CL2016001874A1 - Forma de dosificación oral sólida de liberación modificada que comprende pridopidina y un excipiente de control de velocidad; formulación farmacéutica que comprende a la forma de dosificación; uso de la forma de dosificación o de la formulación farmacéutica para tratar una enfermedad neurodegenerativa o relacionada con dopamina, como la enfermedad de huntington, entre otras. - Google Patents

Forma de dosificación oral sólida de liberación modificada que comprende pridopidina y un excipiente de control de velocidad; formulación farmacéutica que comprende a la forma de dosificación; uso de la forma de dosificación o de la formulación farmacéutica para tratar una enfermedad neurodegenerativa o relacionada con dopamina, como la enfermedad de huntington, entre otras.

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Publication number
CL2016001874A1
CL2016001874A1 CL2016001874A CL2016001874A CL2016001874A1 CL 2016001874 A1 CL2016001874 A1 CL 2016001874A1 CL 2016001874 A CL2016001874 A CL 2016001874A CL 2016001874 A CL2016001874 A CL 2016001874A CL 2016001874 A1 CL2016001874 A1 CL 2016001874A1
Authority
CL
Chile
Prior art keywords
dosage form
pharmaceutical formulation
disease
pridopidine
huntington
Prior art date
Application number
CL2016001874A
Other languages
English (en)
Inventor
Merav Bassan
Daniella Licht
Ioana Lovinger
Laura Yehudit Guilatt
Original Assignee
Teva Pharmaceuticals Int Gmbh
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Publication date
Family has litigation
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=CL2016001874(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceuticals Int Gmbh filed Critical Teva Pharmaceuticals Int Gmbh
Publication of CL2016001874A1 publication Critical patent/CL2016001874A1/es

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    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • 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
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse

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

Abstract

El problema abordado a través de la presente solicitud corresponde a proporcionar formulaciones farmacéuticas de pridopidina en dosis altas que reduzcan la frecuencia de los eventos adversos. Señalan que al impedir que la Cmax alcance valores muy altos, se pueden limitar los eventos adversos. Como solución proponen una forma de dosificación oral sólida de liberación modificada que comprende una cantidad efectiva de pridopidina, o una sal farmacéuticamente aceptable de la misma, y por lo menos un excipiente de control de velocidad farmacéuticamente aceptable. Además se divulga una formulación farmacéutica que comprende a la forma de dosificación, y el uso de la forma de dosificación o de la formulación farmacéutica en el tratamiento de una enfermedad neurodegenerativa o una enfermedad relacionada con dopamina como la enfermedad de Huntington, entre otras.
CL2016001874A 2014-01-22 2016-07-22 Forma de dosificación oral sólida de liberación modificada que comprende pridopidina y un excipiente de control de velocidad; formulación farmacéutica que comprende a la forma de dosificación; uso de la forma de dosificación o de la formulación farmacéutica para tratar una enfermedad neurodegenerativa o relacionada con dopamina, como la enfermedad de huntington, entre otras. CL2016001874A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461930358P 2014-01-22 2014-01-22
US201462050626P 2014-09-15 2014-09-15

Publications (1)

Publication Number Publication Date
CL2016001874A1 true CL2016001874A1 (es) 2017-05-12

Family

ID=53543863

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016001874A CL2016001874A1 (es) 2014-01-22 2016-07-22 Forma de dosificación oral sólida de liberación modificada que comprende pridopidina y un excipiente de control de velocidad; formulación farmacéutica que comprende a la forma de dosificación; uso de la forma de dosificación o de la formulación farmacéutica para tratar una enfermedad neurodegenerativa o relacionada con dopamina, como la enfermedad de huntington, entre otras.

Country Status (20)

Country Link
US (3) US20150202302A1 (es)
EP (2) EP4049657A1 (es)
JP (2) JP6949487B2 (es)
KR (1) KR102479759B1 (es)
CN (1) CN106170287A (es)
AU (1) AU2015209411A1 (es)
CA (1) CA2937243C (es)
CL (1) CL2016001874A1 (es)
DK (1) DK3096759T3 (es)
EA (1) EA201691454A1 (es)
ES (1) ES2911800T3 (es)
HU (1) HUE058288T2 (es)
IL (2) IL246598B (es)
MX (1) MX2016009427A (es)
PE (1) PE20161220A1 (es)
PL (1) PL3096759T3 (es)
TW (1) TW201605446A (es)
UA (1) UA122053C2 (es)
UY (1) UY35962A (es)
WO (1) WO2015112601A1 (es)

Families Citing this family (24)

* 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
US20130197031A1 (en) 2010-09-03 2013-08-01 IVAX International GmbH Deuterated analogs of pridopidine useful as dopaminergic stabilizers
UY34503A (es) 2011-12-08 2013-07-31 Ivax Int Gmbh ?sal de bromhidrato de pridopidina?
US11090297B2 (en) 2013-06-21 2021-08-17 Prilenia Neurotherapeutics Ltd. Pridopidine for treating huntington's disease
ES2879631T3 (es) 2013-06-21 2021-11-22 Prilenia Neurotherapeutics Ltd Pridopidina para el tratamiento de la enfermedad de Huntington
EP4049657A1 (en) 2014-01-22 2022-08-31 Prilenia Neurotherapeutics Ltd. Modified release formulations of pridopidine
TW201613859A (en) 2014-06-30 2016-04-16 Teva Pharma Analogs of PRIDOPIDINE, their preparation and use
US9796673B2 (en) 2014-12-22 2017-10-24 Teva Pharmaceuticals International Gmbh L-tartrate salt of pridopidine
HUE060353T2 (hu) 2015-02-25 2023-02-28 Prilenia Neurotherapeutics Ltd Pridopidin alkalmazása memória javítására
US11471449B2 (en) 2015-02-25 2022-10-18 Prilenia Neurotherapeutics Ltd. Use of pridopidine to improve cognitive function and for treating Alzheimer's disease
US20170020854A1 (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
WO2017147366A1 (en) * 2016-02-24 2017-08-31 Teva Pharmaceuticals International Gmbh Treatment of neurodegenerative eye disease using pridopidine
CA3151507C (en) 2016-08-24 2024-05-28 Prilenia Neurotherapeutics Ltd. Use of pridopidine for treating functional decline
CA3035099C (en) * 2016-08-24 2023-01-17 Prilenia Therapeutics Development Ltd. Use of pridopidine for treating dystonias
WO2018053280A1 (en) * 2016-09-16 2018-03-22 Teva Pharmaceuticals International Gmbh Use of pridopidine for treating rett syndrome
US12102627B2 (en) * 2016-09-16 2024-10-01 Prilenia Neurotherapeutics Ltd. Use of pridopidine for treating rett syndrome
CA3050700C (en) 2017-01-20 2023-10-03 Prilenia Neurotherapeutics Ltd. Use of pridopidine for the treatment of fragile x syndrome
FI3668509T3 (fi) 2017-08-14 2023-03-14 Prilenia Neurotherapeutics Ltd Menetelmä hoitaa amyotrofista lateraaliskleroosia pridopidiinilla
JP2020532517A (ja) * 2017-08-30 2020-11-12 プリレニア ニューロセラピューティクス リミテッド 高濃度プリドピジン製剤
EP3678664A1 (en) 2017-09-08 2020-07-15 Prilenia Neurotherapeutics Ltd. Pridopidine for treating drug induced dyskinesias
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
BR112021015346A2 (pt) * 2019-02-04 2021-10-05 Prilenia Neurotherapeutics Ltd. Uso de pridopidina de baixa dose para a doença de parkinson e outras doenças associadas ao parkinsonismo

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SE9904724D0 (sv) 1999-12-22 1999-12-22 Carlsson A Research Ab New modulators of dopamine neurotransmission I
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UY34503A (es) * 2011-12-08 2013-07-31 Ivax Int Gmbh ?sal de bromhidrato de pridopidina?
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EP4049657A1 (en) 2014-01-22 2022-08-31 Prilenia Neurotherapeutics Ltd. Modified release formulations of pridopidine

Also Published As

Publication number Publication date
EP3096759B1 (en) 2022-04-06
JP6949487B2 (ja) 2021-10-13
PE20161220A1 (es) 2016-11-23
JP7266298B2 (ja) 2023-04-28
KR102479759B1 (ko) 2022-12-21
TW201605446A (zh) 2016-02-16
IL246598B (en) 2021-01-31
US20240041855A1 (en) 2024-02-08
CA2937243A1 (en) 2015-07-30
PL3096759T3 (pl) 2022-06-13
CA2937243C (en) 2023-07-18
UY35962A (es) 2015-08-31
MX2016009427A (es) 2016-12-08
IL246598A0 (en) 2016-08-31
IL280485B2 (en) 2023-05-01
EP3096759A4 (en) 2017-08-02
EP3096759A1 (en) 2016-11-30
DK3096759T3 (da) 2022-05-09
JP2020023518A (ja) 2020-02-13
CN106170287A (zh) 2016-11-30
ES2911800T3 (es) 2022-05-20
IL280485A (en) 2021-03-01
IL280485B1 (en) 2023-01-01
US20150202302A1 (en) 2015-07-23
EA201691454A1 (ru) 2017-01-30
US20190209542A1 (en) 2019-07-11
JP2017503823A (ja) 2017-02-02
KR20160125385A (ko) 2016-10-31
AU2015209411A1 (en) 2016-09-01
WO2015112601A1 (en) 2015-07-30
EP4049657A1 (en) 2022-08-31
HUE058288T2 (hu) 2022-07-28
UA122053C2 (uk) 2020-09-10

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