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
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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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)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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 (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
AU2007235517B2 (en) 2006-04-03 2013-01-31 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of Restless Legs Syndrome
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
WO2020127461A1 (en) * 2018-12-19 2020-06-25 Galecto Biotech Ab Amorphous form of 5-bromopyridin-3-yl 3-deoxy-3-[4-(3,4,5-trifluorophenyl)-1h-1,2,3-triazol-1-yl]-1-thio-alpha-d-galactopyranoside
US20230028539A1 (en) * 2019-12-06 2023-01-26 Shanghai Pharmaceuticals Holding Co., Ltd. Pharmaceutical composition, complementary kit and application thereof
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
KR20040105740A (ko) * 2002-02-25 2004-12-16 엘란 파마슈티칼스, 인크. 염증 치료제의 투여 방법
JP2007518754A (ja) * 2004-01-22 2007-07-12 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 モノアミン神経伝達物質再取込みインヒビターとドーパミンアゴニストを含む医薬組成物
KR20060124712A (ko) * 2004-02-20 2006-12-05 노파르티스 아게 신경퇴행 및 인지 장애를 치료하기 위한 ｄｐｐ ⅳ 억제제
US20060018957A1 (en) * 2004-07-26 2006-01-26 Lerner E I Pharmaceutical dosage forms including rasagiline
AU2007235517B2 (en) * 2006-04-03 2013-01-31 Teva Pharmaceutical Industries, Ltd. Use of rasagiline for the treatment of Restless Legs Syndrome
EP2150239A1 (en) * 2007-04-24 2010-02-10 Boehringer Ingelheim International GmbH Combination with an extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
JP2012500283A (ja) * 2008-08-19 2012-01-05 ノップ ニューロサイエンシーズ、インク． （ｒ）−プラミペキソールを使用した組成物並びにその方法

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

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