AU2010337822B2 - Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof - Google Patents

Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof Download PDF

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Publication number
AU2010337822B2
AU2010337822B2 AU2010337822A AU2010337822A AU2010337822B2 AU 2010337822 B2 AU2010337822 B2 AU 2010337822B2 AU 2010337822 A AU2010337822 A AU 2010337822A AU 2010337822 A AU2010337822 A AU 2010337822A AU 2010337822 B2 AU2010337822 B2 AU 2010337822B2
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AU
Australia
Prior art keywords
glatiramer
pharmaceutical composition
composition according
acceptable salt
pharmaceutically acceptable
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.)
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Application number
AU2010337822A
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English (en)
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AU2010337822A1 (en
Inventor
Ehud Marom
Shai Rubnov
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.)
Mapi Pharma Ltd
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Mapi Pharma Ltd
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
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Publication of AU2010337822A1 publication Critical patent/AU2010337822A1/en
Application granted granted Critical
Publication of AU2010337822B2 publication Critical patent/AU2010337822B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Epoxy Resins (AREA)
  • Epoxy Compounds (AREA)
AU2010337822A 2010-01-04 2010-08-19 Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof Active AU2010337822B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US29192810P 2010-01-04 2010-01-04
US61/291,928 2010-01-04
PCT/IL2010/000679 WO2011080733A1 (en) 2010-01-04 2010-08-19 Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof

Publications (2)

Publication Number Publication Date
AU2010337822A1 AU2010337822A1 (en) 2012-07-12
AU2010337822B2 true AU2010337822B2 (en) 2016-03-17

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2010337822A Active AU2010337822B2 (en) 2010-01-04 2010-08-19 Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof

Country Status (21)

Country Link
US (1) US8796226B2 (cg-RX-API-DMAC7.html)
EP (2) EP2398488B1 (cg-RX-API-DMAC7.html)
JP (2) JP5916622B2 (cg-RX-API-DMAC7.html)
CN (3) CN107184954A (cg-RX-API-DMAC7.html)
AU (1) AU2010337822B2 (cg-RX-API-DMAC7.html)
BR (1) BR112012016459B1 (cg-RX-API-DMAC7.html)
CA (1) CA2784394C (cg-RX-API-DMAC7.html)
CY (1) CY1120975T1 (cg-RX-API-DMAC7.html)
DK (2) DK3536333T3 (cg-RX-API-DMAC7.html)
ES (2) ES2928900T3 (cg-RX-API-DMAC7.html)
HK (1) HK1244430A1 (cg-RX-API-DMAC7.html)
HR (2) HRP20221208T1 (cg-RX-API-DMAC7.html)
HU (2) HUE060304T2 (cg-RX-API-DMAC7.html)
LT (2) LT2398488T (cg-RX-API-DMAC7.html)
MX (3) MX392126B (cg-RX-API-DMAC7.html)
PL (2) PL2398488T3 (cg-RX-API-DMAC7.html)
PT (2) PT2398488T (cg-RX-API-DMAC7.html)
SI (1) SI2398488T1 (cg-RX-API-DMAC7.html)
SM (2) SMT202200422T1 (cg-RX-API-DMAC7.html)
TR (1) TR201818858T4 (cg-RX-API-DMAC7.html)
WO (1) WO2011080733A1 (cg-RX-API-DMAC7.html)

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US8377885B2 (en) 2010-01-04 2013-02-19 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
EP2699317B1 (en) 2011-04-21 2016-08-10 Mapi Pharma Limited Random pentapolymer for treatment of autoimmune diseases
WO2013038399A1 (en) 2011-09-18 2013-03-21 Bio Plasmar Ltd Bio-degradable compositions and use thereof
WO2014128079A1 (en) * 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation
CN103169670B (zh) * 2013-03-22 2016-07-06 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
MX2016001422A (es) * 2013-07-29 2016-10-05 Aizant Drug Res Solutions Pvt Ltd Composicion farmaceutica de fingolimod.
WO2015100370A2 (en) * 2013-12-23 2015-07-02 Kineta One, Llc Sustained release depot formulations of therapeutic proteins, and uses thereof
WO2015140790A1 (en) 2014-03-17 2015-09-24 Mapi Pharma Ltd. Sublingual delivery of glatiramer acetate
WO2017053346A1 (en) 2015-09-21 2017-03-30 Teva Pharmaceuticals International Gmbh Sustained release olanzapine formulations
US12161688B2 (en) 2016-06-30 2024-12-10 Mapi Pharma Ltd Treatment of inflammatory bowel disease with long acting glatiramer and adipose-derived stem cells
JP7232752B2 (ja) * 2016-08-28 2023-03-03 マピ ファーマ リミテッド 酢酸グラチラマーを含有する微小粒子を調製する方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
JP7193448B2 (ja) * 2016-08-31 2022-12-20 マピ ファーマ リミテッド 酢酸グラチラマーを含むデポシステム
JP6712003B2 (ja) * 2016-10-28 2020-06-17 スパインセラＳｐｉｎｅｔｈｅｒａ 医薬組成物及びその使用
WO2018172850A1 (en) 2017-03-20 2018-09-27 Teva Pharmaceuticals International Gmbh Sustained release olanzapine formulaitons
IL316573A (en) * 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
IL269893B2 (en) 2017-05-15 2023-10-01 Stem Cell Medicine Ltd Treatment of multiple sclerosis with adipose-derived stem cells
CA3062964C (en) * 2017-05-15 2024-11-12 Mapi Pharma Ltd. TREATMENT OF MULTIPLE SCLEROSIS WITH A LONG-ACTING GLATIRAMER AND ADIPE-DERIVED STEM CELLS
WO2019002228A1 (en) 2017-06-26 2019-01-03 Institut Pasteur TREATMENTS TO REMOVE HIV RESERVOIRS AND REDUCE VIRAL LOAD
WO2022003662A1 (en) * 2020-06-29 2022-01-06 Mapi Pharma Ltd. Low burst-release liraglutide depot systems
JP2023550545A (ja) * 2020-11-02 2023-12-01 シムハ・アイエル－１８・インコーポレイテッド インターロイキン－１８バリアントおよび使用の方法
WO2022153262A1 (en) 2021-01-18 2022-07-21 Anton Frenkel Pharmaceutical dosage form
US20220296524A1 (en) * 2021-01-29 2022-09-22 Tionlab Therapeutics Initial burst release controlled depot composition and a method thereof
US11865213B2 (en) 2021-07-05 2024-01-09 Mapi Pharma Ltd. Semaglutide depot systems and use thereof
CA3227324A1 (en) 2021-07-06 2023-01-12 Mark Hasleton Treatment of serotonin reuptake inhibitor withdrawal syndrome
WO2023170493A1 (en) * 2022-03-07 2023-09-14 Hadidi Naghmeh Drug delivery using a parenteral pharmaceutical composition
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Also Published As

Publication number Publication date
EP2398488A4 (en) 2014-06-11
MX374215B (es) 2025-03-04
US20120015891A1 (en) 2012-01-19
HK1245667A1 (zh) 2018-08-31
LT3536333T (lt) 2022-11-10
MX392126B (es) 2025-03-21
SMT202200422T1 (it) 2022-11-18
CN107661490B (zh) 2021-12-31
CA2784394A1 (en) 2011-07-07
US8796226B2 (en) 2014-08-05
PL2398488T3 (pl) 2019-03-29
TR201818858T4 (tr) 2019-01-21
MX349162B (es) 2017-07-14
ES2699692T3 (es) 2019-02-12
HUE060304T2 (hu) 2023-02-28
HRP20182076T1 (hr) 2019-02-08
EP2398488B1 (en) 2018-11-14
LT2398488T (lt) 2019-01-25
MX2012007760A (es) 2012-08-01
BR112012016459A2 (pt) 2017-10-03
PT2398488T (pt) 2018-12-20
AU2010337822A1 (en) 2012-07-12
DK2398488T3 (en) 2019-01-28
JP5916622B2 (ja) 2016-05-11
SMT201900020T1 (it) 2019-02-28
CY1120975T1 (el) 2019-12-11
CN102686235A (zh) 2012-09-19
PT3536333T (pt) 2022-11-11
CA2784394C (en) 2016-12-13
DK3536333T3 (da) 2022-10-24
PL3536333T3 (pl) 2022-12-05
WO2011080733A1 (en) 2011-07-07
HK1244430A1 (zh) 2018-08-10
CN107184954A (zh) 2017-09-22
EP3536333A1 (en) 2019-09-11
SI2398488T1 (sl) 2019-02-28
HRP20221208T1 (hr) 2022-12-09
MX2020003805A (es) 2022-05-05
BR112012016459B1 (pt) 2020-01-14
JP2013516403A (ja) 2013-05-13
CN107661490A (zh) 2018-02-06
EP2398488A1 (en) 2011-12-28
ES2928900T3 (es) 2022-11-23
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JP2016074696A (ja) 2016-05-12
EP3536333B1 (en) 2022-08-03

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