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 (OSRAM) |
| EP (1) | EP1677766B1 (OSRAM) |
| JP (1) | JP2007509891A (OSRAM) |
| AT (1) | ATE549015T1 (OSRAM) |
| AU (1) | AU2004285284B2 (OSRAM) |
| BR (1) | BRPI0415557A (OSRAM) |
| CA (1) | CA2543689A1 (OSRAM) |
| MX (1) | MXPA06004700A (OSRAM) |
| NO (1) | NO20062051L (OSRAM) |
| NZ (1) | NZ547284A (OSRAM) |
| RU (1) | RU2372893C2 (OSRAM) |
| WO (1) | WO2005041934A2 (OSRAM) |
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 |
| JP2009527554A (ja) * | 2006-02-24 | 2009-07-30 | テバ ファーマシューティカル インダストリーズ リミティド | コハク酸メトプロロールｅ．ｒ．の錠剤およびその調製方法 |
| PT3103448T (pt) * | 2006-09-26 | 2019-07-12 | Novartis Ag | Composições farmacêuticas que compreendem um modulador de s1p |
| EP2184056B1 (en) | 2007-08-27 | 2019-04-24 | Asahi Kasei Kabushiki Kaisha | Process for production of tablets containing both crystalline cellulose and 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 |
| KR101454056B1 (ko) * | 2007-09-21 | 2014-10-27 | 에보니크 룀 게엠베하 | 에탄올의 영향에 대하여 내성을 가지는 비-오피오이드용 ｐｈ-의존성 조절 방출 제약 조성물 |
| KR101571179B1 (ko) | 2008-01-10 | 2015-11-23 | 에보니크 룀 게엠베하 | 증가된 맥동성 활성 물질 방출을 갖는 코팅된 제약학적 또는 건강기능성 제제 |
| MX2010007578A (es) * | 2008-01-10 | 2010-08-03 | Evonik Roehm Gmbh | Preparacion nutriceutica o farmaceutica revestida con una liberacion acelerada controlada de sustancia activa. |
| EP2309999A1 (en) * | 2008-06-26 | 2011-04-20 | McNeil-PPC, Inc. | Coated particles containing pharmaceutically active agents |
| JPWO2010026993A1 (ja) * | 2008-09-03 | 2012-02-02 | 武田薬品工業株式会社 | 製剤における吸収性改善方法および吸収性が改善された製剤 |
| KR20120003436A (ko) * | 2009-03-18 | 2012-01-10 | 에보니크 룀 게엠베하 | 중합체 혼합물 및 부형제를 포함하는 코팅을 이용하는, 에탄올의 영향에 대한 내성을 갖는 제어 방출 제약 조성물 |
| HUE032817T2 (en) * | 2009-03-18 | 2017-11-28 | Evonik Roehm Gmbh | Regulated release pharmaceutical composition comprising a coating containing neutral vinyl polymers and excipients and resistant to the influence of ethanol |
| KR20120033305A (ko) * | 2009-05-12 | 2012-04-06 | 비피에스아이 홀딩스, 엘엘씨. | 미립자인 비점착제를 포함하는 필름 코팅 및 상기 필름코팅이 코팅된 기재 |
| MX2011011919A (es) * | 2009-05-12 | 2012-01-27 | Bpsi Holdings Llc | Sistemas de recubrimiento de pelicula de liberacion inmediata con barrera contra humedad mejorada y sustratos recubiertos con dichos sistemas. |
| 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 |
| EP2755640B1 (en) * | 2011-09-16 | 2017-07-26 | Purdue Pharma LP | Tamper resistant pharmaceutical formulations |
| WO2016174664A1 (en) | 2015-04-29 | 2016-11-03 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| US11638759B2 (en) | 2019-08-13 | 2023-05-02 | Darlene E. McCord | Non-activated, amorphous, pH neutral, two-part bedside-ready clay delivery system that treats pathogen infections in humans and animals |
| 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 |
| WO2023076855A1 (en) | 2021-10-25 | 2023-05-04 | Mccord Darlene E | 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 |
| JP2001515854A (ja) * | 1997-09-11 | 2001-09-25 | ニュコメデ ダンマルク アクティーゼルスカブ | 非ステロイド性抗炎症薬物質（ＮＳＡＩＤｓ）の改良された開放性多重−単位組成物 |
| 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 |
| EP1355633B1 (en) * | 2001-12-19 | 2005-01-19 | AstraZeneca AB | NEW FILM COATING containing an ethyl acrylate/methyl methacrylate copolymer and polyvinyl acetate |
| CA2534367A1 (en) * | 2003-08-06 | 2005-02-17 | Nirmal Mulye | Pharmaceutical composition containing water soluble drug |
-
2004
- 2004-10-28 EP EP04790997A patent/EP1677766B1/de not_active Revoked
- 2004-10-28 JP JP2006537197A patent/JP2007509891A/ja active Pending
- 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 MX MXPA06004700A patent/MXPA06004700A/es active IP Right Grant
- 2004-10-28 RU RU2006118689/15A patent/RU2372893C2/ru not_active IP Right Cessation
- 2004-10-28 AT AT04790997T patent/ATE549015T1/de active
- 2004-10-28 BR BRPI0415557-2A patent/BRPI0415557A/pt not_active Application Discontinuation
- 2004-10-28 AU AU2004285284A patent/AU2004285284B2/en not_active Ceased
- 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
-
2006
- 2006-05-08 NO NO20062051A patent/NO20062051L/no unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20080254112A1 (en) | 2008-10-16 |
| RU2006118689A (ru) | 2007-12-20 |
| BRPI0415557A (pt) | 2006-12-26 |
| EP1677766A2 (de) | 2006-07-12 |
| EP1677766B1 (de) | 2012-03-14 |
| AU2004285284A1 (en) | 2005-05-12 |
| AU2004285284B2 (en) | 2010-03-25 |
| NO20062051L (no) | 2006-07-25 |
| WO2005041934A2 (de) | 2005-05-12 |
| MXPA06004700A (es) | 2006-07-05 |
| RU2372893C2 (ru) | 2009-11-20 |
| ATE549015T1 (de) | 2012-03-15 |
| WO2005041934A3 (de) | 2005-12-01 |
| CA2543689A1 (en) | 2005-05-12 |
| JP2007509891A (ja) | 2007-04-19 |
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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 |