PT4025187T - Regimes de administração associados a formulações injetáveis de paliperidona de libertação prolongada - Google Patents

Regimes de administração associados a formulações injetáveis de paliperidona de libertação prolongada

Info

Publication number
PT4025187T
PT4025187T PT217246511T PT21724651T PT4025187T PT 4025187 T PT4025187 T PT 4025187T PT 217246511 T PT217246511 T PT 217246511T PT 21724651 T PT21724651 T PT 21724651T PT 4025187 T PT4025187 T PT 4025187T
Authority
PT
Portugal
Prior art keywords
extended release
dosing regimens
injectable formulations
regimens associated
release paliperidone
Prior art date
Application number
PT217246511T
Other languages
English (en)
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
Publication of PT4025187T publication Critical patent/PT4025187T/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (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)
PT217246511T 2020-11-30 2021-05-07 Regimes de administração associados a formulações injetáveis de paliperidona de libertação prolongada PT4025187T (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202063119382P 2020-11-30 2020-11-30

Publications (1)

Publication Number Publication Date
PT4025187T true PT4025187T (pt) 2024-02-28

Family

ID=75888042

Family Applications (1)

Application Number Title Priority Date Filing Date
PT217246511T PT4025187T (pt) 2020-11-30 2021-05-07 Regimes de administração associados a formulações injetáveis de paliperidona de libertação prolongada

Country Status (19)

Country Link
US (2) US11324751B1 (pt)
EP (2) EP4385564A2 (pt)
JP (1) JP2023552149A (pt)
KR (1) KR20230116837A (pt)
CN (1) CN116507320A (pt)
AU (2) AU2021387679B2 (pt)
CA (1) CA3203448A1 (pt)
DK (1) DK4025187T3 (pt)
FI (1) FI4025187T3 (pt)
HR (1) HRP20240086T1 (pt)
HU (1) HUE065387T2 (pt)
IL (1) IL303251A (pt)
LT (1) LT4025187T (pt)
MX (1) MX2023006370A (pt)
PL (1) PL4025187T3 (pt)
PT (1) PT4025187T (pt)
RS (1) RS65133B1 (pt)
SI (1) SI4025187T1 (pt)
WO (1) WO2022111858A1 (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022112367A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Methods for ensuring resuspension of paliperidone palmitate formulations
IL311134A (en) * 2021-08-30 2024-04-01 Janssen Pharmaceutica Nv Dosing regimens associated with delayed-release paliperidone injection formulations

Family Cites Families (12)

* Cited by examiner, † Cited by third party
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
US20080214808A1 (en) 2005-04-25 2008-09-04 Thomas Frederik Ernestine Spittaels Preparation of Aseptic 3-[2-[4-((6-Fluoro-1,2-Benzisoxazol-3-Yl)-1-Piperidinyl]-6,7,8,9-Tetrahydro-9-Hydroxy-2-Methyl-4H-Pyrido[1,2-a]Pyrimidin-4-One Palmitate Ester
ES2868353T3 (es) 2007-12-19 2021-10-21 Janssen Pharmaceutica Nv Régimen de dosificación asociado a ésteres de paliperidona inyectables de larga acción
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
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
ES2802299T3 (es) * 2015-04-07 2021-01-18 Janssen Pharmaceuticals Inc Régimen de dosificación para dosis olvidadas para ésteres de paliperidona inyectables de acción prolongada
BR112020011614A2 (pt) * 2017-12-14 2020-12-08 SpecGx LLC Processo de moagem de uma etapa para preparar ésteres de paliperidona micronizada

Also Published As

Publication number Publication date
IL303251A (en) 2023-07-01
EP4025187A1 (en) 2022-07-13
LT4025187T (lt) 2024-02-12
EP4385564A2 (en) 2024-06-19
AU2021387679B2 (en) 2024-01-18
CA3203448A1 (en) 2022-06-02
TW202222318A (zh) 2022-06-16
FI4025187T3 (fi) 2024-02-13
US20230105276A1 (en) 2023-04-06
HRP20240086T1 (hr) 2024-03-29
WO2022111858A1 (en) 2022-06-02
CN116507320A (zh) 2023-07-28
AU2021387679A1 (en) 2023-07-20
RS65133B1 (sr) 2024-02-29
MX2023006370A (es) 2023-08-07
HUE065387T2 (hu) 2024-05-28
US20220168306A1 (en) 2022-06-02
SI4025187T1 (sl) 2024-03-29
AU2024202306A1 (en) 2024-05-02
PL4025187T3 (pl) 2024-04-29
KR20230116837A (ko) 2023-08-04
DK4025187T3 (da) 2024-03-04
JP2023552149A (ja) 2023-12-14
US11324751B1 (en) 2022-05-10
EP4025187B1 (en) 2024-01-03

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