CA2874702C - Paliperidone implant formulation - Google Patents

Paliperidone implant formulation Download PDF

Info

Publication number
CA2874702C
CA2874702C CA2874702A CA2874702A CA2874702C CA 2874702 C CA2874702 C CA 2874702C CA 2874702 A CA2874702 A CA 2874702A CA 2874702 A CA2874702 A CA 2874702A CA 2874702 C CA2874702 C CA 2874702C
Authority
CA
Canada
Prior art keywords
polymer
paliperidone
drug
composition
molecular weight
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
CA2874702A
Other languages
English (en)
French (fr)
Other versions
CA2874702A1 (en
Inventor
Ibon Gutierro Aduriz
Guillermo Franco Rodriguez
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.)
Laboratorios Farmaceuticos Rovi SA
Original Assignee
Laboratorios Farmaceuticos Rovi SA
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47074463&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2874702(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Laboratorios Farmaceuticos Rovi SA filed Critical Laboratorios Farmaceuticos Rovi SA
Publication of CA2874702A1 publication Critical patent/CA2874702A1/en
Application granted granted Critical
Publication of CA2874702C publication Critical patent/CA2874702C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K47/30—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)
CA2874702A 2012-05-31 2013-05-31 Paliperidone implant formulation Active CA2874702C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12170366.4 2012-05-31
EP12170366.4A EP2529757B1 (en) 2011-05-31 2012-05-31 Paliperidone implant formulation
PCT/EP2013/061319 WO2013178811A1 (en) 2012-05-31 2013-05-31 Paliperidone implant formulation

Publications (2)

Publication Number Publication Date
CA2874702A1 CA2874702A1 (en) 2013-12-05
CA2874702C true CA2874702C (en) 2021-05-11

Family

ID=47074463

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2874702A Active CA2874702C (en) 2012-05-31 2013-05-31 Paliperidone implant formulation

Country Status (29)

Country Link
EP (1) EP2529757B1 (enExample)
JP (1) JP6430933B2 (enExample)
KR (1) KR101892496B1 (enExample)
CN (2) CN109966239A (enExample)
AU (1) AU2013269546B2 (enExample)
BR (1) BR112014029208B1 (enExample)
CA (1) CA2874702C (enExample)
CL (1) CL2014003215A1 (enExample)
CO (1) CO7160109A2 (enExample)
CY (1) CY1114975T1 (enExample)
DK (1) DK2529757T3 (enExample)
EA (1) EA029921B1 (enExample)
ES (1) ES2456917T3 (enExample)
HR (1) HRP20140158T1 (enExample)
IL (1) IL235850A0 (enExample)
IN (1) IN2014DN10673A (enExample)
MA (1) MA37661B1 (enExample)
MX (1) MX365097B (enExample)
MY (1) MY181549A (enExample)
NZ (1) NZ703319A (enExample)
PH (1) PH12014502668B1 (enExample)
PL (1) PL2529757T3 (enExample)
PT (1) PT2529757E (enExample)
SG (1) SG11201407971QA (enExample)
SI (1) SI2529757T1 (enExample)
SM (1) SMT201400044B (enExample)
UA (1) UA115987C2 (enExample)
WO (1) WO2013178811A1 (enExample)
ZA (1) ZA201409297B (enExample)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2529756B1 (en) * 2011-05-31 2021-05-19 Laboratorios Farmaceuticos Rovi, S.A. Risperidone and/or Paliperidone implant formulation
US10285936B2 (en) 2010-05-31 2019-05-14 Laboratorios Farmacéuticos Rovi, S.A. Injectable composition with aromatase inhibitor
US10335366B2 (en) 2010-05-31 2019-07-02 Laboratorios Farmacéuticos Rovi, S.A. Risperidone or paliperidone implant formulation
EP2394664B1 (en) 2010-05-31 2016-06-01 Laboratorios Farmaceuticos Rovi, S.A. Antipsychotic injectable depot composition
US10350159B2 (en) 2010-05-31 2019-07-16 Laboratories Farmacéuticos Rovi, S.A. Paliperidone implant formulation
US10881605B2 (en) 2010-05-31 2021-01-05 Laboratorios Farmaceuticos Rovi, S.A. Methods for the preparation of injectable depot compositions
SI2394663T1 (sl) 2010-05-31 2022-02-28 Laboratorios Farmaceuticos Rovi, S.A. Sestave za injicirane biološko razgradljive vsadke in situ
US10463607B2 (en) 2010-05-31 2019-11-05 Laboratorios Farmaceutics Rofi S.A. Antipsychotic Injectable Depot Composition
SI2529757T1 (sl) * 2011-05-31 2014-05-30 Laboratorios Farmaceuticos Rovi, S.A. Formulacija paliperidon implantata
DK3744326T3 (da) 2015-04-07 2024-02-05 Janssen Pharmaceutica Nv Doseringsregime for glemte doser til langtidsvirkende injicerbare paliperidonestere
CN106038569A (zh) * 2016-05-26 2016-10-26 湖南赛沃药业有限公司 一种帕利哌酮植入剂及其制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
AU2017319728B2 (en) * 2016-08-31 2024-09-05 Mapi Pharma Ltd Depot systems comprising glatiramer acetate
IL316573A (en) 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
EP3700531B1 (en) * 2017-10-27 2025-06-25 Geneora Pharma (Shijiazhuang) Co., Ltd. Dosage regimen of paliperidone palmitate extended-release injectable suspension
EP3803866A4 (en) 2018-05-24 2022-03-16 Nureva Inc. METHOD, APPARATUS, AND COMPUTER READABLE MATERIALS FOR MANAGING SEMI-CONSTANT (PERSISTENT) SOUND SOURCES IN MICROPHONE CATCH/HOME AREAS
CN111989068B (zh) 2018-05-24 2024-10-25 塞拉尼斯伊娃高性能聚合物公司 用于持续释放大分子药物化合物的可植入器件
CA3087238A1 (en) 2018-05-24 2019-11-28 Celanese EVA Performance Polymers Corporation Implantable device for sustained release of a macromolecular drug compound
PE20210047A1 (es) 2018-06-12 2021-01-08 Farm Rovi Lab Sa Composicion inyectable
SI4025187T1 (sl) 2020-11-30 2024-03-29 Janssen Pharmaceutica Nv Režimi odmerjanja, povezani s formulacijami paliperidona za injiciranje s podaljšanim sproščanjem
CN116528836A (zh) 2020-11-30 2023-08-01 詹森药业有限公司 与延长释放帕潘立酮可注射制剂相关的给药方案
EP4025188B1 (en) 2020-11-30 2024-01-10 Janssen Pharmaceutica NV Dosing regimens associated with extended release paliperidone injectable formulations
EP4329734A4 (en) 2021-04-26 2025-04-02 Celanese EVA Performance Polymers LLC Implantable device for the delayed release of a macromolecular drug compound
US12594236B2 (en) 2021-07-16 2026-04-07 Laboratorios Farmaceuticos Rovi, S.A. Method of treating acute exacerbation of schizophrenia with long-acting injectable depot composition
US12318387B2 (en) 2021-07-16 2025-06-03 Laboratorios Farmaceuticos Rovi, S.A. Method of treating acute exacerbation of schizophrenia with long-acting injectable depot composition
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
TW202313047A (zh) 2021-09-21 2023-04-01 西班牙商禾霏藥品實驗室有限公司 抗精神病可注射儲積型組合物
WO2023233051A1 (es) 2022-05-18 2023-12-07 Laboratorios Farmacéuticos Rovi, S.A. Composiciones inyectables de liberación prolongada para su uso en el tratamiento con risperidona junto a inhibidores de la enzima cyp2d6

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1660039B1 (en) * 2003-07-18 2016-09-28 Oakwood Laboratories L.L.C. Prevention of molecular weight reduction of the polymer, impurity formation and gelling in polymer compositions
JP2008509144A (ja) 2004-08-04 2008-03-27 アルザ・コーポレーシヨン 上昇するゼロ次放出パターンを示す持続薬剤放出組成物、そのような組成物を製造する方法
US8852638B2 (en) * 2005-09-30 2014-10-07 Durect Corporation Sustained release small molecule drug formulation
US8314110B2 (en) 2007-04-19 2012-11-20 Youxin Li Compounds for treating mental disorders, and preparation and uses thereof
EP2152315B1 (en) * 2007-05-25 2016-01-06 Indivior UK Limited Sustained delivery formulations of risperidone compounds
WO2009015828A1 (en) 2007-07-27 2009-02-05 Synthon B.V. Paliperidone derivatives
CA2655335C (en) 2007-12-19 2016-09-06 Janssen Pharmaceutica N.V. Prolonged-release injectable suspensions of paliperidone palmitate, and dosage forms and delivery systems incorporating same
US8758780B2 (en) 2009-10-06 2014-06-24 Ascendis Pharma As Subcutaneous paliperidone composition
EP2394664B1 (en) 2010-05-31 2016-06-01 Laboratorios Farmaceuticos Rovi, S.A. Antipsychotic injectable depot composition
EP2529756B1 (en) * 2011-05-31 2021-05-19 Laboratorios Farmaceuticos Rovi, S.A. Risperidone and/or Paliperidone implant formulation
SI2394663T1 (sl) * 2010-05-31 2022-02-28 Laboratorios Farmaceuticos Rovi, S.A. Sestave za injicirane biološko razgradljive vsadke in situ
SI2529757T1 (sl) * 2011-05-31 2014-05-30 Laboratorios Farmaceuticos Rovi, S.A. Formulacija paliperidon implantata

Also Published As

Publication number Publication date
SI2529757T1 (sl) 2014-05-30
SMT201400044B (it) 2014-05-07
JP6430933B2 (ja) 2018-11-28
NZ703319A (en) 2016-12-23
CA2874702A1 (en) 2013-12-05
CN104349792A (zh) 2015-02-11
KR20150015020A (ko) 2015-02-09
MX2014014484A (es) 2015-02-24
EA201401348A1 (ru) 2015-04-30
CN109966239A (zh) 2019-07-05
SG11201407971QA (en) 2014-12-30
MY181549A (en) 2020-12-28
WO2013178811A1 (en) 2013-12-05
PL2529757T3 (pl) 2014-04-30
CL2014003215A1 (es) 2015-07-10
EP2529757B1 (en) 2014-01-08
AU2013269546A1 (en) 2015-01-22
IN2014DN10673A (enExample) 2015-08-28
ES2456917T3 (es) 2014-04-24
BR112014029208A2 (pt) 2017-06-27
JP2015518035A (ja) 2015-06-25
DK2529757T3 (en) 2014-02-24
IL235850A0 (en) 2015-01-29
PH12014502668A1 (en) 2015-02-02
MA37661B1 (fr) 2016-12-30
CO7160109A2 (es) 2015-01-15
EA029921B1 (ru) 2018-05-31
CY1114975T1 (el) 2016-12-14
PT2529757E (pt) 2014-02-27
PH12014502668B1 (en) 2015-02-02
ZA201409297B (en) 2015-12-23
HRP20140158T1 (hr) 2014-04-25
MX365097B (es) 2019-05-22
KR101892496B1 (ko) 2018-10-04
UA115987C2 (uk) 2018-01-25
MA37661A1 (fr) 2016-03-31
EP2529757A1 (en) 2012-12-05
BR112014029208B1 (pt) 2020-04-07
AU2013269546B2 (en) 2017-12-14

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