NZ547284A - Pharmaceutical agent-containing formulation comprising a coating of a film forming polymer - Google Patents
Pharmaceutical agent-containing formulation comprising a coating of a film forming polymerInfo
- Publication number
- NZ547284A NZ547284A NZ547284A NZ54728404A NZ547284A NZ 547284 A NZ547284 A NZ 547284A NZ 547284 A NZ547284 A NZ 547284A NZ 54728404 A NZ54728404 A NZ 54728404A NZ 547284 A NZ547284 A NZ 547284A
- Authority
- NZ
- New Zealand
- Prior art keywords
- process according
- ingredient
- active
- coating
- salt
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 78
- 238000000576 coating method Methods 0.000 title claims abstract description 58
- 239000011248 coating agent Substances 0.000 title claims abstract description 56
- 229920000642 polymer Polymers 0.000 title claims abstract description 55
- 238000009472 formulation Methods 0.000 title claims abstract description 54
- 239000008177 pharmaceutical agent Substances 0.000 title 1
- 239000004480 active ingredient Substances 0.000 claims abstract description 88
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 54
- 238000000034 method Methods 0.000 claims abstract description 49
- 230000008569 process Effects 0.000 claims abstract description 41
- 239000006185 dispersion Substances 0.000 claims abstract description 34
- -1 fatty acid salt Chemical class 0.000 claims abstract description 32
- 239000010410 layer Substances 0.000 claims abstract description 26
- 238000002360 preparation method Methods 0.000 claims abstract description 26
- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 25
- 239000000194 fatty acid Substances 0.000 claims abstract description 25
- 229930195729 fatty acid Natural products 0.000 claims abstract description 25
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229920000058 polyacrylate Polymers 0.000 claims abstract description 15
- 150000003839 salts Chemical class 0.000 claims abstract description 10
- 229960002237 metoprolol Drugs 0.000 claims abstract description 8
- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical group COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 claims abstract description 8
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims abstract description 5
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 claims abstract description 3
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims abstract description 3
- 239000007900 aqueous suspension Substances 0.000 claims abstract description 3
- 229960002781 bisoprolol Drugs 0.000 claims abstract description 3
- VHYCDWMUTMEGQY-UHFFFAOYSA-N bisoprolol Chemical compound CC(C)NCC(O)COC1=CC=C(COCCOC(C)C)C=C1 VHYCDWMUTMEGQY-UHFFFAOYSA-N 0.000 claims abstract description 3
- 150000004677 hydrates Chemical class 0.000 claims abstract description 3
- LLPOLZWFYMWNKH-CMKMFDCUSA-N hydrocodone Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)CC(=O)[C@@H]1OC1=C2C3=CC=C1OC LLPOLZWFYMWNKH-CMKMFDCUSA-N 0.000 claims abstract description 3
- 229960000240 hydrocodone Drugs 0.000 claims abstract description 3
- 229960005181 morphine Drugs 0.000 claims abstract description 3
- 239000002356 single layer Substances 0.000 claims abstract description 3
- 239000012453 solvate Substances 0.000 claims abstract description 3
- 229960004380 tramadol Drugs 0.000 claims abstract description 3
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 claims abstract description 3
- 239000008188 pellet Substances 0.000 claims description 59
- 239000003826 tablet Substances 0.000 claims description 40
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 36
- 239000000454 talc Substances 0.000 claims description 32
- 235000012222 talc Nutrition 0.000 claims description 32
- 229910052623 talc Inorganic materials 0.000 claims description 32
- 229920003163 Eudragit® NE 30 D Polymers 0.000 claims description 23
- 239000002775 capsule Substances 0.000 claims description 23
- 235000019359 magnesium stearate Nutrition 0.000 claims description 18
- 239000002552 dosage form Substances 0.000 claims description 17
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 15
- 239000008187 granular material Substances 0.000 claims description 15
- 238000005507 spraying Methods 0.000 claims description 14
- 239000008185 minitablet Substances 0.000 claims description 13
- 239000004094 surface-active agent Substances 0.000 claims description 13
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims description 11
- 238000009501 film coating Methods 0.000 claims description 11
- 239000007888 film coating Substances 0.000 claims description 11
- 239000000126 substance Substances 0.000 claims description 11
- 229910052783 alkali metal Inorganic materials 0.000 claims description 9
- RGHAZVBIOOEVQX-UHFFFAOYSA-N Metoprolol succinate Chemical compound OC(=O)CCC(O)=O.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 RGHAZVBIOOEVQX-UHFFFAOYSA-N 0.000 claims description 8
- 239000013078 crystal Substances 0.000 claims description 8
- 229960000939 metoprolol succinate Drugs 0.000 claims description 8
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 7
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 7
- 239000007903 gelatin capsule Substances 0.000 claims description 7
- 229910052749 magnesium Inorganic materials 0.000 claims description 7
- 239000011777 magnesium Substances 0.000 claims description 7
- 229910052708 sodium Inorganic materials 0.000 claims description 7
- 239000011734 sodium Substances 0.000 claims description 7
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 6
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical group 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 description 6
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 6
- 159000000013 aluminium salts Chemical class 0.000 claims description 6
- GHVNFZFCNZKVNT-UHFFFAOYSA-N decanoic acid Chemical compound CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 claims description 6
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims description 6
- IPCSVZSSVZVIGE-UHFFFAOYSA-N hexadecanoic acid Chemical compound CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims description 6
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims description 6
- 229910052700 potassium Inorganic materials 0.000 claims description 6
- 239000011591 potassium Substances 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 229910000329 aluminium sulfate Inorganic materials 0.000 claims description 5
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical compound [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 claims description 5
- 239000000440 bentonite Substances 0.000 claims description 5
- 229910000278 bentonite Inorganic materials 0.000 claims description 5
- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 claims description 5
- SMBKCSPGKDEPFO-UHFFFAOYSA-L calcium;docosanoate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCCCCCC([O-])=O SMBKCSPGKDEPFO-UHFFFAOYSA-L 0.000 claims description 5
- 239000000470 constituent Substances 0.000 claims description 5
- 239000007921 spray Substances 0.000 claims description 5
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 4
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 4
- 239000011575 calcium Substances 0.000 claims description 4
- 229910052791 calcium Inorganic materials 0.000 claims description 4
- 239000004615 ingredient Substances 0.000 claims description 4
- 125000005397 methacrylic acid ester group Chemical group 0.000 claims description 4
- WSWCOQWTEOXDQX-MQQKCMAXSA-M (E,E)-sorbate Chemical class C\C=C\C=C\C([O-])=O WSWCOQWTEOXDQX-MQQKCMAXSA-M 0.000 claims description 3
- 229910002012 Aerosil® Inorganic materials 0.000 claims description 3
- 239000005995 Aluminium silicate Substances 0.000 claims description 3
- 239000005632 Capric acid (CAS 334-48-5) Substances 0.000 claims description 3
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 claims description 3
- 239000005639 Lauric acid Substances 0.000 claims description 3
- 235000021314 Palmitic acid Nutrition 0.000 claims description 3
- 125000005396 acrylic acid ester group Chemical group 0.000 claims description 3
- 239000013543 active substance Substances 0.000 claims description 3
- 235000012211 aluminium silicate Nutrition 0.000 claims description 3
- 229960000892 attapulgite Drugs 0.000 claims description 3
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 3
- YGANSGVIUGARFR-UHFFFAOYSA-N dipotassium dioxosilane oxo(oxoalumanyloxy)alumane oxygen(2-) Chemical compound [O--].[K+].[K+].O=[Si]=O.O=[Al]O[Al]=O YGANSGVIUGARFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052622 kaolinite Inorganic materials 0.000 claims description 3
- 159000000003 magnesium salts Chemical group 0.000 claims description 3
- 229910052627 muscovite Inorganic materials 0.000 claims description 3
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 claims description 3
- 229960002446 octanoic acid Drugs 0.000 claims description 3
- MUZQPDBAOYKNLO-RKXJKUSZSA-N oxycodone hydrochloride Chemical compound [H+].[Cl-].O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C MUZQPDBAOYKNLO-RKXJKUSZSA-N 0.000 claims description 3
- 229910052625 palygorskite Inorganic materials 0.000 claims description 3
- 229910052903 pyrophyllite Inorganic materials 0.000 claims description 3
- 229910052902 vermiculite Inorganic materials 0.000 claims description 3
- 239000010455 vermiculite Substances 0.000 claims description 3
- 235000019354 vermiculite Nutrition 0.000 claims description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 2
- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 claims description 2
- 229910052901 montmorillonite Inorganic materials 0.000 claims description 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims description 2
- 229940095064 tartrate Drugs 0.000 claims description 2
- 229910052751 metal Inorganic materials 0.000 claims 2
- 239000002184 metal Substances 0.000 claims 2
- 239000001828 Gelatine Substances 0.000 claims 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 1
- 239000003513 alkali Substances 0.000 claims 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-L fumarate(2-) Chemical compound [O-]C(=O)\C=C\C([O-])=O VZCYOOQTPOCHFL-OWOJBTEDSA-L 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 239000011162 core material Substances 0.000 description 48
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 18
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 18
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 16
- 239000004014 plasticizer Substances 0.000 description 14
- 229920003134 Eudragit® polymer Polymers 0.000 description 13
- 229920001577 copolymer Polymers 0.000 description 11
- 229920003161 Eudragit® RS 30 D Polymers 0.000 description 9
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 9
- 235000010980 cellulose Nutrition 0.000 description 9
- 229920002678 cellulose Polymers 0.000 description 9
- 229960000278 theophylline Drugs 0.000 description 9
- 239000001069 triethyl citrate Substances 0.000 description 9
- 235000013769 triethyl citrate Nutrition 0.000 description 9
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 9
- 239000001913 cellulose Substances 0.000 description 8
- 150000004665 fatty acids Chemical class 0.000 description 8
- 239000003381 stabilizer Substances 0.000 description 8
- 229920003153 Eudragit® NE polymer Polymers 0.000 description 7
- 229920003152 Eudragit® RS polymer Polymers 0.000 description 7
- 239000002518 antifoaming agent Substances 0.000 description 7
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 description 7
- FSXVSUSRJXIJHB-UHFFFAOYSA-M ethyl prop-2-enoate;methyl 2-methylprop-2-enoate;trimethyl-[2-(2-methylprop-2-enoyloxy)ethyl]azanium;chloride Chemical compound [Cl-].CCOC(=O)C=C.COC(=O)C(C)=C.CC(=C)C(=O)OCC[N+](C)(C)C FSXVSUSRJXIJHB-UHFFFAOYSA-M 0.000 description 7
- 229920001296 polysiloxane Polymers 0.000 description 7
- 235000000346 sugar Nutrition 0.000 description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical class OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- 150000001340 alkali metals Chemical class 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 229920001223 polyethylene glycol Polymers 0.000 description 6
- 239000000377 silicon dioxide Substances 0.000 description 6
- 235000012239 silicon dioxide Nutrition 0.000 description 6
- 229920003151 Eudragit® RL polymer Polymers 0.000 description 5
- 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 description 5
- 239000007864 aqueous solution Substances 0.000 description 5
- 239000001768 carboxy methyl cellulose Substances 0.000 description 5
- 239000004815 dispersion polymer Substances 0.000 description 5
- 239000000839 emulsion Substances 0.000 description 5
- 229940075507 glyceryl monostearate Drugs 0.000 description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 5
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 description 5
- DNKKLDKIFMDAPT-UHFFFAOYSA-N n,n-dimethylmethanamine;2-methylprop-2-enoic acid Chemical compound CN(C)C.CC(=C)C(O)=O.CC(=C)C(O)=O DNKKLDKIFMDAPT-UHFFFAOYSA-N 0.000 description 5
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 5
- 235000015424 sodium Nutrition 0.000 description 5
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 5
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- 229920003137 Eudragit® S polymer Polymers 0.000 description 4
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 4
- 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 description 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 4
- 229920002472 Starch Polymers 0.000 description 4
- 150000001342 alkaline earth metals Chemical class 0.000 description 4
- 229940061587 calcium behenate Drugs 0.000 description 4
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 4
- 239000007884 disintegrant Substances 0.000 description 4
- 238000009509 drug development Methods 0.000 description 4
- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 description 4
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 description 4
- 239000008101 lactose Substances 0.000 description 4
- 229920000136 polysorbate Polymers 0.000 description 4
- 229950008882 polysorbate Drugs 0.000 description 4
- 150000004760 silicates Chemical class 0.000 description 4
- 239000008107 starch Substances 0.000 description 4
- 235000019698 starch Nutrition 0.000 description 4
- 238000013268 sustained release Methods 0.000 description 4
- 239000012730 sustained-release form Substances 0.000 description 4
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 4
- PPKXEPBICJTCRU-XMZRARIVSA-N (R,R)-tramadol hydrochloride Chemical compound Cl.COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 PPKXEPBICJTCRU-XMZRARIVSA-N 0.000 description 3
- RZPZLFIUFMNCLY-WLHGVMLRSA-N (e)-but-2-enedioic acid;1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]propan-2-ol Chemical compound OC(=O)\C=C\C(O)=O.CC(C)NCC(O)COC1=CC=C(COCCOC(C)C)C=C1 RZPZLFIUFMNCLY-WLHGVMLRSA-N 0.000 description 3
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Chemical class OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical class OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 description 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 3
- 235000021355 Stearic acid Nutrition 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 239000011230 binding agent Substances 0.000 description 3
- 229960005400 bisoprolol fumarate Drugs 0.000 description 3
- 238000013270 controlled release Methods 0.000 description 3
- 230000001419 dependent effect Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 3
- 239000000314 lubricant Substances 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 229960004715 morphine sulfate Drugs 0.000 description 3
- GRVOTVYEFDAHCL-RTSZDRIGSA-N morphine sulfate pentahydrate Chemical compound O.O.O.O.O.OS(O)(=O)=O.O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O.O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O GRVOTVYEFDAHCL-RTSZDRIGSA-N 0.000 description 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 3
- 229960000381 omeprazole Drugs 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 230000035699 permeability Effects 0.000 description 3
- 230000000979 retarding effect Effects 0.000 description 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 3
- 239000000600 sorbitol Chemical class 0.000 description 3
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- 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
- A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE2003151301 DE10351301A1 (de) | 2003-10-31 | 2003-10-31 | Retardierte Dosisform aus mehreren Einzeleinheiten |
| DE200410014828 DE102004014828A1 (de) | 2004-03-24 | 2004-03-24 | Pharmazeutische wirkstoffhaltige Formulierung mit Überzug |
| PCT/EP2004/012230 WO2005041934A2 (de) | 2003-10-31 | 2004-10-28 | Pharmazeutische wirkstoffhaltige formulierung mit überzug |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| NZ547284A true NZ547284A (en) | 2009-12-24 |
Family
ID=34553325
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NZ547284A NZ547284A (en) | 2003-10-31 | 2004-10-28 | Pharmaceutical agent-containing formulation comprising a coating of a film forming polymer |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20080254112A1 (enExample) |
| EP (1) | EP1677766B1 (enExample) |
| JP (1) | JP2007509891A (enExample) |
| AT (1) | ATE549015T1 (enExample) |
| AU (1) | AU2004285284B2 (enExample) |
| BR (1) | BRPI0415557A (enExample) |
| CA (1) | CA2543689A1 (enExample) |
| MX (1) | MXPA06004700A (enExample) |
| NO (1) | NO20062051L (enExample) |
| NZ (1) | NZ547284A (enExample) |
| RU (1) | RU2372893C2 (enExample) |
| WO (1) | WO2005041934A2 (enExample) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102005024614A1 (de) * | 2005-05-25 | 2006-11-30 | Röhm Gmbh | Verwendung von Polymermischungen zur Herstellung von überzogenen Arzneiformen sowie Arzneiform mit polymerem Mischüberzug |
| ATE536864T1 (de) * | 2006-02-24 | 2011-12-15 | Teva Pharma | Metoprololsuccinat tabletten mit verlängerter freisetzung und verfahren für deren herstellung |
| SI3103448T1 (sl) * | 2006-09-26 | 2019-11-29 | Novartis Ag | Farmacevtski sestavek, ki vsebuje modulator S1P |
| US8367115B2 (en) | 2007-08-27 | 2013-02-05 | Asahi Kasei Chemicals Corporation | Process for production of crystalline cellulose and tablets containing granules |
| CN101801357B (zh) * | 2007-09-21 | 2013-08-07 | 赢创罗姆有限公司 | 耐受乙醇的影响的pH依赖性受控释放的药物组合物 |
| ES2393805T3 (es) * | 2007-09-21 | 2012-12-28 | Evonik Röhm Gmbh | Composición farmacéutica de liberación controlada dependiente del pH para compuestos no opioides con resistencia frente a la influencia del etanol |
| HUE043474T2 (hu) | 2008-01-10 | 2019-08-28 | Evonik Roehm Gmbh | Bevont gyógyszerészeti vagy gyógyhatású étrend-kiegészítõ készítmény javított pulzáló hatóanyag-felszabadulással |
| JP2011509266A (ja) * | 2008-01-10 | 2011-03-24 | エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング | 活性物質の制御放出が促進された、コーティングされた医薬製剤もしくはニュートラシューティカル製剤 |
| CN102119027A (zh) * | 2008-06-26 | 2011-07-06 | 麦克内尔-Ppc股份有限公司 | 含有药物活性剂的包衣颗粒 |
| EP2329823A4 (en) | 2008-09-03 | 2013-04-03 | Takeda Pharmaceutical | PROCESS FOR INCREASING THE ABSORPTION ABILITY OF A PREPARATION AND PREPARATION WITH INCREASED ABSORPTION ABILITY |
| CN102365083A (zh) * | 2009-03-18 | 2012-02-29 | 赢创罗姆有限公司 | 采用包含聚合物混合物和赋形剂的包衣的具有耐乙醇影响的控释药物组合物 |
| KR101571198B1 (ko) * | 2009-03-18 | 2015-11-23 | 에보니크 룀 게엠베하 | 중성 비닐 중합체 및 부형제를 포함하는 코팅을 이용하는, 에탄올의 영향에 대한 내성을 갖는 제어 방출 제약 조성물 |
| CN102421423B (zh) | 2009-05-12 | 2014-11-05 | Bpsi控股有限责任公司 | 增强型防潮即释薄膜包衣系统和覆有该包衣的基体 |
| BRPI1007724A2 (pt) * | 2009-05-12 | 2017-09-19 | Bpsi Holdings Llc | Composição de revestimento seco, suspensão aquosa, substrato oral, método para preparação de dispersão aquosa de revestimento, forma de dosagem oral farmaceuticamente aceitável e método de preparação de formas de dosagem sólidas orais farmaceuticamente aceitáveis |
| EP2564837B1 (en) | 2010-04-30 | 2019-01-30 | Takeda Pharmaceutical Company Limited | Enteric tablet |
| BR112012027794A2 (pt) | 2010-04-30 | 2016-08-02 | Takeda Pharmaceutical | tablete entérico |
| FR2968559B1 (fr) * | 2010-12-14 | 2012-12-28 | Alexandra Fregonese | Nouvelles compositions a base d'argile et de beepollen, leur procede de preparation et leurs utilisations en nutrition et en therapeutique |
| ES2583132T3 (es) * | 2011-09-16 | 2016-09-19 | Purdue Pharma L.P. | Formulaciones de liberación inmediata resistentes a alteración |
| CA2847611A1 (en) * | 2011-09-16 | 2013-03-21 | Purdue Pharma L.P. | Tamper resistant pharmaceutical formulations |
| US20170042806A1 (en) | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| EP4013372A4 (en) | 2019-08-13 | 2023-08-30 | McCord, Darlene E. | NON-ACTIVATED, AMORPHIC, PH-NEUTRAL, TWO-PIECE, BED-SIDE READY SOUND SYSTEM FOR THE TREATMENT OF PATHOGENIC INFECTIONS IN HUMAN AND ANIMAL |
| JP7482645B2 (ja) * | 2020-02-18 | 2024-05-14 | 沢井製薬株式会社 | 核粒子を含む顆粒の製造方法 |
| US12213993B2 (en) | 2021-10-25 | 2025-02-04 | Darlene E. McCord | Coated medicinal clay compositions, pharmaceutical compositions, and delivery of cation sources and methods of use thereof |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5110814A (en) * | 1989-01-11 | 1992-05-05 | Asta Pharma Ag | Azelastine and its salts used to combat psoriasis |
| DE3900811A1 (de) * | 1989-01-13 | 1990-07-19 | Kali Chemie Pharma Gmbh | Neue arzneiform |
| CH687810A5 (de) * | 1995-05-24 | 1997-02-28 | Mepha Ag | Pelletformulierung mit Omeprazol. |
| CA2177769C (en) * | 1995-06-07 | 1999-08-24 | Gyanesh P. Khare | Particulate compositions that comprise zinc aluminate |
| DE19732903A1 (de) * | 1997-07-30 | 1999-02-04 | Falk Pharma Gmbh | Pellet-Formulierung zur Behandlung des Intestinaltraktes |
| ATE252892T1 (de) * | 1997-09-11 | 2003-11-15 | Nycomed Danmark Aps | Aus mehreren einzeleinheiten zusammengesetzte arzneimittel mit nicht-steroidalen wirkstoffen (nsaids) |
| CN1195500C (zh) * | 1998-05-18 | 2005-04-06 | 武田药品工业株式会社 | 可口腔崩解的片剂 |
| DE19905906A1 (de) * | 1999-02-11 | 2000-08-17 | Basf Ag | Verwendung von wasserlöslichen oder wasserdispergierbaren Polyether-haltigen Polymerisaten als Überzugsmittel, Bindemittel und/oder filmbildender Hilfsstoff in pharmazeutischen Darreichungsformen |
| DE19850238A1 (de) * | 1998-10-31 | 2000-05-04 | Triple Trian Beteiligungs Gmbh | Verfahren und Vorrichtung zur Kompensation von Elektrosmog |
| US7070803B2 (en) * | 2000-03-31 | 2006-07-04 | Nycomed Austria Gmbh | Controlled release pharmaceutical composition for oral use containing midodrine and/or active metabolite, desglymidodrine |
| US6749867B2 (en) * | 2000-11-29 | 2004-06-15 | Joseph R. Robinson | Delivery system for omeprazole and its salts |
| SE0100200D0 (sv) * | 2001-01-24 | 2001-01-24 | Astrazeneca Ab | New film coating |
| DE10149674A1 (de) * | 2001-10-09 | 2003-04-24 | Apogepha Arzneimittel Gmbh | Orale Darreichungsformen für Propiverin oder seinen pharmazeutisch annehmbaren Salzen mit verlängerter Wirkstoffreisetzung |
| BR0206441A (pt) * | 2001-12-19 | 2003-12-30 | Astrazeneca Ab | Composição de revestimento de pelìcula, revestimento de pelìcula cobrindo um núcleo farmacêutico, formulação farmacêutica de liberação modificada, e, processos para preparar uma composição de revestimento de pelìcula, um revestimento de pelìcula e uma formulação |
| US7897179B2 (en) * | 2003-08-06 | 2011-03-01 | Nostrum Pharmaceuticals, Inc. | Pharmaceutical composition containing water soluble drug |
-
2004
- 2004-10-28 EP EP04790997A patent/EP1677766B1/de not_active Revoked
- 2004-10-28 RU RU2006118689/15A patent/RU2372893C2/ru not_active IP Right Cessation
- 2004-10-28 NZ NZ547284A patent/NZ547284A/en not_active IP Right Cessation
- 2004-10-28 US US10/577,569 patent/US20080254112A1/en not_active Abandoned
- 2004-10-28 AT AT04790997T patent/ATE549015T1/de active
- 2004-10-28 MX MXPA06004700A patent/MXPA06004700A/es active IP Right Grant
- 2004-10-28 WO PCT/EP2004/012230 patent/WO2005041934A2/de not_active Ceased
- 2004-10-28 CA CA002543689A patent/CA2543689A1/en not_active Abandoned
- 2004-10-28 BR BRPI0415557-2A patent/BRPI0415557A/pt not_active Application Discontinuation
- 2004-10-28 JP JP2006537197A patent/JP2007509891A/ja active Pending
- 2004-10-28 AU AU2004285284A patent/AU2004285284B2/en not_active Ceased
-
2006
- 2006-05-08 NO NO20062051A patent/NO20062051L/no unknown
Also Published As
| Publication number | Publication date |
|---|---|
| RU2372893C2 (ru) | 2009-11-20 |
| BRPI0415557A (pt) | 2006-12-26 |
| NO20062051L (no) | 2006-07-25 |
| AU2004285284B2 (en) | 2010-03-25 |
| ATE549015T1 (de) | 2012-03-15 |
| JP2007509891A (ja) | 2007-04-19 |
| AU2004285284A1 (en) | 2005-05-12 |
| US20080254112A1 (en) | 2008-10-16 |
| EP1677766B1 (de) | 2012-03-14 |
| MXPA06004700A (es) | 2006-07-05 |
| CA2543689A1 (en) | 2005-05-12 |
| WO2005041934A3 (de) | 2005-12-01 |
| WO2005041934A2 (de) | 2005-05-12 |
| RU2006118689A (ru) | 2007-12-20 |
| EP1677766A2 (de) | 2006-07-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PSEA | Patent sealed | ||
| RENW | Renewal (renewal fees accepted) | ||
| RENW | Renewal (renewal fees accepted) | ||
| RENW | Renewal (renewal fees accepted) |
Free format text: PATENT RENEWED FOR 3 YEARS UNTIL 28 OCT 2017 BY CPA GLOBAL Effective date: 20140903 |
|
| LAPS | Patent lapsed |