HRP20240800T1 - 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
- HRP20240800T1 HRP20240800T1 HRP20240800TT HRP20240800T HRP20240800T1 HR P20240800 T1 HRP20240800 T1 HR P20240800T1 HR P20240800T T HRP20240800T T HR P20240800TT HR P20240800 T HRP20240800 T HR P20240800T HR P20240800 T1 HRP20240800 T1 HR P20240800T1
- Authority
- HR
- Croatia
- Prior art keywords
- pp6m
- paliperidone palmitate
- use according
- pp3m
- pp1m
- Prior art date
Links
- 238000013265 extended release Methods 0.000 title claims 4
- 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 1
- 239000007972 injectable composition Substances 0.000 title 1
- 229960001057 paliperidone Drugs 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 40
- 229960000635 paliperidone palmitate Drugs 0.000 claims 26
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
- 239000006172 buffering agent Substances 0.000 claims 4
- 239000000375 suspending agent Substances 0.000 claims 3
- 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 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- 230000037396 body weight Effects 0.000 claims 2
- 229960002303 citric acid monohydrate Drugs 0.000 claims 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 2
- 239000003906 humectant Substances 0.000 claims 2
- 229940102213 injectable suspension Drugs 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000000087 stabilizing effect Effects 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
Classifications
-
- 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
- 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
- A61K47/06—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
-
- 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)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (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)
- Diabetes (AREA)
- Hematology (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 | |
| PCT/EP2021/062198 WO2022111860A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
| EP21725105.7A EP4025189B1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240800T1 true HRP20240800T1 (hr) | 2024-09-27 |
Family
ID=75904921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240800TT HRP20240800T1 (hr) | 2020-11-30 | 2021-05-07 | Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US11439647B2 (enExample) |
| EP (1) | EP4025189B1 (enExample) |
| JP (1) | JP2023551009A (enExample) |
| KR (1) | KR20230116836A (enExample) |
| CN (1) | CN116528836A (enExample) |
| AU (1) | AU2021389587A1 (enExample) |
| CA (1) | CA3203015A1 (enExample) |
| DK (1) | DK4025189T3 (enExample) |
| ES (1) | ES2981035T3 (enExample) |
| FI (1) | FI4025189T3 (enExample) |
| HR (1) | HRP20240800T1 (enExample) |
| HU (1) | HUE067072T2 (enExample) |
| IL (1) | IL303252A (enExample) |
| LT (1) | LT4025189T (enExample) |
| MX (1) | MX2023006368A (enExample) |
| PL (1) | PL4025189T3 (enExample) |
| RS (1) | RS65815B1 (enExample) |
| TW (1) | TW202222317A (enExample) |
| WO (1) | WO2022111860A1 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL4005555T3 (pl) | 2020-11-30 | 2024-09-02 | Janssen Pharmaceutica Nv | Sposoby zapewniania ponownego zawieszenia preparatów palmitynianu paliperydonu |
| SI4025187T1 (sl) | 2020-11-30 | 2024-03-29 | Janssen Pharmaceutica Nv | Režimi odmerjanja, povezani s formulacijami paliperidona za injiciranje s podaljšanim sproščanjem |
| CN116528836A (zh) | 2020-11-30 | 2023-08-01 | 詹森药业有限公司 | 与延长释放帕潘立酮可注射制剂相关的给药方案 |
| 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 (17)
| 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 |
| CN101163702B (zh) | 2005-04-25 | 2011-09-07 | 詹森药业有限公司 | 制备无菌的3-[2-[4-(6-氟-1,2-苯并异唑-3-基)-1-哌啶基]乙基]-6,7,8,9-四氢-9-羟基-2-甲基-4H-吡啶并[1,2-a]嘧啶-4-酮棕榈酸酯的方法 |
| CA2655335C (en) | 2007-12-19 | 2016-09-06 | Janssen Pharmaceutica N.V. | Prolonged-release injectable suspensions of paliperidone palmitate, and dosage forms and delivery systems incorporating same |
| US8758780B2 (en) | 2009-10-06 | 2014-06-24 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| AU2010313290A1 (en) * | 2009-10-30 | 2012-05-17 | Janssen Pharmaceutica Nv | Dosing regimen associated with long-acting injectable paliperidone esters |
| SI2529757T1 (sl) | 2011-05-31 | 2014-05-30 | Laboratorios Farmaceuticos Rovi, S.A. | Formulacija paliperidon implantata |
| WO2016157061A1 (en) | 2015-03-31 | 2016-10-06 | Wockhardt Limited | Aseptic wet milling process for paliperidone palmitate |
| DK3744326T3 (da) * | 2015-04-07 | 2024-02-05 | Janssen Pharmaceutica Nv | Doseringsregime for glemte doser til langtidsvirkende injicerbare paliperidonestere |
| US20190183896A1 (en) | 2017-12-14 | 2019-06-20 | SpecGx LLC | One step milling process for preparing micronized paliperidone esters |
| EP4025188B1 (en) | 2020-11-30 | 2024-01-10 | Janssen Pharmaceutica NV | Dosing regimens associated with extended release paliperidone injectable formulations |
| CN116528836A (zh) | 2020-11-30 | 2023-08-01 | 詹森药业有限公司 | 与延长释放帕潘立酮可注射制剂相关的给药方案 |
| SI4025187T1 (sl) | 2020-11-30 | 2024-03-29 | Janssen Pharmaceutica Nv | Režimi odmerjanja, povezani s formulacijami paliperidona za injiciranje s podaljšanim sproščanjem |
| PL4005555T3 (pl) | 2020-11-30 | 2024-09-02 | Janssen Pharmaceutica Nv | Sposoby zapewniania ponownego zawieszenia preparatów palmitynianu paliperydonu |
| 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 CN CN202180080431.1A patent/CN116528836A/zh active Pending
- 2021-05-07 DK DK21725105.7T patent/DK4025189T3/da active
- 2021-05-07 US US17/314,245 patent/US11439647B2/en active Active
- 2021-05-07 KR KR1020237021404A patent/KR20230116836A/ko active Pending
- 2021-05-07 RS RS20240853A patent/RS65815B1/sr unknown
- 2021-05-07 ES ES21725105T patent/ES2981035T3/es active Active
- 2021-05-07 IL IL303252A patent/IL303252A/en unknown
- 2021-05-07 TW TW110116511A patent/TW202222317A/zh unknown
- 2021-05-07 HU HUE21725105A patent/HUE067072T2/hu unknown
- 2021-05-07 CA CA3203015A patent/CA3203015A1/en active Pending
- 2021-05-07 HR HRP20240800TT patent/HRP20240800T1/hr unknown
- 2021-05-07 JP JP2023532513A patent/JP2023551009A/ja active Pending
- 2021-05-07 PL PL21725105.7T patent/PL4025189T3/pl unknown
- 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 LT LTEPPCT/EP2021/062198T patent/LT4025189T/lt unknown
- 2021-05-07 FI FIEP21725105.7T patent/FI4025189T3/fi active
- 2021-05-07 MX MX2023006368A patent/MX2023006368A/es unknown
-
2022
- 2022-09-09 US US17/941,464 patent/US12053474B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| EP4025189A1 (en) | 2022-07-13 |
| US20220168305A1 (en) | 2022-06-02 |
| CA3203015A1 (en) | 2022-06-02 |
| IL303252A (en) | 2023-07-01 |
| PL4025189T3 (pl) | 2024-09-23 |
| US12053474B2 (en) | 2024-08-06 |
| MX2023006368A (es) | 2023-08-07 |
| DK4025189T3 (da) | 2024-06-10 |
| ES2981035T3 (es) | 2024-10-07 |
| HUE067072T2 (hu) | 2024-09-28 |
| JP2023551009A (ja) | 2023-12-06 |
| AU2021389587A1 (en) | 2023-07-13 |
| WO2022111860A1 (en) | 2022-06-02 |
| FI4025189T3 (fi) | 2024-07-02 |
| EP4025189B1 (en) | 2024-06-05 |
| AU2021389587A9 (en) | 2024-09-26 |
| KR20230116836A (ko) | 2023-08-04 |
| US20230010558A1 (en) | 2023-01-12 |
| LT4025189T (lt) | 2024-07-10 |
| CN116528836A (zh) | 2023-08-01 |
| US11439647B2 (en) | 2022-09-13 |
| RS65815B1 (sr) | 2024-08-30 |
| TW202222317A (zh) | 2022-06-16 |
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