين-1-1ايل)بوتكسيل]-1اتش-كوينولين-2-وان أو ملح منه |
| AR088372A1 (es) | 2011-10-19 | 2014-05-28 | Otsuka Pharma Co Ltd | Solucion para administracion oral |
| JP2013139441A (ja) | 2011-12-28 | 2013-07-18 | Otsuka Pharmaceut Co Ltd | マイクロスフェア |
| TW201332572A (zh) | 2011-12-28 | 2013-08-16 | Otsuka Pharma Co Ltd | 具有經取代的β－環糊精之藥物製劑 |
| TW201343201A (zh) | 2012-03-06 | 2013-11-01 | Otsuka Pharma Co Ltd | 持續釋放型口服固體製劑 |
| TWI562991B (en) | 2012-04-23 | 2016-12-21 | Otsuka Pharma Co Ltd | Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same |
| AR090775A1 (es) | 2012-04-23 | 2014-12-03 | Otsuka Pharma Co Ltd | Preparado inyectable |
| JOP20200109A1 (ar) * | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
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