BRPI0416109A - processo para preparação de composições de clopidogrel - Google Patents
processo para preparação de composições de clopidogrelInfo
- Publication number
- BRPI0416109A BRPI0416109A BRPI0416109-2A BRPI0416109A BRPI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A BR PI0416109 A BRPI0416109 A BR PI0416109A
- Authority
- BR
- Brazil
- Prior art keywords
- clopidogrel
- granules
- particles
- aggregates
- preparing
- Prior art date
Links
- 239000005552 B01AC04 - Clopidogrel Substances 0.000 title abstract 6
- GKTWGGQPFAXNFI-HNNXBMFYSA-N clopidogrel Chemical compound C1([C@H](N2CC=3C=CSC=3CC2)C(=O)OC)=CC=CC=C1Cl GKTWGGQPFAXNFI-HNNXBMFYSA-N 0.000 title abstract 6
- 229960003009 clopidogrel Drugs 0.000 title abstract 6
- 239000000203 mixture Substances 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 3
- 239000008187 granular material Substances 0.000 abstract 6
- 239000002245 particle Substances 0.000 abstract 6
- 239000012615 aggregate Substances 0.000 abstract 3
- 150000003839 salts Chemical group 0.000 abstract 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract 2
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 abstract 2
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical group CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000004372 Polyvinyl alcohol Substances 0.000 abstract 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 abstract 1
- 230000002209 hydrophobic effect Effects 0.000 abstract 1
- 229920002689 polyvinyl acetate Polymers 0.000 abstract 1
- 239000011118 polyvinyl acetate Substances 0.000 abstract 1
- 229920002451 polyvinyl alcohol Polymers 0.000 abstract 1
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
"PROCESSO PARA PREPARAçãO DE COMPOSIçõES DE CLOPIDOGREL". Esta invenção refere-se a uma composição adequada para administração oral, compreendendo clopidogrel em forma de sal farmaceuticamente aceitável, essa composição compreendendo: um revestimento polimérico selecionado em um acetato de polivinila ou um álcool polivinílico, e um componente hidrofóbico compreendendo um óleo vegetal hidrogenado, em que o sal é selecionado em mesilato, bromidrato, iodrato e cloridrato, e em que o clopidogrel está na forma de partículas, grânulos ou aglomerados revestidos. Em outro aspecto, a invenção apresenta um processo para a preparação de comprimidos compreendendo clopidogrel em forma de sal farmaceuticamente aceitável, esse processo compreendendo: a) a compactação do clopidrogrel com componentes anidros ou substancialmente anidros para formar agregados, b) a desintegração dos agregados para formar grânulos ou partículas, c) opcionalmente, a misturação dos grânulos ou partículas com pelo menos um componente adicional, e d) a compactação ou compressão dos grânulos ou partículas assim formadas em comprimidos, em que o clopidogrel é usado em forma de mesilato, bromidrato, iodrato ou cloridrato, e o processo adicionalmente compreende a misturação de um seqüestrante de umidade com os agregados, grânulos ou partículas. Uma etapa de revestimento de grânulos ou partículas pode ser incluída depois da etapa b) ou da etapa c), quando presente, e antes da etapa d).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0325603.9A GB0325603D0 (en) | 2003-11-03 | 2003-11-03 | Organic compounds |
| PCT/EP2004/012437 WO2005048992A1 (en) | 2003-11-03 | 2004-11-03 | Process for preparing clopidogrel compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0416109A true BRPI0416109A (pt) | 2007-01-02 |
Family
ID=29725839
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0416109-2A BRPI0416109A (pt) | 2003-11-03 | 2004-11-03 | processo para preparação de composições de clopidogrel |
Country Status (8)
| Country | Link |
|---|---|
| EP (1) | EP1682096A1 (pt) |
| JP (1) | JP2007527414A (pt) |
| CN (1) | CN101848705A (pt) |
| AU (1) | AU2004290511A1 (pt) |
| BR (1) | BRPI0416109A (pt) |
| CA (1) | CA2540965A1 (pt) |
| GB (1) | GB0325603D0 (pt) |
| WO (1) | WO2005048992A1 (pt) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005070464A2 (en) * | 2004-01-21 | 2005-08-04 | Biofarma Ilac Sanayi Ve Ticaret A.S. | A tablet formulation of clopidogrel bisulphate |
| CA2561006A1 (en) | 2004-04-20 | 2005-11-03 | Sanofi-Aventis | Clopidogrel salt and polymorphic forms thereof |
| KR20070012675A (ko) * | 2004-04-20 | 2007-01-26 | 사노피-아벤티스 | 메틸(+)-(Ｓ)-α-(2-클로로페닐)-6,7-디히드로티에노[3,2-Ｃ]피리딘-5(4Ｈ) 아세테이트 히드로브로마이드, 클로피도그렐히드로브로마이드의 다형성 형태 |
| CA2594763A1 (en) * | 2005-02-24 | 2006-08-31 | Teva Pharmaceutical Industries Ltd. | Clopidogrel base suitable for pharmaceutical formulation and preparation thereof |
| DE202005013839U1 (de) * | 2005-09-01 | 2005-10-27 | Helm Ag | Pharmazeutische Formulierung für Salze monobasischer Säuren mit Clopidogrel |
| WO2007054968A2 (en) * | 2005-09-20 | 2007-05-18 | Torrent Pahrmaceuticals Limited | Novel pharmaceutical compositions of clopidogrel mesylate |
| IS2385B (is) * | 2006-02-10 | 2008-07-15 | Actavis Group Hf. | Klópidógrel bísúlfat lyfjasamsetningar |
| CZ2006160A3 (cs) * | 2006-03-09 | 2007-09-05 | Zentiva, A. S | Farmaceutická kompozice clopidogrelu hydrogenbromidu |
| US20100145053A1 (en) * | 2006-04-05 | 2010-06-10 | Cadila Healthcare Limited | Modified release clopidogrel formulation |
| ES2342965T5 (es) | 2006-04-13 | 2013-04-03 | Acino Pharma Ag | Gliceridos parciales como lubricantes para composiciones farmacéuticas que contienen derviados de tieno(3,2-c)piridina |
| DE502006005452D1 (de) * | 2006-04-13 | 2010-01-07 | Rentschler Pharma Gmbh | Poloxamere als Schmiermittel für pharmazeutische Zusammensetzungen enthaltend ThienoÄ3,2-cÜpyridin-Derivate |
| WO2007128476A1 (en) * | 2006-05-04 | 2007-11-15 | Sandoz Ag | Pharmaceutical compositions containing clopidogrel hydrochloride |
| KR20080055355A (ko) * | 2006-12-15 | 2008-06-19 | 에스케이케미칼주식회사 | 보관안정성이 우수한 클로피도그렐 함유 포접 복합체 |
| KR20080055356A (ko) * | 2006-12-15 | 2008-06-19 | 에스케이케미칼주식회사 | 보관안정성이 우수한 클로피도그렐 함유 포접 복합체 |
| EP1970054A3 (en) | 2007-03-14 | 2009-06-03 | Ranbaxy Laboratories Limited | Clopidogrel tablets |
| WO2008129468A2 (en) * | 2007-04-20 | 2008-10-30 | Wockhardt Research Centre | Pharmaceutical compositions of clopidogrel |
| ES2376057T3 (es) * | 2008-02-26 | 2012-03-08 | Laboratorios Lesvi, S.L. | Formulaciones farmacéuticas que contienen clopidogrel. |
| EP2107061A1 (en) | 2008-04-02 | 2009-10-07 | Krka Tovarna Zdravil, D.D., Novo Mesto | Process for the preparation of optically enriched clopidogrel |
| DE602008002820D1 (de) | 2008-04-25 | 2010-11-11 | Sandoz Ag | Hydrogensulfat von 2-Acetoxy-5-(a-cyclopropylcarbonyl-2-fluorbenzyl)-4,5,6,7-tetrahydrothienoÄ3,2-cÜpyridin und dessen Zubereitung |
| WO2010094471A1 (en) | 2009-02-17 | 2010-08-26 | Krka, D. D., Novo Mesto | Pharmaceutical compositions comprising prasugrel base or its pharmaceutically acceptable acid addition salts and processes for their preparation |
| JP2013032289A (ja) * | 2009-10-28 | 2013-02-14 | Daiichi Sankyo Co Ltd | ワックス安定製剤 |
| ES2363964B1 (es) | 2009-11-20 | 2012-08-22 | Gp Pharm, S.A. | Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados. |
| CN101766573B (zh) | 2010-02-05 | 2013-02-13 | 上海安必生制药技术有限公司 | 硫酸氢氯吡格雷固体制剂的制备工艺 |
| CN101851247B (zh) * | 2010-06-04 | 2013-05-29 | 浙江华海药业股份有限公司 | 含有硫酸氢氯吡格雷晶体颗粒的组合物 |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2363053C (en) * | 2001-11-09 | 2011-01-25 | Bernard Charles Sherman | Clopidogrel bisulfate tablet formulation |
| WO2004074215A1 (en) * | 2003-02-03 | 2004-09-02 | Sunil Sadanand Nadkarni | Process for preparation of clopidogrel, its salts and pharmaceutical compositions |
-
2003
- 2003-11-03 GB GBGB0325603.9A patent/GB0325603D0/en not_active Ceased
-
2004
- 2004-11-03 AU AU2004290511A patent/AU2004290511A1/en not_active Abandoned
- 2004-11-03 JP JP2006537245A patent/JP2007527414A/ja not_active Withdrawn
- 2004-11-03 BR BRPI0416109-2A patent/BRPI0416109A/pt not_active Application Discontinuation
- 2004-11-03 WO PCT/EP2004/012437 patent/WO2005048992A1/en not_active Ceased
- 2004-11-03 CA CA002540965A patent/CA2540965A1/en not_active Abandoned
- 2004-11-03 CN CN200480032288A patent/CN101848705A/zh active Pending
- 2004-11-03 EP EP04797570A patent/EP1682096A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| GB0325603D0 (en) | 2003-12-10 |
| AU2004290511A1 (en) | 2005-06-02 |
| EP1682096A1 (en) | 2006-07-26 |
| CA2540965A1 (en) | 2005-06-02 |
| JP2007527414A (ja) | 2007-09-27 |
| CN101848705A (zh) | 2010-09-29 |
| WO2005048992A1 (en) | 2005-06-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| HRP20200046T1 (hr) | Formulacije apiksabana | |
| EA200900733A1 (ru) | ЗАМЕЩЁННЫЕ ПРОИЗВОДНЫЕ 2,3-ДИГИДРОИМИДАЗО[1,2-c]ХИНАЗОЛИНА, ПОЛЕЗНЫЕ ДЛЯ ЛЕЧЕНИЯ ГИПЕРПРОЛИФЕРАТИВНЫХ НАРУШЕНИЙ И БОЛЕЗНЕЙ, СВЯЗАННЫХ С АНГИОГЕНЕЗОМ | |
| WO2001085257A3 (en) | Opioid antagonist compositions and dosage forms | |
| MX2009002757A (es) | Formulacion de farmaco resistente al abuso. | |
| WO2014144661A4 (en) | Rapidly dispersible dosage form of topiramate | |
| WO2007126362A8 (en) | Compounds that are agonists of muscarinic receptors and that may be effective in treating pain, alzheimer's disease and/or schizophrenia | |
| BRPI0705488A (pt) | composição nanoparticulada estável, métodos de preparar a mesma e de prevenir e/ou tratar uma infecção bacteriana, composição farmacêutica, e, forma de dosagem | |
| BRPI0411165A (pt) | composição farmacêutica, forma de unidade de dosagem e métodos para preparar seu uso | |
| WO2009017838A3 (en) | Combinations of jak-2 inhibitors and other agents | |
| WO2007086914A3 (en) | Nanoparticulate clopidogrel formulations | |
| WO2011106416A3 (en) | Abuse-resistant formulations | |
| WO2006076620A3 (en) | Bendamustine pharmaceutical compositions for lyophilisation | |
| ITFI20100047A1 (it) | Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi. | |
| ZA200810124B (en) | Pharmaceutical combination comprising 3-(3-dimethyl-amino-1-ethyl-2-methyl-propyl)-phenol and Paracetamol | |
| BRPI0413693A (pt) | composição farmacêutica para a prevenção e tratamento da viciação em um mamìfero | |
| TWI386205B (zh) | Ｓｒｃ／ａｂｌ抑制劑之調配物 | |
| WO2008039615A3 (en) | Controlled release hydrogel formulation | |
| BR0307666A (pt) | Composição farmacêutica compreendendo n-[(1-n-butil-4-piperidinil)metil]-3,4-diidro-2h[1-3]oxazi no(3,2-a) indol-10-carboxamida ou sal e processo para esta compreendendo granulação seca | |
| CA2648538A1 (en) | Oral rapid release pharmaceutical formulation for pyridylmethylsulfinyl-benzimidazoles | |
| JP4521454B2 (ja) | フィルムコーティング錠剤 | |
| CA2157921C (en) | Pharmaceutical compositions comprising paracetamol and l-cysteine or a precursor thereof | |
| WO2008030512A3 (en) | Polystyrene sulfonate polymer tablets, their preparation and use | |
| WO2007140555A1 (en) | Pharmaceutical composition comprising cyclobenzaprine and aceclofenac in association | |
| HRP20171177T1 (hr) | Formulacija koja obuhvaća spoj benzotiazolona | |
| WO2007015270A3 (en) | Novel controlled release compositions of selective serotonin reuptake inhibitors |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B11A | Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing | ||
| B11Y | Definitive dismissal acc. article 33 of ipl - extension of time limit for request of examination expired |