HRP20240086T1 - Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem - Google Patents
Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem Download PDFInfo
- Publication number
- HRP20240086T1 HRP20240086T1 HRP20240086TT HRP20240086T HRP20240086T1 HR P20240086 T1 HRP20240086 T1 HR P20240086T1 HR P20240086T T HRP20240086T T HR P20240086TT HR P20240086 T HRP20240086 T HR P20240086T HR P20240086 T1 HRP20240086 T1 HR P20240086T1
- Authority
- HR
- Croatia
- Prior art keywords
- paliperidone palmitate
- dose
- paliperidone
- use according
- palmitate
- Prior art date
Links
- PMXMIIMHBWHSKN-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCC(O)C4=NC=3C)=NOC2=C1 PMXMIIMHBWHSKN-UHFFFAOYSA-N 0.000 title claims 8
- 229960001057 paliperidone Drugs 0.000 title claims 8
- 238000013265 extended release Methods 0.000 title claims 5
- 239000007972 injectable composition Substances 0.000 title 1
- VOMKSBFLAZZBOW-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC3=C(C)N=C4N(C3=O)CCCC4OC(=O)CCCCCCCCCCCCCCC)=NOC2=C1 VOMKSBFLAZZBOW-UHFFFAOYSA-N 0.000 claims 37
- 229960000635 paliperidone palmitate Drugs 0.000 claims 37
- 229940102213 injectable suspension Drugs 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 208000028017 Psychotic disease Diseases 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- 210000003205 muscle Anatomy 0.000 claims 2
- 230000036470 plasma concentration Effects 0.000 claims 2
- 201000000980 schizophrenia Diseases 0.000 claims 2
- 239000000375 suspending agent Substances 0.000 claims 2
- 208000020925 Bipolar disease Diseases 0.000 claims 1
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 208000020186 Schizophreniform disease Diseases 0.000 claims 1
- 239000013011 aqueous formulation Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960002303 citric acid monohydrate Drugs 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- 229940102215 extended release suspension Drugs 0.000 claims 1
- 239000003906 humectant Substances 0.000 claims 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 208000022610 schizoaffective disease Diseases 0.000 claims 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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
- 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
- A61K9/0012—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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (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 |
|---|---|---|---|
| US202063119382P | 2020-11-30 | 2020-11-30 | |
| EP21724651.1A EP4025187B1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
| PCT/EP2021/062144 WO2022111858A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240086T1 true HRP20240086T1 (hr) | 2024-03-29 |
Family
ID=75888042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240086TT HRP20240086T1 (hr) | 2020-11-30 | 2021-05-07 | Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem |
Country Status (24)
| Country | Link |
|---|---|
| US (2) | US11324751B1 (OSRAM) |
| EP (2) | EP4385564A3 (OSRAM) |
| JP (2) | JP7792409B2 (OSRAM) |
| KR (1) | KR20230116837A (OSRAM) |
| CN (1) | CN116507320A (OSRAM) |
| AU (3) | AU2021387679B2 (OSRAM) |
| CA (1) | CA3203448A1 (OSRAM) |
| DK (1) | DK4025187T3 (OSRAM) |
| ES (1) | ES2974822T3 (OSRAM) |
| FI (1) | FI4025187T3 (OSRAM) |
| HR (1) | HRP20240086T1 (OSRAM) |
| HU (1) | HUE065387T2 (OSRAM) |
| IL (1) | IL303251A (OSRAM) |
| LT (1) | LT4025187T (OSRAM) |
| MA (1) | MA71365A (OSRAM) |
| MX (2) | MX2023006370A (OSRAM) |
| PL (1) | PL4025187T3 (OSRAM) |
| PT (1) | PT4025187T (OSRAM) |
| RS (1) | RS65133B1 (OSRAM) |
| SI (1) | SI4025187T1 (OSRAM) |
| SM (1) | SMT202400075T1 (OSRAM) |
| TW (2) | TWI838623B (OSRAM) |
| WO (1) | WO2022111858A1 (OSRAM) |
| ZA (1) | ZA202400851B (OSRAM) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2023006370A (es) | 2020-11-30 | 2023-08-07 | Janssen Pharmaceutica Nv | Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada. |
| CA3203015A1 (en) | 2020-11-30 | 2022-06-02 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
| CN116528837B (zh) | 2020-11-30 | 2025-03-14 | 詹森药业有限公司 | 用于确保棕榈酸帕潘立酮制剂再悬浮的方法 |
| MX2024002215A (es) | 2021-08-20 | 2024-05-10 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada. |
| AU2022337993A1 (en) * | 2021-08-30 | 2024-04-11 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
Family Cites Families (19)
| 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 |
| JP5249748B2 (ja) | 2005-04-25 | 2013-07-31 | ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ | 無菌３−［２−［４−（６−フルオロ−１，２−ベンズイソオキサゾール−３−イル）−１−ピペリジニル］エチル］−６，７，８，９−テトラヒドロ−９−ヒドロキシ−２−メチル−４Ｈ−ピリド［１，２−ａ］ピリミジン−４−オンパルミチン酸エステルの製造 |
| CN101932327A (zh) | 2007-12-19 | 2010-12-29 | 詹森药业有限公司 | 与长效注射用帕潘立酮酯相关的给药方案 |
| WO2011042453A1 (en) | 2009-10-06 | 2011-04-14 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| KR20120116401A (ko) | 2009-10-30 | 2012-10-22 | 얀센 파마슈티카 엔.브이. | 장기-작용성의 주사가능한 팔리페리돈 에스테르와 관련된 투약 요법 |
| EP2529757B1 (en) | 2011-05-31 | 2014-01-08 | Laboratorios Farmaceuticos Rovi, S.A. | Paliperidone implant formulation |
| WO2016157061A1 (en) * | 2015-03-31 | 2016-10-06 | Wockhardt Limited | Aseptic wet milling process for paliperidone palmitate |
| FI3744326T3 (fi) * | 2015-04-07 | 2024-02-02 | Janssen Pharmaceutica Nv | Annosteluohjelma pitkävaikutteisten injektoitavien paliperidoniestereiden ottamatta jääneille annoksille |
| JP6668387B2 (ja) * | 2015-06-19 | 2020-03-18 | ヤンセン ファーマシューティカ エヌ．ベー． | 薬物の投与及び混合のための装置及び方法、並びにそのための適切な技法のトレーニング |
| ES3037855T3 (en) * | 2017-12-14 | 2025-10-08 | SpecGx LLC | One step milling process for preparing micronized paliperidone esters |
| SMT202400077T1 (it) | 2020-11-30 | 2024-03-13 | Janssen Pharmaceutica Nv | Regimi di dosaggio associati con formulazioni iniettabili di paliperidone a rilascio prolungato |
| MX2023006370A (es) | 2020-11-30 | 2023-08-07 | Janssen Pharmaceutica Nv | Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada. |
| CA3203015A1 (en) | 2020-11-30 | 2022-06-02 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
| CN116528837B (zh) | 2020-11-30 | 2025-03-14 | 詹森药业有限公司 | 用于确保棕榈酸帕潘立酮制剂再悬浮的方法 |
| MX2024002215A (es) | 2021-08-20 | 2024-05-10 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada. |
| AU2022337993A1 (en) | 2021-08-30 | 2024-04-11 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
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2021
- 2021-05-07 MX MX2023006370A patent/MX2023006370A/es unknown
- 2021-05-07 WO PCT/EP2021/062144 patent/WO2022111858A1/en not_active Ceased
- 2021-05-07 EP EP23219073.6A patent/EP4385564A3/en active Pending
- 2021-05-07 EP EP21724651.1A patent/EP4025187B1/en active Active
- 2021-05-07 TW TW110116513A patent/TWI838623B/zh active
- 2021-05-07 CN CN202180080436.4A patent/CN116507320A/zh active Pending
- 2021-05-07 ES ES21724651T patent/ES2974822T3/es active Active
- 2021-05-07 HU HUE21724651A patent/HUE065387T2/hu unknown
- 2021-05-07 TW TW113108928A patent/TWI897289B/zh active
- 2021-05-07 LT LTEPPCT/EP2021/062144T patent/LT4025187T/lt unknown
- 2021-05-07 FI FIEP21724651.1T patent/FI4025187T3/fi active
- 2021-05-07 PT PT217246511T patent/PT4025187T/pt unknown
- 2021-05-07 IL IL303251A patent/IL303251A/en unknown
- 2021-05-07 SM SM20240075T patent/SMT202400075T1/it unknown
- 2021-05-07 PL PL21724651.1T patent/PL4025187T3/pl unknown
- 2021-05-07 SI SI202130112T patent/SI4025187T1/sl unknown
- 2021-05-07 DK DK21724651.1T patent/DK4025187T3/da active
- 2021-05-07 US US17/314,281 patent/US11324751B1/en active Active
- 2021-05-07 HR HRP20240086TT patent/HRP20240086T1/hr unknown
- 2021-05-07 RS RS20240087A patent/RS65133B1/sr unknown
- 2021-05-07 AU AU2021387679A patent/AU2021387679B2/en active Active
- 2021-05-07 KR KR1020237021416A patent/KR20230116837A/ko not_active Ceased
- 2021-05-07 MA MA71365A patent/MA71365A/fr unknown
- 2021-05-07 CA CA3203448A patent/CA3203448A1/en active Pending
- 2021-05-07 JP JP2023532443A patent/JP7792409B2/ja active Active
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2022
- 2022-05-06 US US17/738,422 patent/US12208100B2/en active Active
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2023
- 2023-05-30 MX MX2024013364A patent/MX2024013364A/es unknown
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2024
- 2024-01-25 ZA ZA2024/00851A patent/ZA202400851B/en unknown
- 2024-04-10 AU AU2024202306A patent/AU2024202306B2/en active Active
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2025
- 2025-10-14 JP JP2025172891A patent/JP2026027249A/ja active Pending
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2026
- 2026-03-12 AU AU2026201895A patent/AU2026201895A1/en active Pending
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