WO2011053829A1 - Dosing regimen associated with long-acting injectable paliperidone esters - Google Patents

Dosing regimen associated with long-acting injectable paliperidone esters Download PDF

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Publication number
WO2011053829A1
WO2011053829A1 PCT/US2010/054807 US2010054807W WO2011053829A1 WO 2011053829 A1 WO2011053829 A1 WO 2011053829A1 US 2010054807 W US2010054807 W US 2010054807W WO 2011053829 A1 WO2011053829 A1 WO 2011053829A1
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WO
WIPO (PCT)
Prior art keywords
dose
paliperidone palmitate
paliperidone
patient
day
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.)
Ceased
Application number
PCT/US2010/054807
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English (en)
French (fr)
Inventor
Peter H. Lewyn-Briscoe
Cristiana Gassmann-Mayer
Srihari Gopal
David W. Hough
Bart M. M. Remmerie
Mahesh N. Samtani
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
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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.)
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Publication date
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Priority to JP2012537131A priority Critical patent/JP2013509435A/ja
Priority to EP10773821A priority patent/EP2493473A1/en
Priority to AU2010313290A priority patent/AU2010313290A1/en
Priority to CA2742393A priority patent/CA2742393A1/en
Priority to CN2010800504164A priority patent/CN102802631A/zh
Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Priority to MX2012005083A priority patent/MX2012005083A/es
Priority to BR112012010195A priority patent/BR112012010195A2/pt
Priority to NZ599558A priority patent/NZ599558A/en
Publication of WO2011053829A1 publication Critical patent/WO2011053829A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K9/08—Solutions
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

Definitions

  • Paliperidone palmitate injection has been developed to provide sustained plasma concentrations of paliperidone when administered once monthly, which may greatly enhance compliance with dosing.
  • Paliperidone palmitate formulated as an aqueous nanosuspension is described in U.S. Patent Numbers. 6,577,545 and 6,555,544.
  • a dosing regimen of paliperidone palmitate for treating patients is disclosed in US Patent Application Publication No. 20090163519.
  • paliperidone palmitate provides benefits of sustained dose release in plasma without significant concentration variation, regular monitor, reduced side effects and increased treatment efficacy.
  • the administration of paliperidone palmitate may improve effectiveness of psychotic treatment.
  • a dosing regimen for administering paliperidone palmitate to a patient in need of psychiatric treatment, wherein said patient misses a stabilized monthly maintenance dose for more than about 4 weeks and less than about 6 weeks, comprising administering intramuscularly in the deltoid a first reinitiation loading dose of paliperidone as a paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; and administering intramuscularly in the gluteal a reinitiation maintenance dose of paliperidone as a paliperidone ester in a sustained release formulation on the 23 rd day to about the 37 th day or between about 30 ⁇ 7 day after said first day of treatment.
  • the maintenance dose may be administered intramuscularly into the deltoid or gluteal muscle, and the gluteal muscle is preferred.
  • the maintenance dose may be titrated up or down in view of the patients' conditions such as response to the medication and renal function.
  • the terms "the first loading dose of the reinitiation regimen”, “the first dose of the reinitiation regimen”, “the first reinitiation dose” or variant thereof refer to the dose to be administered on day 1 when patients return to treatment.
  • the terms “the second loading dose of the reinitiation regimen”, “the second dose of the reinitiation regimen”, “the second reinitiation dose” or variant thereof refer to the dose to be administered after a week after the treatment day 1 ; and the terms “the maintenance dose of the reinitiation regimen”, “the reinitiation maintenance dose” or variant thereof refer to the dose to be administered monthly after the treatment day 1.
  • PluronicTM F108 corresponds to poloxamer 338 and is the polyoxyethylene, polyoxypropylene block copolymer that conforms generally to the formula
  • the antipsychotic agent and, optionally, the surface modifier can be dispersed in the liquid medium using suitable agitation such as, for example, a roller mill or a Cowles type mixer, until a homogeneous dispersion is achieved.
  • Thiothixene Hydrochloride Tioperidone Hydrochloride; Tiospirone Hydrochloride; Trifluoperazine Hydrochloride; Trifluperidol; Triflupromazine; Triflupromazine Hydrochloride; and Ziprasidone Hydrochloride.
  • the simulations also showed that patients who missed their week 4 maintenance dose and returned to re-initiation at week 7 or 8 (i.e., time lapse since last injection is more than about 6 weeks and less than about 6 months) may be administered with two re-initiation doses at the previously stabilized dose followed by monthly injections.
  • the two doses at day 1/day 8 allow re-attainment of steady-state plasma concentration quickly (Figure 3).
  • the two reinitiation doses were injected into the deltoid muscle with a 1.0 inch 23-G needle for the patients weighting less than about 90 kg or a 1.5 inch 22-G for those weighting equal or more than about 90 kg.

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/US2010/054807 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters Ceased WO2011053829A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
NZ599558A NZ599558A (en) 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters
EP10773821A EP2493473A1 (en) 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters
AU2010313290A AU2010313290A1 (en) 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters
CA2742393A CA2742393A1 (en) 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters
CN2010800504164A CN102802631A (zh) 2009-10-30 2010-10-29 与长效注射用帕潘立酮酯相关的给药方案
JP2012537131A JP2013509435A (ja) 2009-10-30 2010-10-29 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
MX2012005083A MX2012005083A (es) 2009-10-30 2010-10-29 Regimen de dosificacion asociado con esteres de paliperidona inyetables de accion prolongada.
BR112012010195A BR112012010195A2 (pt) 2009-10-30 2010-10-29 regime de dosagem associado a ésteres de paliperidona injetável de longa ação

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25669609P 2009-10-30 2009-10-30
US61/256,696 2009-10-30

Publications (1)

Publication Number Publication Date
WO2011053829A1 true WO2011053829A1 (en) 2011-05-05

Family

ID=43302985

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/054807 Ceased WO2011053829A1 (en) 2009-10-30 2010-10-29 Dosing regimen associated with long-acting injectable paliperidone esters

Country Status (12)

Country Link
US (2) US20110105536A1 (enExample)
EP (1) EP2493473A1 (enExample)
JP (2) JP2013509435A (enExample)
KR (1) KR20120116401A (enExample)
CN (1) CN102802631A (enExample)
AU (2) AU2010313290A1 (enExample)
BR (1) BR112012010195A2 (enExample)
CA (1) CA2742393A1 (enExample)
CL (1) CL2012001110A1 (enExample)
MX (1) MX2012005083A (enExample)
NZ (1) NZ599558A (enExample)
WO (1) WO2011053829A1 (enExample)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102993200A (zh) * 2011-09-10 2013-03-27 鲁翠涛 帕潘立酮氨基酸酯及其制备方法
US9439906B2 (en) 2007-12-19 2016-09-13 Janssen Pharmaceutica Nv Dosing regimen associated with long acting injectable paliperidone esters
EP3280416B1 (en) 2015-04-07 2020-04-22 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US11304951B1 (en) 2020-11-30 2022-04-19 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US11324751B1 (en) 2020-11-30 2022-05-10 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US11439647B2 (en) 2020-11-30 2022-09-13 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US20240325293A1 (en) * 2021-03-17 2024-10-03 Medincell S.A. Long Acting Injectable Formulation Comprising Risperidone And Biodegradable Polymers
RU2830456C1 (ru) * 2019-09-25 2024-11-19 Янссен Фармасьютиклз, Инк. Соединение систем для введения лекарственных средств
US12431230B2 (en) 2019-09-25 2025-09-30 Janssen Pharmaceuticals, Inc. Interconnection of drug administration systems
US12472184B2 (en) 2021-08-20 2025-11-18 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Families Citing this family (11)

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Publication number Priority date Publication date Assignee Title
UA72189C2 (uk) 1997-11-17 2005-02-15 Янссен Фармацевтика Н.В. Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот
WO2011114213A1 (en) 2010-03-15 2011-09-22 Inventia Healthcare Private Limited Stabilized prolonged release pharmaceutical composition comprising atypical antipsychotic
EP3156056B1 (en) 2011-03-18 2023-12-06 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising sorbitan esters
CA2867121C (en) 2012-03-19 2021-05-25 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising fatty acid esters
AU2013235523B9 (en) 2012-03-19 2018-01-04 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising glycerol esters
AU2013235526B2 (en) * 2012-03-19 2017-11-30 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising benzyl alcohol
ES2792149T3 (es) 2012-09-19 2020-11-10 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que tienen estabilidad de almacenamiento mejorada
AU2015231278B2 (en) 2014-03-20 2020-01-23 Alkermes Pharma Ireland Limited Aripiprazole formulations having increased injection speeds
ITUB20155193A1 (it) * 2015-11-03 2017-05-03 Italfarmaco Spa Sospensioni orali di Givinostat fisicamente e chimicamente stabili
CA3092335A1 (en) 2018-03-05 2019-09-12 Alkermes Pharma Ireland Limited Aripiprazole dosing strategy
US20220062557A1 (en) * 2020-09-02 2022-03-03 Janssen Pharmaceutica Nv Pre-filled syringe with optimized stopper placement

Citations (7)

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US5254556A (en) 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
US6077843A (en) 1996-05-20 2000-06-20 Janssen Pharmaceutica, N.V. Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
US6555544B2 (en) 1997-11-17 2003-04-29 Janssen Pharmaceutica, N.V. Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
US6577545B2 (en) 2000-07-11 2003-06-10 Samsung Electronics Co., Ltd. Integrated circuit memory devices having efficient multi-row address test capability and methods of operating same
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
US20070197591A1 (en) * 2005-12-12 2007-08-23 Sandra Boom Use of paliperidone for the treatment of a mental disorder in a psychiatric patient with reduced hepatic function
US20090163519A1 (en) 2007-12-19 2009-06-25 An Vermeulen Dosing regimen associated with long acting injectable paliperidone esters

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US5254556A (en) 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
US6077843A (en) 1996-05-20 2000-06-20 Janssen Pharmaceutica, N.V. Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
US6555544B2 (en) 1997-11-17 2003-04-29 Janssen Pharmaceutica, N.V. Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
US6577545B2 (en) 2000-07-11 2003-06-10 Samsung Electronics Co., Ltd. Integrated circuit memory devices having efficient multi-row address test capability and methods of operating same
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
US20070197591A1 (en) * 2005-12-12 2007-08-23 Sandra Boom Use of paliperidone for the treatment of a mental disorder in a psychiatric patient with reduced hepatic function
US20090163519A1 (en) 2007-12-19 2009-06-25 An Vermeulen Dosing regimen associated with long acting injectable paliperidone esters
WO2009080651A1 (en) * 2007-12-19 2009-07-02 Janssen Pharmaceutica Nv Dosing regimen associated with long acting injectable paliperidone esters

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Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9439906B2 (en) 2007-12-19 2016-09-13 Janssen Pharmaceutica Nv Dosing regimen associated with long acting injectable paliperidone esters
CN102993200B (zh) * 2011-09-10 2016-02-03 鲁翠涛 帕潘立酮氨基酸酯及其制备方法
CN102993200A (zh) * 2011-09-10 2013-03-27 鲁翠涛 帕潘立酮氨基酸酯及其制备方法
EP3744326B1 (en) 2015-04-07 2023-12-06 Janssen Pharmaceutica NV Dosing regimen for missed doses for long-acting injectable paliperidone esters
EP3280416B1 (en) 2015-04-07 2020-04-22 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US12431230B2 (en) 2019-09-25 2025-09-30 Janssen Pharmaceuticals, Inc. Interconnection of drug administration systems
RU2830456C1 (ru) * 2019-09-25 2024-11-19 Янссен Фармасьютиклз, Инк. Соединение систем для введения лекарственных средств
US11439647B2 (en) 2020-11-30 2022-09-13 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US12053474B2 (en) 2020-11-30 2024-08-06 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US11324751B1 (en) 2020-11-30 2022-05-10 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US12208100B2 (en) 2020-11-30 2025-01-28 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US11304951B1 (en) 2020-11-30 2022-04-19 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
US20240325293A1 (en) * 2021-03-17 2024-10-03 Medincell S.A. Long Acting Injectable Formulation Comprising Risperidone And Biodegradable Polymers
US12329851B2 (en) * 2021-03-17 2025-06-17 Medincell S.A. Long acting injectable formulation comprising risperidone and biodegradable polymers
US12472184B2 (en) 2021-08-20 2025-11-18 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Also Published As

Publication number Publication date
JP2016102123A (ja) 2016-06-02
EP2493473A1 (en) 2012-09-05
AU2010313290A1 (en) 2012-05-17
CN102802631A (zh) 2012-11-28
MX2012005083A (es) 2012-09-28
NZ599558A (en) 2014-09-26
JP2013509435A (ja) 2013-03-14
US20130331402A1 (en) 2013-12-12
CL2012001110A1 (es) 2012-10-19
KR20120116401A (ko) 2012-10-22
US20110105536A1 (en) 2011-05-05
CA2742393A1 (en) 2011-05-05
AU2015243103A1 (en) 2015-11-05
BR112012010195A2 (pt) 2016-04-26

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