HRP20130108T1 - Farmaceutski sastav koji sadrži aleglitazar - Google Patents

Farmaceutski sastav koji sadrži aleglitazar Download PDF

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Publication number
HRP20130108T1
HRP20130108T1 HRP20130108AT HRP20130108T HRP20130108T1 HR P20130108 T1 HRP20130108 T1 HR P20130108T1 HR P20130108A T HRP20130108A T HR P20130108AT HR P20130108 T HRP20130108 T HR P20130108T HR P20130108 T1 HRP20130108 T1 HR P20130108T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical composition
sodium
aleglitazar
salt
solution
Prior art date
Application number
HRP20130108AT
Other languages
English (en)
Inventor
Alexander Glomme
Paul Wojtera
Original Assignee
F. Hoffmann - La Roche Ag
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 F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20130108T1 publication Critical patent/HRP20130108T1/hr

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Classifications

    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42Oxazoles
    • A61K31/422Oxazoles not condensed and containing further heterocyclic rings
    • 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Claims (17)

1. Farmaceutski sastav, naznačen time, da sadrži 0,01 mg do 0,9 mg aleglitazara ili njegove soli, koji se dobiva pomoću: (a) raspršivanja otopine, koja sadrži aleglitazar ili njegovu sol, na razrjeđivač i dezintegrator; (b) miješanja s lubrikantom sastava dobivenog u koraku (a); i (c) opcijski stlačivanja sastava dobivenog u koraku (b).
2. Postupak za proizvodnju farmaceutskog sastava, koji sadrži 0,01 mg do 0,9 mg aleglitazara ili njegove soli, naznačen time, da obuhvaća: (a) raspršivanje otopine, koja sadrži aleglitazar ili njegovu sol, na razrjeđivač i dezintegrator; (b) miješanje s lubrikantom sastava dobivenog u koraku (a); i (c) opcijski stlačivanje sastava dobivenog u koraku (b).
3. Farmaceutski sastav ili postupak prema zahtjevu 1 ili 2, naznačen time, da otopina iz koraka (a) je vodena otopina.
4. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 3, naznačen time, da je otopina iz koraka (a) puferirana s fosfatnim puferom.
5. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 4, naznačen time, da je razrjeđivač odabran između šećera, mikrokristalične celuloze, laktoze, škroba i njihovih mješavina.
6. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 5, naznačen time, da otopina iz koraka (a) obuhvaća vezivo odabrano između povidona, HPMC-a i preželatiniziranog škroba.
7. Farmaceutski sastav ili postupak prema zahtjevu 6, naznačen time, da vezivo je povidon.
8. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da otopina iz koraka (a) obuhvaća tenzid odabran između tween 80, polioksietilen-polioksipropilen kopolimera i natrijevog lauril sulfata.
9. Farmaceutski sastav ili postupak prema zahtjevu 8, naznačen time, da tenzid je natrijev lauril sulfat.
10. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 9, naznačen time, da je dezintegrator odabran između križno povezanog polivinil pirolidona, škroba, kroskarmeloze-natrij, natrijeve karboksimetil celuloze i natrijevog škrobnog glikolata.
11. Farmaceutski sastav ili postupak prema zahtjevu 10, naznačen time, da dezintegrator je kroskarmeloza-natrij.
12. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 11, naznačen time, da je lubrikant odabran između stearinske kiseline, magnezijevog stearata, gliceril behenata i natrijevog stearil fumarata.
13. Farmaceutski sastav ili postupak prema zahtjevu 12, naznačen time, da lubrikant je magnezijev stearat.
14. Farmaceutski sastav ili postupak prema bilo kojem od zahtjeva 1 do 13, naznačen time, da obuhvaća natrijevu sol od aleglitazara.
15. Farmaceutski sastav, naznačen time, da obuhvaća: aleglitazar ili njegovu natrijevu sol 0,01 – 0,9 mg dinatrijev fosfat 1 – 1,5 mg natrijev dihidrogen fosfat 0,01 – 0,3 mg natrijev lauril sulfat 0,1 – 2 mg povidon 0,1 – 20 mg laktoza 20 – 110 mg mikrokristalična celuloza 5 – 100 mg kroskarmeloza-natrij 0,5 – 20 mg magnezijev stearat 0,5 – 3 mg.
16. Farmaceutski sastav prema bilo kojem od zahtjeva 1 ili 3 do 15, naznačen time, da je u obliku tablete.
17. Farmaceutski sastav prema bilo kojem od zahtjeva 1 ili 3 do 16, naznačen time, da se upotrebljava kao lijek za liječenje ili profilaksu dijabetesa tipa II ili kardiovaskularnih bolesti.
HRP20130108AT 2009-01-23 2013-02-07 Farmaceutski sastav koji sadrži aleglitazar HRP20130108T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09151254 2009-01-23
PCT/EP2010/050343 WO2010084066A1 (en) 2009-01-23 2010-01-13 Pharmaceutical composition comprising aleglitazar

Publications (1)

Publication Number Publication Date
HRP20130108T1 true HRP20130108T1 (hr) 2013-03-31

Family

ID=42112184

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130108AT HRP20130108T1 (hr) 2009-01-23 2013-02-07 Farmaceutski sastav koji sadrži aleglitazar

Country Status (25)

Country Link
US (2) US20100190835A1 (hr)
EP (1) EP2389166B1 (hr)
JP (1) JP5619027B2 (hr)
KR (2) KR20110105798A (hr)
CN (1) CN102292074B (hr)
AR (1) AR075041A1 (hr)
AU (1) AU2010206249B2 (hr)
BR (1) BRPI1007237B1 (hr)
CA (1) CA2748896C (hr)
CL (1) CL2011001777A1 (hr)
CY (1) CY1113641T1 (hr)
DK (1) DK2389166T3 (hr)
ES (1) ES2397558T3 (hr)
HR (1) HRP20130108T1 (hr)
IL (1) IL213671A (hr)
MX (1) MX2011007381A (hr)
PE (2) PE20160746A1 (hr)
PL (1) PL2389166T3 (hr)
PT (1) PT2389166E (hr)
RU (1) RU2537224C2 (hr)
SG (1) SG173058A1 (hr)
SI (1) SI2389166T1 (hr)
TW (1) TWI406861B (hr)
WO (1) WO2010084066A1 (hr)
ZA (1) ZA201104670B (hr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013181384A1 (en) 2012-05-31 2013-12-05 Ratiopharm Gmbh Solid state forms of aleglitazar sodium
WO2014016369A1 (en) 2012-07-27 2014-01-30 Ratiopharm Gmbh Pharmaceutical formulation comprising aleglitazar and complexing agent
WO2014016371A1 (en) 2012-07-27 2014-01-30 Ratiopharm Gmbh Micronized aleglitazar
WO2014016370A1 (en) * 2012-07-27 2014-01-30 Ratiopharm Gmbh Amorphous aleglitazar
CA2879500A1 (en) * 2012-09-12 2014-03-20 F. Hoffmann-La Roche Ag Solid forms of (s)-2-methoxy-3-{4-[2-(5-methyl-2-phenyl-oxazol-4-yl)-ethoxy]-benzo[b]thiophen-7-yl}-propionic acid and of salts thereof
IL293480B2 (en) * 2016-08-10 2024-02-01 Hoffmann La Roche Medical preparations containing AKT protein kinase inhibitors
CN114404375B (zh) * 2022-01-21 2023-06-27 武汉九珑人福药业有限责任公司 一种叶酸固体制剂及其原料组合物、制备方法和应用

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2772615B1 (fr) * 1997-12-23 2002-06-14 Lipha Comprime multicouche pour la liberation instantanee puis prolongee de substances actives
MXPA03010435A (es) * 2001-05-15 2004-03-09 Hoffmann La Roche Derivados de oxazol acido carboxilico sustituidos para uso como activadores de proliferacion del peroximosa(ppar-alfa y gama) en el tratamiento de diabetes.
GB0303600D0 (en) * 2003-02-17 2003-03-19 Glaxo Group Ltd Novel therapeutic method and compositions
US7262303B2 (en) * 2003-09-29 2007-08-28 Hoffman-La Roche Inc. Process for the production of chiral propionic acid derivatives
US20060051413A1 (en) * 2004-09-08 2006-03-09 Chow Sing S M Method of enhancing absorptions of transmucosal administration formulations
BRPI0606187A2 (pt) * 2005-02-25 2009-06-09 Hoffmann La Roche comprimidos com capacidade de dispersão da substáncia do fármaco melhorada
US20060270722A1 (en) * 2005-05-31 2006-11-30 Thornberry Nancy A Combination of a dipeptidyl peptidase-IV inhibitor and a dual PPAR agonist for the treatment of diabetes and obesity
FR2894477A1 (fr) * 2005-12-13 2007-06-15 Galderma Res & Dev Utilisation du naveglitazar pour la preparation d'une composition pharmaceutique destinee au traitement des affections dermatologiques
US20100210692A1 (en) * 2007-03-28 2010-08-19 Farmer Stephen R Methods of treatment using sirt modulators and compositions containing sirt1 modulators

Also Published As

Publication number Publication date
CL2011001777A1 (es) 2012-02-24
US20130072529A1 (en) 2013-03-21
TW201035089A (en) 2010-10-01
JP2012515741A (ja) 2012-07-12
SI2389166T1 (sl) 2013-02-28
BRPI1007237B1 (pt) 2019-05-28
TWI406861B (zh) 2013-09-01
CY1113641T1 (el) 2016-06-22
CA2748896C (en) 2017-01-03
PT2389166E (pt) 2013-01-08
IL213671A0 (en) 2011-07-31
AR075041A1 (es) 2011-03-02
SG173058A1 (en) 2011-08-29
CN102292074A (zh) 2011-12-21
WO2010084066A1 (en) 2010-07-29
BRPI1007237A2 (pt) 2016-02-16
ES2397558T3 (es) 2013-03-07
AU2010206249A1 (en) 2011-06-30
PL2389166T3 (pl) 2013-04-30
US20100190835A1 (en) 2010-07-29
RU2011134964A (ru) 2013-02-27
KR20110105798A (ko) 2011-09-27
JP5619027B2 (ja) 2014-11-05
EP2389166B1 (en) 2012-11-21
DK2389166T3 (da) 2012-12-17
RU2537224C2 (ru) 2014-12-27
CA2748896A1 (en) 2010-07-29
MX2011007381A (es) 2011-08-12
KR20140002812A (ko) 2014-01-08
PE20160746A1 (es) 2016-08-01
CN102292074B (zh) 2013-08-21
PE20120421A1 (es) 2012-05-04
AU2010206249B2 (en) 2015-07-09
EP2389166A1 (en) 2011-11-30
ZA201104670B (en) 2012-03-28
IL213671A (en) 2015-11-30

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