JP2023551009A - 持続放出パリペリドン注射可能製剤に関連する投与レジメン - Google Patents
持続放出パリペリドン注射可能製剤に関連する投与レジメン Download PDFInfo
- Publication number
- JP2023551009A JP2023551009A JP2023532513A JP2023532513A JP2023551009A JP 2023551009 A JP2023551009 A JP 2023551009A JP 2023532513 A JP2023532513 A JP 2023532513A JP 2023532513 A JP2023532513 A JP 2023532513A JP 2023551009 A JP2023551009 A JP 2023551009A
- Authority
- JP
- Japan
- Prior art keywords
- pp6m
- dose
- paliperidone palmitate
- pp3m
- paliperidone
- 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.)
- Pending
Links
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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/0019—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
-
- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Child & Adolescent Psychology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Dispersion Chemistry (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 (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063119363P | 2020-11-30 | 2020-11-30 | |
| US63/119,363 | 2020-11-30 | ||
| PCT/EP2021/062198 WO2022111860A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023551009A true JP2023551009A (ja) | 2023-12-06 |
| JP2023551009A5 JP2023551009A5 (https=) | 2024-05-17 |
Family
ID=75904921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023532513A Pending JP2023551009A (ja) | 2020-11-30 | 2021-05-07 | 持続放出パリペリドン注射可能製剤に関連する投与レジメン |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US11439647B2 (https=) |
| EP (1) | EP4025189B1 (https=) |
| JP (1) | JP2023551009A (https=) |
| KR (1) | KR20230116836A (https=) |
| CN (1) | CN116528836A (https=) |
| AU (1) | AU2021389587A1 (https=) |
| CA (1) | CA3203015A1 (https=) |
| DK (1) | DK4025189T3 (https=) |
| ES (1) | ES2981035T3 (https=) |
| FI (1) | FI4025189T3 (https=) |
| HR (1) | HRP20240800T1 (https=) |
| HU (1) | HUE067072T2 (https=) |
| IL (1) | IL303252A (https=) |
| LT (1) | LT4025189T (https=) |
| MX (1) | MX2023006368A (https=) |
| PL (1) | PL4025189T3 (https=) |
| RS (1) | RS65815B1 (https=) |
| TW (1) | TW202222317A (https=) |
| WO (1) | WO2022111860A1 (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7839162B2 (ja) | 2020-11-30 | 2026-04-01 | ヤンセン ファーマシューティカ エヌ．ベー． | パルミチン酸パリペリドン製剤の再懸濁を確実にする方法 |
| ES2981035T3 (es) | 2020-11-30 | 2024-10-07 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada |
| MX2023006370A (es) | 2020-11-30 | 2023-08-07 | Janssen Pharmaceutica Nv | Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada. |
| MX2024002215A (es) | 2021-08-20 | 2024-05-10 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada. |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2013509435A (ja) * | 2009-10-30 | 2013-03-14 | ヤンセン ファーマシューティカ エヌ．ベー． | 長時間作用型注入可能パリペリドンエステルに関連した投与レジメン |
| JP2018510894A (ja) * | 2015-04-07 | 2018-04-19 | ヤンセン ファーマシューティカルズ，インコーポレーテッド | 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5158952A (en) | 1988-11-07 | 1992-10-27 | Janssen Pharmaceutica N.V. | 3-[2-[4-(6-fluoro-1,2-benzisoxozol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9 tetrahydro-9-hydroxy-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one, compositions and method of use |
| US5254556A (en) | 1988-11-07 | 1993-10-19 | Janssen Pharmaceutica N.V. | 3-piperidinyl-1,2-benzisoxazoles |
| TW487572B (en) | 1996-05-20 | 2002-05-21 | Janssen Pharmaceutica Nv | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters |
| UA72189C2 (uk) | 1997-11-17 | 2005-02-15 | Янссен Фармацевтика Н.В. | Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот |
| WO2006114384A1 (en) | 2005-04-25 | 2006-11-02 | Janssen Pharmaceutica N.V. | Preparation of aseptic 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyridio[1,2-a]pyrimidin-4-one palmitate ester |
| KR102318070B1 (ko) | 2007-12-19 | 2021-10-27 | 얀센 파마슈티카 엔.브이. | 장기 작용성 주사가능 팔리페리돈 에스테르와 관련된 투여 요법 |
| WO2011042453A1 (en) | 2009-10-06 | 2011-04-14 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| ES2456917T3 (es) | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
| WO2016157061A1 (en) * | 2015-03-31 | 2016-10-06 | Wockhardt Limited | Aseptic wet milling process for paliperidone palmitate |
| PL3723760T3 (pl) * | 2017-12-14 | 2025-10-20 | SpecGx LLC | Jednoetapowy sposób mielenia w celu wytworzenia zmikronizowanych estrów paliperydonu |
| KR102794804B1 (ko) | 2020-11-30 | 2025-04-10 | 얀센 파마슈티카 엔브이 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 |
| MX2023006370A (es) | 2020-11-30 | 2023-08-07 | Janssen Pharmaceutica Nv | Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada. |
| ES2981035T3 (es) | 2020-11-30 | 2024-10-07 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada |
| JP7839162B2 (ja) | 2020-11-30 | 2026-04-01 | ヤンセン ファーマシューティカ エヌ．ベー． | パルミチン酸パリペリドン製剤の再懸濁を確実にする方法 |
| MX2024002215A (es) | 2021-08-20 | 2024-05-10 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada. |
-
2021
- 2021-05-07 ES ES21725105T patent/ES2981035T3/es active Active
- 2021-05-07 JP JP2023532513A patent/JP2023551009A/ja active Pending
- 2021-05-07 KR KR1020237021404A patent/KR20230116836A/ko active Pending
- 2021-05-07 CN CN202180080431.1A patent/CN116528836A/zh active Pending
- 2021-05-07 TW TW110116511A patent/TW202222317A/zh unknown
- 2021-05-07 US US17/314,245 patent/US11439647B2/en active Active
- 2021-05-07 RS RS20240853A patent/RS65815B1/sr unknown
- 2021-05-07 CA CA3203015A patent/CA3203015A1/en active Pending
- 2021-05-07 DK DK21725105.7T patent/DK4025189T3/da active
- 2021-05-07 EP EP21725105.7A patent/EP4025189B1/en active Active
- 2021-05-07 WO PCT/EP2021/062198 patent/WO2022111860A1/en not_active Ceased
- 2021-05-07 AU AU2021389587A patent/AU2021389587A1/en not_active Abandoned
- 2021-05-07 MX MX2023006368A patent/MX2023006368A/es unknown
- 2021-05-07 HU HUE21725105A patent/HUE067072T2/hu unknown
- 2021-05-07 LT LTEPPCT/EP2021/062198T patent/LT4025189T/lt unknown
- 2021-05-07 FI FIEP21725105.7T patent/FI4025189T3/fi active
- 2021-05-07 HR HRP20240800TT patent/HRP20240800T1/hr unknown
- 2021-05-07 PL PL21725105.7T patent/PL4025189T3/pl unknown
- 2021-05-07 IL IL303252A patent/IL303252A/en unknown
-
2022
- 2022-09-09 US US17/941,464 patent/US12053474B2/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2013509435A (ja) * | 2009-10-30 | 2013-03-14 | ヤンセン ファーマシューティカ エヌ．ベー． | 長時間作用型注入可能パリペリドンエステルに関連した投与レジメン |
| JP2018510894A (ja) * | 2015-04-07 | 2018-04-19 | ヤンセン ファーマシューティカルズ，インコーポレーテッド | 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン |
Non-Patent Citations (2)
| Title |
|---|
| "A STUDY OF PALIPERIDONE PALMITATE 6-MONTH FORMULATION",［ONLINE］, JPN6025023424, 16 June 2020 (2020-06-16), ISSN: 0005614607 * |
| HEALTH AND QUALITY OF LIFE OUTCOMES, vol. 10, no. 35, JPN6025023425, 2012, pages 1 - 9, ISSN: 0005614608 * |
Also Published As
| Publication number | Publication date |
|---|---|
| US20220168305A1 (en) | 2022-06-02 |
| LT4025189T (lt) | 2024-07-10 |
| EP4025189B1 (en) | 2024-06-05 |
| US12053474B2 (en) | 2024-08-06 |
| KR20230116836A (ko) | 2023-08-04 |
| US20230010558A1 (en) | 2023-01-12 |
| US11439647B2 (en) | 2022-09-13 |
| WO2022111860A1 (en) | 2022-06-02 |
| CA3203015A1 (en) | 2022-06-02 |
| HUE067072T2 (hu) | 2024-09-28 |
| IL303252A (en) | 2023-07-01 |
| TW202222317A (zh) | 2022-06-16 |
| FI4025189T3 (fi) | 2024-07-02 |
| DK4025189T3 (da) | 2024-06-10 |
| EP4025189A1 (en) | 2022-07-13 |
| RS65815B1 (sr) | 2024-08-30 |
| AU2021389587A1 (en) | 2023-07-13 |
| AU2021389587A9 (en) | 2024-09-26 |
| PL4025189T3 (pl) | 2024-09-23 |
| CN116528836A (zh) | 2023-08-01 |
| ES2981035T3 (es) | 2024-10-07 |
| HRP20240800T1 (hr) | 2024-09-27 |
| MX2023006368A (es) | 2023-08-07 |
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| JP7792959B2 (ja) | 持続放出パリペリドン注射可能製剤に関連する投与レジメン | |
| JP2023551009A (ja) | 持続放出パリペリドン注射可能製剤に関連する投与レジメン | |
| EP4137136A1 (en) | Dosing regimens associated with extended release paliperidone injectable formulations |
Legal Events
| Date | Code | Title | Description |
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| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20240502 |
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| A621 | Written request for application examination |
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| A977 | Report on retrieval |
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| A131 | Notification of reasons for refusal |
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| A02 | Decision of refusal |
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