CZ2008740A3 - Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem - Google Patents

Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem Download PDF

Info

Publication number: CZ2008740A3
Authority: CZ; Czechia
Prior art keywords: atorvastatin; telmisartan; pharmaceutical composition; mixture; composition according
Prior art date: 2008-11-24

Application number

CZ20080740A

Other languages

Czech (cs)

English (en)

Other versions

CZ301299B6 (cs

Inventor

Prokopová@Alena

Linek@Jan

Gryczová@Eva

Original Assignee

Zentiva, A.S.

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.)

2008-11-24

Filing date

2008-11-24

Publication date

2010-01-06

2008-11-24 Application filed by Zentiva, A.S. filed Critical Zentiva, A.S.

2008-11-24 Priority to CZ20080740A priority Critical patent/CZ2008740A3/cs

2009-11-16 Priority to PCT/CZ2009/000138 priority patent/WO2010057449A2/fr

2010-01-06 Publication of CZ301299B6 publication Critical patent/CZ301299B6/cs

2010-01-06 Publication of CZ2008740A3 publication Critical patent/CZ2008740A3/cs

Links

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 title claims abstract description 109
239000005537 C09CA07 - Telmisartan Substances 0.000 title claims abstract description 56
229960005187 telmisartan Drugs 0.000 title claims abstract description 56
XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 title claims abstract description 53
XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 title claims abstract description 52
229960005370 atorvastatin Drugs 0.000 title claims abstract description 52
239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 35
239000007787 solid Substances 0.000 title claims abstract description 6
239000004480 active ingredient Substances 0.000 title abstract description 8
239000000203 mixture Substances 0.000 claims abstract description 68
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 66
239000000945 filler Substances 0.000 claims abstract description 40
KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims abstract description 39
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 abstract description 38
239000008187 granular material Substances 0.000 claims abstract description 36
229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 31
235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 31
239000002245 particle Substances 0.000 claims abstract description 30
229960003194 meglumine Drugs 0.000 claims abstract description 28
DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims abstract description 11
FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 9
VTYYLEPIZMXCLO-UHFFFAOYSA-L calcium carbonate Substances [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 7
150000004676 glycans Chemical class 0.000 claims abstract description 7
239000011777 magnesium Substances 0.000 claims abstract description 7
229910052749 magnesium Inorganic materials 0.000 claims abstract description 7
229920001282 polysaccharide Polymers 0.000 claims abstract description 7
239000005017 polysaccharide Substances 0.000 claims abstract description 7
150000002772 monosaccharides Chemical class 0.000 claims abstract description 6
229920001542 oligosaccharide Polymers 0.000 claims abstract description 5
150000002482 oligosaccharides Chemical class 0.000 claims abstract description 5
BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims abstract description 4
229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 4
150000007529 inorganic bases Chemical class 0.000 claims abstract description 4
150000007530 organic bases Chemical class 0.000 claims abstract description 4
239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 4
150000003839 salts Chemical class 0.000 claims abstract 6
239000000292 calcium oxide Substances 0.000 claims abstract 2
ODINCKMPIJJUCX-UHFFFAOYSA-N calcium oxide Inorganic materials [Ca]=O ODINCKMPIJJUCX-UHFFFAOYSA-N 0.000 claims abstract 2
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 46
239000010410 layer Substances 0.000 claims description 33
229920000168 Microcrystalline cellulose Polymers 0.000 claims description 31
235000019813 microcrystalline cellulose Nutrition 0.000 claims description 31
239000008108 microcrystalline cellulose Substances 0.000 claims description 31
229940016286 microcrystalline cellulose Drugs 0.000 claims description 31
WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 27
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 24
235000019359 magnesium stearate Nutrition 0.000 claims description 23
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 16
239000001863 hydroxypropyl cellulose Substances 0.000 claims description 16
235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 16
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 description 15
VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims description 15
239000000600 sorbitol Substances 0.000 claims description 15
235000010356 sorbitol Nutrition 0.000 claims description 15
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 description 14
239000000126 substance Substances 0.000 claims description 14
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 description 13
239000011230 binding agent Substances 0.000 claims description 13
239000008101 lactose Substances 0.000 claims description 13
238000000034 method Methods 0.000 claims description 13
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 description 12
239000013543 active substance Substances 0.000 claims description 11
239000011575 calcium Substances 0.000 claims description 11
150000001720 carbohydrates Chemical class 0.000 claims description 11
239000000546 pharmaceutical excipient Substances 0.000 claims description 11
CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 9
239000007884 disintegrant Substances 0.000 claims description 8
239000000314 lubricant Substances 0.000 claims description 8
239000000395 magnesium oxide Substances 0.000 claims description 8
AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical group [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 8
239000002585 base Substances 0.000 claims description 7
OJRHUICOVVSGSY-RXMQYKEDSA-N (2s)-2-chloro-3-methylbutan-1-ol Chemical compound CC(C)[C@H](Cl)CO OJRHUICOVVSGSY-RXMQYKEDSA-N 0.000 claims description 6
OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 6
239000007921 spray Substances 0.000 claims description 6
229920002785 Croscarmellose sodium Polymers 0.000 claims description 5
229910052791 calcium Inorganic materials 0.000 claims description 5
229960001770 atorvastatin calcium Drugs 0.000 claims description 4
239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 4
235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 4
238000004519 manufacturing process Methods 0.000 claims description 4
QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 4
238000001694 spray drying Methods 0.000 claims description 4
150000005846 sugar alcohols Chemical class 0.000 claims description 4
235000021355 Stearic acid Nutrition 0.000 claims description 3
235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 3
238000002156 mixing Methods 0.000 claims description 3
OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 3
239000002356 single layer Substances 0.000 claims description 3
239000008117 stearic acid Substances 0.000 claims description 3
229920002472 Starch Polymers 0.000 claims description 2
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 description 2
229960001681 croscarmellose sodium Drugs 0.000 claims description 2
229960000913 crospovidone Drugs 0.000 claims description 2
239000011363 dried mixture Substances 0.000 claims description 2
238000004898 kneading Methods 0.000 claims description 2
229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 2
235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 2
238000002360 preparation method Methods 0.000 claims description 2
239000008107 starch Substances 0.000 claims description 2
235000019698 starch Nutrition 0.000 claims description 2
229940093932 potassium hydroxide Drugs 0.000 claims 7
229960005168 croscarmellose Drugs 0.000 claims 3
239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims 3
229920000136 polysorbate Polymers 0.000 claims 3
229940083542 sodium Drugs 0.000 claims 3
150000004100 telmisartan derivatives Chemical class 0.000 claims 3
239000002253 acid Substances 0.000 claims 2
239000001095 magnesium carbonate Substances 0.000 claims 2
CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
239000003513 alkali Substances 0.000 claims 1
229960005069 calcium Drugs 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
239000000428 dust Substances 0.000 claims 1
238000000227 grinding Methods 0.000 claims 1
229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
235000011160 magnesium carbonates Nutrition 0.000 claims 1
159000000003 magnesium salts Chemical class 0.000 claims 1
229940091250 magnesium supplement Drugs 0.000 claims 1
229950008882 polysorbate Drugs 0.000 claims 1
XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims 1
238000007873 sieving Methods 0.000 claims 1
235000011182 sodium carbonates Nutrition 0.000 claims 1
KKCBUQHMOMHUOY-UHFFFAOYSA-N sodium oxide Chemical compound [O-2].[Na+].[Na+] KKCBUQHMOMHUOY-UHFFFAOYSA-N 0.000 claims 1
229910001948 sodium oxide Inorganic materials 0.000 claims 1
RSGAIWOEJXRYRV-UHFFFAOYSA-M sodium;2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoate Chemical compound [Na+].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 RSGAIWOEJXRYRV-UHFFFAOYSA-M 0.000 claims 1
239000008247 solid mixture Substances 0.000 claims 1
239000011734 sodium Substances 0.000 abstract description 10
229910052708 sodium Inorganic materials 0.000 abstract description 3
ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 abstract description 2
230000001476 alcoholic effect Effects 0.000 abstract description 2
229910052700 potassium Inorganic materials 0.000 abstract description 2
239000011591 potassium Substances 0.000 abstract description 2
AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 abstract 1
239000000920 calcium hydroxide Substances 0.000 abstract 1
229910001861 calcium hydroxide Inorganic materials 0.000 abstract 1
BRPQOXSCLDDYGP-UHFFFAOYSA-N calcium oxide Chemical class [O-2].[Ca+2] BRPQOXSCLDDYGP-UHFFFAOYSA-N 0.000 abstract 1
239000003826 tablet Substances 0.000 description 18
229940069328 povidone Drugs 0.000 description 16
229960002920 sorbitol Drugs 0.000 description 13
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 11
239000004615 ingredient Substances 0.000 description 11
235000014633 carbohydrates Nutrition 0.000 description 9
229960001375 lactose Drugs 0.000 description 9
239000008119 colloidal silica Substances 0.000 description 8
239000012792 core layer Substances 0.000 description 6
229940101538 telmisartan 80 mg Drugs 0.000 description 6
229920000881 Modified starch Polymers 0.000 description 4
-1 alkali metal salt Chemical class 0.000 description 4
238000001035 drying Methods 0.000 description 4
WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 3
OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
229940049950 atorvastatin 10 mg Drugs 0.000 description 3
229940049949 atorvastatin 20 mg Drugs 0.000 description 3
229940075614 colloidal silicon dioxide Drugs 0.000 description 3
238000004090 dissolution Methods 0.000 description 3
230000000694 effects Effects 0.000 description 3
238000005469 granulation Methods 0.000 description 3
230000003179 granulation Effects 0.000 description 3
229940071676 hydroxypropylcellulose Drugs 0.000 description 3
229960001021 lactose monohydrate Drugs 0.000 description 3
239000008363 phosphate buffer Substances 0.000 description 3
239000002904 solvent Substances 0.000 description 3
239000003381 stabilizer Substances 0.000 description 3
239000000454 talc Substances 0.000 description 3
229910052623 talc Inorganic materials 0.000 description 3
235000012222 talc Nutrition 0.000 description 3
208000024172 Cardiovascular disease Diseases 0.000 description 2
JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 description 2
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 description 2
UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 2
229930195725 Mannitol Natural products 0.000 description 2
TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 2
150000001447 alkali salts Chemical class 0.000 description 2
229960004977 anhydrous lactose Drugs 0.000 description 2
239000001506 calcium phosphate Substances 0.000 description 2
229910000389 calcium phosphate Inorganic materials 0.000 description 2
235000011010 calcium phosphates Nutrition 0.000 description 2
159000000007 calcium salts Chemical class 0.000 description 2
CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
235000013539 calcium stearate Nutrition 0.000 description 2
239000008116 calcium stearate Substances 0.000 description 2
239000003795 chemical substances by application Substances 0.000 description 2
HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
239000011248 coating agent Substances 0.000 description 2
238000000576 coating method Methods 0.000 description 2
229920001577 copolymer Polymers 0.000 description 2
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 2
229960002003 hydrochlorothiazide Drugs 0.000 description 2
239000003112 inhibitor Substances 0.000 description 2
239000000594 mannitol Substances 0.000 description 2
235000010355 mannitol Nutrition 0.000 description 2
229960001855 mannitol Drugs 0.000 description 2
HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 2
229920000609 methyl cellulose Polymers 0.000 description 2
239000001923 methylcellulose Substances 0.000 description 2
235000010981 methylcellulose Nutrition 0.000 description 2
239000000049 pigment Substances 0.000 description 2
239000004014 plasticizer Substances 0.000 description 2
230000002265 prevention Effects 0.000 description 2
239000008213 purified water Substances 0.000 description 2
229940045902 sodium stearyl fumarate Drugs 0.000 description 2
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 description 2
125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 2
239000000811 xylitol Substances 0.000 description 2
235000010447 xylitol Nutrition 0.000 description 2
229960002675 xylitol Drugs 0.000 description 2
HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 2
239000004475 Arginine Substances 0.000 description 1
201000001320 Atherosclerosis Diseases 0.000 description 1
BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
229920002261 Corn starch Polymers 0.000 description 1
229920000832 Cutin Polymers 0.000 description 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 description 1
208000035150 Hypercholesterolemia Diseases 0.000 description 1
206010020772 Hypertension Diseases 0.000 description 1
ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
235000019759 Maize starch Nutrition 0.000 description 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 description 1
229930006000 Sucrose Natural products 0.000 description 1
238000010521 absorption reaction Methods 0.000 description 1
239000000654 additive Substances 0.000 description 1
229910052783 alkali metal Inorganic materials 0.000 description 1
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 description 1
229960000528 amlodipine Drugs 0.000 description 1
ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
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 description 1
230000015572 biosynthetic process Effects 0.000 description 1
230000036772 blood pressure Effects 0.000 description 1
229960001714 calcium phosphate Drugs 0.000 description 1
230000002612 cardiopulmonary effect Effects 0.000 description 1
230000005800 cardiovascular problem Effects 0.000 description 1
235000010980 cellulose Nutrition 0.000 description 1
229920002678 cellulose Polymers 0.000 description 1
239000001913 cellulose Substances 0.000 description 1
235000013339 cereals Nutrition 0.000 description 1
235000012000 cholesterol Nutrition 0.000 description 1
238000011260 co-administration Methods 0.000 description 1
238000002648 combination therapy Methods 0.000 description 1
238000007906 compression Methods 0.000 description 1
230000006835 compression Effects 0.000 description 1
239000013078 crystal Substances 0.000 description 1
238000009826 distribution Methods 0.000 description 1
238000007908 dry granulation Methods 0.000 description 1
230000002526 effect on cardiovascular system Effects 0.000 description 1
239000012530 fluid Substances 0.000 description 1
239000008103 glucose Substances 0.000 description 1
229960001031 glucose Drugs 0.000 description 1
239000001257 hydrogen Substances 0.000 description 1
229910052739 hydrogen Inorganic materials 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 description 1
239000007942 layered tablet Substances 0.000 description 1
229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
239000000463 material Substances 0.000 description 1
239000011159 matrix material Substances 0.000 description 1
208000030159 metabolic disease Diseases 0.000 description 1
238000012986 modification Methods 0.000 description 1
230000004048 modification Effects 0.000 description 1
238000004806 packaging method and process Methods 0.000 description 1
230000008092 positive effect Effects 0.000 description 1
230000003389 potentiating effect Effects 0.000 description 1
238000004393 prognosis Methods 0.000 description 1
239000000376 reactant Substances 0.000 description 1
239000003087 receptor blocking agent Substances 0.000 description 1
239000005720 sucrose Substances 0.000 description 1
229960004793 sucrose Drugs 0.000 description 1
IMRYETFJNLKUHK-UHFFFAOYSA-N traseolide Chemical compound CC1=C(C(C)=O)C=C2C(C(C)C)C(C)C(C)(C)C2=C1 IMRYETFJNLKUHK-UHFFFAOYSA-N 0.000 description 1
238000005406 washing Methods 0.000 description 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- 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
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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
- A61K9/2009—Inorganic compounds
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Public Health (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Medicinal Chemistry (AREA)
Veterinary Medicine (AREA)
General Health & Medical Sciences (AREA)
Bioinformatics & Cheminformatics (AREA)
Engineering & Computer Science (AREA)
Biophysics (AREA)
Molecular Biology (AREA)
Inorganic Chemistry (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

CZ20080740A 2008-11-24 2008-11-24 Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem CZ2008740A3 (cs)

Priority Applications (2)

Application Number	Priority Date	Filing Date	Title
CZ20080740A CZ2008740A3 (cs)	2008-11-24	2008-11-24	Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem
PCT/CZ2009/000138 WO2010057449A2 (fr)	2008-11-24	2009-11-16	Composition pharmaceutique solide comprenant de l'atorvastatine et du telmisartan en tant que substances actives

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
CZ20080740A CZ2008740A3 (cs)	2008-11-24	2008-11-24	Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem

Publications (2)

Publication Number	Publication Date
CZ301299B6 CZ301299B6 (cs)	2010-01-06
CZ2008740A3 true CZ2008740A3 (cs)	2010-01-06

Family

ID=41462928

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CZ20080740A CZ2008740A3 (cs)	2008-11-24	2008-11-24	Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem

Country Status (2)

Country	Link
CZ (1)	CZ2008740A3 (fr)
WO (1)	WO2010057449A2 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
KR101248804B1 (ko) *	2010-05-14	2013-03-29	한미사이언스 주식회사	ＨＭＧ-ＣｏＡ 환원효소 억제제 및 이베살탄을 포함하는 이층정 약제학적 복합제제
WO2014068507A1 (fr) *	2012-11-02	2014-05-08	Abbott Healthcare Pvt. Ltd.	Compositions pharmaceutiques orales solides de telmisartan essentiellement exemptes de tensioactifs
CN106176658A (zh) *	2016-06-29	2016-12-07	扬子江药业集团四川海蓉药业有限公司	一种阿托伐他汀钙片及其制备方法
WO2019130049A1 (fr)	2017-12-29	2019-07-04	Grünenthal GmbH	Combinaison pharmaceutique comprenant du chlorhydrate de tramadol à libération prolongée et de l'étoricoxib à libération immédiate, et son utilisation pour le traitement de la douleur

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CA2186606A1 (fr)	1994-03-29	1995-10-05	Edward B. Nelson	Traitement de l'atherosclerose
EP1514543A1 (fr) *	1997-08-29	2005-03-16	Pfizer Inc.	Ttherapie combinee utilisant de l'atorvastatine et un antihypertenseur
GT199800126A (es) *	1997-08-29	2000-01-29		Terapia de combinacion.
BR0215514A (pt)	2002-01-16	2004-12-21	Boehringer Ingelheim Pharma	Comprimido farmacêutico de bicamada compreendendo telmisartan e um diurético e preparação deste
DE10301371A1 (de) *	2003-01-16	2004-08-05	Boehringer Ingelheim Pharma Gmbh & Co. Kg	Pharmazeutische Kombination zur Prophylaxe oder Therapie von kardiovaskulären, kardiopulmonalen, pulmonalen oder renalen Krankheiten
DE10319450A1 (de)	2003-04-30	2004-11-18	Boehringer Ingelheim Pharma Gmbh & Co. Kg	Pharmazeutische Formulierung des Telmisartan Natriumsalzes
SE526257C2 (sv) *	2003-12-22	2005-08-09	Operax Ab	Metod för att kontrollera vidarebefordringskvaliteten i ett datanät
US20060078615A1 (en) *	2004-10-12	2006-04-13	Boehringer Ingelheim International Gmbh	Bilayer tablet of telmisartan and simvastatin
ME01615B (me)	2004-11-05	2014-09-20	Boehringer Ingelheim Int	Dvoslojna tableta koja sadrži telmisartan i amlodipin
CA2623018A1 (fr) *	2005-11-22	2007-05-31	Teva Pharmaceutical Industries Ltd.	Compositions pharmaceutiques de telmisartan
US8637078B2 (en)	2005-11-24	2014-01-28	Boehringer Ingelheim International Gmbh	Bilayer tablet comprising telmisartan and diuretic
US8642083B2 (en) *	2006-10-30	2014-02-04	Hanall Biopharma Co., Ltd.	Controlled release complex composition comprising angiotensin-II-receptor blockers and HMG-CoA reductase inhibitors
WO2008068217A2 (fr) *	2006-12-04	2008-06-12	Boehringer Ingelheim International Gmbh	Composition pharmaceutique
CZ300047B6 (cs) *	2007-03-02	2009-01-21	Zentiva, A. S.	Farmaceutická kompozice s obsahem úcinné látky atorvastatinu

2008
- 2008-11-24 CZ CZ20080740A patent/CZ2008740A3/cs not_active IP Right Cessation
2009
- 2009-11-16 WO PCT/CZ2009/000138 patent/WO2010057449A2/fr not_active Ceased

Also Published As

Publication number	Publication date
WO2010057449A3 (fr)	2011-03-17
CZ301299B6 (cs)	2010-01-06
WO2010057449A2 (fr)	2010-05-27

Legal Events

Date	Code	Title	Description
2020-06-10	MM4A	Patent lapsed due to non-payment of fee	Effective date: 20191124

Publication	Publication Date	Title
CA2722093C (fr)	2015-04-28	Compositions pharmaceutiques comprenant du brivaracetam
US8673353B2 (en)	2014-03-18	Tablet having improved elution properties
KR100463496B1 (ko)	2005-01-06	고가용성 약물용 서방성 메트리스 시스템
PL188233B1 (pl)	2004-12-31	Sposób formowania sprasowanej stałej, doustnej postaci dawkowania valsartanu
IL181282A (en)	2012-10-31	Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
EP1646374A1 (fr)	2006-04-19	Comprimes a liberation controlee de metformine
EP2554159A1 (fr)	2013-02-06	Formes pharmaceutiques comportant de l'apixaban et améliorant d'uniformité de contenu
CA2532485A1 (fr)	2005-01-27	Comprimes contenant de l'ambroxol
SK18062002A3 (sk)	2003-07-01	Pevné orálne farmaceutické kompozície obsahujúce valsartan
WO2008155620A1 (fr)	2008-12-24	Forme posologique contenant une matrice dispersible de granulés à libération entretenue
CN101626755A (zh)	2010-01-13	包含酸不稳定药物的双单元片剂
CN101087589A (zh)	2007-12-12	含有缬沙坦的固体药物组合物
CN103239719A (zh)	2013-08-14	二甲双胍复方药物组合物及其制备方法
CZ2008740A3 (cs)	2010-01-06	Pevná farmaceutická kompozice s úcinnými látkami atorvastatinem a telmisartanem
AU2014295100A1 (en)	2016-02-11	Antitubercular composition comprising rifampicin, isoniazid, ethambutol and pyrazinamide and its process of preparation.
SK50232004A3 (sk)	2005-04-01	Spôsob prípravy tabliet z farmaceuticky aktívnych látok, ktoré majú nevýhodné tabletačné vlastnosti s granulačnou kvapalinou obsahujúcou mikrokryštalickú celulózu
AU2009243734B2 (en)	2014-02-27	Granulate comprising escitalopram oxalate
JP2018517739A (ja)	2018-07-05	アログリプチン製剤
WO2011080502A2 (fr)	2011-07-07	Nouvelle forme pharmaceutique destinée au traitement de troubles liés à l'acide gastrique
EP3511001B1 (fr)	2021-09-22	Comprimé contenant de la pirfénidone et formulation de capsule
JP2026504297A (ja)	2026-02-04	ブリーバラセタムの二重放出三層錠剤およびその製造方法
WO2005089720A1 (fr)	2005-09-29	Comprimes a base de valsartan et procede de preparation associe
EP2934494B1 (fr)	2019-06-12	Formulation pharmaceutique de n-[5-[2-(3,5-diméthoxyphényl)éthyl]-2h-pyrazol-3-yl]-4-[(3r,5s)-3,5-diméthylpipérazin-1-yl]benzamide
US20080220064A1 (en)	2008-09-11	Extended release matrix formulations of morphine
WO2010112221A1 (fr)	2010-10-07	Compositions pharmaceutiques renfermant de la mémantine