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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JP
Japan
Prior art keywords
pp6m
dose
paliperidone palmitate
pp3m
paliperidone
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Pending
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JP2023532513A
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English (en)
Japanese (ja)
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JP2023551009A5 (OSRAM
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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Hematology (AREA)
  • Diabetes (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 (OSRAM) 2024-05-17

Family

ID=75904921

Family Applications (1)

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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 (OSRAM)
EP (1) EP4025189B1 (OSRAM)
JP (1) JP2023551009A (OSRAM)
KR (1) KR20230116836A (OSRAM)
CN (1) CN116528836A (OSRAM)
AU (1) AU2021389587A1 (OSRAM)
CA (1) CA3203015A1 (OSRAM)
DK (1) DK4025189T3 (OSRAM)
ES (1) ES2981035T3 (OSRAM)
FI (1) FI4025189T3 (OSRAM)
HR (1) HRP20240800T1 (OSRAM)
HU (1) HUE067072T2 (OSRAM)
IL (1) IL303252A (OSRAM)
LT (1) LT4025189T (OSRAM)
MX (1) MX2023006368A (OSRAM)
PL (1) PL4025189T3 (OSRAM)
RS (1) RS65815B1 (OSRAM)
TW (1) TW202222317A (OSRAM)
WO (1) WO2022111860A1 (OSRAM)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
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.

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

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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
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
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
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
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
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.

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 *

Also Published As

Publication number Publication date
US12053474B2 (en) 2024-08-06
RS65815B1 (sr) 2024-08-30
KR20230116836A (ko) 2023-08-04
WO2022111860A1 (en) 2022-06-02
ES2981035T3 (es) 2024-10-07
MX2023006368A (es) 2023-08-07
IL303252A (en) 2023-07-01
CN116528836A (zh) 2023-08-01
AU2021389587A1 (en) 2023-07-13
AU2021389587A9 (en) 2024-09-26
PL4025189T3 (pl) 2024-09-23
DK4025189T3 (da) 2024-06-10
EP4025189A1 (en) 2022-07-13
HRP20240800T1 (hr) 2024-09-27
TW202222317A (zh) 2022-06-16
EP4025189B1 (en) 2024-06-05
FI4025189T3 (fi) 2024-07-02
LT4025189T (lt) 2024-07-10
HUE067072T2 (hu) 2024-09-28
US20220168305A1 (en) 2022-06-02
US11439647B2 (en) 2022-09-13
US20230010558A1 (en) 2023-01-12
CA3203015A1 (en) 2022-06-02

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