CA2937243C - Modified release formulations of pridopidine - Google Patents

Modified release formulations of pridopidine Download PDF

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Publication number
CA2937243C
CA2937243C CA2937243A CA2937243A CA2937243C CA 2937243 C CA2937243 C CA 2937243C CA 2937243 A CA2937243 A CA 2937243A CA 2937243 A CA2937243 A CA 2937243A CA 2937243 C CA2937243 C CA 2937243C
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CA
Canada
Prior art keywords
pridopidine
solid oral
dosage form
oral dosage
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.)
Active
Application number
CA2937243A
Other languages
English (en)
French (fr)
Other versions
CA2937243A1 (en
Inventor
Daniella Licht
Ioana Lovinger
Laura Yehudit Guilatt
Merav Bassan
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.)
Prilenia Neurotherapeutics Ltd
Original Assignee
Prilenia Neurotherapeutics 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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=53543863&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2937243(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Prilenia Neurotherapeutics Ltd filed Critical Prilenia Neurotherapeutics Ltd
Publication of CA2937243A1 publication Critical patent/CA2937243A1/en
Application granted granted Critical
Publication of CA2937243C publication Critical patent/CA2937243C/en
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Classifications

    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2068Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/451Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
CA2937243A 2014-01-22 2015-01-21 Modified release formulations of pridopidine Active CA2937243C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461930358P 2014-01-22 2014-01-22
US61/930,358 2014-01-22
US201462050626P 2014-09-15 2014-09-15
US62/050,626 2014-09-15
PCT/US2015/012248 WO2015112601A1 (en) 2014-01-22 2015-01-21 Modified release formulations of pridopidine

Publications (2)

Publication Number Publication Date
CA2937243A1 CA2937243A1 (en) 2015-07-30
CA2937243C true CA2937243C (en) 2023-07-18

Family

ID=53543863

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2937243A Active CA2937243C (en) 2014-01-22 2015-01-21 Modified release formulations of pridopidine

Country Status (20)

Country Link
US (3) US20150202302A1 (enExample)
EP (2) EP3096759B1 (enExample)
JP (2) JP6949487B2 (enExample)
KR (1) KR102479759B1 (enExample)
CN (1) CN106170287A (enExample)
AU (1) AU2015209411A1 (enExample)
CA (1) CA2937243C (enExample)
CL (1) CL2016001874A1 (enExample)
DK (1) DK3096759T3 (enExample)
EA (1) EA201691454A1 (enExample)
ES (1) ES2911800T3 (enExample)
HU (1) HUE058288T2 (enExample)
IL (2) IL246598B (enExample)
MX (1) MX377576B (enExample)
PE (1) PE20161220A1 (enExample)
PL (1) PL3096759T3 (enExample)
TW (1) TW201605446A (enExample)
UA (1) UA122053C2 (enExample)
UY (1) UY35962A (enExample)
WO (1) WO2015112601A1 (enExample)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE46117E1 (en) 1999-12-22 2016-08-23 Teva Pharmaceuticals International Gmbh Modulators of dopamine neurotransmission
SG10201506761XA (en) 2010-09-03 2015-10-29 Teva Pharmaceuticals Int Gmbh Deuterated analogs of pridopidine useful as dopaminergic stabilizers
US9012476B2 (en) 2011-12-08 2015-04-21 IVAX International GmbH Hydrobromide salt of pridopidine
MX384234B (es) 2013-06-21 2025-03-14 Prilenia Neurotherapeutics Ltd Uso de pridopidina para el tratamiento de enfermedad de huntington.
US11090297B2 (en) 2013-06-21 2021-08-17 Prilenia Neurotherapeutics Ltd. Pridopidine for treating huntington's disease
US20150202302A1 (en) 2014-01-22 2015-07-23 IVAX International GmbH Modified release formulations of pridopidine
TW201613859A (en) 2014-06-30 2016-04-16 Teva Pharma Analogs of PRIDOPIDINE, their preparation and use
MX2017008136A (es) 2014-12-22 2018-03-06 Teva Pharmaceuticals Int Gmbh Sal de l-tartrato de pridopidina.
US11471449B2 (en) 2015-02-25 2022-10-18 Prilenia Neurotherapeutics Ltd. Use of pridopidine to improve cognitive function and for treating Alzheimer's disease
EP4282479A3 (en) 2015-02-25 2024-02-21 Prilenia Neurotherapeutics Ltd. Use of pridopidine to treat depression or anxiety
WO2017015615A1 (en) * 2015-07-22 2017-01-26 Teva Pharmaceuticals International Gmbh Pridopidine base formulations and their use
AR105434A1 (es) 2015-07-22 2017-10-04 Teva Pharmaceuticals Int Gmbh Proceso para preparar pridopidina
US11738012B2 (en) 2016-02-24 2023-08-29 Prilenia Neurotherapeutics Ltd. Treatment of neurodegenerative eye disease using pridopidine
DK3503890T3 (da) * 2016-08-24 2025-01-27 Prilenia Neurotherapeutics Ltd Anvendelse af pridopidin til behandling af dystonier
BR112019003732A2 (pt) 2016-08-24 2020-02-18 Prilenia Therapeutics Development Ltd. Aplicação de pridopidina para tratamento de declínio funcional
US12102627B2 (en) * 2016-09-16 2024-10-01 Prilenia Neurotherapeutics Ltd. Use of pridopidine for treating rett syndrome
MX388845B (es) 2016-09-16 2025-03-20 Prilenia Neurotherapeutics Ltd Uso de pridopidina para tratar el sindrome de rett.
JP7114604B2 (ja) 2017-01-20 2022-08-08 プリレニア ニューロセラピューティクス リミテッド 脆弱x症候群の治療のためのプリドピジンの使用
DK3668509T3 (da) 2017-08-14 2023-02-20 Prilenia Neurotherapeutics Ltd Fremgangsmåde til behandling af amyotrofisk lateralsklerose med pridopidin
MX2020002310A (es) * 2017-08-30 2020-09-17 Prilenia Neurotherapeutics Ltd Formas de dosificacion de alta concentracion de pridopidina.
CN111343982A (zh) 2017-09-08 2020-06-26 普瑞尼亚神经治疗有限公司 用于治疗药物诱发的异动症的普利多匹定
US12036213B2 (en) 2017-09-08 2024-07-16 Prilenia Neurotherapeutics Ltd. Pridopidine for treating drug induced dyskinesias
KR20200056071A (ko) 2018-11-14 2020-05-22 한화토탈 주식회사 내열성, 강성 및 용융 강도가 우수한 폴리올레핀 수지 조성물
JP7585561B2 (ja) 2019-02-04 2024-11-19 プリレニア ニューロセラピューティクス リミテッド パーキンソン病およびパーキンソニズムに関連する他の疾患のための低用量プリドピジン
WO2024258929A1 (en) * 2023-06-12 2024-12-19 Unravel Biosciences, Inc. Methods for treating diseases associated with taf1 loss of function

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4020983B2 (ja) * 1995-07-07 2007-12-12 帝國製薬株式会社 持続性製剤およびその製法
SE9904724D0 (sv) 1999-12-22 1999-12-22 Carlsson A Research Ab New modulators of dopamine neurotransmission I
KR20030019326A (ko) 2000-03-21 2003-03-06 니뽄 신야쿠 가부시키가이샤 방출 제어형 경구 투여 제제
AR030557A1 (es) * 2000-04-14 2003-08-27 Jagotec Ag Una tableta en multicapa de liberacion controlada y metodo de tratamiento
GB0125088D0 (en) 2001-10-18 2001-12-12 Smithkline Beecham Cork Ltd New use
AU2004268663B2 (en) * 2003-09-02 2010-12-09 Pfizer Products Inc. Sustained release dosage forms of ziprasidone
AU2005293754B2 (en) 2004-10-13 2011-07-21 Teva Pharmaceuticals International Gmbh Process for the synthesis of 4-(3-methanesulfonylphenyl)-1-N-propyl-piperidine
US20110206782A1 (en) * 2010-02-24 2011-08-25 Auspex Pharmaceuticals, Inc. Piperidine modulators of dopamine receptor
US9012476B2 (en) * 2011-12-08 2015-04-21 IVAX International GmbH Hydrobromide salt of pridopidine
JP6177875B2 (ja) * 2012-04-04 2017-08-09 テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハーTeva Pharmaceuticals International GmbH 併用療法のための医薬組成物
MX384234B (es) * 2013-06-21 2025-03-14 Prilenia Neurotherapeutics Ltd Uso de pridopidina para el tratamiento de enfermedad de huntington.
US20150202302A1 (en) 2014-01-22 2015-07-23 IVAX International GmbH Modified release formulations of pridopidine

Also Published As

Publication number Publication date
EA201691454A1 (ru) 2017-01-30
UA122053C2 (uk) 2020-09-10
EP3096759A4 (en) 2017-08-02
IL280485A (en) 2021-03-01
IL280485B1 (en) 2023-01-01
HUE058288T2 (hu) 2022-07-28
IL246598A0 (en) 2016-08-31
TW201605446A (zh) 2016-02-16
JP2017503823A (ja) 2017-02-02
JP6949487B2 (ja) 2021-10-13
KR20160125385A (ko) 2016-10-31
IL246598B (en) 2021-01-31
US20190209542A1 (en) 2019-07-11
ES2911800T3 (es) 2022-05-20
PL3096759T3 (pl) 2022-06-13
EP3096759A1 (en) 2016-11-30
IL280485B2 (en) 2023-05-01
US20240041855A1 (en) 2024-02-08
US20150202302A1 (en) 2015-07-23
MX377576B (es) 2025-03-04
CN106170287A (zh) 2016-11-30
WO2015112601A1 (en) 2015-07-30
MX2016009427A (es) 2016-12-08
KR102479759B1 (ko) 2022-12-21
CL2016001874A1 (es) 2017-05-12
AU2015209411A1 (en) 2016-09-01
JP7266298B2 (ja) 2023-04-28
DK3096759T3 (da) 2022-05-09
CA2937243A1 (en) 2015-07-30
EP4049657A1 (en) 2022-08-31
UY35962A (es) 2015-08-31
PE20161220A1 (es) 2016-11-23
JP2020023518A (ja) 2020-02-13
EP3096759B1 (en) 2022-04-06

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