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 PDF

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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
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Japan
Prior art keywords
pp6m
dose
paliperidone palmitate
pp3m
paliperidone
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JP2023532513A
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Japanese (ja)
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JP2023551009A5 (enExample
Inventor
ミルツ，ルース
ウィーガンド，フランク
サンガ，パンナ
ルーイ，ジョン
Original Assignee
ヤンセン ファーマシューティカ エヌ．ベー．
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Publication of JP2023551009A publication Critical patent/JP2023551009A/ja
Publication of JP2023551009A5 publication Critical patent/JP2023551009A5/ja
Pending legal-status Critical Current

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    • 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

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  • 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)
JP2023532513A 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 Pending JP2023551009A (ja)

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 (enExample) 2024-05-17

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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 (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)

* Cited by examiner, † Cited by third party
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.

Citations (2)

* Cited by examiner, † Cited by third party
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)

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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
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
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.

Patent Citations (2)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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 *

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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
HRP20240800T1 (hr) 2024-09-27
MX2023006368A (es) 2023-08-07
DK4025189T3 (da) 2024-06-10
ES2981035T3 (es) 2024-10-07
HUE067072T2 (hu) 2024-09-28
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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