WO2009147681A1 - Pharmaceutical compositions for treatment of parkinson's disease - Google Patents

Pharmaceutical compositions for treatment of parkinson's disease Download PDF

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Publication number
WO2009147681A1
WO2009147681A1 PCT/IL2009/000567 IL2009000567W WO2009147681A1 WO 2009147681 A1 WO2009147681 A1 WO 2009147681A1 IL 2009000567 W IL2009000567 W IL 2009000567W WO 2009147681 A1 WO2009147681 A1 WO 2009147681A1
Authority
WO
WIPO (PCT)
Prior art keywords
levodopa
carbidopa
rasagiline
combination
selegiline
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.)
Ceased
Application number
PCT/IL2009/000567
Other languages
English (en)
French (fr)
Inventor
Itschak Lamensdorf
Yoram Sela
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
Original Assignee
Pharma Two B 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41051156&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009147681(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CA2726833A priority Critical patent/CA2726833C/en
Priority to PL09758025T priority patent/PL2303330T5/pl
Priority to JP2011512269A priority patent/JP5648216B2/ja
Priority to NZ590291A priority patent/NZ590291A/xx
Priority to CN200980129250.2A priority patent/CN102105169B/zh
Priority to DK09758025.2T priority patent/DK2303330T4/da
Priority to BRPI0914902A priority patent/BRPI0914902B8/pt
Priority to MX2010013393A priority patent/MX2010013393A/es
Application filed by Pharma Two B Ltd filed Critical Pharma Two B Ltd
Priority to NO09758025A priority patent/NO2303330T3/no
Priority to LTEP09758025.2T priority patent/LT2303330T/lt
Priority to EP09758025.2A priority patent/EP2303330B2/en
Priority to US12/996,455 priority patent/US8969417B2/en
Priority to ES09758025T priority patent/ES2659394T5/es
Priority to RU2010154716/15A priority patent/RU2540470C9/ru
Priority to AU2009254730A priority patent/AU2009254730B2/en
Publication of WO2009147681A1 publication Critical patent/WO2009147681A1/en
Priority to IL209804A priority patent/IL209804A0/en
Anticipated expiration legal-status Critical
Priority to ZA2011/00034A priority patent/ZA201100034B/en
Priority to US14/602,518 priority patent/US9259418B2/en
Priority to CY20181100112T priority patent/CY1119865T1/el
Ceased legal-status Critical Current

Links

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
    • A61K31/137—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • 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

Definitions

  • Parkinson's disease is a neurodegenerative disorder characterized by a chronic and progressive loss of dopamine neurons in substantia nigra pars compacta, leading to movement disorders including dyskinesia, resting tremor, rigidity, and gait disturbance.
  • the present invention relates to pharmaceutical compositions for treatment of Parkinson's disease comprising a fixed dose combination of two different active agents selected from compounds having a symptomatic or neuroprotective effects, or both, in Parkinson's patients, wherein the molar ratio of the two compounds is in the range of 1:1 to 1:100.
  • Figs. 1 A-C show neuroprotective effect of Parkinson drugs and combinations of the drugs on serum-free medium induced apoptosis in PC 12 cells as measured by % viable cells.
  • Fig. IA (1) Starvation; (2) ropinirole, 200 ⁇ M; (3) ropinirole, lOO ⁇ M; (4) rasagiline, 50 ⁇ M; (5) rasagiline, lOO ⁇ M; (6) combination of ropinirole, 200 ⁇ M:rasagiline, 50 ⁇ M; (7) combination of ropinirole, 100 ⁇ M:rasagiline, lO ⁇ M; Fig.
  • Figs. 2 A-D show neuroprotective effect of Parkinson drugs and combinations on MPP+ induced apoptosis in PC 12 cells as measured by % viable cells. In Figs. 2A-C the neuroprotective effect is measured as % viability of control, while in Fig. 2D it is measured as % toxicity .Fig.
  • one of the two active agents is a spin-trapping agent such as, but not limited to, 4-hydroxy-[2,2,6,6-tetramethylpiperidine-l-oxyl (tempol), ⁇ - (4-pyridyl-l-oxide)-N-tert-butyl nitrone (POBN), or ⁇ -phenyl-tert-butyl nitrone (PBN), known as neuroprotective agents.
  • a spin-trapping agent such as, but not limited to, 4-hydroxy-[2,2,6,6-tetramethylpiperidine-l-oxyl (tempol), ⁇ - (4-pyridyl-l-oxide)-N-tert-butyl nitrone (POBN), or ⁇ -phenyl-tert-butyl nitrone (PBN), known as neuroprotective agents.
  • the pharmaceutical composition comprises a combination of a dopamine receptor agonist in combination with a MAO inhibitor.
  • the pharmaceutical composition comprises a dopamine receptor agonist selected from pramipexole, ropinirole piribedil, lisuride, cabergoline, apomorphine, rotigotine, bromocriptine or pergolide in combination with a propargylamine type MAO-B inhibitor such as rasagiline or selegiline.
  • the pharmaceutical composition of the invention contains a fixed dose combination of the two active agents in which each of the active agents is formulated for immediate release, controlled release, or both immediate and controlled release.
  • the two active agents in the composition may also be formulated in a pellets dosage form (capsules) with different release patterns: one agent for immediate release and the other for controlled release, or each of the agents both for immediate and controlled release, in which case 10, 20, 30, 40, 50, 60, 70, 80 or 90% of the dose is for controlled release and the remaining for immediate release.
  • a pellets dosage form capsules
  • release patterns one agent for immediate release and the other for controlled release, or each of the agents both for immediate and controlled release, in which case 10, 20, 30, 40, 50, 60, 70, 80 or 90% of the dose is for controlled release and the remaining for immediate release.
  • Sample preparation for HPLC analysis of DA and metabolites Striatum tissue samples were homogenized in ice in 500ul homogenization buffer (0.1M perchloric acid, 0.02% EDTA and 1% ETOH) using OMNI Tip homogenizing kit of OMNI International (intermediate speed, 3X 10 seconds with 5 seconds intervals). The homogenates were sonicated for 5 minutes then centrifuged at 15,000 RPM at 4°C for 15min. The supernatants were transferred into fresh tubes and Dopamine content was analyzed by HPLC.
  • Example 1 In vitro rapid screening of drug combinations protecting from cell death.
  • Figs. 3A-B show the locomotion activity as tested by Rota rod latency (Fig. 3A) and Rota rod distance (Fig. 3B) on day 5 of the study (5 drug administrations).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PCT/IL2009/000567 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of parkinson's disease Ceased WO2009147681A1 (en)

Priority Applications (19)

Application Number Priority Date Filing Date Title
AU2009254730A AU2009254730B2 (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of Parkinson's disease
LTEP09758025.2T LT2303330T (lt) 2008-06-06 2009-06-07 Farmacinės kompozicijos, skirtos parkinsono ligai gydyti
JP2011512269A JP5648216B2 (ja) 2008-06-06 2009-06-07 パーキンソン病治療医薬組成物
NZ590291A NZ590291A (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of parkinson's disease
CN200980129250.2A CN102105169B (zh) 2008-06-06 2009-06-07 用于治疗帕金森病的药物组合物
DK09758025.2T DK2303330T4 (da) 2008-06-06 2009-06-07 Farmaceutiske sammensætninger til behandling af parkinsons sygdom
BRPI0914902A BRPI0914902B8 (pt) 2008-06-06 2009-06-07 Composição farmacêutica para uso no tratamento de mal de parkinson
US12/996,455 US8969417B2 (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of Parkinsons disease
PL09758025T PL2303330T5 (pl) 2008-06-06 2009-06-07 Kompozycje farmaceutyczne do leczenia choroby Parkinsona
NO09758025A NO2303330T3 (https=) 2008-06-06 2009-06-07
EP09758025.2A EP2303330B2 (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of parkinson's disease
CA2726833A CA2726833C (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of parkinson's disease
MX2010013393A MX2010013393A (es) 2008-06-06 2009-06-07 Composiciones farmaceuticas para el tratamiento de la enfermedad de parkinson.
ES09758025T ES2659394T5 (es) 2008-06-06 2009-06-07 Composiciones farmacéuticas para el tratamiento de la enfermedad de Parkinson
RU2010154716/15A RU2540470C9 (ru) 2008-06-06 2009-06-07 Фармацевтические композиции для лечения болезни паркинсона
IL209804A IL209804A0 (en) 2008-06-06 2010-12-06 Pharmaceutical compositions for treatment of parkinson's disease
ZA2011/00034A ZA201100034B (en) 2008-06-06 2011-01-03 Pharmaceutical compositions for treatment of parkinson's disease
US14/602,518 US9259418B2 (en) 2008-06-06 2015-01-22 Pharmaceutical compositions for treatment of Parkinson's disease
CY20181100112T CY1119865T1 (el) 2008-06-06 2018-01-31 Φαρμακευτικες συνθεσεις για την αντιμετωπιση της νοσου του παρκινσον

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5932608P 2008-06-06 2008-06-06
US61/059,326 2008-06-06

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/996,455 A-371-Of-International US8969417B2 (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of Parkinsons disease
US14/602,518 Division US9259418B2 (en) 2008-06-06 2015-01-22 Pharmaceutical compositions for treatment of Parkinson's disease

Publications (1)

Publication Number Publication Date
WO2009147681A1 true WO2009147681A1 (en) 2009-12-10

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ID=41051156

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2009/000567 Ceased WO2009147681A1 (en) 2008-06-06 2009-06-07 Pharmaceutical compositions for treatment of parkinson's disease

Country Status (22)

Country Link
US (2) US8969417B2 (https=)
EP (1) EP2303330B2 (https=)
JP (1) JP5648216B2 (https=)
KR (1) KR101613749B1 (https=)
CN (1) CN102105169B (https=)
AU (1) AU2009254730B2 (https=)
BR (1) BRPI0914902B8 (https=)
CA (1) CA2726833C (https=)
CL (1) CL2010001358A1 (https=)
CY (1) CY1119865T1 (https=)
DK (1) DK2303330T4 (https=)
ES (1) ES2659394T5 (https=)
HU (1) HUE037974T2 (https=)
LT (1) LT2303330T (https=)
MX (1) MX2010013393A (https=)
NO (1) NO2303330T3 (https=)
NZ (1) NZ590291A (https=)
PL (1) PL2303330T5 (https=)
PT (1) PT2303330T (https=)
RU (1) RU2540470C9 (https=)
WO (1) WO2009147681A1 (https=)
ZA (1) ZA201100034B (https=)

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WO2013105092A1 (en) 2012-01-12 2013-07-18 Pharma Two B Ltd. Fixed dose combination therapy of parkinson's disease
WO2013168032A1 (en) * 2012-05-07 2013-11-14 Micro Labs Limited Pharmaceutical compositions comprising rasagiline
US20150297530A1 (en) * 2012-01-12 2015-10-22 Pharma Two B Ltd. Fixed dose combination therapy of parkinson's disease
EP2900226A4 (en) * 2012-09-27 2016-03-30 Teva Pharma COMBINATION OF RASAGILIN AND PRIDOPIDIN FOR TREATING NEURODEGENERATIVE DISORDERS, ESPECIALLY HUNTINGTON'S DISEASE
WO2016190766A1 (en) 2015-05-26 2016-12-01 Technophage, Investigação E Desenvolvimento Em Biotecnologia, Sa Compositions for use in treating parkinson's disease and related disorders
EP2994453A4 (en) * 2013-03-15 2017-04-12 Techfields Pharma Co., Ltd. Novel high penetration drugs and their compositions thereof for treatment of parkinson diseases
WO2020084168A1 (en) * 2018-10-26 2020-04-30 Icm (Institut Du Cerveau Et De La Moelle Épinière) Tetracycline compound for treating drug-induced dyskinesia
EP3003308B1 (en) * 2013-05-30 2020-09-30 Sorbonne Université New drug for the treatment and/or prevention of depressive disorders
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
RU2771522C9 (ru) * 2012-01-12 2022-09-05 Фарма Ту Б Лтд. Терапия болезни паркинсона с применением комбинации с фиксированными дозами
US11896573B2 (en) 2020-07-24 2024-02-13 XWPharma Ltd. Pharmaceutical compositions and pharmacokinetics of a gamma-hydroxybutyric acid derivative
US11925710B2 (en) 2020-10-05 2024-03-12 XWPharma Ltd. Modified release compositions of a GAMMA-hydroxybutyric acid derivative
US11944597B2 (en) 2021-03-19 2024-04-02 XWPharma Ltd. Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
US12337066B2 (en) 2020-06-18 2025-06-24 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients

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CN104473942A (zh) * 2014-12-12 2015-04-01 青岛大学 一种抗帕金森氏病的药物组合物
WO2017070293A1 (en) * 2015-10-20 2017-04-27 Ironwood Pharmaceuticals, Inc. Phosphodiesterase 9 inhibitor and levodopa therapy
US20170143681A1 (en) * 2015-11-02 2017-05-25 Apkarian Technologies Llc Methods and compositions for treating pain
US20190343780A1 (en) * 2016-12-22 2019-11-14 Rvx Therapeutics Ltd. Low dose drug combinations for use in preventing and treating neuronal damage
WO2019010491A1 (en) * 2017-07-07 2019-01-10 University Of Pittsburgh-Of The Commonwealth System Of Higher Education COMBINATIONS OF MEDICINES FOR THE PROTECTION AGAINST THE DEATH OF NEURONAL CELLS
US20190153102A1 (en) 2017-09-28 2019-05-23 Prothena Biosciences Limited Dosing regimes for treatment of synucleinopathies
JP6596483B2 (ja) * 2017-12-28 2019-10-23 テックフィールズ ファーマ カンパニー リミテッド パ−キンソン病治療用の新規高透過薬物及びその組成物
CN113924086A (zh) * 2019-04-17 2022-01-11 维奇健康科学有限责任公司 液体药物组合物
CA3139559A1 (en) * 2019-05-09 2020-11-12 Apkarian Technologies Llc Methods and compositions for treating pain
IL301039A (en) 2020-09-10 2023-05-01 Prothena Biosciences Ltd Treatment of parkinson's disease
CN114762684B (zh) * 2021-01-14 2023-11-21 华益泰康药业股份有限公司 一种治疗帕金森的缓释胶囊及其制备方法
KR102903389B1 (ko) * 2022-11-30 2025-12-23 주식회사한국파마 신경퇴행성 질환 예방 또는 치료용 필름코팅정제

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