AU2021386450B2 - Dosing regimens associated with extended release paliperidone injectable formulations - Google Patents

Dosing regimens associated with extended release paliperidone injectable formulations Download PDF

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Publication number
AU2021386450B2
AU2021386450B2 AU2021386450A AU2021386450A AU2021386450B2 AU 2021386450 B2 AU2021386450 B2 AU 2021386450B2 AU 2021386450 A AU2021386450 A AU 2021386450A AU 2021386450 A AU2021386450 A AU 2021386450A AU 2021386450 B2 AU2021386450 B2 AU 2021386450B2
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AU
Australia
Prior art keywords
suspension
dose
paliperidone palmitate
initiation
patient
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AU2021386450A
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English (en)
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AU2021386450A1 (en
AU2021386450A9 (en
Inventor
Srihari Gopal
Huybrecht T'jollyn
Raja Venkatasubramanian
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Publication of AU2021386450A1 publication Critical patent/AU2021386450A1/en
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Priority to AU2024204213A priority Critical patent/AU2024204213B2/en
Publication of AU2021386450A9 publication Critical patent/AU2021386450A9/en
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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
    • 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
    • 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

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  • 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)
AU2021386450A 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations Active AU2021386450B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024204213A AU2024204213B2 (en) 2020-11-30 2024-06-20 Dosing regimens associated with extended release paliperidone injectable formulations

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
AU2024204213A Division AU2024204213B2 (en) 2020-11-30 2024-06-20 Dosing regimens associated with extended release paliperidone injectable formulations

Publications (3)

Publication Number Publication Date
AU2021386450A1 AU2021386450A1 (en) 2023-07-13
AU2021386450B2 true AU2021386450B2 (en) 2024-03-21
AU2021386450A9 AU2021386450A9 (en) 2025-03-13

Family

ID=75888043

Family Applications (2)

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AU2021386450A Active AU2021386450B2 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations
AU2024204213A Active AU2024204213B2 (en) 2020-11-30 2024-06-20 Dosing regimens associated with extended release paliperidone injectable formulations

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024204213A Active AU2024204213B2 (en) 2020-11-30 2024-06-20 Dosing regimens associated with extended release paliperidone injectable formulations

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
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
US20170281629A1 (en) * 2015-04-07 2017-10-05 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US20190183896A1 (en) * 2017-12-14 2019-06-20 SpecGx LLC One step milling process for preparing micronized paliperidone esters

Family Cites Families (11)

* 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
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
BR112012010195A2 (pt) 2009-10-30 2016-04-26 Janssen Pharmaceutica Nv regime de dosagem associado a ésteres de paliperidona injetável de longa ação
ES2456917T3 (es) 2011-05-31 2014-04-24 Laboratorios Farmacéuticos Rovi, S.A. Formulación de implante de paliperidona
HK1254640A1 (zh) * 2015-06-19 2019-07-26 Janssen Pharmaceutica, N.V. 用於药物施用和混合的设备和方法及用於所述设备和方法的适当技术的训练
KR102794804B1 (ko) * 2020-11-30 2025-04-10 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
US20170281629A1 (en) * 2015-04-07 2017-10-05 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US10143693B2 (en) * 2015-04-07 2018-12-04 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US20190183896A1 (en) * 2017-12-14 2019-06-20 SpecGx LLC One step milling process for preparing micronized paliperidone esters

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "lnvega Sustenna Reference ID: 3657038", LNVEGA, 1 November 2014 (2014-11-01), pages 1 - 56, XP055780705, Retrieved from the Internet [retrieved on 20210301] *

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
JP7792959B2 (ja) 2025-12-26
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
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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