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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.

Info

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
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=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

Links

Classifications

    • 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
    • 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
    • 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Psychology (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Anesthesiology (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) MX377576B (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)

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MX2013002453A (es) 2010-09-03 2013-08-01 Ivax Int Gmbh Analogos deuterados de pridopidina utiles como estabilizadores dopaminergicos.
CA2856749A1 (en) 2011-12-08 2013-06-13 IVAX International GmbH The hydrobromide salt of pridopidine
US11090297B2 (en) 2013-06-21 2021-08-17 Prilenia Neurotherapeutics Ltd. Pridopidine for treating huntington's disease
PE20160195A1 (es) 2013-06-21 2016-05-14 Teva Pharmaceuticals Int Gmbh Uso de pridopidina en dosis altas para el tratamiento de enfermedad de huntington
MX377576B (es) 2014-01-22 2025-03-04 Prilenia Neurotherapeutics Ltd Formulaciones de pridopidina de liberación modificada.
TW201613859A (en) 2014-06-30 2016-04-16 Teva Pharma Analogs of PRIDOPIDINE, their preparation and use
JP2018505147A (ja) 2014-12-22 2018-02-22 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 プリドピジンのl−酒石酸塩
US11471449B2 (en) 2015-02-25 2022-10-18 Prilenia Neurotherapeutics Ltd. Use of pridopidine to improve cognitive function and for treating Alzheimer's disease
CA2977264C (en) 2015-02-25 2021-12-07 Teva Pharmaceuticals International Gmbh Use of pridopidine to improve cognitive function and for treating alzheimer's disease
AR105434A1 (es) 2015-07-22 2017-10-04 Teva Pharmaceuticals Int Gmbh Proceso para preparar pridopidina
WO2017015615A1 (en) * 2015-07-22 2017-01-26 Teva Pharmaceuticals International Gmbh Pridopidine base formulations and their use
CA3015512C (en) * 2016-02-24 2024-01-16 Teva Pharmaceuticals International Gmbh Treatment of neurodegenerative eye disease using pridopidine
PL3504187T3 (pl) 2016-08-24 2025-06-09 Prilenia Neurotherapeutics Ltd. Stosowanie pridopidyny w leczeniu zaburzeń czynnościowych
DK3503890T3 (da) * 2016-08-24 2025-01-27 Prilenia Neurotherapeutics Ltd Anvendelse af pridopidin til behandling af dystonier
MX388845B (es) * 2016-09-16 2025-03-20 Prilenia Neurotherapeutics Ltd Uso de pridopidina para tratar el sindrome de rett.
US12102627B2 (en) 2016-09-16 2024-10-01 Prilenia Neurotherapeutics Ltd. Use of pridopidine for treating rett syndrome
PL3570940T3 (pl) 2017-01-20 2024-06-17 Prilenia Neurotherapeutics Ltd. Pridopidyna do zastosowania w leczeniu zespołu łamliwego chromosomu x
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Also Published As

Publication number Publication date
UY35962A (es) 2015-08-31
KR102479759B1 (ko) 2022-12-21
IL246598B (en) 2021-01-31
JP7266298B2 (ja) 2023-04-28
HUE058288T2 (hu) 2022-07-28
IL280485A (en) 2021-03-01
IL280485B1 (en) 2023-01-01
PL3096759T3 (pl) 2022-06-13
US20190209542A1 (en) 2019-07-11
PE20161220A1 (es) 2016-11-23
CN106170287A (zh) 2016-11-30
CA2937243A1 (en) 2015-07-30
CA2937243C (en) 2023-07-18
AU2015209411A1 (en) 2016-09-01
DK3096759T3 (da) 2022-05-09
EP4049657A1 (en) 2022-08-31
US20240041855A1 (en) 2024-02-08
US20150202302A1 (en) 2015-07-23
UA122053C2 (uk) 2020-09-10
KR20160125385A (ko) 2016-10-31
JP2017503823A (ja) 2017-02-02
IL246598A0 (en) 2016-08-31
IL280485B2 (en) 2023-05-01
JP2020023518A (ja) 2020-02-13
MX377576B (es) 2025-03-04
WO2015112601A1 (en) 2015-07-30
EP3096759A4 (en) 2017-08-02
EP3096759A1 (en) 2016-11-30
EP3096759B1 (en) 2022-04-06
TW201605446A (zh) 2016-02-16
EA201691454A1 (ru) 2017-01-30
MX2016009427A (es) 2016-12-08
JP6949487B2 (ja) 2021-10-13
ES2911800T3 (es) 2022-05-20

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