HRP20120072T1 - Farmaceutske formulacije koje sadrže klopidogrel - Google Patents

Farmaceutske formulacije koje sadrže klopidogrel Download PDF

Info

Publication number: HRP20120072T1
Authority: HR; Croatia
Prior art keywords: clopidogrel; preparation according; weight; preparation; pharmaceutically acceptable
Prior art date: 2008-02-26

Application number

HR20120072T

Other languages

English (en)

Croatian (hr)

Inventor

Diez Martin Ignacio

Ubeda P�rez Carmen

Aranzazu Arino Ros Maria

Original Assignee

Laboratorios Lesvi

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.)

2008-02-26

Filing date

2012-01-23

Publication date

2012-02-29

2012-01-23 Application filed by Laboratorios Lesvi filed Critical Laboratorios Lesvi

2012-02-29 Publication of HRP20120072T1 publication Critical patent/HRP20120072T1/hr

Links

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 claims 9
239000005552 B01AC04 - Clopidogrel Substances 0.000 title claims 7
229960003009 clopidogrel Drugs 0.000 title claims 7
239000008194 pharmaceutical composition Substances 0.000 title 1
150000003839 salts Chemical class 0.000 claims abstract 7
239000000203 mixture Substances 0.000 claims abstract 5
SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims abstract 2
239000000314 lubricant Substances 0.000 claims 5
229950010562 clopidogrel hydrobromide Drugs 0.000 claims 4
229950010477 clopidogrel hydrogen sulphate Drugs 0.000 claims 4
FDEODCTUSIWGLK-UHFFFAOYSA-N hydrogen sulfate;hydron;methyl 2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate Chemical compound OS(O)(=O)=O.C1CC=2SC=CC=2CN1C(C(=O)OC)C1=CC=CC=C1Cl FDEODCTUSIWGLK-UHFFFAOYSA-N 0.000 claims 4
QKLHYWAZTQRTBR-RSAXXLAASA-N methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate;hydrobromide Chemical compound Br.C1([C@H](N2CC=3C=CSC=3CC2)C(=O)OC)=CC=CC=C1Cl QKLHYWAZTQRTBR-RSAXXLAASA-N 0.000 claims 4
239000007884 disintegrant Substances 0.000 claims 3
229920002472 Starch Polymers 0.000 claims 2
229950010557 clopidogrel besilate Drugs 0.000 claims 2
239000008107 starch Substances 0.000 claims 2
GNWCZBXSKIIURR-UHFFFAOYSA-N (2-docosanoyloxy-3-hydroxypropyl) docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(CO)OC(=O)CCCCCCCCCCCCCCCCCCCCC GNWCZBXSKIIURR-UHFFFAOYSA-N 0.000 claims 1
SERLAGPUMNYUCK-YJOKQAJESA-N 6-O-alpha-D-glucopyranosyl-D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-YJOKQAJESA-N 0.000 claims 1
229920002261 Corn starch Polymers 0.000 claims 1
LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
235000021355 Stearic acid Nutrition 0.000 claims 1
229930006000 Sucrose Natural products 0.000 claims 1
SZYSLWCAWVWFLT-UTGHZIEOSA-N [(2s,3s,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)-2-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxolan-2-yl]methyl octadecanoate Chemical group O([C@@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@]1(COC(=O)CCCCCCCCCCCCCCCCC)O[C@H](CO)[C@@H](O)[C@@H]1O SZYSLWCAWVWFLT-UTGHZIEOSA-N 0.000 claims 1
239000003795 chemical substances by application Substances 0.000 claims 1
229950010560 clopidogrel hydrochloride Drugs 0.000 claims 1
239000008120 corn starch Substances 0.000 claims 1
235000014113 dietary fatty acids Nutrition 0.000 claims 1
238000007907 direct compression Methods 0.000 claims 1
238000007908 dry granulation Methods 0.000 claims 1
239000000194 fatty acid Substances 0.000 claims 1
229930195729 fatty acid Natural products 0.000 claims 1
150000004665 fatty acids Chemical class 0.000 claims 1
238000009472 formulation Methods 0.000 claims 1
XLYOFNOQVPJJNP-ZSJDYOACSA-N heavy water Substances [2H]O[2H] XLYOFNOQVPJJNP-ZSJDYOACSA-N 0.000 claims 1
239000008172 hydrogenated vegetable oil Substances 0.000 claims 1
239000001341 hydroxy propyl starch Substances 0.000 claims 1
239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
235000013828 hydroxypropyl starch Nutrition 0.000 claims 1
229960003511 macrogol Drugs 0.000 claims 1
238000000034 method Methods 0.000 claims 1
XIHVAFJSGWDBGA-RSAXXLAASA-N methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate;hydrochloride Chemical compound Cl.C1([C@H](N2CC=3C=CSC=3CC2)C(=O)OC)=CC=CC=C1Cl XIHVAFJSGWDBGA-RSAXXLAASA-N 0.000 claims 1
QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
229960000502 poloxamer Drugs 0.000 claims 1
229920001983 poloxamer Polymers 0.000 claims 1
229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
229920001592 potato starch Polymers 0.000 claims 1
229940069328 povidone Drugs 0.000 claims 1
235000019698 starch Nutrition 0.000 claims 1
239000008117 stearic acid Substances 0.000 claims 1
239000005720 sucrose Substances 0.000 claims 1
-1 sucrose ester Chemical class 0.000 claims 1
239000000454 talc Substances 0.000 claims 1
229910052623 talc Inorganic materials 0.000 claims 1
VOCBWIIFXDYGNZ-IXKNJLPQSA-N testosterone enanthate Chemical class C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCCCC)[C@@]1(C)CC2 VOCBWIIFXDYGNZ-IXKNJLPQSA-N 0.000 claims 1
238000005550 wet granulation Methods 0.000 claims 1
239000008203 oral pharmaceutical composition Substances 0.000 abstract 2
239000003085 diluting agent Substances 0.000 abstract 1
235000010439 isomalt Nutrition 0.000 abstract 1
239000000905 isomalt Substances 0.000 abstract 1
HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 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
- A61K9/2013—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
- 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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4365—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
- 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
- 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

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (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)
Cosmetics (AREA)

HR20120072T 2008-02-26 2012-01-23 Farmaceutske formulacije koje sadrže klopidogrel HRP20120072T1 (hr)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
EP08380057A EP2095815B1 (fr)	2008-02-26	2008-02-26	Formules pharmaceutiques contenant du clopidogrel

Publications (1)

Publication Number	Publication Date
HRP20120072T1 true HRP20120072T1 (hr)	2012-02-29

Family

ID=39561443

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
HR20120072T HRP20120072T1 (hr)	2008-02-26	2012-01-23	Farmaceutske formulacije koje sadrže klopidogrel

Country Status (6)

Country	Link
US (1)	US20090214646A1 (fr)
EP (1)	EP2095815B1 (fr)
AT (1)	ATE530172T1 (fr)
ES (1)	ES2376057T3 (fr)
HR (1)	HRP20120072T1 (fr)
PT (1)	PT2095815E (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
PL2467027T3 (pl) *	2009-08-18	2017-08-31	Cargill, Incorporated	Sposób sprasowania izomaltu
CN103181885A (zh) *	2011-12-30	2013-07-03	北京韩美药品有限公司	氯吡格雷的固体制剂及制备方法
HUP1400294A2 (hu)	2014-06-13	2015-12-28	Skillpharm Kft	Clopidogrel új alkalmazása

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
FR2530247B1 (fr) *	1982-07-13	1986-05-16	Sanofi Sa	Nouveaux derives de la thieno (3, 2-c) pyridine, leur procede de preparation et leur application therapeutique
FR2623810B2 (fr) *	1987-02-17	1992-01-24	Sanofi Sa	Sels de l'alpha-(tetrahydro-4,5,6,7 thieno(3,2-c) pyridyl-5) (chloro-2 phenyl) -acetate de methyle dextrogyre et compositions pharmaceutiques en contenant
FR2779726B1 (fr) *	1998-06-15	2001-05-18	Sanofi Sa	Forme polymorphe de l'hydrogenosulfate de clopidogrel
KR100768034B1 (ko) *	1999-03-17	2007-10-17	다이이찌 세이야꾸 가부시기가이샤	의약 조성물
CA2363053C (fr) *	2001-11-09	2011-01-25	Bernard Charles Sherman	Formulation pour pastilles de bisulfate de clopidogrel
GB2393181A (en)	2002-09-19	2004-03-24	Cipla Ltd	Amorphous clopidogrel
GB0325603D0 (en) *	2003-11-03	2003-12-10	Sandoz Ag	Organic compounds
WO2005070464A2 (fr)	2004-01-21	2005-08-04	Biofarma Ilac Sanayi Ve Ticaret A.S.	Formulation de comprimes de bisulfate de clopidogrel
WO2005103058A1 (fr)	2004-04-20	2005-11-03	Sanofi-Aventis	Formes polymorphes d'hydrobromure d'acetate de methyl(+)-(s)-$g(a)-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4h), hydrobromure de clopidrogel
KR20070009851A (ko)	2005-07-14	2007-01-19	씨제이 주식회사	클로피도그렐 황산수소염 함유 약학 조성물
KR20070044323A (ko)	2005-10-24	2007-04-27	에스케이케미칼주식회사	보관안정성이 개선된 클로피도그렐 황산수소염 함유 경구용제제
IS2385B (is)	2006-02-10	2008-07-15	Actavis Group Hf.	Klópidógrel bísúlfat lyfjasamsetningar
DE202006020892U1 (de)	2006-04-13	2010-10-21	Riemser Arzneimittel Ag	Partialglyceride als Schmiermittel für pharmazeutische Zusammensetzungen enthaltend Thieno[3,2-c]pyridin-Derivate

2008
- 2008-02-26 ES ES08380057T patent/ES2376057T3/es active Active
- 2008-02-26 AT AT08380057T patent/ATE530172T1/de not_active IP Right Cessation
- 2008-02-26 PT PT08380057T patent/PT2095815E/pt unknown
- 2008-02-26 EP EP08380057A patent/EP2095815B1/fr active Active
- 2008-04-28 US US12/110,555 patent/US20090214646A1/en not_active Abandoned
2012
- 2012-01-23 HR HR20120072T patent/HRP20120072T1/hr unknown

Also Published As

Publication number	Publication date
EP2095815A1 (fr)	2009-09-02
ATE530172T1 (de)	2011-11-15
ES2376057T3 (es)	2012-03-08
EP2095815B1 (fr)	2011-10-26
US20090214646A1 (en)	2009-08-27
PT2095815E (pt)	2012-02-03

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