ES2981035T3 - Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada - Google Patents

Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada Download PDF

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Publication number
ES2981035T3
ES2981035T3 ES21725105T ES21725105T ES2981035T3 ES 2981035 T3 ES2981035 T3 ES 2981035T3 ES 21725105 T ES21725105 T ES 21725105T ES 21725105 T ES21725105 T ES 21725105T ES 2981035 T3 ES2981035 T3 ES 2981035T3
Authority
ES
Spain
Prior art keywords
pp6m
paliperidone palmitate
pp3m
approximately
pp1m
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES21725105T
Other languages
English (en)
Spanish (es)
Inventor
Ruth Milz
Frank Wiegand
Panna Sanga
John Louie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Pharmaceutica NV
Original Assignee
Janssen Pharmaceutica NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Application granted granted Critical
Publication of ES2981035T3 publication Critical patent/ES2981035T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
  • 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)
ES21725105T 2020-11-30 2021-05-07 Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada Active ES2981035T3 (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
ES2981035T3 true ES2981035T3 (es) 2024-10-07

Family

ID=75904921

Family Applications (1)

Application Number Title Priority Date Filing Date
ES21725105T Active ES2981035T3 (es) 2020-11-30 2021-05-07 Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada

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.

Family Cites Families (17)

* Cited by examiner, † Cited by third party
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
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
KR20120116401A (ko) 2009-10-30 2012-10-22 얀센 파마슈티카 엔.브이. 장기-작용성의 주사가능한 팔리페리돈 에스테르와 관련된 투약 요법
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
FI3744326T3 (fi) 2015-04-07 2024-02-02 Janssen Pharmaceutica Nv Annosteluohjelma pitkävaikutteisten injektoitavien paliperidoniestereiden ottamatta jääneille annoksille
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.

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
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
JP2023551009A (ja) 2023-12-06
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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