AU2013208653B2 - Fixed dose combination therapy of Parkinson's disease - Google Patents

Fixed dose combination therapy of Parkinson's disease Download PDF

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Publication number
AU2013208653B2
AU2013208653B2 AU2013208653A AU2013208653A AU2013208653B2 AU 2013208653 B2 AU2013208653 B2 AU 2013208653B2 AU 2013208653 A AU2013208653 A AU 2013208653A AU 2013208653 A AU2013208653 A AU 2013208653A AU 2013208653 B2 AU2013208653 B2 AU 2013208653B2
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AU
Australia
Prior art keywords
pramipexole
rasagiline
weight
pellets
pharmaceutical composition
Prior art date
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Active
Application number
AU2013208653A
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English (en)
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AU2013208653A1 (en
Inventor
Pninit Litman
Nurit Livnah
Sarit ZAKSH
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.)
Pharma Two B Ltd
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Pharma Two B Ltd
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Publication date
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Application filed by Pharma Two B Ltd filed Critical Pharma Two B Ltd
Publication of AU2013208653A1 publication Critical patent/AU2013208653A1/en
Application granted granted Critical
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/428Thiazoles condensed with carbocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/41Amines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Psychology (AREA)
  • Birds (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2013208653A 2012-01-12 2013-01-10 Fixed dose combination therapy of Parkinson's disease Active AU2013208653B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261585824P 2012-01-12 2012-01-12
US61/585,824 2012-01-12
PCT/IL2013/050025 WO2013105092A1 (en) 2012-01-12 2013-01-10 Fixed dose combination therapy of parkinson's disease

Publications (2)

Publication Number Publication Date
AU2013208653A1 AU2013208653A1 (en) 2014-08-28
AU2013208653B2 true AU2013208653B2 (en) 2017-04-20

Family

ID=48781101

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013208653A Active AU2013208653B2 (en) 2012-01-12 2013-01-10 Fixed dose combination therapy of Parkinson's disease

Country Status (21)

Country Link
US (1) US20150079187A1 (enExample)
EP (1) EP2802319B1 (enExample)
JP (1) JP6243351B2 (enExample)
KR (2) KR102276896B1 (enExample)
CN (1) CN104168896B (enExample)
AU (1) AU2013208653B2 (enExample)
CA (1) CA2860952C (enExample)
CY (1) CY1119793T1 (enExample)
DK (1) DK2802319T3 (enExample)
ES (1) ES2655676T3 (enExample)
HU (1) HUE038029T2 (enExample)
IL (1) IL233572B (enExample)
IN (1) IN2014MN01568A (enExample)
LT (1) LT2802319T (enExample)
MX (1) MX360409B (enExample)
NO (2) NO2802319T3 (enExample)
PL (1) PL2802319T3 (enExample)
PT (1) PT2802319T (enExample)
RS (1) RS56742B1 (enExample)
RU (1) RU2642962C9 (enExample)
WO (1) WO2013105092A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2007369A4 (en) 2006-04-03 2009-07-01 Teva Pharma USE OF RASAGILINE FOR THE TREATMENT OF LEG SYNDROME WITHOUT REST
CN104367565A (zh) * 2014-11-21 2015-02-25 哈尔滨圣吉药业股份有限公司 一种盐酸普拉克索缓释微丸
CN105147627B (zh) * 2015-08-19 2019-04-12 天津红日药业股份有限公司 一种含有盐酸普拉克索的药物组合物及其制备方法
CA3072994A1 (en) * 2017-08-17 2019-02-21 Zi-Qiang Gu Pamoate salt of monoamine anti-parkinson's agents, method of preparation and use thereof
CA3122935A1 (en) * 2018-12-19 2020-06-25 Galecto Biotech Ab Amorphous form and process
WO2021109880A1 (zh) * 2019-12-06 2021-06-10 上海医药集团股份有限公司 药物组合物、成套药盒及其应用
WO2023112024A1 (en) * 2021-12-14 2023-06-22 Pharma Two B Ltd. Method of treating parkinson's disease

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009147681A1 (en) * 2008-06-06 2009-12-10 Pharma Two B Ltd. Pharmaceutical compositions for treatment of parkinson's disease
WO2011095973A1 (en) * 2010-02-03 2011-08-11 Pharma Two B Ltd. Extended release formulations of rasagiline and uses thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL215263B1 (pl) * 2002-02-25 2013-11-29 Elan Pharm Inc Kompozycja do przewleklego leczenia patologicznego zapalenia i zastosowanie natalizumabu lub jego immunologicznie aktywnego fragmentu do wytwarzania leku
WO2005070428A1 (en) * 2004-01-22 2005-08-04 Boehringer Ingelheim International Gmbh Pharmaceutical composition comprising a monoamine neurotransmitter re-uptake inhibitor and a dopamine agonist
KR20060124712A (ko) * 2004-02-20 2006-12-05 노파르티스 아게 신경퇴행 및 인지 장애를 치료하기 위한 dpp ⅳ 억제제
EP1778196A4 (en) * 2004-07-26 2008-12-17 Teva Pharma PHARMACEUTICAL DOSAGES CONTAINING RASAGILINE
EP2007369A4 (en) * 2006-04-03 2009-07-01 Teva Pharma USE OF RASAGILINE FOR THE TREATMENT OF LEG SYNDROME WITHOUT REST
US20100092554A1 (en) * 2007-04-24 2010-04-15 Boehringer Ingelheim International Gmbh Combination with an extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
CN102186350A (zh) * 2008-08-19 2011-09-14 诺普神经科学股份有限公司 使用(r)-普拉克索的组合物与方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009147681A1 (en) * 2008-06-06 2009-12-10 Pharma Two B Ltd. Pharmaceutical compositions for treatment of parkinson's disease
WO2011095973A1 (en) * 2010-02-03 2011-08-11 Pharma Two B Ltd. Extended release formulations of rasagiline and uses thereof

Also Published As

Publication number Publication date
AU2013208653A1 (en) 2014-08-28
KR20140138629A (ko) 2014-12-04
US20150079187A1 (en) 2015-03-19
MX2014008537A (es) 2014-11-25
KR102276896B1 (ko) 2021-07-14
EP2802319A1 (en) 2014-11-19
RU2017146994A (ru) 2018-10-22
RU2017146994A3 (enExample) 2021-03-16
IN2014MN01568A (enExample) 2015-05-08
DK2802319T3 (da) 2018-01-29
RU2014132940A (ru) 2016-02-27
HK1203847A1 (en) 2015-11-06
KR20200013791A (ko) 2020-02-07
RU2642962C9 (ru) 2018-05-04
MX360409B (es) 2018-10-30
JP2015508411A (ja) 2015-03-19
IL233572B (en) 2020-05-31
NO2901008T3 (enExample) 2018-08-04
RU2642962C2 (ru) 2018-01-29
EP2802319A4 (en) 2015-07-01
ES2655676T3 (es) 2018-02-21
HUE038029T2 (hu) 2018-09-28
CY1119793T1 (el) 2018-06-27
CN104168896B (zh) 2018-08-10
RS56742B1 (sr) 2018-03-30
RU2771522C2 (ru) 2022-05-05
CA2860952C (en) 2020-09-15
CN104168896A (zh) 2014-11-26
PT2802319T (pt) 2018-01-29
NO2802319T3 (enExample) 2018-03-24
EP2802319B1 (en) 2017-10-25
CA2860952A1 (en) 2013-07-18
JP6243351B2 (ja) 2017-12-06
PL2802319T3 (pl) 2018-04-30
LT2802319T (lt) 2018-04-10
IL233572A0 (en) 2014-08-31
WO2013105092A1 (en) 2013-07-18

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