MX350531B - Granulados que comprenden acetato de eslicarbazepina. - Google Patents

Granulados que comprenden acetato de eslicarbazepina.

Info

Publication number
MX350531B
MX350531B MX2013007491A MX2013007491A MX350531B MX 350531 B MX350531 B MX 350531B MX 2013007491 A MX2013007491 A MX 2013007491A MX 2013007491 A MX2013007491 A MX 2013007491A MX 350531 B MX350531 B MX 350531B
Authority
MX
Mexico
Prior art keywords
composition
granules
relates
eslicarbazepine acetate
granulates
Prior art date
Application number
MX2013007491A
Other languages
English (en)
Other versions
MX2013007491A (es
Inventor
Cardoso De Vasconcelos Teófilo
Jorge Dos Santos Lima Ricardo
Cerdeira De Campos Costa Rui
Miguel Da Costa Barrocas Pedro
Sofia De Castro Pereira Lígia
Cristina De Almeida Jerónimo Paula
Original Assignee
BIAL PORTELA & Cª S A
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
Application filed by BIAL PORTELA & Cª S A filed Critical BIAL PORTELA & Cª S A
Publication of MX2013007491A publication Critical patent/MX2013007491A/es
Publication of MX350531B publication Critical patent/MX350531B/es

Links

Classifications

    • 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
    • A61K9/1682—Processes
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La invención se refiere a una composición farmacéutica sólida, la composición que comprende acetato de eslicarbazepina y uno o más excipientes farmacéuticamente aceptables, en donde la composición está en la forma de gránulos, y en donde al menos 90 % de los gránulos de la composición tienen un tamaño de partícula de 90 µm o más, y/o en donde al menos 50 % de los gránulos de la composición tienen un tamaño de partícula de 250 µm o más. La composición también se refiere a un proceso para producir una composición granular. Adicionalmente, la invención se refiere al uso de la composición en terapia y en particular en el tratamiento o prevención de un trastorno seleccionado de epilepsia, dolor neuropático, migraña, fibromialgia y trastornos afectivos.
MX2013007491A 2010-12-31 2011-12-30 Granulados que comprenden acetato de eslicarbazepina. MX350531B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201061428905P 2010-12-31 2010-12-31
PCT/PT2011/000048 WO2012091593A1 (en) 2010-12-31 2011-12-30 Granulates comprising eslicarbazepine acetate

Publications (2)

Publication Number Publication Date
MX2013007491A MX2013007491A (es) 2013-08-01
MX350531B true MX350531B (es) 2017-09-08

Family

ID=45509615

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013007491A MX350531B (es) 2010-12-31 2011-12-30 Granulados que comprenden acetato de eslicarbazepina.

Country Status (11)

Country Link
US (1) US20140302152A1 (es)
EP (1) EP2658528A1 (es)
JP (1) JP6133786B2 (es)
KR (1) KR20130132572A (es)
AU (1) AU2011353171A1 (es)
BR (1) BR112013016818A2 (es)
CA (1) CA2823512A1 (es)
MX (1) MX350531B (es)
RU (1) RU2625747C2 (es)
UA (1) UA115420C2 (es)
WO (1) WO2012091593A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060252745A1 (en) 2005-05-06 2006-11-09 Almeida Jose L D Methods of preparing pharmaceutical compositions comprising eslicarbazepine acetate and methods of use
WO2013032351A1 (en) 2011-08-26 2013-03-07 BIAL - PORTELA & Cª, S.A. Treatments involving eslicarbazepine acetate or eslicarbazepine
US20140099426A1 (en) * 2012-10-10 2014-04-10 Pharmavite Llc Natural coating formulas and composition for coating tablets
GB201306095D0 (en) * 2013-04-04 2013-05-22 Bial Portela & Ca Sa New treatments
FR3027802B1 (fr) * 2014-10-31 2018-03-02 Ethypharm Granules de principe actif a double masquage de gout, leur procede de preparation et comprimes orodispersibles les contenant
RU2686694C2 (ru) * 2015-10-01 2019-04-30 Закрытое Акционерное Общество "Фармфирма "Сотекс" Комбинированный лекарственный препарат в форме шипучих таблеток и способ его получения
HUE057788T2 (hu) 2015-12-18 2022-06-28 Jubilant Generics Ltd Eslikarbazepin szilárd orális dózisformái
WO2019058353A1 (en) 2017-09-25 2019-03-28 Jubilant Generics Limited MODIFIED RELEASE SUSPENSION OF ESLICARBAZEPINE
CN112546006B (zh) * 2020-12-25 2022-10-14 河北医科大学第二医院 一种治疗神经疾病的药物组合物及其制备方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5831972B2 (ja) * 1980-01-17 1983-07-09 塩野義製薬株式会社 粒剤の製造法
PT101732B (pt) 1995-06-30 1997-12-31 Portela & Ca Sa Novas di-hidrodibenzo<b,f>azepinas substituidas processo para a sua preparacao composicoes farmaceuticas que as contem e utilizacao dos novos compostos na preparacao de composicoes farmaceuticas empregues em doencas do sistema nervoso
AR048672A1 (es) * 2004-03-22 2006-05-17 Novartis Ag Tabletas de desintegracion que comprenden licarbazepina
BRPI0520258A2 (pt) * 2005-05-06 2009-09-15 Portela & Ca Sa uso de uma composição farmacêutica, método para preparar uma composição farmacêutica, e, uso de uma quantidade eficaz de acetato de eslicarbazepina
US8372431B2 (en) * 2007-10-26 2013-02-12 Bial-Portela & C.A., S.A. Pharmaceutical composition comprising licarbazepine acetate
US20100323016A1 (en) * 2008-07-18 2010-12-23 Biljana Nadjsombati Modified release formulation and methods of use

Also Published As

Publication number Publication date
WO2012091593A1 (en) 2012-07-05
EP2658528A1 (en) 2013-11-06
JP2014501276A (ja) 2014-01-20
CA2823512A1 (en) 2012-07-05
US20140302152A1 (en) 2014-10-09
AU2011353171A1 (en) 2013-07-11
JP6133786B2 (ja) 2017-05-24
BR112013016818A2 (pt) 2016-09-27
RU2013134749A (ru) 2015-02-10
KR20130132572A (ko) 2013-12-04
MX2013007491A (es) 2013-08-01
RU2625747C2 (ru) 2017-07-18
WO2012091593A8 (en) 2013-08-22
UA115420C2 (uk) 2017-11-10

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