KR102732030B1 - 아리피프라졸 주사가능한 제제의 투여 방법 - Google Patents
아리피프라졸 주사가능한 제제의 투여 방법 Download PDFInfo
- Publication number
- KR102732030B1 KR102732030B1 KR1020227037401A KR20227037401A KR102732030B1 KR 102732030 B1 KR102732030 B1 KR 102732030B1 KR 1020227037401 A KR1020227037401 A KR 1020227037401A KR 20227037401 A KR20227037401 A KR 20227037401A KR 102732030 B1 KR102732030 B1 KR 102732030B1
- Authority
- KR
- South Korea
- Prior art keywords
- aripiprazole
- injectable
- salt
- injectable formulation
- patient
- 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.)
- Active
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Classifications
-
- 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
- A61K9/0012—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
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Psychiatry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Hospice & Palliative Care (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020247038040A KR20240165486A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 주사가능한 제제의 투여 방법 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063003544P | 2020-04-01 | 2020-04-01 | |
| US63/003,544 | 2020-04-01 | ||
| PCT/JP2021/014192 WO2021201238A1 (en) | 2020-04-01 | 2021-04-01 | Methods of administering an aripiprazole injectable preparation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020247038040A Division KR20240165486A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 주사가능한 제제의 투여 방법 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20220161403A KR20220161403A (ko) | 2022-12-06 |
| KR102732030B1 true KR102732030B1 (ko) | 2024-11-20 |
Family
ID=75581573
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020227037401A Active KR102732030B1 (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 주사가능한 제제의 투여 방법 |
| KR1020227037400A Pending KR20220161402A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 치료의 용량 개시 방법 |
| KR1020247038040A Pending KR20240165486A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 주사가능한 제제의 투여 방법 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020227037400A Pending KR20220161402A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 치료의 용량 개시 방법 |
| KR1020247038040A Pending KR20240165486A (ko) | 2020-04-01 | 2021-04-01 | 아리피프라졸 주사가능한 제제의 투여 방법 |
Country Status (16)
| Country | Link |
|---|---|
| US (5) | US20220160621A1 (https=) |
| EP (3) | EP4125903B1 (https=) |
| JP (4) | JP7584535B2 (https=) |
| KR (3) | KR102732030B1 (https=) |
| CN (3) | CN115397420A (https=) |
| AU (2) | AU2021245713A1 (https=) |
| BR (2) | BR112022018647A2 (https=) |
| CA (3) | CA3136727A1 (https=) |
| ES (1) | ES2995466T3 (https=) |
| HR (1) | HRP20241574T1 (https=) |
| HU (1) | HUE069157T2 (https=) |
| MX (2) | MX2022012353A (https=) |
| PL (1) | PL4125903T3 (https=) |
| TW (3) | TWI865760B (https=) |
| WO (2) | WO2021201238A1 (https=) |
| ZA (1) | ZA202210633B (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| TWI865760B (zh) | 2020-04-01 | 2024-12-11 | 日商大塚製藥股份有限公司 | 阿立哌唑注射用製劑之投予方法 |
| US20250387321A1 (en) | 2023-03-17 | 2025-12-25 | Otsuka Pharmaceutical Co., Ltd. | Methods of dispersing aripiprazole injectable preparations |
| AU2024263986A1 (en) * | 2023-04-26 | 2025-10-09 | Otsuka Pharmaceutical Co., Ltd. | Dose initiation for schizophrenia or bipolar i disorder treatment with aripiprazole |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190099494A1 (en) * | 2012-04-23 | 2019-04-04 | Otsuka Pharmaceutical Co., Ltd. | Injectable preparation |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7053092B2 (en) | 2001-01-29 | 2006-05-30 | Otsuka Pharmaceutical Co., Ltd. | 5-HT1a receptor subtype agonist |
| 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 |
| ATE411797T2 (de) * | 2003-10-23 | 2008-11-15 | Otsuka Pharma Co Ltd | Sterile injizierbare aripiprazol-formulierung mit kontrollierter freisetzung und verfahren |
| MX2009014115A (es) | 2007-06-25 | 2010-04-21 | Otsuka Pharma Co Ltd | Microesferas que tienen estructura de nucleo/corteza. |
| 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 |
| JP2020520380A (ja) * | 2017-05-16 | 2020-07-09 | ボウ リバー エルエルシー | 処置法 |
| EP3761983A1 (en) * | 2018-03-05 | 2021-01-13 | Alkermes Pharma Ireland Limited | Aripiprazole dosing strategy |
| CN108498456B (zh) | 2018-05-16 | 2021-01-01 | 丽珠医药集团股份有限公司 | 一种阿立哌唑缓释微球及其制备方法 |
| CN110327296B (zh) | 2019-08-06 | 2021-10-22 | 深圳市泛谷药业股份有限公司 | 一种阿立哌唑长效注射制剂及其制备方法 |
| TWI865760B (zh) | 2020-04-01 | 2024-12-11 | 日商大塚製藥股份有限公司 | 阿立哌唑注射用製劑之投予方法 |
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2021
- 2021-04-01 TW TW110112186A patent/TWI865760B/zh active
- 2021-04-01 JP JP2022559751A patent/JP7584535B2/ja active Active
- 2021-04-01 WO PCT/JP2021/014192 patent/WO2021201238A1/en not_active Ceased
- 2021-04-01 US US17/594,292 patent/US20220160621A1/en not_active Abandoned
- 2021-04-01 CN CN202180025911.8A patent/CN115397420A/zh active Pending
- 2021-04-01 CN CN202180026022.3A patent/CN115379842A/zh active Pending
- 2021-04-01 CA CA3136727A patent/CA3136727A1/en active Pending
- 2021-04-01 PL PL21720012.0T patent/PL4125903T3/pl unknown
- 2021-04-01 EP EP21720012.0A patent/EP4125903B1/en active Active
- 2021-04-01 BR BR112022018647A patent/BR112022018647A2/pt unknown
- 2021-04-01 ES ES21720012T patent/ES2995466T3/es active Active
- 2021-04-01 TW TW110112185A patent/TWI906279B/zh active
- 2021-04-01 KR KR1020227037401A patent/KR102732030B1/ko active Active
- 2021-04-01 AU AU2021245713A patent/AU2021245713A1/en active Pending
- 2021-04-01 KR KR1020227037400A patent/KR20220161402A/ko active Pending
- 2021-04-01 MX MX2022012353A patent/MX2022012353A/es unknown
- 2021-04-01 TW TW113142852A patent/TW202523329A/zh unknown
- 2021-04-01 US US17/907,583 patent/US20230129919A1/en not_active Abandoned
- 2021-04-01 CA CA3163321A patent/CA3163321C/en active Active
- 2021-04-01 CA CA3212191A patent/CA3212191A1/en active Pending
- 2021-04-01 AU AU2021248212A patent/AU2021248212A1/en active Pending
- 2021-04-01 CN CN202411916296.1A patent/CN119792290A/zh active Pending
- 2021-04-01 HR HRP20241574TT patent/HRP20241574T1/hr unknown
- 2021-04-01 KR KR1020247038040A patent/KR20240165486A/ko active Pending
- 2021-04-01 EP EP24205231.4A patent/EP4467194A3/en active Pending
- 2021-04-01 EP EP21720011.2A patent/EP3941470A1/en active Pending
- 2021-04-01 JP JP2022559750A patent/JP7733000B2/ja active Active
- 2021-04-01 MX MX2022012354A patent/MX2022012354A/es unknown
- 2021-04-01 BR BR112022018721A patent/BR112022018721A2/pt unknown
- 2021-04-01 WO PCT/JP2021/014194 patent/WO2021201239A1/en not_active Ceased
- 2021-04-01 HU HUE21720012A patent/HUE069157T2/hu unknown
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2022
- 2022-09-26 ZA ZA2022/10633A patent/ZA202210633B/en unknown
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2023
- 2023-03-15 US US18/184,135 patent/US20230225962A1/en not_active Abandoned
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2024
- 2024-06-03 US US18/732,392 patent/US20240374506A1/en active Pending
- 2024-11-05 JP JP2024193628A patent/JP2025020306A/ja active Pending
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2025
- 2025-08-21 JP JP2025137577A patent/JP2025176037A/ja active Pending
- 2025-10-08 US US19/352,541 patent/US20260034053A1/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190099494A1 (en) * | 2012-04-23 | 2019-04-04 | Otsuka Pharmaceutical Co., Ltd. | Injectable preparation |
Non-Patent Citations (2)
| Title |
|---|
| CNS Drugs, 31(7), 617-624, 2017, |
| Expert Review of Clinical Pharmacology, 9(1), 169-186, 2015. |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0105 | International application |
St.27 status event code: A-0-1-A10-A15-nap-PA0105 |
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| PG1501 | Laying open of application |
St.27 status event code: A-1-1-Q10-Q12-nap-PG1501 |
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| A201 | Request for examination | ||
| A302 | Request for accelerated examination | ||
| E13-X000 | Pre-grant limitation requested |
St.27 status event code: A-2-3-E10-E13-lim-X000 |
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| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
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| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
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| PA0201 | Request for examination |
St.27 status event code: A-1-2-D10-D11-exm-PA0201 |
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| PA0302 | Request for accelerated examination |
St.27 status event code: A-1-2-D10-D17-exm-PA0302 St.27 status event code: A-1-2-D10-D16-exm-PA0302 |
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| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
St.27 status event code: A-1-2-D10-D21-exm-PE0902 |
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| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
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| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
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| E701 | Decision to grant or registration of patent right | ||
| PE0701 | Decision of registration |
St.27 status event code: A-1-2-D10-D22-exm-PE0701 |
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| PA0104 | Divisional application for international application |
St.27 status event code: A-0-1-A10-A18-div-PA0104 St.27 status event code: A-0-1-A10-A16-div-PA0104 |
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| PR0701 | Registration of establishment |
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| PR1002 | Payment of registration fee |
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