BR112013016818A2 - formulação - Google Patents
formulaçãoInfo
- Publication number
- BR112013016818A2 BR112013016818A2 BR112013016818A BR112013016818A BR112013016818A2 BR 112013016818 A2 BR112013016818 A2 BR 112013016818A2 BR 112013016818 A BR112013016818 A BR 112013016818A BR 112013016818 A BR112013016818 A BR 112013016818A BR 112013016818 A2 BR112013016818 A2 BR 112013016818A2
- Authority
- BR
- Brazil
- Prior art keywords
- granules
- composition
- particle size
- drying
- resulting
- Prior art date
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
- A61K31/55—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
- A61K9/14—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
- 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
- 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
- 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
formulação a invenção refere-se a uma composição farmacêutica sólida, cuja composição compreende acetato de eslicarbazepina e um ou mais excipientes farmaceuticamente aceitáveis, em que a composição está na forma de grânulos, e em que, pelo menos, 90% dos grânulos da composição têm um tamanho de partícula de 90 um ou mais, e/ou em que, pelo menos, 50% dos grânulos da composiçãp têm um tamanho de partícula de 250 um ou mais. a invenção refere-se também a um processo para produzir uma composição granulada compreendendo um agente farmaceuticamente ativo, cujo processo compreende: (1) granular uma mistura compreendendo um agente farmaceuticamente ativo e um ou mais excipientes farmaceuticamnte aceitáveis utilizando um primeiro líquido de granulação; (2) secar os grânulos formados em (1); (3) opcionalmente, calibrar o tamanho dos grânulos resultantes de (2); (4) granular os grânulos resultantes de (2) ou (3), utilizando um segundo líquido de granulação; (5) secar os grânulos formados em (4); (6) revestir os grânulos resultantes de (5), utilizando um líquido de revestimento; e (7) secar os grânulos revestidos formados em (6), em que, pelo menos, 90% dos grânulos revestidos que são produzidos têm um tamanho de partícula de 90 um ou mais e/ou em que, pelo menos, 50% dos grânulos revestidos que são produzidos têm um tamanho de partícula de 250 um ou mais. além disso, a invenção refere-se à utilização da composição em terapia e, em particular, no tratamento ou prevenção de um distúrbio selecionado de epilepsia, dor neuropática, enxaquecas, fibromialgia e distúrbios afetivos.
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 (1)
Publication Number | Publication Date |
---|---|
BR112013016818A2 true BR112013016818A2 (pt) | 2016-09-27 |
Family
ID=45509615
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112013016818A BR112013016818A2 (pt) | 2010-12-31 | 2011-12-30 | formulação |
Country Status (11)
Country | Link |
---|---|
US (1) | US20140302152A1 (pt) |
EP (1) | EP2658528A1 (pt) |
JP (1) | JP6133786B2 (pt) |
KR (1) | KR20130132572A (pt) |
AU (1) | AU2011353171A1 (pt) |
BR (1) | BR112013016818A2 (pt) |
CA (1) | CA2823512A1 (pt) |
MX (1) | MX350531B (pt) |
RU (1) | RU2625747C2 (pt) |
UA (1) | UA115420C2 (pt) |
WO (1) | WO2012091593A1 (pt) |
Families Citing this family (9)
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 |
EP2747770A1 (en) | 2011-08-26 | 2014-07-02 | 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 |
EP3402488B1 (en) | 2015-12-18 | 2021-10-27 | Jubilant Generics Limited | Solid oral dosage forms of eslicarbazepine |
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)
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 |
MX366496B (es) * | 2005-05-06 | 2019-07-11 | Bial Portela & Ca Sa | Metodos para preparar composiciones farmaceuticas que comprenden acetato de eslicarbazepina y metodos de uso. |
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 |
-
2011
- 2011-12-30 UA UAA201308508A patent/UA115420C2/uk unknown
- 2011-12-30 MX MX2013007491A patent/MX350531B/es active IP Right Grant
- 2011-12-30 EP EP11811186.3A patent/EP2658528A1/en not_active Withdrawn
- 2011-12-30 AU AU2011353171A patent/AU2011353171A1/en not_active Abandoned
- 2011-12-30 KR KR1020137020179A patent/KR20130132572A/ko not_active Application Discontinuation
- 2011-12-30 US US13/977,894 patent/US20140302152A1/en not_active Abandoned
- 2011-12-30 RU RU2013134749A patent/RU2625747C2/ru not_active IP Right Cessation
- 2011-12-30 BR BR112013016818A patent/BR112013016818A2/pt not_active IP Right Cessation
- 2011-12-30 WO PCT/PT2011/000048 patent/WO2012091593A1/en active Application Filing
- 2011-12-30 CA CA2823512A patent/CA2823512A1/en not_active Abandoned
- 2011-12-30 JP JP2013547384A patent/JP6133786B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
JP6133786B2 (ja) | 2017-05-24 |
MX350531B (es) | 2017-09-08 |
CA2823512A1 (en) | 2012-07-05 |
WO2012091593A8 (en) | 2013-08-22 |
JP2014501276A (ja) | 2014-01-20 |
UA115420C2 (uk) | 2017-11-10 |
US20140302152A1 (en) | 2014-10-09 |
RU2625747C2 (ru) | 2017-07-18 |
AU2011353171A1 (en) | 2013-07-11 |
RU2013134749A (ru) | 2015-02-10 |
MX2013007491A (es) | 2013-08-01 |
KR20130132572A (ko) | 2013-12-04 |
WO2012091593A1 (en) | 2012-07-05 |
EP2658528A1 (en) | 2013-11-06 |
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