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ME00083B - Farmaceutski oblik dronedarona za parenteralnu upotrebu - Google Patents

Farmaceutski oblik dronedarona za parenteralnu upotrebu

Info

Publication number
ME00083B
ME00083B MEP-2008-204A MEP2008204A ME00083B ME 00083 B ME00083 B ME 00083B ME P2008204 A MEP2008204 A ME P2008204A ME 00083 B ME00083 B ME 00083B
Authority
ME
Montenegro
Prior art keywords
pharmaceutical form
form according
metal
fact
cyclodextrin
Prior art date
Application number
MEP-2008-204A
Other languages
English (en)
French (fr)
Inventor
Seve Frederique Bourriague
Thierry Breul
Original Assignee
Sanofi Synthelabo
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 Sanofi Synthelabo filed Critical Sanofi Synthelabo
Publication of ME00083B publication Critical patent/ME00083B/me

Links

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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/06Antiarrhythmics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Abstract

Ovaj se pronalazak odnosi na farmaceutski oblik za parenteralnu upotrebu,okarakterisan je time što uključuje: dronedaron ili neku od njegovih farmaceutski prihvatljivih solikao aktivnog principa; fiziološki prihvatljiv puferovani rastvor koji održava pH farmaceutskogoblika između 3 i 5; fiziološki prihvatljiv u vodi rastvoran β-ciklodekstrinski derivat.

Claims (19)

1. Farmaceutski oblik za parenteralnu primenu, naznačen time što ukljucuje:- kao aktivni princip dronedaron ili jednu od njegovih farmaceutski prihvatljivih soli, fiziološki prihvatljivi puferski rastvor sposoban da održi pH rastvara izmežu 3 i 5,- fiziološki prihvatljivi u vodi rastvorni ciklodekstrinski derivat.
2. Farmaceutski oblik prema zahtevu l, naznacen time što ukljucuje 0,01% do 4% aktivnog principa.
3. Farmaceutski oblik prema zahtevu 2, naznacen time što ukljucuje 0,4% do 0,8% aktivnog prlnclpa.
4. Farmaceutski oblik prema nekom od zahteva l do 3, naznacen time što je puferski rastvor neki vodeni rastvor koji ukljucuje puferski sistem odabran od sledecih: - sircetna kiselina /acetatna so gde je metal alkalni metal, - furrama kiselina l furraratna so gde j e metal alkalni metal, - cilibama kiselina /sukcinatna so gde je metal alkalni metal, - limunska kiselina /citratna so gde je metal alkalni metal, - vinska kiselina /tartaratna so gde je metal alkalni metal, - mlecna kiselina /laktatna so gde je metal alkalni metal, - maleinska kiselina /maleatna so gde je metal alkalni metal, - metansulfonatna kiselina /metansulfonatna so gde je metal alkalni metal, - monofosfatna so gde je metal alkalni metal .
5. Farmaceutski oblik prema zahtevu 4, naznacen time što puferski sistem cini monofosfatna so gde je metal alkalni metal.
6. Farmaceutski oblik prema zahtevu 4, naznacen time što puferski rastvor monofosfatne soli gde je metal alkalni metal održava pH rastvora na 4,5.
7. Farmaceutski oblik prema nekom od zahteva l do 6, naznacen time što je vrednost jonske jacine puferovanog rastvara izmedu 0,005 molarne i 0,5 molarne.
8. Farmaceutski oblik prema zahtevu 7, naznacen je time što je vrednost jonske jacine puferovanog rastvara izmedu 0,01 molarne i 0,2 molarne.
9. Farmaceutski oblik prema zahtevima 7 ili 8, naznacen time što je vrednost jonske jacine puferovanog rastvara izmedu 0,05 i 0,15 molarne.
10. Farmaceutski oblik prema zahtevima l do 9, naznacen time što je puferovani rastvor 0,05 do 0,15 molarni vodeni rastvor monofosfatne soli gde je metal alkalni metal.
11. Farmaceutski oblik prema zahtevu 4, 5, 6 ili 10, naznacen time što je alkalni metal natrijum ili kalijum.
12. Farmaceutski oblik prema nekom od zahteva l do ll, naznacen time što je u vodi rastvorni β ciklodekstrinski derivat odabran izmedu hidroksipropil β-ciklodekstrina, sulfobutil etarskog derivata ciklodekstrina, dimetil-β-ciklodekstrina, trimetil-β ciklodekstrin, kao i njihovih smesa.
13. Farmaceutski oblik prema nekom od zahteva l do 12, naznacen time što je u vodi rastvorni β- ciklodekstrinski derivat hidroksipropil-P-ciklodekstrin.
14. Farmaceutski oblik prema nekom od zahteva l do 13, naznacen time što je u vodi rastvorni p-ciklodekstrinski derivat prisutan u odnosu od 0,5 do 50%.
15. Farmaceutski oblik prema nekom od zahteva l do 14, naznacen time što je u vodi rastvorni β ciklodekstrinski derivat prisutan u odnosu od 5 do 20 puta težine dronedarona ili neke od njegovih farmaceutski prihvatljivih soli.
16. Farmaceutski oblik prema zahtevu 15, naznacen time što je u vodi rastvorni P-ciklodekstrinski derivat prisutan u odnosu od 12 do 13 puta težine dronedarona ili neke od njegovih farmaceutski prihvatljivih soli.
17. Farmaceutski oblik prema nekom od zahteva l do 16, naznacen time što dodatno ukljucuje neko zaštitno sredstvo.
18. Farmaceutski oblik prema nekom od zahteva l do 17, naznacen time što dodatno ukljucuje neko jedinjenje koje omogucava održavanje izotonicnosti.
19. Farmaceutski oblik prema nekom od zahteva l do 18, naznacen time što je aktivni prlnclp dronedaron hidrohlorid. FARMACEUTSKI OBLIK DRONEDARONA ZA PARENTERALNO PRIMENU APSTRAKT
MEP-2008-204A 2000-12-11 2001-12-10 Farmaceutski oblik dronedarona za parenteralnu upotrebu ME00083B (me)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0016071A FR2817750B1 (fr) 2000-12-11 2000-12-11 Composition pharmaceutique de dronedarone pour administration parenterale
PCT/FR2001/003903 WO2002047660A1 (fr) 2000-12-11 2001-12-10 Composition pharmaceutique de dronedarone pour administration parenterale

Publications (1)

Publication Number Publication Date
ME00083B true ME00083B (me) 2010-10-10

Family

ID=8857483

Family Applications (2)

Application Number Title Priority Date Filing Date
MEP-204/08A MEP20408A (en) 2000-12-11 2001-12-10 Pharmaceutical dronedarone composition for parenteral administration
MEP-2008-204A ME00083B (me) 2000-12-11 2001-12-10 Farmaceutski oblik dronedarona za parenteralnu upotrebu

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MEP-204/08A MEP20408A (en) 2000-12-11 2001-12-10 Pharmaceutical dronedarone composition for parenteral administration

Country Status (30)

Country Link
US (1) US6939865B2 (me)
EP (1) EP1343473B1 (me)
JP (1) JP4399161B2 (me)
KR (1) KR100849758B1 (me)
CN (1) CN1235566C (me)
AR (1) AR031649A1 (me)
AT (1) ATE348599T1 (me)
AU (2) AU2002217229B2 (me)
BG (1) BG66187B1 (me)
BR (1) BR0116060B1 (me)
CA (1) CA2427375C (me)
CZ (1) CZ297788B6 (me)
DE (1) DE60125411T2 (me)
EA (1) EA005314B1 (me)
FR (1) FR2817750B1 (me)
HU (1) HU229372B1 (me)
IL (2) IL155428A0 (me)
IS (1) IS2349B (me)
MA (1) MA26969A1 (me)
ME (2) MEP20408A (me)
MX (1) MXPA03005221A (me)
NO (1) NO332294B1 (me)
NZ (1) NZ525661A (me)
OA (1) OA12416A (me)
PL (1) PL199846B1 (me)
RS (1) RS50348B (me)
SK (1) SK287115B6 (me)
TW (1) TWI246926B (me)
WO (1) WO2002047660A1 (me)
ZA (1) ZA200303406B (me)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR059574A1 (es) * 2006-02-14 2008-04-16 Wyeth Corp Formulaciones farmaceuticas acuosas de ligandos selectivos er-beta
GB0719180D0 (en) 2007-10-02 2007-11-14 Cambrex Karlskoga Ab New process
JP2011518785A (ja) * 2008-04-17 2011-06-30 サノフイ−アベンテイス 心血管入院または死亡の予防に用いる薬剤を調製するためのドロネダロンの使用
FR2930149B1 (fr) * 2008-04-17 2011-02-18 Sanofi Aventis Association de dronedarone avec au moins un diuretique, son application en therapeutique
EP2116239A1 (en) * 2008-04-29 2009-11-11 Sanofi-Aventis Method for managing the risks associated with an increase in serum creatinine during dronedarone treatment
FR2959132A1 (fr) * 2010-04-22 2011-10-28 Sanofi Aventis Procedes pour l'evaluation et la reduction des risques
TWI508726B (zh) 2009-12-21 2015-11-21 Gilead Sciences Inc 治療心房纖維性顫動之方法
US20120005128A1 (en) * 2010-06-29 2012-01-05 Sanofi Methods for reducing the risk of an adverse dronedarone / calcium channel blockers interaction in a patient suffering from atrial fibrilation
US8602215B2 (en) 2010-06-30 2013-12-10 Sanofi Methods for reducing the risk of an adverse dronedarone/beta-blockers interaction in a patient suffering from atrial fibrillation
CN102342907A (zh) 2010-07-30 2012-02-08 江苏恒瑞医药股份有限公司 决奈达隆固体分散体及其制备方法
KR20120094557A (ko) * 2011-02-01 2012-08-27 동아제약주식회사 피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제
CN102908307A (zh) * 2011-08-03 2013-02-06 天津市嵩锐医药科技有限公司 供注射用盐酸决奈达隆药物组合物及其制备方法
WO2014009500A1 (en) * 2012-07-12 2014-01-16 Sanofi Anti-tumoral composition comprising the compound 1-(6-{[6-(4-fluorophenyl)[1,2,4]triazolo[4,3-b]pyridazin-3-yl]sulfanyl}-1,3-benzothiazol-2-yl)-3-(2-morpholin-4-ylethyl)urea
CN114377148B (zh) * 2020-10-20 2023-09-29 上海博志研新药物研究有限公司 盐酸决奈达隆药物组合物、其制备方法及应用
CN115702878B (zh) * 2021-08-16 2024-05-10 上海云晟研新生物科技有限公司 盐酸决奈达隆注射组合物、其制备方法及应用
WO2024120458A1 (zh) * 2022-12-07 2024-06-13 荣昌生物制药(烟台)股份有限公司 TACI-Fc融合蛋白液体药物制剂

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
FR2746013B1 (fr) * 1996-03-18 1998-05-29 Sanofi Sa Utilisation de composes antiarythmiques dans la prevention de la mortalite post infarctus
JP2004327321A (ja) * 2003-04-25 2004-11-18 Jst Mfg Co Ltd コネクタ

Also Published As

Publication number Publication date
MEP20408A (en) 2010-06-10
EP1343473B1 (fr) 2006-12-20
KR20030060985A (ko) 2003-07-16
CN1235566C (zh) 2006-01-11
HU229372B1 (en) 2013-11-28
BR0116060A (pt) 2004-03-02
JP2004528277A (ja) 2004-09-16
FR2817750B1 (fr) 2003-02-21
MXPA03005221A (es) 2004-03-26
CZ20031612A3 (cs) 2003-09-17
US6939865B2 (en) 2005-09-06
DE60125411T2 (de) 2007-10-11
BR0116060B1 (pt) 2013-12-31
SK287115B6 (sk) 2009-12-07
AR031649A1 (es) 2003-09-24
OA12416A (fr) 2006-04-18
JP4399161B2 (ja) 2010-01-13
HUP0500842A2 (hu) 2005-12-28
AU1722902A (en) 2002-06-24
KR100849758B1 (ko) 2008-07-31
AU2002217229B2 (en) 2006-05-18
NO332294B1 (no) 2012-08-20
PL362788A1 (en) 2004-11-02
FR2817750A1 (fr) 2002-06-14
NZ525661A (en) 2004-11-26
IS2349B (is) 2008-04-15
ATE348599T1 (de) 2007-01-15
BG66187B1 (bg) 2011-12-30
NO20031958L (no) 2003-06-11
BG107748A (bg) 2004-03-31
US20040044070A1 (en) 2004-03-04
DE60125411D1 (de) 2007-02-01
YU46503A (sh) 2006-08-17
EP1343473A1 (fr) 2003-09-17
IL155428A0 (en) 2003-11-23
EA005314B1 (ru) 2004-12-30
EA200300406A1 (ru) 2003-10-30
CZ297788B6 (cs) 2007-03-28
PL199846B1 (pl) 2008-11-28
WO2002047660A1 (fr) 2002-06-20
RS50348B (sr) 2009-11-10
TWI246926B (en) 2006-01-11
CN1479610A (zh) 2004-03-03
ZA200303406B (en) 2004-05-03
CA2427375C (fr) 2011-02-01
MA26969A1 (fr) 2004-12-20
IL155428A (en) 2007-10-31
SK7262003A3 (en) 2004-02-03
HK1055906A1 (en) 2004-01-30
CA2427375A1 (fr) 2002-06-20
NO20031958D0 (no) 2003-04-29
IS6801A (is) 2003-04-30

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