CA2871398C - Injectable formulation of a benzothiophene compound for use in the treatment and prevention of a central nervous system disorder - Google Patents
Injectable formulation of a benzothiophene compound for use in the treatment and prevention of a central nervous system disorder Download PDFInfo
- Publication number
- CA2871398C CA2871398C CA2871398A CA2871398A CA2871398C CA 2871398 C CA2871398 C CA 2871398C CA 2871398 A CA2871398 A CA 2871398A CA 2871398 A CA2871398 A CA 2871398A CA 2871398 C CA2871398 C CA 2871398C
- Authority
- CA
- Canada
- Prior art keywords
- compound
- injectable preparation
- salt
- dihydrate
- benzo
- 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.)
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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
- A61K31/495—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
- A61K47/02—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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or 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
- A61K9/0012—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Dispersion Chemistry (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261636932P | 2012-04-23 | 2012-04-23 | |
| US61/636,932 | 2012-04-23 | ||
| US201361791896P | 2013-03-15 | 2013-03-15 | |
| US61/791,896 | 2013-03-15 | ||
| PCT/JP2013/061950 WO2013161830A1 (ja) | 2012-04-23 | 2013-04-23 | 注射製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2871398A1 CA2871398A1 (en) | 2013-10-31 |
| CA2871398C true CA2871398C (en) | 2021-04-27 |
Family
ID=49483139
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2871398A Active CA2871398C (en) | 2012-04-23 | 2013-04-23 | Injectable formulation of a benzothiophene compound for use in the treatment and prevention of a central nervous system disorder |
Country Status (31)
| Country | Link |
|---|---|
| US (6) | US20150086632A1 (OSRAM) |
| EP (1) | EP2868318B2 (OSRAM) |
| JP (1) | JP6249944B2 (OSRAM) |
| KR (1) | KR102168263B1 (OSRAM) |
| CN (4) | CN110638752A (OSRAM) |
| AR (1) | AR090775A1 (OSRAM) |
| AU (1) | AU2013253518B2 (OSRAM) |
| BR (1) | BR112014026398B1 (OSRAM) |
| CA (1) | CA2871398C (OSRAM) |
| CO (1) | CO7151499A2 (OSRAM) |
| CY (1) | CY1123195T1 (OSRAM) |
| DK (1) | DK2868318T4 (OSRAM) |
| EA (1) | EA026124B1 (OSRAM) |
| ES (1) | ES2727454T5 (OSRAM) |
| HR (1) | HRP20190841T4 (OSRAM) |
| HU (1) | HUE043686T2 (OSRAM) |
| IL (1) | IL235211A0 (OSRAM) |
| IN (1) | IN2014DN08870A (OSRAM) |
| JO (1) | JO3524B1 (OSRAM) |
| LT (1) | LT2868318T (OSRAM) |
| MX (1) | MX361722B (OSRAM) |
| MY (1) | MY169099A (OSRAM) |
| NZ (1) | NZ630255A (OSRAM) |
| PH (1) | PH12014502366A1 (OSRAM) |
| PL (1) | PL2868318T5 (OSRAM) |
| PT (1) | PT2868318T (OSRAM) |
| SG (2) | SG10201608684QA (OSRAM) |
| SI (1) | SI2868318T2 (OSRAM) |
| TW (1) | TWI641395B (OSRAM) |
| UA (1) | UA118084C2 (OSRAM) |
| WO (1) | WO2013161830A1 (OSRAM) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| JOP20210047A1 (ar) * | 2012-10-25 | 2017-06-16 | Otsuka Pharma Co Ltd | عامل وقائي و/أو علاجي للأعراض السلوكية والنفسية المصحوبة بمرض تنكسي عصبي أو الأعراض الإندفاعية المصحوبة بمرض ذهني، يحتوي على بريكسبيرازول أو ملحه |
| WO2017106641A1 (en) * | 2015-12-17 | 2017-06-22 | Assia Chemical Industries Ltd. | Solid state forms of brexpiprazole |
| WO2017134038A1 (en) | 2016-02-01 | 2017-08-10 | Hexal Ag | Anhydrate-free polymorphically pure micronized crystalline brexpiprazole dihydrate for use in intramuscular injectable sustained release formulations |
| WO2017208251A1 (en) * | 2016-05-31 | 2017-12-07 | Cipla Limited | A new stable polymorph of brexpiprazole and process for preparation thereof |
| US20200093821A1 (en) | 2016-08-16 | 2020-03-26 | Hexal Ag | Pharmaceutical Compositions of a Benzothiophene Compound |
| WO2018141886A1 (en) * | 2017-02-02 | 2018-08-09 | Hexal Aktiengesellschaft | Crystalline brexpiprazole |
| EA202192646A1 (ru) * | 2019-03-28 | 2021-12-09 | Оцука Фармасьютикал Ко., Лтд. | Лиофилизированная композиция, содержащая соединение бензоазепина |
| JPWO2021029020A1 (OSRAM) * | 2019-08-13 | 2021-02-18 | ||
| CN117794517A (zh) * | 2021-09-07 | 2024-03-29 | 四川科伦药物研究院有限公司 | 注射用布瑞哌唑长效制剂及其制备方法 |
| CN117214053A (zh) * | 2023-10-17 | 2023-12-12 | 海南卫康制药(潜山)有限公司 | 一种注射用头孢呋辛钠肌注混悬液的粒度测定方法 |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3402195B2 (ja) * | 1997-05-14 | 2003-04-28 | 千寿製薬株式会社 | 再分散性の良い水性懸濁液剤 |
| KR20010012188A (ko) | 1997-05-14 | 2001-02-15 | 요시다 쇼지 | 재분산성이 양호한 수성 현탁액제 |
| US6656505B2 (en) * | 2000-07-21 | 2003-12-02 | Alpharma Uspd Inc. | Method for forming an aqueous flocculated suspension |
| WO2002015878A1 (fr) * | 2000-08-25 | 2002-02-28 | Senju Pharmaceutical Co., Ltd. | Preparations en suspension aqueuse |
| AR033485A1 (es) * | 2001-09-25 | 2003-12-26 | Otsuka Pharma Co Ltd | Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma |
| US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| JP4836797B2 (ja) * | 2003-10-23 | 2011-12-14 | 大塚製薬株式会社 | 放出制御性無菌注射アリピプラゾール製剤および方法 |
| TWI320783B (en) * | 2005-04-14 | 2010-02-21 | Otsuka Pharma Co Ltd | Heterocyclic compound |
| JP4315393B2 (ja) | 2005-04-14 | 2009-08-19 | 大塚製薬株式会社 | 複素環化合物 |
| CA2622758A1 (en) | 2005-09-15 | 2007-03-29 | Elan Pharma International, Limited | Nanoparticulate aripiprazole formulations |
| TW200808375A (en) | 2006-05-12 | 2008-02-16 | Otsuka Pharma Co Ltd | Hydrogel suspension and manufacturing process thereof |
| TWI415629B (zh) * | 2006-10-26 | 2013-11-21 | Otsuka Pharma Co Ltd | 含有瑞巴匹特之水性醫藥懸浮物及其製造方法 |
| MX2010001311A (es) * | 2007-07-31 | 2010-04-21 | Otsuka Pharma Co Ltd | Metodo para producir una suspensi?n de aripiprazol y formulacion liofilizada. |
| JP5581227B2 (ja) * | 2008-03-11 | 2014-08-27 | アルコン リサーチ， リミテッド | 硝子体内注射のための低粘度、高凝集トリアムシノロンアセトニド懸濁剤 |
| EP2367572B1 (en) * | 2008-11-19 | 2018-08-29 | Merial, Inc. | Formulations comprising ceftiofur and benzyl alcohol |
| MX344235B (es) * | 2010-08-24 | 2016-12-07 | Otsuka Pharmaceutical Co Ltd * | Suspension y composicion en torta que contiene un derivado de carbostirilo y aceite de silicona y/o un derivado de aceite de silicona. |
| JP5893616B2 (ja) * | 2010-10-18 | 2016-03-23 | 大日本住友製薬株式会社 | 注射用徐放性製剤 |
| PL2685979T3 (pl) * | 2011-03-18 | 2017-02-28 | Alkermes Pharma Ireland Limited | Kompozycje farmaceutyczne do wstrzykiwania zawierające środek nierozpuszczalny w wodzie, środek przeciwpsychotyczny, laurynian sorbitanu i polisorbat 20 |
| JP2012232958A (ja) | 2011-05-09 | 2012-11-29 | Otsuka Pharmaceut Co Ltd | 注射製剤 |
| WO2013142205A1 (en) * | 2012-03-19 | 2013-09-26 | Alkermes Pharma Ireland Limited | Pharmaceutical compositions comprising benzyl alcohol |
| 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 |
| JOP20200109A1 (ar) * | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
-
2013
- 2013-04-22 AR ARP130101320A patent/AR090775A1/es not_active Application Discontinuation
- 2013-04-23 UA UAA201412554A patent/UA118084C2/uk unknown
- 2013-04-23 BR BR112014026398-1A patent/BR112014026398B1/pt active IP Right Grant
- 2013-04-23 SG SG10201608684QA patent/SG10201608684QA/en unknown
- 2013-04-23 JP JP2014512621A patent/JP6249944B2/ja active Active
- 2013-04-23 NZ NZ630255A patent/NZ630255A/en unknown
- 2013-04-23 IN IN8870DEN2014 patent/IN2014DN08870A/en unknown
- 2013-04-23 WO PCT/JP2013/061950 patent/WO2013161830A1/ja not_active Ceased
- 2013-04-23 DK DK13781458.8T patent/DK2868318T4/da active
- 2013-04-23 CA CA2871398A patent/CA2871398C/en active Active
- 2013-04-23 US US14/395,681 patent/US20150086632A1/en not_active Abandoned
- 2013-04-23 EA EA201491937A patent/EA026124B1/ru not_active IP Right Cessation
- 2013-04-23 HU HUE13781458A patent/HUE043686T2/hu unknown
- 2013-04-23 JO JOP/2013/0115A patent/JO3524B1/ar active
- 2013-04-23 PT PT13781458T patent/PT2868318T/pt unknown
- 2013-04-23 TW TW102114433A patent/TWI641395B/zh active
- 2013-04-23 SI SI201331442T patent/SI2868318T2/sl unknown
- 2013-04-23 CN CN201911077087.1A patent/CN110638752A/zh active Pending
- 2013-04-23 ES ES13781458T patent/ES2727454T5/es active Active
- 2013-04-23 HR HRP20190841TT patent/HRP20190841T4/hr unknown
- 2013-04-23 EP EP13781458.8A patent/EP2868318B2/en active Active
- 2013-04-23 AU AU2013253518A patent/AU2013253518B2/en active Active
- 2013-04-23 LT LTEP13781458.8T patent/LT2868318T/lt unknown
- 2013-04-23 CN CN201710701596.1A patent/CN107536802A/zh active Pending
- 2013-04-23 CN CN201380021612.2A patent/CN104363912A/zh active Pending
- 2013-04-23 MX MX2014012734A patent/MX361722B/es active IP Right Grant
- 2013-04-23 PL PL13781458T patent/PL2868318T5/pl unknown
- 2013-04-23 CN CN202010921162.4A patent/CN111888329A/zh active Pending
- 2013-04-23 SG SG11201406775UA patent/SG11201406775UA/en unknown
- 2013-04-23 MY MYPI2014703102A patent/MY169099A/en unknown
- 2013-04-23 KR KR1020147032097A patent/KR102168263B1/ko active Active
-
2014
- 2014-10-20 IL IL235211A patent/IL235211A0/en active IP Right Grant
- 2014-10-22 PH PH12014502366A patent/PH12014502366A1/en unknown
- 2014-11-21 CO CO14255947A patent/CO7151499A2/es unknown
-
2017
- 2017-09-12 US US15/702,361 patent/US10624889B2/en active Active
-
2019
- 2019-06-06 CY CY20191100602T patent/CY1123195T1/el unknown
-
2020
- 2020-01-28 US US16/775,222 patent/US20200163960A1/en not_active Abandoned
-
2022
- 2022-02-11 US US17/650,822 patent/US20220305007A1/en not_active Abandoned
-
2023
- 2023-12-15 US US18/541,083 patent/US20240277702A1/en not_active Abandoned
-
2024
- 2024-11-22 US US18/956,268 patent/US20250241909A1/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20180423 |