JP7792959B2 - 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

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Publication number
JP7792959B2
JP7792959B2 JP2023532489A JP2023532489A JP7792959B2 JP 7792959 B2 JP7792959 B2 JP 7792959B2 JP 2023532489 A JP2023532489 A JP 2023532489A JP 2023532489 A JP2023532489 A JP 2023532489A JP 7792959 B2 JP7792959 B2 JP 7792959B2
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Prior art keywords
suspension
dose
paliperidone palmitate
paliperidone
pp6m
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JP2023532489A
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English (en)
Japanese (ja)
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JP2023552329A (ja
JP2023552329A5 (https=
Inventor
ゴパル，スリハリ
ヴェンカタスブラマニアン，ラジャ
ティ’ジョリン，ユイブレシュト
Original Assignee
ヤンセン ファーマシューティカ エヌ．ベー．
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Application filed by ヤンセン ファーマシューティカ エヌ．ベー． filed Critical ヤンセン ファーマシューティカ エヌ．ベー．
Publication of JP2023552329A publication Critical patent/JP2023552329A/ja
Publication of JP2023552329A5 publication Critical patent/JP2023552329A5/ja
Priority to JP2025173295A priority Critical patent/JP2026027255A/ja
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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
    • 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)
JP2023532489A 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 Active JP7792959B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025173295A JP2026027255A (ja) 2020-11-30 2025-10-15 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

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063119405P 2020-11-30 2020-11-30
US63/119,405 2020-11-30
PCT/EP2021/062147 WO2022111859A1 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025173295A Division JP2026027255A (ja) 2020-11-30 2025-10-15 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

Publications (3)

Publication Number Publication Date
JP2023552329A JP2023552329A (ja) 2023-12-15
JP2023552329A5 JP2023552329A5 (https=) 2024-05-17
JP7792959B2 true JP7792959B2 (ja) 2025-12-26

Family

ID=75888043

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2023532489A Active JP7792959B2 (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
JP2025173295A Pending JP2026027255A (ja) 2020-11-30 2025-10-15 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

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025173295A Pending JP2026027255A (ja) 2020-11-30 2025-10-15 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 (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)

* Cited by examiner, † Cited by third party
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.

Citations (3)

* 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
JP2018520382A (ja) 2015-06-19 2018-07-26 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

Family Cites Families (11)

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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
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
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

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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
JP2018520382A (ja) 2015-06-19 2018-07-26 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

Non-Patent Citations (1)

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Health and Quality of Life Outcomes，2012年，Vol.10, No.35，pp.1-9

Also Published As

Publication number Publication date
SMT202400077T1 (it) 2024-03-13
WO2022111859A1 (en) 2022-06-02
AU2021386450A1 (en) 2023-07-13
SI4025188T1 (sl) 2024-03-29
AU2024204213B2 (en) 2026-02-26
US11304951B1 (en) 2022-04-19
US20260060986A1 (en) 2026-03-05
EP4025188A1 (en) 2022-07-13
JP2026027255A (ja) 2026-02-18
JP2023552329A (ja) 2023-12-15
KR20250053980A (ko) 2025-04-22
US20220249495A1 (en) 2022-08-11
TWI877363B (zh) 2025-03-21
KR102794804B1 (ko) 2025-04-10
MX2024009188A (es) 2024-08-06
PT4025188T (pt) 2024-02-29
AU2024204213A1 (en) 2024-07-11
HUE065573T2 (hu) 2024-06-28
RS65178B1 (sr) 2024-03-29
CA3203566A1 (en) 2022-06-02
LT4025188T (lt) 2024-03-12
TW202222319A (zh) 2022-06-16
AU2021386450B2 (en) 2024-03-21
EP4356966A3 (en) 2024-07-17
DK4025188T3 (da) 2024-03-04
HRP20240074T1 (hr) 2024-03-29
ES2973583T3 (es) 2024-06-20
CN116583270A (zh) 2023-08-11
IL303253A (en) 2023-07-01
PL4025188T3 (pl) 2024-06-17
EP4356966A2 (en) 2024-04-24
TW202539685A (zh) 2025-10-16
FI4025188T3 (fi) 2024-02-21
AU2021386450A9 (en) 2025-03-13
EP4025188B1 (en) 2024-01-10
MX2023006366A (es) 2023-08-07
KR20230116013A (ko) 2023-08-03

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