HRP20230178T3 - Farmaceutski pripravci temeljeni na nadgradnjama antagonista/blokatora angiotenzinskog receptora (arb) i inhibitoru neutralne endopeptidaze (nep) - Google Patents
Farmaceutski pripravci temeljeni na nadgradnjama antagonista/blokatora angiotenzinskog receptora (arb) i inhibitoru neutralne endopeptidaze (nep)Info
- Publication number
- HRP20230178T3 HRP20230178T3 HRP20230178TT HRP20230178T HRP20230178T3 HR P20230178 T3 HRP20230178 T3 HR P20230178T3 HR P20230178T T HRP20230178T T HR P20230178TT HR P20230178 T HRP20230178 T HR P20230178T HR P20230178 T3 HRP20230178 T3 HR P20230178T3
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- oral dosage
- solid oral
- form according
- weight
- Prior art date
Links
- 102000003729 Neprilysin Human genes 0.000 title 1
- 108090000028 Neprilysin Proteins 0.000 title 1
- 229940127282 angiotensin receptor antagonist Drugs 0.000 title 1
- 229940125364 angiotensin receptor blocker Drugs 0.000 title 1
- 239000003112 inhibitor Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000006186 oral dosage form Substances 0.000 claims 40
- 239000007787 solid Substances 0.000 claims 33
- 239000011248 coating agent Substances 0.000 claims 14
- 238000000576 coating method Methods 0.000 claims 14
- 238000002360 preparation method Methods 0.000 claims 11
- 239000002253 acid Substances 0.000 claims 9
- USAWIVMZUYOXCF-UHFFFAOYSA-N Valsartan metabolite Chemical compound C1=CC(C(=O)O)=CC=C1C1=CC=CC=C1C1=NNN=N1 USAWIVMZUYOXCF-UHFFFAOYSA-N 0.000 claims 8
- 150000001875 compounds Chemical class 0.000 claims 8
- 239000000546 pharmaceutical excipient Substances 0.000 claims 8
- 239000004072 C09CA03 - Valsartan Substances 0.000 claims 7
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims 7
- 229960004699 valsartan Drugs 0.000 claims 7
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 5
- 239000011230 binding agent Substances 0.000 claims 5
- 229960000913 crospovidone Drugs 0.000 claims 5
- 239000002552 dosage form Substances 0.000 claims 5
- 239000000314 lubricant Substances 0.000 claims 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- 239000001913 cellulose Substances 0.000 claims 4
- 239000007884 disintegrant Substances 0.000 claims 4
- 238000004090 dissolution Methods 0.000 claims 4
- 239000000945 filler Substances 0.000 claims 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 4
- 238000000338 in vitro Methods 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 3
- 229920002472 Starch Polymers 0.000 claims 3
- 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 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 3
- 239000008363 phosphate buffer Substances 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 235000019698 starch Nutrition 0.000 claims 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims 2
- FERIUCNNQQJTOY-UHFFFAOYSA-M Butyrate Chemical compound CCCC([O-])=O FERIUCNNQQJTOY-UHFFFAOYSA-M 0.000 claims 2
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Natural products CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 2
- 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 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 238000010521 absorption reaction Methods 0.000 claims 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 2
- 239000011575 calcium Substances 0.000 claims 2
- 229910052791 calcium Inorganic materials 0.000 claims 2
- 235000010980 cellulose Nutrition 0.000 claims 2
- 229920002678 cellulose Polymers 0.000 claims 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 2
- 239000008121 dextrose Substances 0.000 claims 2
- 150000004676 glycans Chemical class 0.000 claims 2
- 239000011777 magnesium Substances 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 229920001282 polysaccharide Polymers 0.000 claims 2
- 239000005017 polysaccharide Substances 0.000 claims 2
- 229920003124 powdered cellulose Polymers 0.000 claims 2
- 235000019814 powdered cellulose Nutrition 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- SOBHUZYZLFQYFK-UHFFFAOYSA-K trisodium;hydroxy-[[phosphonatomethyl(phosphonomethyl)amino]methyl]phosphinate Chemical compound [Na+].[Na+].[Na+].OP(O)(=O)CN(CP(O)([O-])=O)CP([O-])([O-])=O SOBHUZYZLFQYFK-UHFFFAOYSA-K 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 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
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 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
- 239000004375 Dextrin Substances 0.000 claims 1
- 229920001353 Dextrin Polymers 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 229920002907 Guar gum Polymers 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
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 240000008042 Zea mays Species 0.000 claims 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 229940072056 alginate Drugs 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical compound [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 claims 1
- 229940063655 aluminum stearate Drugs 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229940105329 carboxymethylcellulose Drugs 0.000 claims 1
- 239000004359 castor oil Substances 0.000 claims 1
- 235000019438 castor oil Nutrition 0.000 claims 1
- 239000004927 clay Substances 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 235000005822 corn Nutrition 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 229920006037 cross link polymer Polymers 0.000 claims 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims 1
- 235000019425 dextrin Nutrition 0.000 claims 1
- GXGAKHNRMVGRPK-UHFFFAOYSA-N dimagnesium;dioxido-bis[[oxido(oxo)silyl]oxy]silane Chemical compound [Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O GXGAKHNRMVGRPK-UHFFFAOYSA-N 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229920001971 elastomer Polymers 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 claims 1
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 claims 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 239000000665 guar gum Substances 0.000 claims 1
- 235000010417 guar gum Nutrition 0.000 claims 1
- 229960002154 guar gum Drugs 0.000 claims 1
- -1 hydroxypropyl Chemical group 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- 239000000395 magnesium oxide Substances 0.000 claims 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims 1
- 239000000391 magnesium silicate Substances 0.000 claims 1
- 235000019793 magnesium trisilicate Nutrition 0.000 claims 1
- 229940099273 magnesium trisilicate Drugs 0.000 claims 1
- 229910000386 magnesium trisilicate Inorganic materials 0.000 claims 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 235000010356 sorbitol Nutrition 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 239000006188 syrup Substances 0.000 claims 1
- 235000020357 syrup Nutrition 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- 235000019731 tricalcium phosphate Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K31/41—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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Emergency Medicine (AREA)
- Urology & Nephrology (AREA)
- Hospice & Palliative Care (AREA)
- Vascular Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (30)
1. Čvrsti oralni oblik doziranja u obliku tablete, naznačen time, da sadrži:
(a) spoj trinatrijev [3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil) propionat-(S)-3'-metil-2'-(pentanoil{2"-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat]hemipentahidrat u koncentraciji od oko 4% do oko 60% po masi čvrstog oralnog oblika doziranja; i
(b) najmanje jednu farmaceutski prihvatljivu pomoćnu tvar.
2. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 1, naznačen time, da doza spoja iznosi 100 mg, 200 mg ili 400 mg.
3. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 1 ili 2, naznačen time, da je oralni oblik doziranja formulacija s trenutačnim otpuštanjem.
4. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da oralni oblik doziranja pokazuje in vitro profil otapanja, takav da, kada se mjeri USP postupkom s lopaticom pri oko 50 okretaja u minuti u 900 mL 0,05M fosfatnog pufera pri pH 6,8 i na 37±0,5°C, nakon 10 minuta, oslobađa se prosječno od oko 10% do prosječno od oko 100% (po masi) slobodne kiseline valsartana, ili njezine farmaceutski prihvatljive soli, nakon 20 minuta, oslobađa se prosječno od oko 30% do prosječno oko 100% (po masi) slobodne kiseline valsartana, ili njezine farmaceutski prihvatljive soli, i nakon 30 minuta, oslobađa se prosječno od oko 40% do prosječno oko 100% (po masi) slobodne kiseline valsartana, ili njezine farmaceutski prihvatljive soli.
5. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da oralni oblik doziranja osigurava brzinu apsorpcije slobodne kiseline valsartana s tmax od 1 do 2,2 h nakon primjene pojedinačne doze navedenog oblika doziranja.
6. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 5, naznačen time, da oralni oblik doziranja sadrži oko 200 mg spoja i osigurava brzinu apsorpcije slobodne kiseline valsartana s tmax od 1,5 do 1,9 h nakon primjene pojedinačne doze navedenog oblika doziranja.
7. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 4, naznačen time, da
kada se mjeri USP postupkom s lopaticom pri oko 50 okretaja u minuti u 900 mL 0,05M fosfatnog pufera pri pH 6,8 i na 37±0,5°C, ili kada se mjeri USP postupkom s lopaticom pri oko 75 okretaja u minuti u 1000 mL fosfatnog pufera pri pH 4,5 i na 37±0,5°C,
(a) kada je spoj prisutan u količini od 100 mg po jediničnom obliku doziranja, oralni oblik doziranja pokazuje in vitro profil otapanja tako da se nakon 10 minuta, oslobađa prosječno 50% slobodne kiseline valsartana, nakon 20 minuta, oslobađa se prosječno 85% slobodne kiseline valsartana, nakon 30 minuta, oslobađa se prosječno 95% slobodne kiseline valsartana, ili
(b) kada je spoj prisutan u količini od 200 mg po jediničnom obliku doziranja, oralni oblik doziranja pokazuje in vitro profil otapanja tako da se nakon 10 min, oslobađa prosječno 50% slobodne kiseline valsartana, nakon 20 minuta, oslobađa se prosječno 85% slobodne kiseline valsartana, nakon 30 minuta, oslobađa se prosječno 95% slobodne kiseline valsartana, ili
(c) kada je spoj prisutan u količini od 400 mg po jediničnom obliku doziranja, oralni oblik doziranja pokazuje in vitro profil otapanja tako da se nakon 10 min, oslobađa prosječno 40% slobodne kiseline valsartana, nakon 20 min, oslobađa se prosječno 70% slobodne kiseline valsartana, nakon 30 min, oslobađa se prosječno 90% slobodne kiseline valsartana.
8. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da je farmaceutski prihvatljiva pomoćna tvar sredstvo za raspadanje odabrano iz skupine koja se sastoji od škrobova, gline, celuloze, alginata, gume, umreženih polimera, umrežene natrijeve karboksimetilceluloze ili natrijeve kroskarmeloze, umrežene kalcijeve karboksimetilceluloze, sojinih polisaharida i guar gume, poželjno pri čemu je sredstvo za raspadanje umreženi polivinil pirolidon ili krospovidon.
9. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 8, naznačen time, da je sredstvo za raspadanje prisutno u koncentraciji od 0% do 65% po masi pripravka prije izbornog oblaganja, poželjno od 1% do 40% po masi pripravka prije izbornog oblaganja.
10. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 9, naznačen time, da je sredstvo za raspadanje prisutno u koncentraciji od 0,05% do 10% po masi pripravka prije izbornog oblaganja.
11. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3 ili patentnim zahtjevima od 8 do 10, naznačen time, da farmaceutski prihvatljiva pomoćna tvar je vezivo odabrano iz skupine koju čine škrobovi, celuloze, saharoza, dekstroza, kukuruzni sirup, polisaharidi i želatina; osobito gdje je vezivo hidroksipropil celuloza.
12. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 11, naznačen time, da je vezivo hidroksipropil celuloza.
13. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 12, naznačen time, da je vezivo hidroksipropil celuloza koja ima sadržaj hidroksipropila od 5 do 16% po masi i MW od 80 000 do 1 150 000, točnije 140 000 do 850 000.
14. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 11 do 13, naznačen time, da je vezivo prisutno u koncentraciji od 1% do 60% po masi pripravka prije izbornog oblaganja, poželjno od 5% do 30% po masi pripravka prije izbornog oblaganja, ako je tableta valjkom zbijena tableta.
15. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3 ili patentnim zahtjevima od 8 do 14, naznačen time, da je farmaceutski prihvatljiva pomoćna tvar punilo, pri čemu je punilo odabrano iz skupine koja se sastoji od slastičarskog šećera, kompresibilnog šećera, dekstrata, dekstrina, dekstroze, laktoze, manitola, mikrokristalne celuloze, praškaste celuloze, sorbitola, i saharoze; poželjno pri čemu je punilo mikrokristalna celuloza.
16. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 15, naznačen time, da je punilo prisutno u koncentraciji od 4% do 60% po masi pripravka prije izbornog oblaganja.
17. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3 ili patentnim zahtjevima od 8 do 16, naznačen time, da je farmaceutski prihvatljiva pomoćna tvar lubrikant ili sredstvo za klizanje odabrano iz skupine koju čine koloidni silicijev dioksid, magnezijev trisilikat, škrobovi, trobazični kalcijev fosfat, magnezijev stearat, aluminijev stearat, kalcijev stearat, magnezijev karbonat, magnezijev oksid, polietilen glikol, praškasta celuloza, gliceril behenat, stearinska kiselina, hidrogenirano ricinusovo ulje, glicerol monostearat i natrijev stearil fumarat; poželjno pri čemu je lubrikant magnezijev stearat.
18. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 17, naznačen time, da je sredstvo za klizanje prisutno u koncentraciji od 0% do 10% po masi pripravka prije izbornog oblaganja, poželjno do 2% po masi pripravka prije izbornog oblaganja.
19. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 17, naznačen time, da je lubrikant prisutan u koncentraciji od 0% do 5% po masi pripravka prije izbornog oblaganja, poželjno od 0,5% do 5% po masi pripravka prije izbornog oblaganja.
20. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1-3, 8, 10-13, 15, 17-19, naznačen time, da se u navedenom čvrstom oralnom obliku doziranja ukupna količina svih farmaceutski prihvatljivih pomoćnih tvari nalazi u rasponu od 35% do 55% po masi, točnije 40% do 45% po masi, od pripravka prije bilo kakvog izbornog oblaganja.
21. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 1 do 3 ili patentnom zahtjevu 20, naznačen time, da se aktivna tvar u čvrstom oralnom obliku doziranja u potpunosti sastoji od spoja trinatrijevog [3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil)propionat-(S)-3'-metil-2'-(pentanoil{2"-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat]hemipentahidrata, a farmaceutski prihvatljive pomoćne tvari sadrže (i) mikrokristalnu celulozu, (ii) hidroksipropilcelulozu, (iii) krospovidon, (iv) Mg, Ca ili Al stearat, (v) bezvodni koloidni silicijev dioksid i (vi) talk.
22. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 21, naznačen time, da je Mg stearat prisutan u količini od 1,0 do 6,0% po masi, bezvodni koloidni silicijev dioksid je prisutan u količini od 0,1 do 2% po masi, mikrokristalna celuloza je prisutna u količinu od 10 do 30% po masi, i krospovidon je prisutan u količini od 1 do 20% po masi, od pripravka prije bilo kakvog izbornog oblaganja.
23. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 21 ili 22, naznačen time, da je farmaceutski prihvatljiva pomoćna tvar krospovidon i pri čemu je krospovidon prisutan u količini od 5 do 15% po masi, poželjno 8-10% po masi, od pripravka prije bilo kakvog izbornog oblaganja.
24. Čvrsti oralni oblik doziranja prema bilo kojem prethodnom patentnom zahtjevu, naznačen time, da je tableta pripravljena postupkom suhe formulacije.
25. Čvrsti oralni oblik doziranja prema bilo kojem prethodnom patentnom zahtjevu, naznačen time, da je tableta valjkom zbijena tableta.
26. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 25, naznačen time, da doza spoja iznosi od 50 do 800 mg.
27. Čvrsti oralni oblik doziranja prema patentnim zahtjevima 25 i 26, naznačen time, da se tableta oblikuje pomoću sile sabijanja od 20 do 60, poželjno od 20 do 40 kN.
28. Čvrsti oralni oblik doziranja prema bilo kojem od patentnih zahtjeva 25 do 27, naznačen time, da se postupak proizvodnje provodi (i) u odsutnosti vode, i/ili (ii) pri relativnoj vlažnosti < 55%, i/ili (iii) pri sobnoj temperaturi (20-25°C).
29. Čvrsti oralni oblik doziranja prema patentnom zahtjevu 28, naznačen time, da se postupak proizvodnje provodi (i) u odsutnosti vode, (ii) pri relativnoj vlažnosti < 55%, i (iii) pri sobnoj temperaturi (20-25°C).
30. Čvrsti oralni oblik doziranja prema bilo kojem prethodnom patentnom zahtjevu, naznačen time, da je za uporabu u liječenju, pri čemu je jedinična doza terapijskog sredstva 100 mg, 200 mg ili 400 mg dnevno.
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| EP16157767.1A EP3067043B1 (en) | 2007-11-06 | 2008-11-04 | Pharmaceutical compositions based on superstructures of angiotensin receptor antagonist/blocker (arb) and neutral endopeptidase (nep) inhibitor |
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| HRP20150459TT HRP20150459T1 (hr) | 2007-11-06 | 2015-04-28 | Farmaceutski pripravci na bazi superstruktura antagonista/blokatora angiontenzinskih receptora (arb) i inhibitora neutralne endopeptidaze (nep) |
| HRP20160988TT HRP20160988T1 (hr) | 2007-11-06 | 2016-08-02 | Farmaceutski sastavi s dvostrukim djelovanjem na temelju superstruktura od antagonista/blokatora receptora angiotenzina (arb) i neutralnih inhibitora endopeptidaze (nep) |
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| HRP20160988TT HRP20160988T1 (hr) | 2007-11-06 | 2016-08-02 | Farmaceutski sastavi s dvostrukim djelovanjem na temelju superstruktura od antagonista/blokatora receptora angiotenzina (arb) i neutralnih inhibitora endopeptidaze (nep) |
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Families Citing this family (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2536514T3 (es) | 2007-11-06 | 2015-05-26 | Novartis Ag | Composiciones farmacéuticas de doble acción basadas en superestructuras de antagonista/bloqueador de receptores de angiotensina (ARB) y receptor de endopeptidasa neutra (NEP) |
| MX2011012627A (es) | 2009-05-28 | 2011-12-14 | Novartis Ag | Derivados aminobutiricos sustituidos como inhibidores de nepralisina. |
| EP2594557B1 (en) | 2009-05-28 | 2016-08-10 | Novartis AG | Substituted aminopropionic derivatives as neprilysin inhibitors |
| JO2967B1 (en) | 2009-11-20 | 2016-03-15 | نوفارتس ايه جي | Acetic acid derivatives of carbamoyl methyl amino are substituted as new NEP inhibitors |
| CA2807830C (en) * | 2010-08-24 | 2018-04-03 | Novartis Ag | Treatment of hypertension and/or prevention or treatment of heart failure in a mammal receiving anti-coagulant therapy |
| US8673974B2 (en) | 2010-11-16 | 2014-03-18 | Novartis Ag | Substituted amino bisphenyl pentanoic acid derivatives as NEP inhibitors |
| MA37850A1 (fr) | 2012-08-24 | 2018-07-31 | Novartis Ag | Inhibiteurs de nep pour le traitement de maladies caractérisées par un agrandissement atrial ou une remodélisation atriale |
| EA026989B1 (ru) | 2013-02-14 | 2017-06-30 | Новартис Аг | Производные замещенной бисфенилбутановой кислоты в качестве ингибиторов nep с улучшенной in vivo эффективностью |
| CN105073762B (zh) | 2013-02-14 | 2017-03-08 | 诺华股份有限公司 | 作为nep(中性内肽酶)抑制剂的取代的联苯丁酰膦酸衍生物 |
| US20160206597A1 (en) * | 2013-08-26 | 2016-07-21 | Toni Lynne Bransford | New Use |
| WO2015028941A1 (en) | 2013-08-26 | 2015-03-05 | Novartis Ag | New use |
| WO2015154673A1 (en) * | 2014-04-10 | 2015-10-15 | Zhaoyin Wang | Novel prodrugs and combinations for treatment of hypertension and cardiovascular diseases |
| CN105461647B (zh) * | 2014-09-28 | 2018-06-29 | 四川海思科制药有限公司 | 缬沙坦沙库比曲三钠盐复合物的固态形式及其制备方法和用途 |
| MX2017007426A (es) | 2014-12-08 | 2018-04-20 | Crystal Pharmatech Co Ltd | Formas cristalinas de complejo supramolecular trisodico que comprende valsartan y ahu-377 y metodos de las mismas. |
| CN104473938B (zh) * | 2014-12-30 | 2017-06-09 | 北京瑞都医药科技有限公司 | 一种治疗慢性心衰药物及其制备方法 |
| CN104826115A (zh) * | 2015-04-19 | 2015-08-12 | 浙江巨泰药业有限公司 | 一种抗心衰药物组合物及其制备方法 |
| HRP20230480T1 (hr) | 2015-05-11 | 2023-07-21 | Novartis Ag | Režim doziranja sakubitrila i valsartana za liječenje zatajenja srca |
| US20180140579A1 (en) | 2015-05-29 | 2018-05-24 | Novartis Ag | Sacubitril and valsartan for treating metabolic disease |
| CN106309388A (zh) * | 2015-06-30 | 2017-01-11 | 深圳信立泰药业股份有限公司 | 一种用于心衰治疗的药物组合物及其制备方法 |
| WO2017006254A1 (en) | 2015-07-08 | 2017-01-12 | Novartis Ag | Drug combination comprising an angiotensin ii receptor antagonist, a neutral endopeptidase inhibitor and a mineralcorticoid receptor antagonist |
| CN105997993B (zh) * | 2015-07-11 | 2018-03-30 | 麦丽芳 | 一种用于心血管疾病治疗的固体口服型制剂及其制备方法 |
| CN105997994A (zh) * | 2015-07-11 | 2016-10-12 | 凌莉 | 一种固体口服型制剂及其制备方法 |
| CN106176724A (zh) * | 2015-07-11 | 2016-12-07 | 凌莉 | 一种稳定的固体药物组合物及其制备方法 |
| CN106074421A (zh) * | 2015-07-11 | 2016-11-09 | 凌莉 | 一种提高稳定性的药物组合物 |
| CN106176725A (zh) * | 2015-07-11 | 2016-12-07 | 凌莉 | 一种提高稳定性的药物组合物及其制备方法和用途 |
| CN106176723A (zh) * | 2015-07-11 | 2016-12-07 | 凌莉 | 一种固体药物组合物及其制备方法 |
| WO2017012600A1 (en) | 2015-07-20 | 2017-01-26 | Zentiva, K.S. | A pharmaceutical composition containing valsartan and sacubitril and methods for preparation and stabilization thereof |
| CN106389374A (zh) * | 2015-08-03 | 2017-02-15 | 深圳信立泰药业股份有限公司 | 一种含有lcz696的药物组合物及其制备方法 |
| JP6598985B2 (ja) | 2015-08-28 | 2019-10-30 | ノバルティス アーゲー | 新規の使用 |
| WO2017037596A1 (en) * | 2015-08-28 | 2017-03-09 | Dr. Reddy's Laboratories Limited | Amorphous solid dispersion of lcz-696 |
| WO2017063581A1 (zh) * | 2015-10-16 | 2017-04-20 | 深圳信立泰药业股份有限公司 | 一种用于心血管疾病治疗的口服制剂及其制备方法 |
| CN105669581B (zh) * | 2015-11-09 | 2017-03-22 | 成都苑东生物制药股份有限公司 | 一种血管紧张受体拮抗剂和中性内肽酶抑制剂复合物 |
| WO2017085573A1 (en) * | 2015-11-20 | 2017-05-26 | Lupin Limited | Amorphous sacubitril-valsartan complex and process for preparation thereof |
| CN105330609B (zh) * | 2015-12-07 | 2017-12-22 | 南京正大天晴制药有限公司 | 一种制备lcz696的方法 |
| CN105929031B (zh) * | 2015-12-18 | 2018-08-21 | 重庆两江药物研发中心有限公司 | 一种血管紧张素受体拮抗剂和nep抑制剂的复合物中杂质的分离方法 |
| CN105935358B (zh) * | 2015-12-18 | 2019-06-07 | 重庆两江药物研发中心有限公司 | 一种沙库比曲缬沙坦缓释剂及其制备方法 |
| CN106905253B (zh) * | 2015-12-23 | 2020-01-03 | 正大天晴药业集团股份有限公司 | 一种超分子复合物的结晶 |
| US10722471B2 (en) * | 2016-02-03 | 2020-07-28 | Novartis Ag | Galenic formulations of organic compounds |
| US20190054069A1 (en) * | 2016-02-03 | 2019-02-21 | Novartis Ag | New use of a combination of sacubitril and valsartan |
| CN105748420B (zh) * | 2016-03-04 | 2018-11-06 | 山东省药学科学院 | 一种治疗心力衰竭的lcz696缓释骨架片的制备方法 |
| CN105902506A (zh) * | 2016-06-12 | 2016-08-31 | 佛山市腾瑞医药科技有限公司 | 一种沙卡布曲缬沙坦制剂及其应用 |
| WO2018069937A1 (en) | 2016-10-13 | 2018-04-19 | Mylan Laboratories Limited | Solid dispersions of trisodium sacubitril valsartan and process for the preparation thereof |
| WO2018178295A1 (en) | 2017-03-31 | 2018-10-04 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Stable hot-melt extrudate containing valsartan and sacubitril |
| ES2890573T3 (es) * | 2017-03-31 | 2022-01-20 | Tiefenbacher Alfred E Gmbh & Co Kg | Producto extruido de fusión en caliente estable que contiene valsartán y sacubitrilo |
| WO2018211479A1 (en) | 2017-05-19 | 2018-11-22 | Lupin Limited | Stabilized compositions of angiotensin ii inhibitors and neutral endopeptidase inhibitors and process for preparation thereof |
| US11382866B2 (en) | 2017-07-06 | 2022-07-12 | Mankind Pharma Ltd. | Fixed dose pharmaceutical composition of valsartan and sacubitril |
| WO2019020706A1 (en) | 2017-07-28 | 2019-01-31 | Synthon B.V. | PHARMACEUTICAL COMPOSITION COMPRISING SACUBITRIL AND VALSARTAN |
| WO2019073062A1 (en) | 2017-10-13 | 2019-04-18 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | TABLET CONTAINING VALSARTAN AND SACUBITRIL |
| WO2019180735A1 (en) * | 2018-03-19 | 2019-09-26 | Natco Pharma Limited | Stable pharmaceutical compositions comprising sacubitril-valsartan complex |
| US11877576B2 (en) | 2018-06-22 | 2024-01-23 | Ideaz, Llc | Diphenyl tablets and methods of preparing the same |
| US20210177803A1 (en) | 2018-08-23 | 2021-06-17 | Novartis Ag | New pharmaceutical use for the treatment of heart failure |
| WO2020039394A1 (en) | 2018-08-24 | 2020-02-27 | Novartis Ag | New drug combinations |
| EP3766484B1 (en) | 2019-07-19 | 2021-08-25 | Zentiva, K.S. | Solid pharmaceutical dosage form comprising valsartan and sacubitril |
| KR102545274B1 (ko) | 2020-02-26 | 2023-06-20 | 에리슨제약(주) | 사쿠비트릴 및 발사르탄을 포함하는 심부전 치료용 서방성 제제, 및 이를 포함하는 다중방출 복합제제와 이의 제조방법 |
| KR20210120560A (ko) | 2020-03-27 | 2021-10-07 | 주식회사 유영제약 | 고함량의 주성분을 포함하는 정제 및 그 제조방법 |
| KR20210138510A (ko) | 2020-05-12 | 2021-11-19 | 에리슨제약(주) | 사쿠비트릴, 발사르탄 및 네비보롤을 포함하는 심부전 및 허혈성 심질환의 예방 또는 치료용 약제학적 조성물 및 이를 포함하는 약제학적 복합제제 |
| KR20220091767A (ko) | 2020-12-24 | 2022-07-01 | 주식회사 보령 | 사쿠비트릴 발사르탄 하이브리드 화합물 또는 그 약제학적으로 허용되는 염을 유효성분으로 포함하는 약제학적 조성물 |
| KR102486815B1 (ko) | 2021-01-20 | 2023-01-10 | 주식회사 대웅제약 | Nep 저해제 및 arb를 포함하는 약학 조성물 및 이의 제조 방법 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US608220A (en) | 1898-08-02 | Mechanical movement | ||
| US607355A (en) | 1898-07-12 | Carrier for bicycles | ||
| US607893A (en) | 1898-07-26 | Automatic switch-operating machine | ||
| US735093A (en) | 1903-01-31 | 1903-08-04 | Oscar Greenwald | Elevator-cable guard. |
| GB9613470D0 (en) * | 1996-06-27 | 1996-08-28 | Ciba Geigy Ag | Small solid oral dosage form |
| US6558699B2 (en) * | 1997-11-17 | 2003-05-06 | Smithkline Beecham Corporation | High drug load immediate and modified release oral dosage formulations and processes for their manufacture |
| IL136142A0 (en) * | 1997-11-17 | 2001-05-20 | Smithkline Beecham Corp | High drug load immediate and modified release oral dosage formulations and processes for their manufacture |
| US6248729B1 (en) * | 1998-06-17 | 2001-06-19 | Bristol-Myers Squibb Co. | Combination of an ADP-receptor blocking antiplatelet drug and antihypertensive drug and a method for preventing a cerebral infarction employing such combination |
| CZ297795B6 (cs) * | 1998-12-23 | 2007-03-28 | Novartis Ag | Tablety obsahující valsartan |
| PL205715B1 (pl) | 2000-07-19 | 2010-05-31 | Novartis Ag | Sól wapniowa walsartanu w postaci tetrahydratu, preparat farmaceutyczny zawierający tę sól, zastosowanie i sposób wytwarzania tej soli |
| CN1615134A (zh) | 2002-01-17 | 2005-05-11 | 诺瓦提斯公司 | 含有缬沙坦和nep抑制剂的药物组合物 |
| US7468390B2 (en) * | 2002-01-17 | 2008-12-23 | Novartis Ag | Methods of treatment and pharmaceutical composition |
| JP3751287B2 (ja) * | 2002-03-27 | 2006-03-01 | バイエル薬品株式会社 | 小型化されたニフェジピン有核錠剤 |
| WO2003089417A1 (en) | 2002-04-15 | 2003-10-30 | Dr. Reddy's Laboratories Limited | Novel crystalline forms of (s)-n-(1-carboxy-2-methyl-prop-1-yl) -n-pentanoyl-n- [2’-(1h-tetrazol-5-yl-)- biphenyl-4-yl methyl] amine (valsartan) |
| GB0209265D0 (en) | 2002-04-23 | 2002-06-05 | Novartis Ag | Organic compounds |
| DE602004013405T2 (de) | 2003-03-17 | 2009-05-07 | Teva Pharmaceutical Industries Ltd. | Polymorphe formen von valsartan |
| EP1648515B1 (en) | 2003-07-16 | 2012-11-21 | Boehringer Ingelheim International GmbH | Chlorthalidone combinations |
| GB0402262D0 (en) * | 2004-02-02 | 2004-03-10 | Novartis Ag | Process for the manufacture of organic compounds |
| GT200600371A (es) | 2005-08-17 | 2007-03-21 | Formas de dosis sólidas de valsartan y amlodipina y método para hacer las mismas | |
| US20090304755A1 (en) * | 2005-10-27 | 2009-12-10 | Raghu Rami Reddy Kasu | Pharmaceutical formulation of losartan |
| US20080227836A1 (en) | 2005-10-31 | 2008-09-18 | Lupin Ltd | Stable Solid Oral Dosage Forms of Valsartan |
| CA2628793C (en) | 2005-11-07 | 2015-01-27 | Stryker Corporation | Patient handling device including local status indication, one-touch fowler angle adjustment, and power-on alarm configuration |
| WO2007056324A2 (en) | 2005-11-08 | 2007-05-18 | Novartis Ag | Combination of an angiotensin ii receptor blocker, a calcium channel blocker and another active agent |
| AR057882A1 (es) * | 2005-11-09 | 2007-12-26 | Novartis Ag | Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra |
| EP1897537A1 (en) * | 2006-09-04 | 2008-03-12 | Novartis AG | Composition comprising an angiotensin II receptor antagonist |
| ES2536514T3 (es) | 2007-11-06 | 2015-05-26 | Novartis Ag | Composiciones farmacéuticas de doble acción basadas en superestructuras de antagonista/bloqueador de receptores de angiotensina (ARB) y receptor de endopeptidasa neutra (NEP) |
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