AU2013269547B2 - Risperidone or paliperidone implant formulation - Google Patents

Risperidone or paliperidone implant formulation Download PDF

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Publication number
AU2013269547B2
AU2013269547B2 AU2013269547A AU2013269547A AU2013269547B2 AU 2013269547 B2 AU2013269547 B2 AU 2013269547B2 AU 2013269547 A AU2013269547 A AU 2013269547A AU 2013269547 A AU2013269547 A AU 2013269547A AU 2013269547 B2 AU2013269547 B2 AU 2013269547B2
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AU
Australia
Prior art keywords
polymer
risperidone
molecular weight
kda
dose
Prior art date
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Active
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AU2013269547A
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English (en)
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AU2013269547A1 (en
Inventor
Guillermo Franco Rodriguez
Ibon Gutierro Aduriz
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.)
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Application filed by Laboratorios Farmaceuticos Rovi SA filed Critical Laboratorios Farmaceuticos Rovi SA
Publication of AU2013269547A1 publication Critical patent/AU2013269547A1/en
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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
AU2013269547A 2012-05-31 2013-05-31 Risperidone or paliperidone implant formulation Active AU2013269547B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12170362.3A EP2529756B1 (en) 2011-05-31 2012-05-31 Risperidone and/or Paliperidone implant formulation
EP12170362.3 2012-05-31
PCT/EP2013/061320 WO2013178812A1 (en) 2012-05-31 2013-05-31 Risperidone or paliperidone implant formulation

Publications (2)

Publication Number Publication Date
AU2013269547A1 AU2013269547A1 (en) 2015-01-22
AU2013269547B2 true AU2013269547B2 (en) 2018-03-15

Family

ID=46147376

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013269547A Active AU2013269547B2 (en) 2012-05-31 2013-05-31 Risperidone or paliperidone implant formulation

Country Status (32)

Country Link
EP (2) EP2529756B1 (https=)
JP (1) JP6367795B2 (https=)
KR (1) KR101880716B1 (https=)
CN (1) CN104363923A (https=)
AU (1) AU2013269547B2 (https=)
BR (1) BR112014029209A2 (https=)
CA (1) CA2874765C (https=)
CL (1) CL2014003216A1 (https=)
CO (1) CO7160108A2 (https=)
CY (1) CY1124369T1 (https=)
DK (2) DK2529756T3 (https=)
EA (1) EA031819B1 (https=)
ES (1) ES2878112T3 (https=)
FI (1) FI2854858T3 (https=)
HR (2) HRP20260301T1 (https=)
IL (1) IL235849B (https=)
IN (1) IN2014DN10672A (https=)
LT (2) LT2529756T (https=)
MA (1) MA37664B1 (https=)
MX (1) MX374955B (https=)
MY (1) MY174999A (https=)
NZ (1) NZ703321A (https=)
PH (1) PH12014502667B1 (https=)
PL (2) PL2529756T3 (https=)
PT (2) PT2529756T (https=)
RS (1) RS62059B1 (https=)
SG (1) SG11201407961WA (https=)
SI (1) SI2529756T1 (https=)
SM (1) SMT202100448T1 (https=)
UA (1) UA119430C2 (https=)
WO (1) WO2013178812A1 (https=)
ZA (1) ZA201409299B (https=)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8852638B2 (en) 2005-09-30 2014-10-07 Durect Corporation Sustained release small molecule drug formulation
EP2152315B1 (en) 2007-05-25 2016-01-06 Indivior UK Limited Sustained delivery formulations of risperidone compounds
US10335366B2 (en) 2010-05-31 2019-07-02 Laboratorios Farmacéuticos Rovi, S.A. Risperidone or paliperidone implant formulation
US10285936B2 (en) 2010-05-31 2019-05-14 Laboratorios Farmacéuticos Rovi, S.A. Injectable composition with aromatase inhibitor
US10350159B2 (en) 2010-05-31 2019-07-16 Laboratories Farmacéuticos Rovi, S.A. Paliperidone implant formulation
EP2529757B1 (en) * 2011-05-31 2014-01-08 Laboratorios Farmaceuticos 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
US10463607B2 (en) 2010-05-31 2019-11-05 Laboratorios Farmaceutics Rofi S.A. Antipsychotic Injectable Depot Composition
LT2394664T (lt) 2010-05-31 2016-09-26 Laboratorios Farmaceuticos Rovi, S.A. Antipsichozinė injekcinė depozitinė kompozicija
PT2394663T (pt) 2010-05-31 2021-11-26 Farm Rovi Lab Sa Composições para implantes biodegradáveis injectáveis
LT2529756T (lt) * 2011-05-31 2021-07-26 Laboratorios Farmaceuticos Rovi, S.A. Risperidono ir (arba) paliperidono implantų kompozicija
HK1220628A1 (zh) 2013-03-11 2017-05-12 Durect Corporation 包含高粘度液体载体的可注射控制释放组合物
US20140308352A1 (en) 2013-03-11 2014-10-16 Zogenix Inc. Compositions and methods involving polymer, solvent, and high viscosity liquid carrier material
CN104922085B (zh) * 2015-06-01 2016-10-26 湖南赛沃药业有限公司 一种利培酮植入剂及其制备方法
CN109589304A (zh) * 2017-10-01 2019-04-09 万特制药(海南)有限公司 利培酮口服溶液及其制备方法
US11689849B2 (en) 2018-05-24 2023-06-27 Nureva, Inc. Method, apparatus and computer-readable media to manage semi-constant (persistent) sound sources in microphone pickup/focus zones
KR20260007295A (ko) 2018-05-24 2026-01-13 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치
US11690806B2 (en) 2018-05-24 2023-07-04 Celanese Eva Performance Polymers Llc Implantable device for sustained release of a macromolecular drug compound
PE20210047A1 (es) 2018-06-12 2021-01-08 Farm Rovi Lab Sa Composicion inyectable
BR112023022439A2 (pt) 2021-04-26 2023-12-26 Celanese Eva Performance Polymers Llc Dispositivo implantável para liberação sustentada de um composto de fármaco macromolecular
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
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
AU2023281232A1 (en) 2022-05-18 2024-10-24 Laboratorios Farmacéuticos Rovi, S.A. Prolonged-release injectable compositions for use in treatment with risperidone together with cyp2d6 enzyme inhibitors

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011151355A1 (en) * 2010-05-31 2011-12-08 Laboratorios Farmacéuticos Rovi, S.A. Antipsychotic injectable depot composition
WO2011151356A2 (en) * 2010-05-31 2011-12-08 Laboratorios Farmacéuticos Rovi, S.A. Methods for the preparation of injectable depot compositions
EP2529757A1 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation
EP2529756A2 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Risperidone and/or Paliperidone implant formulation

Family Cites Families (10)

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Publication number Priority date Publication date Assignee Title
CN1074923C (zh) 1993-11-19 2001-11-21 詹森药业有限公司 微囊密封的3-哌啶基取代的1,2-苯并异唑类和1,2-苯并异噻唑类
US7658998B2 (en) * 2003-01-22 2010-02-09 Alkermes Controlled Therapeutics, Inc. Method of preparing sustained release microparticles
WO2005007122A2 (en) * 2003-07-18 2005-01-27 Oakwood Laboratories, L.L.C. Polymer stabilization
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
JP5315336B2 (ja) 2007-04-19 2013-10-16 又欣 李 精神疾患治療用の新規化合物とその調剤及び使用
DK2167039T3 (en) * 2007-05-18 2017-01-09 Durect Corp Improved depot formulations
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
BRPI0821408A2 (pt) 2007-12-19 2015-06-16 Janssen Pharmaceutica Nv Regime de dosagem associado a ésteres de paliperidona injetáveis de longa ação
EP2485712A1 (en) 2009-10-06 2012-08-15 Ascendis Pharma A/S Subcutaneous paliperidone composition

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011151355A1 (en) * 2010-05-31 2011-12-08 Laboratorios Farmacéuticos Rovi, S.A. Antipsychotic injectable depot composition
WO2011151356A2 (en) * 2010-05-31 2011-12-08 Laboratorios Farmacéuticos Rovi, S.A. Methods for the preparation of injectable depot compositions
EP2529757A1 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation
EP2529756A2 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Risperidone and/or Paliperidone implant formulation

Also Published As

Publication number Publication date
CA2874765A1 (en) 2013-12-05
JP6367795B2 (ja) 2018-08-01
ZA201409299B (en) 2015-12-23
SI2529756T1 (sl) 2021-09-30
PH12014502667B1 (en) 2020-01-22
HRP20260301T1 (hr) 2026-04-10
SG11201407961WA (en) 2014-12-30
IN2014DN10672A (https=) 2015-08-28
BR112014029209A2 (pt) 2017-06-27
PT2529756T (pt) 2021-07-28
EA031819B1 (ru) 2019-02-28
HRP20211057T1 (hr) 2021-10-01
PH12014502667A1 (en) 2015-02-02
KR20150016964A (ko) 2015-02-13
CY1124369T1 (el) 2022-07-22
MX374955B (es) 2025-03-06
CN104363923A (zh) 2015-02-18
LT2529756T (lt) 2021-07-26
CL2014003216A1 (es) 2015-07-10
EP2529756A3 (en) 2013-08-07
EP2854858B1 (en) 2025-12-10
CO7160108A2 (es) 2015-01-15
EA201401346A1 (ru) 2015-04-30
RS62059B1 (sr) 2021-07-30
PL2854858T3 (pl) 2026-04-20
CA2874765C (en) 2020-06-02
AU2013269547A1 (en) 2015-01-22
DK2529756T3 (da) 2021-08-02
IL235849B (en) 2019-03-31
EP2529756B1 (en) 2021-05-19
MY174999A (en) 2020-06-01
EP2529756A2 (en) 2012-12-05
MA37664B1 (fr) 2016-11-30
WO2013178812A1 (en) 2013-12-05
NZ703321A (en) 2017-01-27
KR101880716B1 (ko) 2018-08-17
UA119430C2 (uk) 2019-06-25
SMT202100448T1 (it) 2021-09-14
PL2529756T3 (pl) 2021-11-15
EP2854858A1 (en) 2015-04-08
MX2014014483A (es) 2015-02-24
IL235849A0 (en) 2015-01-29
PT2854858T (pt) 2026-03-06
FI2854858T3 (fi) 2026-03-03
LT2854858T (lt) 2026-03-10
MA37664A1 (fr) 2016-03-31
ES2878112T3 (es) 2021-11-18
JP2015518036A (ja) 2015-06-25
DK2854858T3 (da) 2026-03-09

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