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
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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
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Pharma Two B Ltd
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Pharma Two B Ltd
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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
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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
    • A61K31/41—Heterocyclic 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
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/41—Amines
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/167—Agglomerates; 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
    • A61K9/1676—Agglomerates; 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/5084—Mixtures 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Psychology (AREA)
  • Emergency Medicine (AREA)
  • Birds (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 (https=)
EP (1) EP2802319B1 (https=)
JP (1) JP6243351B2 (https=)
KR (2) KR102276896B1 (https=)
CN (1) CN104168896B (https=)
AU (1) AU2013208653B2 (https=)
CA (1) CA2860952C (https=)
CY (1) CY1119793T1 (https=)
DK (1) DK2802319T3 (https=)
ES (1) ES2655676T3 (https=)
HU (1) HUE038029T2 (https=)
IL (1) IL233572B (https=)
IN (1) IN2014MN01568A (https=)
LT (1) LT2802319T (https=)
MX (1) MX360409B (https=)
NO (2) NO2802319T3 (https=)
PL (1) PL2802319T3 (https=)
PT (1) PT2802319T (https=)
RS (1) RS56742B1 (https=)
RU (1) RU2642962C9 (https=)
WO (1) WO2013105092A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5769923B2 (ja) 2006-04-03 2015-08-26 テバ ファーマシューティカル インダストリーズ リミティド レストレスレッグス症候群の治療のためのラサギリンの使用
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
EP3668501A4 (en) * 2017-08-17 2021-03-17 Zi-Qiang Gu MONOAMINE PAMOATE SALTS ANTI-PARKINSON AGENTS, THEIR PREPARATION AND USE
KR20210106477A (ko) * 2018-12-19 2021-08-30 갈렉토 바이오테크 에이비 5-브로모피리딘-3-일 3-데옥시-3-[4-(3,4,5-트리플루오로페닐)-1h-1,2,3-트리아졸-1-일]-1-티오-알파-d-갈락토피라노사이드의 비정질 형태
JP2023504876A (ja) * 2019-12-06 2023-02-07 シャンハイ ファーマシューティカルズ ホールディング カンパニー，リミティド 薬物組成物、キット及びその応用
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)

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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
AU2005215136A1 (en) * 2004-02-20 2005-09-01 Novartis Ag DPP-IV inhibitors for treating neurodegeneration and cognitive disorders
WO2006014973A2 (en) * 2004-07-26 2006-02-09 Teva Pharmaceutical Industries, Ltd. Pharmaceutical dosage forms including rasagiline
JP5769923B2 (ja) 2006-04-03 2015-08-26 テバ ファーマシューティカル インダストリーズ リミティド レストレスレッグス症候群の治療のためのラサギリンの使用
JP2010525018A (ja) * 2007-04-24 2010-07-22 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング プラミペキソール又はその医薬的に許容できる塩を含有する徐放性錠剤型製剤との組成物
KR20110071064A (ko) * 2008-08-19 2011-06-28 크놉 뉴로사이언시스 인코포레이티드 (ｒ)-프라미펙솔을 사용하는 조성물 및 방법

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

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