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)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (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)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Psychiatry (AREA)
- Organic Chemistry (AREA)
- Neurology (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 | |
| PCT/EP2021/062144 WO2022111858A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
| EP21724651.1A EP4025187B1 (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 (https=) |
| EP (2) | EP4025187B1 (https=) |
| JP (2) | JP7792409B2 (https=) |
| KR (1) | KR20230116837A (https=) |
| CN (1) | CN116507320A (https=) |
| AU (3) | AU2021387679B2 (https=) |
| CA (1) | CA3203448A1 (https=) |
| DK (1) | DK4025187T3 (https=) |
| ES (1) | ES2974822T3 (https=) |
| FI (1) | FI4025187T3 (https=) |
| HR (1) | HRP20240086T1 (https=) |
| HU (1) | HUE065387T2 (https=) |
| IL (1) | IL303251A (https=) |
| LT (1) | LT4025187T (https=) |
| MA (1) | MA71365A (https=) |
| MX (2) | MX2023006370A (https=) |
| PL (1) | PL4025187T3 (https=) |
| PT (1) | PT4025187T (https=) |
| RS (1) | RS65133B1 (https=) |
| SI (1) | SI4025187T1 (https=) |
| SM (1) | SMT202400075T1 (https=) |
| TW (2) | TWI897289B (https=) |
| WO (1) | WO2022111858A1 (https=) |
| ZA (1) | ZA202400851B (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 |
| 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. |
| WO2023030870A1 (en) * | 2021-08-30 | 2023-03-09 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
Family Cites Families (19)
| 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 |
| 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 |
| KR102794804B1 (ko) | 2020-11-30 | 2025-04-10 | 얀센 파마슈티카 엔브이 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 |
| 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. |
| WO2023030870A1 (en) | 2021-08-30 | 2023-03-09 | 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 FI FIEP21724651.1T patent/FI4025187T3/fi active
- 2021-05-07 KR KR1020237021416A patent/KR20230116837A/ko not_active Ceased
- 2021-05-07 DK DK21724651.1T patent/DK4025187T3/da active
- 2021-05-07 EP EP21724651.1A patent/EP4025187B1/en active Active
- 2021-05-07 AU AU2021387679A patent/AU2021387679B2/en active Active
- 2021-05-07 MA MA71365A patent/MA71365A/fr unknown
- 2021-05-07 TW TW113108928A patent/TWI897289B/zh active
- 2021-05-07 CN CN202180080436.4A patent/CN116507320A/zh active Pending
- 2021-05-07 HR HRP20240086TT patent/HRP20240086T1/hr unknown
- 2021-05-07 PL PL21724651.1T patent/PL4025187T3/pl unknown
- 2021-05-07 PT PT217246511T patent/PT4025187T/pt unknown
- 2021-05-07 SM SM20240075T patent/SMT202400075T1/it unknown
- 2021-05-07 IL IL303251A patent/IL303251A/en unknown
- 2021-05-07 US US17/314,281 patent/US11324751B1/en active Active
- 2021-05-07 LT LTEPPCT/EP2021/062144T patent/LT4025187T/lt unknown
- 2021-05-07 HU HUE21724651A patent/HUE065387T2/hu unknown
- 2021-05-07 CA CA3203448A patent/CA3203448A1/en active Pending
- 2021-05-07 TW TW110116513A patent/TWI838623B/zh active
- 2021-05-07 ES ES21724651T patent/ES2974822T3/es active Active
- 2021-05-07 JP JP2023532443A patent/JP7792409B2/ja active Active
- 2021-05-07 RS RS20240087A patent/RS65133B1/sr unknown
- 2021-05-07 WO PCT/EP2021/062144 patent/WO2022111858A1/en not_active Ceased
- 2021-05-07 SI SI202130112T patent/SI4025187T1/sl unknown
- 2021-05-07 EP EP23219073.6A patent/EP4385564A3/en active Pending
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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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