HRP20120072T1 - Farmaceutske formulacije koje sadrže klopidogrel - Google Patents

Farmaceutske formulacije koje sadrže klopidogrel Download PDF

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Publication number
HRP20120072T1
HRP20120072T1 HR20120072T HRP20120072T HRP20120072T1 HR P20120072 T1 HRP20120072 T1 HR P20120072T1 HR 20120072 T HR20120072 T HR 20120072T HR P20120072 T HRP20120072 T HR P20120072T HR P20120072 T1 HRP20120072 T1 HR P20120072T1
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HR
Croatia
Prior art keywords
clopidogrel
preparation according
weight
preparation
pharmaceutically acceptable
Prior art date
Application number
HR20120072T
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English (en)
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.)
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Publication date
Application filed by Laboratorios Lesvi filed Critical Laboratorios Lesvi
Publication of HRP20120072T1 publication Critical patent/HRP20120072T1/hr

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Classifications

    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K31/4353Heterocyclic 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
    • A61K31/4365Heterocyclic 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
    • 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
    • A61K9/2013Organic 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
    • A61K9/20Pills, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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)

Abstract

Pripravak u obliku tablete, naznačen time što navedena tableta sadrži farmaceutski prihvatljivu sol klopidogrela i izomaltit. Patent sadrži još 18 patentnih zahtjeva.

Claims (19)

1. Pripravak u obliku tablete, naznačen time što navedena tableta sadrži farmaceutski prihvatljivu sol klopidogrela i izomaltit.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što se farmaceutski prihvatljivu sol klopidogrela bira iz skupine koju čine klopidogrela-hidrogensulfat, klopidogrel-hidrobromid, klopidogrel hidroklorid, klopidogrel-besilat, te klopidogrel-mesilat.
3. Pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je farmaceutski prihvatljiva sol klopidogrela klopidogrel-hidrobromid.
4. Pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je farmaceutski prihvatljiva sol klopidogrela klopidogrel-hidrogensulfat.
5. Pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je farmaceutski prihvatljiva sol klopidogrela klopidogrel-besilat.
6. Pripravak u skladu s patentnim zahtjevom 3, naznačen time što je Oblik A klopidogrel-hidrobromida klopidogrel-hidrobromida.
7. Pripravak u skladu s patentnim zahtjevom 4, naznačen time što je klopidogrel-hidrogensulfat Oblik 1 klopidogrel-hidrogensulfata.
8. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je količina izomaltita između 30 i 65%, težinski, poželjnije između 39 i 50%, težinski, u odnosu na ukupnu težinu pripravka.
9. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što se izomaltit tako bira da ima težinski odnos između 1,1-GPM·2H2O i 1,6-GPS između 1:6 i 4:1, poželjnije između 1:4 i 2:1.
10. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što dodatno sadrži mazivo, izborno pomiješano s talkom.
11. Pripravak u skladu s patentnim zahtjevom 10, naznačen time što se mazivo bira između jednog ili više od sljedećeg: glicerol-dibehenata, hidrogeniranih biljnih ulja, glicerol-mono/di/tripalmitatnih/stearatnih estera, makrogol 3000-6000, stearinske kiseline, poloksamera, te estera saharoze s masnim kiselinama.
12. Pripravak u skladu s patentnim zahtjevom 11, naznačen time što je mazivo saharozni stearat.
13. Pripravak u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačen time što količina maziva je 0,5-7%, težinski, poželjnije 1-5%, težinski, u odnosu na ukupnu težinu pripravka.
14. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što dodatno sadrži sredstvo za raspadanje.
15. Pripravak u skladu s patentnim zahtjevom 14, naznačen time što sredstvo za raspadanje se bira između jednog ili više od sljedećeg: umreženog povidona, hidroksipropilceluloze i drugih vrsta škroba, koje se bira između kukuruznog škroba, krumpirovog škroba, djelomičnog alfa-škroba i hidroksipropilškroba.
16. Pripravak u skladu s patentnim zahtjevom 14 ili 15, naznačen time što je količina sredstva za raspadanje 1 do 20%, težinski, a poželjnije 2 do 15%, težinski, u odnosu na ukupnu težinu pripravka.
17. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što sadrži sljedeću kvantitativnu formulaciju: – farmaceutski prihvatljiva sol klopidogrela: 25-50%, težinski – izomaltit: 30-65%, težinski – sredstvo za raspadanje: 1-20%, težinski – mazivo: 0,5-7%, težinski.
18. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je dodatno obložen filmom.
19. Postupak dobivanja pripravka u skladu s patentnim zahtjevima 1 do 17, naznačen time što ga se provodi izravnim komprimiranjem, vlažnim granuliranjem ili suhim granuliranjem njegovih komponenata.
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 (en) 2008-02-26 2008-02-26 Pharmaceutical formulations containing 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 (hr)
EP (1) EP2095815B1 (hr)
AT (1) ATE530172T1 (hr)
ES (1) ES2376057T3 (hr)
HR (1) HRP20120072T1 (hr)
PT (1) PT2095815E (hr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102480987B (zh) * 2009-08-18 2015-02-25 卡吉尔公司 压缩异麦芽糖酮醇的方法
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
CN1343128B (zh) * 1999-03-17 2010-04-21 第一制药株式会社 药物组合物
CA2363053C (en) * 2001-11-09 2011-01-25 Bernard Charles Sherman Clopidogrel bisulfate tablet formulation
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 (en) 2004-01-21 2005-08-04 Biofarma Ilac Sanayi Ve Ticaret A.S. A tablet formulation of clopidogrel bisulphate
CN1997648A (zh) * 2004-04-20 2007-07-11 赛诺菲-安万特 (+)-(S)-α-(2-氯苯基)-6,7-二氢噻吩并[3,2-C]吡啶-5(4H)乙酸甲酯氢溴酸盐,即氯吡格雷氢溴酸盐的多晶型物
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
ATE464881T1 (de) 2006-04-13 2010-05-15 Riemser Specialty Production Gmbh Partialglyceride als schmiermittel für pharmazeutische zusammensetzungen enthaltend thienoä3,2-cüpyridin-derivate

Also Published As

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

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