CN116583270A - 与延长释放帕潘立酮可注射制剂相关的给药方案 - Google Patents
与延长释放帕潘立酮可注射制剂相关的给药方案 Download PDFInfo
- Publication number
- CN116583270A CN116583270A CN202180080433.0A CN202180080433A CN116583270A CN 116583270 A CN116583270 A CN 116583270A CN 202180080433 A CN202180080433 A CN 202180080433A CN 116583270 A CN116583270 A CN 116583270A
- Authority
- CN
- China
- Prior art keywords
- suspension
- dose
- paliperidone palmitate
- patient
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (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 |
|---|---|---|---|
| US202063119405P | 2020-11-30 | 2020-11-30 | |
| US63/119405 | 2020-11-30 | ||
| PCT/EP2021/062147 WO2022111859A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116583270A true CN116583270A (zh) | 2023-08-11 |
Family
ID=75888043
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202180080433.0A Pending CN116583270A (zh) | 2020-11-30 | 2021-05-07 | 与延长释放帕潘立酮可注射制剂相关的给药方案 |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US11304951B1 (https=) |
| EP (2) | EP4025188B1 (https=) |
| JP (2) | JP7792959B2 (https=) |
| KR (2) | KR102794804B1 (https=) |
| CN (1) | CN116583270A (https=) |
| AU (2) | AU2021386450B2 (https=) |
| CA (1) | CA3203566A1 (https=) |
| DK (1) | DK4025188T3 (https=) |
| ES (1) | ES2973583T3 (https=) |
| FI (1) | FI4025188T3 (https=) |
| HR (1) | HRP20240074T1 (https=) |
| HU (1) | HUE065573T2 (https=) |
| IL (1) | IL303253A (https=) |
| LT (1) | LT4025188T (https=) |
| MX (2) | MX2023006366A (https=) |
| PL (1) | PL4025188T3 (https=) |
| PT (1) | PT4025188T (https=) |
| RS (1) | RS65178B1 (https=) |
| SI (1) | SI4025188T1 (https=) |
| SM (1) | SMT202400077T1 (https=) |
| TW (2) | TWI877363B (https=) |
| WO (1) | WO2022111859A1 (https=) |
Families Citing this family (5)
| 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 |
| KR102794804B1 (ko) * | 2020-11-30 | 2025-04-10 | 얀센 파마슈티카 엔브이 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 |
| 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. |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5254556A (en) | 1988-11-07 | 1993-10-19 | Janssen Pharmaceutica N.V. | 3-piperidinyl-1,2-benzisoxazoles |
| 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 |
| 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 |
| BR112012010195A2 (pt) | 2009-10-30 | 2016-04-26 | Janssen Pharmaceutica Nv | regime de dosagem associado a ésteres de paliperidona injetável de longa ação |
| 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 |
| RS65024B1 (sr) * | 2015-04-07 | 2024-01-31 | Janssen Pharmaceutica Nv | Dozni režim za propuštene doze injektibilnih estara paliperidona sa produženim delovanjem |
| HK1254640A1 (zh) * | 2015-06-19 | 2019-07-26 | Janssen Pharmaceutica, N.V. | 用於药物施用和混合的设备和方法及用於所述设备和方法的适当技术的训练 |
| 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 |
-
2021
- 2021-05-07 KR KR1020237021429A patent/KR102794804B1/ko active Active
- 2021-05-07 RS RS20240116A patent/RS65178B1/sr unknown
- 2021-05-07 TW TW110116515A patent/TWI877363B/zh active
- 2021-05-07 DK DK21724652.9T patent/DK4025188T3/da active
- 2021-05-07 PL PL21724652.9T patent/PL4025188T3/pl unknown
- 2021-05-07 FI FIEP21724652.9T patent/FI4025188T3/fi active
- 2021-05-07 WO PCT/EP2021/062147 patent/WO2022111859A1/en not_active Ceased
- 2021-05-07 LT LTEPPCT/EP2021/062147T patent/LT4025188T/lt unknown
- 2021-05-07 ES ES21724652T patent/ES2973583T3/es active Active
- 2021-05-07 SM SM20240077T patent/SMT202400077T1/it unknown
- 2021-05-07 EP EP21724652.9A patent/EP4025188B1/en active Active
- 2021-05-07 JP JP2023532489A patent/JP7792959B2/ja active Active
- 2021-05-07 CN CN202180080433.0A patent/CN116583270A/zh active Pending
- 2021-05-07 EP EP23219765.7A patent/EP4356966A3/en active Pending
- 2021-05-07 IL IL303253A patent/IL303253A/en unknown
- 2021-05-07 MX MX2023006366A patent/MX2023006366A/es unknown
- 2021-05-07 AU AU2021386450A patent/AU2021386450B2/en active Active
- 2021-05-07 HU HUE21724652A patent/HUE065573T2/hu unknown
- 2021-05-07 CA CA3203566A patent/CA3203566A1/en active Pending
- 2021-05-07 US US17/314,330 patent/US11304951B1/en active Active
- 2021-05-07 TW TW114105894A patent/TW202539685A/zh unknown
- 2021-05-07 HR HRP20240074TT patent/HRP20240074T1/hr unknown
- 2021-05-07 KR KR1020257011387A patent/KR20250053980A/ko active Pending
- 2021-05-07 PT PT217246529T patent/PT4025188T/pt unknown
- 2021-05-07 SI SI202130102T patent/SI4025188T1/sl unknown
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2022
- 2022-04-13 US US17/719,686 patent/US20220249495A1/en not_active Abandoned
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2023
- 2023-05-30 MX MX2024009188A patent/MX2024009188A/es unknown
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2024
- 2024-06-20 AU AU2024204213A patent/AU2024204213B2/en active Active
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2025
- 2025-08-06 US US19/291,832 patent/US20260060986A1/en active Pending
- 2025-10-15 JP JP2025173295A patent/JP2026027255A/ja active Pending
Also Published As
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |