HRP20140212T1 - Dvoslojna tableta koja sadrži telmisartan i amlodipin - Google Patents
Dvoslojna tableta koja sadrži telmisartan i amlodipin Download PDFInfo
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- HRP20140212T1 HRP20140212T1 HRP20140212TT HRP20140212T HRP20140212T1 HR P20140212 T1 HRP20140212 T1 HR P20140212T1 HR P20140212T T HRP20140212T T HR P20140212TT HR P20140212 T HRP20140212 T HR P20140212T HR P20140212 T1 HRP20140212 T1 HR P20140212T1
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- Prior art keywords
- tablet
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- concentrations
- telmisartan
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- 229940043097 telmisartan and amlodipine Drugs 0.000 title 1
- RMMXLENWKUUMAY-UHFFFAOYSA-N telmisartan Chemical compound CCCC1=NC2=C(C)C=C(C=3N(C4=CC=CC=C4N=3)C)C=C2N1CC(C=C1)=CC=C1C1=CC=CC=C1C(O)=O RMMXLENWKUUMAY-UHFFFAOYSA-N 0.000 claims 10
- 239000003795 chemical substances by application Substances 0.000 claims 8
- 210000002966 serum Anatomy 0.000 claims 8
- 239000005537 C09CA07 - Telmisartan Substances 0.000 claims 5
- 229960005187 telmisartan Drugs 0.000 claims 5
- 239000011159 matrix material Substances 0.000 claims 4
- HTIQEAQVCYTUBX-UHFFFAOYSA-N amlodipine Chemical compound CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl HTIQEAQVCYTUBX-UHFFFAOYSA-N 0.000 claims 3
- 229960000528 amlodipine Drugs 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- ZIIUUSVHCHPIQD-UHFFFAOYSA-N 2,4,6-trimethyl-N-[3-(trifluoromethyl)phenyl]benzenesulfonamide Chemical compound CC1=CC(C)=CC(C)=C1S(=O)(=O)NC1=CC=CC(C(F)(F)F)=C1 ZIIUUSVHCHPIQD-UHFFFAOYSA-N 0.000 claims 2
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 2
- 206010012289 Dementia Diseases 0.000 claims 2
- 208000032928 Dyslipidaemia Diseases 0.000 claims 2
- 108010010234 HDL Lipoproteins Proteins 0.000 claims 2
- 102000015779 HDL Lipoproteins Human genes 0.000 claims 2
- 206010019280 Heart failures Diseases 0.000 claims 2
- 208000017170 Lipid metabolism disease Diseases 0.000 claims 2
- 201000001068 Prinzmetal angina Diseases 0.000 claims 2
- 208000007718 Stable Angina Diseases 0.000 claims 2
- 208000006011 Stroke Diseases 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 206010012601 diabetes mellitus Diseases 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 208000010125 myocardial infarction Diseases 0.000 claims 2
- 201000009104 prediabetes syndrome Diseases 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 102000011690 Adiponectin Human genes 0.000 claims 1
- 108010076365 Adiponectin Proteins 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 108010074051 C-Reactive Protein Proteins 0.000 claims 1
- 102100032752 C-reactive protein Human genes 0.000 claims 1
- 208000024172 Cardiovascular disease Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 208000007342 Diabetic Nephropathies Diseases 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 208000002705 Glucose Intolerance Diseases 0.000 claims 1
- 206010018429 Glucose tolerance impaired Diseases 0.000 claims 1
- 108010023302 HDL Cholesterol Proteins 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- 206010022489 Insulin Resistance Diseases 0.000 claims 1
- FFFHZYDWPBMWHY-VKHMYHEASA-N L-homocysteine Chemical compound OC(=O)[C@@H](N)CCS FFFHZYDWPBMWHY-VKHMYHEASA-N 0.000 claims 1
- 108010028554 LDL Cholesterol Proteins 0.000 claims 1
- 238000008214 LDL Cholesterol Methods 0.000 claims 1
- 108010007622 LDL Lipoproteins Proteins 0.000 claims 1
- 102000007330 LDL Lipoproteins Human genes 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 108010033266 Lipoprotein(a) Proteins 0.000 claims 1
- 102000057248 Lipoprotein(a) Human genes 0.000 claims 1
- 108090001030 Lipoproteins Proteins 0.000 claims 1
- 102000004895 Lipoproteins Human genes 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- 102000015439 Phospholipases Human genes 0.000 claims 1
- 108010064785 Phospholipases Proteins 0.000 claims 1
- 239000004743 Polypropylene Substances 0.000 claims 1
- 208000001280 Prediabetic State Diseases 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 208000032109 Transient ischaemic attack Diseases 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 150000008044 alkali metal hydroxides Chemical class 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000002585 base Substances 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 230000006999 cognitive decline Effects 0.000 claims 1
- 208000010877 cognitive disease Diseases 0.000 claims 1
- 238000002425 crystallisation Methods 0.000 claims 1
- 230000008025 crystallization Effects 0.000 claims 1
- 230000003247 decreasing effect Effects 0.000 claims 1
- 208000033679 diabetic kidney disease Diseases 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 239000000975 dye Substances 0.000 claims 1
- 239000003995 emulsifying agent Substances 0.000 claims 1
- 239000011888 foil Substances 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 229920001903 high density polyethylene Polymers 0.000 claims 1
- 239000004700 high-density polyethylene Substances 0.000 claims 1
- 208000006575 hypertriglyceridemia Diseases 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 201000000083 maturity-onset diabetes of the young type 1 Diseases 0.000 claims 1
- 229960003194 meglumine Drugs 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- 150000002772 monosaccharides Chemical group 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 229920001542 oligosaccharide Polymers 0.000 claims 1
- 150000002482 oligosaccharides Chemical class 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- -1 polypropylene Polymers 0.000 claims 1
- 229920001155 polypropylene Polymers 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 238000009490 roller compaction Methods 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 235000010356 sorbitol Nutrition 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 150000005846 sugar alcohols Chemical class 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 201000010875 transient cerebral ischemia Diseases 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 1
Classifications
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- 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
- A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic 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
- A61K31/4164—1,3-Diazoles
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- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
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- Diabetes (AREA)
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- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Urology & Nephrology (AREA)
- Hospice & Palliative Care (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Claims (13)
1. Farmaceutska tableta, naznačena time, da obuhvaća prvi sloj od telmisartana u rastapajućoj tabletnoj matrici koja sadrži osnovno sredstvo odabrano od sljedećih: hidroksidi alkalijskog metala, osnovne aminokiseline i meglumin, zatim sadrži razrjeđivač topiv u vodi i po potrebi ostale pomoćne tvari i dopunska sredstva, te obuhvaća drugi sloj od amlodipina u tabletnoj matrici koja se rastavlja, primjerice dezintegrira ili erodira.
2. Tableta prema zahtjevu 1, naznačena time, da je telmisartan uglavnom u amorfnom obliku.
3. Tableta prema zahtjevu 1, naznačena time, da rastapajuća tabletna matrica ima svojstva trenutačnog oslobađanja.
4. Tableta prema zahtjevu 1, naznačena time, da je razrjeđivač topiv u vodi odabran od monosaharida kao što je glukoza; oligosaharida kao što su saharoza i laktoza; te od šećernih alkohola kao što su sorbitol, manitol i ksilitol.
5. Tableta prema zahtjevu 1, naznačena time, da su ostale pomoćne tvari i dopunska sredstva odabrani od sljedećih: veziva, nosači, punila, lubrikanti, protočna kontrolna sredstva, usporivači kristalizacije, otapala, bojila, pH-kontrolna sredstva, tenzidi i emulgatori.
6. Tableta prema zahtjevu 1, naznačena time, da se sastav prvog sloja tablete od telmisartana proizvodi pomoću sprej-sušenja vodene otopine koja sadrži telmisartan i osnovnu tvar, kako bi se dobio sprejem osušeni granulat, gdje se sprejem osušeni granulat miješa s razrjeđivačem topivim u vodi, kako bi se dobila predsmjesa koja se tada miješa s lubrikantom u svrhu dobivanja konačne smjese.
7. Tableta prema zahtjevu 1, naznačena time, da tabletna matrica drugog sloja, koja se rastavlja primjerice dezintegrira ili erodira, sadrži jedno ili više punila, sredstvo za dezintegraciju, lubrikant te opcijski vezivo, protočno kontrolno sredstvo ili ostale pomoćne tvari i dopunska sredstva.
8. Tableta prema zahtjevu 7, naznačena time, da se sastav drugog sloja tablete od amlodipina proizvodi pomoću izravnog stlačivanja, vlažne granulacije ili postupka sabijanja valjcima.
9. Tableta prema zahtjevu 7, naznačena time, da prvi sloj sadrži telmisartan u količini od 10 do 160 mg, poželjno od 20 do 80 mg ili od 40 do 80 mg.
10. Tableta prema zahtjevu 7, naznačena time, da drugi sloj sadrži amlodipin u količini od 1 do 20 mg, poželjno od 2,5 do 10 mg.
11. Tableta prema zahtjevu 7, naznačena time, da je ona pakirana u obložnom materijalu koji je otporan na vlagu kao što su to blister-pakiranja od aluminijske folije ili polipropilenske cjevčice i HDPE-bočice.
12. Postupak proizvodnje tablete prema zahtjevu 1, naznačen time, da se primjenjuje za liječenje hipertenzije i to samostalno ili u kombinaciji s liječenjem ili prevencijom stanja odabranih iz skupine koju čine: kronična stabilna angina, vazopastična angina, udar, infarkt miokarda, prolazni napad ishemije, kongestivni zastoj srca, kardiovaskularna bolest, dijabetes, otpornost na inzulin, pogoršana tolerancija glukoze, pred-dijabetes, dijabetes mellitus tipa 2, dijabetička nefropatija, metabolički sindrom (sindrom X), pretilost, dislipidemija, hipertrigliceridemija, povišene koncentracije C-reaktivnog proteina u serumu, povišene koncentracije lipoproteina (a) u serumu, povišene koncentracije homocisteina u serumu, povišene koncentracije lipoproteina niske gustoće (LDL-kolesterola) u serumu, povišene koncentracije fosfolipaze povezane s lipoproteinom (A2) u serumu, smanjene koncentracije lipoproteina visoke gustoće (HDL-kolesterola) u serumu, smanjene koncentracije HDL(2b)-kolesterola u serumu, smanjene koncentracije adiponektina u serumu, kognitivno propadanje i demencija.
13. Postupak prema zahtjevu 12, naznačen time, da stanje koje se liječi ili sprečava je kronična stabilna angina, vazopastična angina, udar, infarkt miokarda, kongestivni zastoj srca, dijabetes, dislipidemija ili demencija.
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| EP04026234 | 2004-11-05 | ||
| PCT/EP2005/011596 WO2006048208A1 (en) | 2004-11-05 | 2005-10-29 | Bilayer tablet comprising telmisartan and amlodipine |
Publications (1)
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| HRP20140212T1 true HRP20140212T1 (hr) | 2014-04-11 |
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| HRP20140212TT HRP20140212T1 (hr) | 2004-11-05 | 2014-03-10 | Dvoslojna tableta koja sadrži telmisartan i amlodipin |
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- 2005-10-29 PT PT58106527T patent/PT1814527E/pt unknown
- 2005-11-02 MY MYPI20055193 patent/MY150758A/en unknown
- 2005-11-02 US US11/265,722 patent/US20060110450A1/en not_active Abandoned
- 2005-11-03 PE PE2011000079A patent/PE20110216A1/es not_active Application Discontinuation
- 2005-11-03 UY UY29188A patent/UY29188A1/es not_active Application Discontinuation
- 2005-11-03 PE PE2005001289A patent/PE20061046A1/es not_active Application Discontinuation
- 2005-11-04 AR ARP050104624A patent/AR051618A1/es unknown
- 2005-11-04 TW TW094138683A patent/TWI355268B/zh not_active IP Right Cessation
-
2007
- 2007-03-13 ZA ZA200702119A patent/ZA200702119B/en unknown
- 2007-03-22 NO NO20071514A patent/NO20071514L/no not_active Application Discontinuation
- 2007-05-02 IL IL182926A patent/IL182926A/en active IP Right Grant
-
2014
- 2014-03-07 CY CY20141100180T patent/CY1114957T1/el unknown
- 2014-03-10 HR HRP20140212TT patent/HRP20140212T1/hr unknown
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