TR2022015882A2 - TABLETS IN CAPSULES CONTAINING LANSOPRAZOL - Google Patents
TABLETS IN CAPSULES CONTAINING LANSOPRAZOLInfo
- Publication number
- TR2022015882A2 TR2022015882A2 TR2022/015882 TR2022015882A2 TR 2022015882 A2 TR2022015882 A2 TR 2022015882A2 TR 2022/015882 TR2022/015882 TR 2022/015882 TR 2022015882 A2 TR2022015882 A2 TR 2022015882A2
- Authority
- TR
- Turkey
- Prior art keywords
- pharmaceutical composition
- capsule form
- mixtures
- form containing
- enteric coating
- Prior art date
Links
- 239000002775 capsule Substances 0.000 title claims abstract description 34
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 title claims abstract description 28
- 239000002702 enteric coating Substances 0.000 claims abstract description 57
- 238000009505 enteric coating Methods 0.000 claims abstract description 57
- 239000003826 tablet Substances 0.000 claims abstract description 40
- 239000008185 minitablet Substances 0.000 claims abstract description 33
- 229960003174 lansoprazole Drugs 0.000 claims abstract description 26
- 239000011248 coating agent Substances 0.000 claims abstract description 24
- 238000000576 coating method Methods 0.000 claims abstract description 24
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 23
- 229920003169 water-soluble polymer Polymers 0.000 claims abstract description 11
- 229920001688 coating polymer Polymers 0.000 claims abstract description 10
- 239000000203 mixture Substances 0.000 claims description 71
- 239000000454 talc Substances 0.000 claims description 24
- 235000012222 talc Nutrition 0.000 claims description 24
- 229910052623 talc Inorganic materials 0.000 claims description 24
- 229940033134 talc Drugs 0.000 claims description 24
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 24
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 20
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 16
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 15
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 15
- 229920001577 copolymer Polymers 0.000 claims description 14
- 239000000853 adhesive Substances 0.000 claims description 13
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 13
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 13
- 230000000181 anti-adherent effect Effects 0.000 claims description 12
- 239000001087 glyceryl triacetate Substances 0.000 claims description 12
- 235000013773 glyceryl triacetate Nutrition 0.000 claims description 12
- 229960002622 triacetin Drugs 0.000 claims description 12
- 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 11
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 11
- 239000003085 diluting agent Substances 0.000 claims description 11
- 235000010355 mannitol Nutrition 0.000 claims description 11
- 239000004014 plasticizer Substances 0.000 claims description 11
- 239000001069 triethyl citrate Substances 0.000 claims description 11
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 11
- 235000013769 triethyl citrate Nutrition 0.000 claims description 11
- 239000008101 lactose Substances 0.000 claims description 10
- 229960001375 lactose Drugs 0.000 claims description 10
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 10
- 239000001095 magnesium carbonate Substances 0.000 claims description 10
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 10
- 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 9
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 9
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 9
- 239000004094 surface-active agent Substances 0.000 claims description 9
- 229920002261 Corn starch Polymers 0.000 claims description 8
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 8
- 239000008120 corn starch Substances 0.000 claims description 8
- 229940075507 glyceryl monostearate Drugs 0.000 claims description 8
- 239000000314 lubricant Substances 0.000 claims description 8
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 8
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 8
- 229920000053 polysorbate 80 Polymers 0.000 claims description 8
- 229940068968 polysorbate 80 Drugs 0.000 claims description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims description 7
- 235000019329 dioctyl sodium sulphosuccinate Nutrition 0.000 claims description 7
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 229920002472 Starch Polymers 0.000 claims description 6
- 239000011230 binding agent Substances 0.000 claims description 6
- 239000007884 disintegrant Substances 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- 239000003002 pH adjusting agent Substances 0.000 claims description 6
- APSBXTVYXVQYAB-UHFFFAOYSA-M sodium docusate Chemical compound [Na+].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC APSBXTVYXVQYAB-UHFFFAOYSA-M 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- 229940099112 cornstarch Drugs 0.000 claims description 5
- 229960000878 docusate sodium Drugs 0.000 claims description 5
- -1 hydroxypropyl ethylcellulose Chemical compound 0.000 claims description 5
- 229960001708 magnesium carbonate Drugs 0.000 claims description 5
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 5
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 5
- 239000001856 Ethyl cellulose Substances 0.000 claims description 4
- 229920003139 Eudragit® L 100 Polymers 0.000 claims description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 4
- 239000005913 Maltodextrin Substances 0.000 claims description 4
- 229920002774 Maltodextrin Polymers 0.000 claims description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 239000008121 dextrose Substances 0.000 claims description 4
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 4
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims description 4
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 4
- 229920001249 ethyl cellulose Polymers 0.000 claims description 4
- 229940035034 maltodextrin Drugs 0.000 claims description 4
- 229920000136 polysorbate Polymers 0.000 claims description 4
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims description 4
- 229920003134 Eudragit® polymer Polymers 0.000 claims description 3
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims description 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- 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 3
- 229920001983 poloxamer Polymers 0.000 claims description 3
- 150000003839 salts Chemical class 0.000 claims description 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 2
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical class OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 claims description 2
- QMMJWQMCMRUYTG-UHFFFAOYSA-N 1,2,4,5-tetrachloro-3-(trifluoromethyl)benzene Chemical compound FC(F)(F)C1=C(Cl)C(Cl)=CC(Cl)=C1Cl QMMJWQMCMRUYTG-UHFFFAOYSA-N 0.000 claims description 2
- DMBUODUULYCPAK-UHFFFAOYSA-N 1,3-bis(docosanoyloxy)propan-2-yl docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCCCCCC DMBUODUULYCPAK-UHFFFAOYSA-N 0.000 claims description 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- 239000000263 2,3-dihydroxypropyl (Z)-octadec-9-enoate Substances 0.000 claims description 2
- RZRNAYUHWVFMIP-GDCKJWNLSA-N 3-oleoyl-sn-glycerol Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](O)CO RZRNAYUHWVFMIP-GDCKJWNLSA-N 0.000 claims description 2
- QZCLKYGREBVARF-UHFFFAOYSA-N Acetyl tributyl citrate Chemical compound CCCCOC(=O)CC(C(=O)OCCCC)(OC(C)=O)CC(=O)OCCCC QZCLKYGREBVARF-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- 239000005995 Aluminium silicate Substances 0.000 claims description 2
- LZZYPRNAOMGNLH-UHFFFAOYSA-M Cetrimonium bromide Chemical compound [Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C LZZYPRNAOMGNLH-UHFFFAOYSA-M 0.000 claims description 2
- 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 2
- 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 2
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- FPVVYTCTZKCSOJ-UHFFFAOYSA-N Ethylene glycol distearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCOC(=O)CCCCCCCCCCCCCCCCC FPVVYTCTZKCSOJ-UHFFFAOYSA-N 0.000 claims description 2
- 229930091371 Fructose Natural products 0.000 claims description 2
- 239000005715 Fructose Substances 0.000 claims description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
- 229920001479 Hydroxyethyl methyl cellulose Polymers 0.000 claims description 2
- 239000005639 Lauric acid Substances 0.000 claims description 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 2
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- 229920006243 acrylic copolymer Polymers 0.000 claims description 2
- 229940087168 alpha tocopherol Drugs 0.000 claims description 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 2
- 235000012211 aluminium silicate Nutrition 0.000 claims description 2
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical class [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 2
- 239000001506 calcium phosphate Substances 0.000 claims description 2
- 159000000007 calcium salts Chemical class 0.000 claims description 2
- 229920002301 cellulose acetate Polymers 0.000 claims description 2
- 229960002798 cetrimide Drugs 0.000 claims description 2
- 229960001927 cetylpyridinium chloride Drugs 0.000 claims description 2
- YMKDRGPMQRFJGP-UHFFFAOYSA-M cetylpyridinium chloride Chemical compound [Cl-].CCCCCCCCCCCCCCCC[N+]1=CC=CC=C1 YMKDRGPMQRFJGP-UHFFFAOYSA-M 0.000 claims description 2
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims description 2
- 229940038472 dicalcium phosphate Drugs 0.000 claims description 2
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- HTDKEJXHILZNPP-UHFFFAOYSA-N dioctyl hydrogen phosphate Chemical compound CCCCCCCCOP(O)(=O)OCCCCCCCC HTDKEJXHILZNPP-UHFFFAOYSA-N 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 150000004676 glycans Chemical class 0.000 claims description 2
- 229940049654 glyceryl behenate Drugs 0.000 claims description 2
- 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 2
- 229960001021 lactose monohydrate Drugs 0.000 claims description 2
- 229940033355 lauric acid Drugs 0.000 claims description 2
- FPYJFEHAWHCUMM-UHFFFAOYSA-N maleic anhydride Chemical compound O=C1OC(=O)C=C1 FPYJFEHAWHCUMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- 229940117837 methacrylic acid - methyl methacrylate copolymer (1:2) Drugs 0.000 claims description 2
- 125000005397 methacrylic acid ester group Chemical group 0.000 claims description 2
- RZRNAYUHWVFMIP-UHFFFAOYSA-N monoelaidin Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-UHFFFAOYSA-N 0.000 claims description 2
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims description 2
- 150000003904 phospholipids Chemical class 0.000 claims description 2
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims description 2
- 239000004926 polymethyl methacrylate Substances 0.000 claims description 2
- 229920001282 polysaccharide Polymers 0.000 claims description 2
- 239000005017 polysaccharide Substances 0.000 claims description 2
- 229950008882 polysorbate Drugs 0.000 claims description 2
- 229940068965 polysorbates Drugs 0.000 claims description 2
- 229920002689 polyvinyl acetate Polymers 0.000 claims description 2
- 239000011118 polyvinyl acetate Substances 0.000 claims description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 229920006316 polyvinylpyrrolidine Polymers 0.000 claims description 2
- RMGVATURDVPNOZ-UHFFFAOYSA-M potassium;hexadecyl hydrogen phosphate Chemical compound [K+].CCCCCCCCCCCCCCCCOP(O)([O-])=O RMGVATURDVPNOZ-UHFFFAOYSA-M 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 229960002668 sodium chloride Drugs 0.000 claims description 2
- BTURAGWYSMTVOW-UHFFFAOYSA-M sodium dodecanoate Chemical compound [Na+].CCCCCCCCCCCC([O-])=O BTURAGWYSMTVOW-UHFFFAOYSA-M 0.000 claims description 2
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 229960000984 tocofersolan Drugs 0.000 claims description 2
- LDHQCZJRKDOVOX-UHFFFAOYSA-N trans-crotonic acid Natural products CC=CC(O)=O LDHQCZJRKDOVOX-UHFFFAOYSA-N 0.000 claims description 2
- WEAPVABOECTMGR-UHFFFAOYSA-N triethyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCOC(=O)CC(C(=O)OCC)(OC(C)=O)CC(=O)OCC WEAPVABOECTMGR-UHFFFAOYSA-N 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 235000004835 α-tocopherol Nutrition 0.000 claims description 2
- 239000002076 α-tocopherol Substances 0.000 claims description 2
- 239000004141 Sodium laurylsulphate Substances 0.000 claims 2
- 239000001836 Dioctyl sodium sulphosuccinate Substances 0.000 claims 1
- 229940117845 methacrylic acid - methyl methacrylate copolymer (1:1) Drugs 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 7
- 239000003795 chemical substances by application Substances 0.000 abstract description 5
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 22
- 238000002156 mixing Methods 0.000 description 13
- 229920002785 Croscarmellose sodium Polymers 0.000 description 12
- 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 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 11
- 229960001681 croscarmellose sodium Drugs 0.000 description 11
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 11
- 235000019359 magnesium stearate Nutrition 0.000 description 11
- 239000004574 high-performance concrete Substances 0.000 description 8
- 239000008119 colloidal silica Substances 0.000 description 6
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 6
- 239000008187 granular material Substances 0.000 description 6
- 229940117841 methacrylic acid copolymer Drugs 0.000 description 6
- 229920003145 methacrylic acid copolymer Polymers 0.000 description 6
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 5
- 239000006185 dispersion Substances 0.000 description 5
- 238000011049 filling Methods 0.000 description 5
- 238000009472 formulation Methods 0.000 description 5
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- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
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- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- QKIUAMUSENSFQQ-UHFFFAOYSA-N dimethylazanide Chemical compound C[N-]C QKIUAMUSENSFQQ-UHFFFAOYSA-N 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- RRPFCKLVOUENJB-UHFFFAOYSA-L disodium;2-aminoacetic acid;carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O.NCC(O)=O RRPFCKLVOUENJB-UHFFFAOYSA-L 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
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- 239000012055 enteric layer Substances 0.000 description 1
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- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
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- 125000003976 glyceryl group Chemical group [H]C([*])([H])C(O[H])([H])C(O[H])([H])[H] 0.000 description 1
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- 229920000591 gum Polymers 0.000 description 1
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- 239000003456 ion exchange resin Substances 0.000 description 1
- 229920003303 ion-exchange polymer Polymers 0.000 description 1
- 229960000829 kaolin Drugs 0.000 description 1
- 235000014380 magnesium carbonate Nutrition 0.000 description 1
- 229940037627 magnesium lauryl sulfate Drugs 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 235000012245 magnesium oxide Nutrition 0.000 description 1
- 239000000391 magnesium silicate Substances 0.000 description 1
- 229910052919 magnesium silicate Inorganic materials 0.000 description 1
- 235000019792 magnesium silicate Nutrition 0.000 description 1
- 229940057948 magnesium stearate Drugs 0.000 description 1
- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- ZADYMNAVLSWLEQ-UHFFFAOYSA-N magnesium;oxygen(2-);silicon(4+) Chemical compound [O-2].[O-2].[O-2].[Mg+2].[Si+4] ZADYMNAVLSWLEQ-UHFFFAOYSA-N 0.000 description 1
- IWVKTOUOPHGZRX-UHFFFAOYSA-N methyl 2-methylprop-2-enoate;2-methylprop-2-enoic acid Chemical group CC(=C)C(O)=O.COC(=O)C(C)=C IWVKTOUOPHGZRX-UHFFFAOYSA-N 0.000 description 1
- 229940111688 monobasic potassium phosphate Drugs 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 229920001206 natural gum Polymers 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- SBQLYHNEIUGQKH-UHFFFAOYSA-N omeprazole Chemical compound N1=C2[CH]C(OC)=CC=C2N=C1S(=O)CC1=NC=C(C)C(OC)=C1C SBQLYHNEIUGQKH-UHFFFAOYSA-N 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 235000011007 phosphoric acid Nutrition 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 235000013856 polydextrose Nutrition 0.000 description 1
- 239000001259 polydextrose Substances 0.000 description 1
- 229940035035 polydextrose Drugs 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- GRLPQNLYRHEGIJ-UHFFFAOYSA-J potassium aluminium sulfate Chemical compound [Al+3].[K+].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O GRLPQNLYRHEGIJ-UHFFFAOYSA-J 0.000 description 1
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 description 1
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 1
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical compound [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 description 1
- 229910052939 potassium sulfate Inorganic materials 0.000 description 1
- 235000011151 potassium sulphates Nutrition 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 description 1
- 229940083575 sodium dodecyl sulfate Drugs 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 229940001496 tribasic sodium phosphate Drugs 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
Abstract
Mevcut buluş, mikro veya mini tablete sahip kapsül formunda bir farmasötik kompozisyon ile ilgili olup,tabletler lansoprazol içeren bir çekirdek tablet ve en az bir suda çözünür polimer ve en az bir yapışma önleyici madde içeren bir iç kaplama ve en az bir enterik kaplama polimeri içeren bir enterik kaplama içerir. Kapsüller, basit, hızlı, uygun maliyetli, zaman kazandıran ve endüstriyel olarak uygun bir prosesle elde edilir.The present invention relates to a pharmaceutical composition in capsule form having micro or mini tablets, the tablets comprising a core tablet containing lansoprazole and an inner coating comprising at least one water-soluble polymer and at least one anti-adhesion agent and at least one enteric coating polymer. Contains enteric coating. Capsules are obtained through a simple, fast, cost-effective, time-saving and industrially suitable process.
Description
TARIFNAME LANSOPRAZOL IÇEREN KAPSÜL IÇINDE TABLETLER Bulusun Alani Mevcut bulus, mikro veya mini tablete sahip kapsül formunda bir farmasötik kompozisyon ile ilgili olup, tabletler lansoprazol içeren bir çekirdek tablet ve en az bir suda çözünür polimer ve en az bir yapisma önleyici madde içeren bir iç kaplama ve en az bir enterik kaplama polimeri içeren bir enterik kaplama içerir. Kapsüller, basit, hizli, uygun maliyetli, zaman kazandiran ve endüstriyel olarak uygun bir prosesle Bulusun Arka Plani Lansoprazol, 2-(((3-metil-4-(2,2,2-trifloroetoksi)-2-piridil)metil) sülfinil)-1H-benzoil Imidazol kimyasal adina sahiptir, dimetilamid içinde kolayca çözünen, metanol içinde çözünen, etanol ve eter içinde çözünmeyen, suda hemen hemen çözünmeyen kahverengimsi beyaz kristalin tozdur. Formül I'de gösterilen kimyasal yapiya sahiptir: Formül I Lansoprazol, Takeda Corporation of Japan tarafindan omeprazolden sonra gelistirilen ikinci proton pompasi inhibitörü anti-ülser ilacidir. 1992'de Japon Takeda Pharmaceutical Co., Ltd. ve Houde Company ilk olarak Fransa'da resmi olarak piyasaya sürdü ve Mayis 1995'te Amerika Birlesik Devletleri'nde listelenmek üzere Amerika Birlesik Devletleri Gida ve Ilaç Dairesi (FDA) tarafindan onaylandi. Lansoprazol asidik kosullar altinda son derece kararsizdir ve düsük pH ortaminda kisa sürede inaktif bilesenlere parçalanir, bu nedenle gastrik asit ortaminda kolayca parçalanir. Ilacin biyoyararlanimini artirmak için enterik kapli bir preparat olarak hazirlanmasi gerekmektedir. çapraz bagli polivinilpirolidon ve enterik kaplama maddesi olarak akrilik reçinenin kullanildigi bir lansoprazol enterik kapsül formülasyonunu ve hazirlama yöntemini açiklar. granüller içeren, oral yolla dagilabilen bir lansoprazol tabletini açiklamaktadir. Bu nedenle, istenen stabiliteye, istenen çözünme profiline sahip ve endüstriyel üretime uygun mikro veya mini tablete sahip kapsül formunda bir farmasötik kompozisyonun hazirlanmasi hala gereklidir. Bulusun Ayrintili Açiklamasi Mevcut bulusun baslica amaci, etkin maddenin neden oldugu problemleri ortadan kaldirmak ve ilgili önceki teknige ilave avantajlar kazandirmaktir. Daha ayrintili açiklamak gerekirse, temel amaç, eksipiyanlarin seçimi yardimiyla yüksek fiziksel ve kimyasal stabiliteye ve uzun bir raf ömrüne sahip olan enterik kapli mikro veya mini tabletlere sahip kapsül formunda bir farmasötik kompozisyon saglamaktir. Mevcut bulusun baska bir amaci, iyilestirilmis çözünme profili saglayan enterik kapli mikro veya mini tabletlere sahip, ayni zamanda uygun maliyetli olan kapsül formunda bir farmasötik kompozisyon elde etmektir. Mevcut bulusun baska bir amaci, akiskanlik, sikistirilabilirlik ve içerik tekdüzeligi gibi iyilestirilmis mükemmel farmakomekanik özellikler saglayan enterik kapli mikro veya mini tabletlere sahip kapsül formunda bir farmasötik kompozisyon elde etmektir. Özellikle, asit labil fizyolojik olarak etkin bir maddenin, stabilite amaciyla bazik inorganik tuzlar ve benzerleriyle birlestirilmesi ve ayrica bir enterik katman gibi kaplama katmanlariyla kaplanmasi için bir ihtiyaç vardir. Asit labil fizyolojik olarak etkin maddeyi az miktarda içermesine ragmen küçük enterik kapli mikro veya mini tabletlerin üretilmesi önemli bir problemdir. Bu bulusta hem bir iç kaplama hem de bir enterik kaplamaya sahip mikro veya mini tablete sahip olan kapsül formunda bir farmasötik kompozisyon kullanilmaktadir. Kompozisyon, istenen stabiliteyi ve istenen profili saglamaktadir. Mevcut bulusun bir düzenlemesine göre, kapsül içindeki tabletler, mikro tabletler veya mini tabletler olabilir, bu, tabletlerin boyutuna göre degisir. Kapsül içindeki tabletler, düz veya disbükey üst ve alt kenarlari olan ve tercihen yaklasik olarak esit olan bir çapa ve yükseklige sahip olan silindirik sekildedir ve birbirlerinden bagimsiz olarak tercihen yaklasik 1 mm ila yaklasik 4 mm, daha tercihen yaklasik 1.5 mm ila yaklasik 4.5 mm arasinda bir tablet boyutuna sahiptir. Mevcut bulusun bir düzenlemesine göre mikro veya mini tablet içeren kapsül formunda bir farmasötik kompozisyon olup, burada tabletler sunlari içerir; - lansoprazol içeren çekirdek tablet, - en az bir suda çözünür polimer ve en az bir yapisma önleyici madde içeren iç kaplama, - en az bir enterik kaplama polimeri içeren enterik kaplama, burada çekirdek tabletin enterik kaplamaya agirlik orani 6.0-1.5'tir. Mevcut bulusun bir düzenlemesine göre çekirdek tabletin enterik kaplamaya agirlik orani 6.0 ile 1.5 arasindadir. Tercihen 4.0 ile 2.0 arasindadir. Bu oran istenen çözünme profilini sagladigi gibi farmakomekanik özelliklerin de saglanmasina yardimci olur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda lansoprazol miktari agirlikça %4.0 ile Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda çekirdek tablet miktari agirlikça Mevcut bulusun bir düzenlemesine göre, çekirdek tablet lansoprazol içerir, ayrica en az bir dilüent veya en az bir baglayici veya en az bir dagitici veya en az bir lubrikant veya en az bir glidant veya en az bir sürfaktan veya bunlarin karisimlarini içerir. Mevcut bulusun bir düzenlemesine göre mevcut kompozisyonun iç kaplamasi, sulu bir ortamda hizla dagilacak sekilde tasarlanmistir. Mevcut bulusta, iç kaplama en az bir suda çözünür polimer ve en az bir yapisma önleyici madde içerir. Iki tabaka arasinda oldugu için bu tabakanin etkili olmasi kompozisyon açisindan çok önemlidir. Bu eksipiyanlarin iç kaplamada kullanilmasi, enterik kaplama için mükemmel kaplama yüzeyi saglar ve enterik kaplama ile tablet çekirdegi etkilesimlerinden kaynaklanan bozulmalari önlerken enterik kaplama etkinligini gelistirir. Uygun suda çözünür polimerler, polietilen glikol, polivinilpirolidon, hidroksipropilselüloz, hidroksipropil metilselüloz veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre suda çözünür polimer, hidroksipropil metilselülozdur. Mevcut bulusun bir düzenlemesine göre suda çözünür polimer miktari toplam kompozisyonda agirlikça Uygun yapisma önleyici maddeler, talk, nisasta, kaolin, laktoz veya dekstroz veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, yapisma önleyici madde talktir. Mevcut bulusun bir düzenlemesine göre, yapisma önleyici maddelerin miktari toplam kompozisyonda agirlikça %0.005 ile %1.0 arasindadir. Mevcut bulusun bir düzenlemesine göre, yapisma önleyici maddeler iç kaplamada veya enterik kaplamada veya her ikisinde bulunur. Mevcut bulusun bir düzenlemesine göre, iç kaplama suda çözünür polimer olarak HPMC ve yapisma önleyici madde olarak talk içerir. Her ikisinin de iç kaplamada kullanilmasi, çözünme profili ve imalat kolayligi disinda sasirtici derecede yüksek stabilite saglamistir. Mevcut bulusun bir düzenlemesine göre, iç kaplama ayrica en az bir plastiklestirici içerebilir. Uygun plastiklestiriciler trietil sitrat, polietilen glikol, triasetin, alfa tokoferol, dokusat sodyum, gliseril monooleat, gliseril monostearat, tribütil sitrat, asetil trietil sitrat, asetil tribütil sitrat, bütil stearat, Stearil alkol, propilen glikol, dietil ftalat, dioktil fosfat, sodyum lauril sülfat, sorbitan esterler, potasyum setilfosfat, etilen glikol distearat, sodyum dodekanoat, dioktil sodyum sülfosüksinat, sodyum stearat, benzalkonyum klorürler, polisorbatlar, poloksamerler veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, plastiklestirici trietil sitrat veya triasetin veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, plastiklestirici enterik kaplamada trietil sitrattir. Mevcut bulusun bir düzenlemesine göre, plastiklestirici iç kaplamada triasetindir. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda plastiklestiricilerin miktari agirlikça Mevcut bulusun bir düzenlemesine göre, plastiklestiriciler iç kaplamada veya enterik kaplamada veya her ikisinde bulunur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda iç kaplamanin miktari agirlikça %1.0 ile %10.0 arasindadir. Tercihen toplam kompozisyonda agirlikça %1.0 ile %5.0 arasindadir. Mevcut bulusun bir düzenlemesine göre, enterik kaplama, dozaj formu mideden geçerken lansoprazolün asidik bozunmadan korunmasina yardimci olur. Enterik kaplama, en az bir enterik kaplama polimeri veya en az bir yapisma önleyici madde veya en az bir plastiklestirici veya en az bir sürfaktan veya en az bir lubrikant veya en az bir pH ayarlayici madde veya bunlarin karisimlarini içerir. Uygun enterik kaplama polimerleri, metakrilik asit-metil metakrilat kopolimer (1:2)(Eudragit 5100), metakrilik asit-metil metakrilat kopolimer (, gliseril behenat, hidroksietil metilselüloz, hidroksipropil selüloz, hidroksipropil etilselüloz , etilselüloz, metakrilik asit - etil akrilat kopolimer, polimetilmetakrilat, polivinil asetat, polivinil alkol, polivinilpirolidin, gliseril dibehenat, polietilen oksit, polietilen glikol, selüloz asetat, vinil asetat/krotonik asit kopolimerleri, maleik anhidrit/metil vinil eter kopolimerleri, akrilik kopolimeri veya metakrilik asit esterleri, polioksietilen-alkil eterler veya bunlarin karisimlarini içeren gruptan seçilir. Sadece enterik kaplamada kullanilir. Mevcut bulusun bir düzenlemesine göre, enterik kaplama polimeri, metakrilik asit-metil metakrilat veya metakrilik asit - etil akrilat kopolimer (Eudragit L 30 D-55 veya Kollicoat MAE 30DP) veya bunlarin karisimlaridir. Metakrilik asit kopolimeri, istenen gecikmeli salim profilini elde etmek için tek basina veya baska enterik polimerlerle kombinasyon halinde kullanilir. Ayrica stabilitenin saglanmasina da yardimci olur. Mevcut bulusun bir düzenlemesine göre enterik kaplama polimerlerinin miktari toplam kompozisyonda agirlikça %10.0 ile %250 arasindadir. Mevcut bulusun bir düzenlemesine göre enterik kaplamanin miktari toplam kompozisyonda agirlikça Uygun dilüentler, D-mannitol, laktoz, mikrokristalin selüloz, misir nisastasi, laktoz monohidrat, spreyle kurutulmus mannitol, laktoz, nisasta, dekstroz, sükroz, fruktoz, maltoz, sorbitol, ksilitol, inorganik tuzlar, kalsiyum tuzlari, polisakkaritler, dikalsiyum fosfat, sodyum klorür, maltodekstrin, sükroz- maltodekstrin karisimi, trehaloz, magnezyum karbonat veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre dilüent, D-mannitol veya laktoz veya mikrokristalin selüloz veya misir nisastasi veya magnezyum karbonat veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre dilüent, D-mannitoldür. Mevcut bulusun bir düzenlemesine göre dilüent, laktoz veya mikrokristalin selüloz veya misir nisastasi veya magnezyum karbonat veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda dilüentlerin miktari agirlikça %25.0 ile %70.0 arasindadir. Miktar, istenen içerik tekdüzeligini saglar. Etkin madde miktari tüm kompozisyona göre düsük oldugu için içerik tekdüzeliginin saglanmasi önemlidir. Mevcut bulusun bir düzenlemesine göre, dilüentler çekirdek tablette bulunur. Uygun dagiticilar kroskarmeloz sodyum, düsük ikameli hidroksipropil selüloz, krospovidon, iyon degistirici reçineler, magnezyum alüminyum silika, sodyum karboksimetil selüloz, kalsiyum silikat, sodyum nisasta glikolat, karboksimetil selüloz, kalsiyum karboksimetil selüloz, dokusat sodyum, poliakrilin potasyum, poloksamer, povidon, sodyum aljinat, sodyum glisin karbonat veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre dagitici, kroskarmeloz sodyum veya düsük ikameli hidroksipropil selüloz veya krospovidon veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda dagitici miktari agirlikça %1.0 ile Mevcut bulusun bir düzenlemesine göre, dagiticilar çekirdek tablette bulunur. Uygun baglayicilar hidroksipropil selüloz, polivinilpirolidon, dogal zamklar, jelatin, aljinatlar, sodyum aljinat, zamk, guar zamki, nisasta müsilaji, akasya müsilaji, setostearil alkol, pullulan, polidekstroz, polietilen oksit, pektin, alüminyum hidroksit, hyaluronik asit veya bunlarin karisimlarindan olusan gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, baglayici hidroksipropil selüloz veya polivinilpirolidon veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, baglayicilar çekirdek tablette bulunur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda baglayici miktari agirlikça %0.5 ile Uygun glidantlar, talk, susuz kolloidal silika, kolloidal silikon dioksit, kalsiyum silikat, alüminyum silikat, magnezyum silikat, magnezyum oksit, nisasta veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, glidant talk veya susuz kolloidal silika veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, çekirdek tablette talk kullanildiginda, bir glidant görevi görür. Talk, iç kaplamada veya enterik kaplamada kullanildiginda, yapisma önleyici bir madde görevi görür. Mevcut bulusun bir düzenlemesine göre, glidantlar çekirdek tablette bulunur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda glidant miktari agirlikça %0.1 ile %4.0 arasindadir. Uygun sürfaktanlar, polisorbat 80, gliseril monostearat, sodyum dodesil sülfat, sodyum lauril sülfat, setilpiridinyum klorür, dokusat sodyum, laurik asit, polioksietilen sorbitan yagli asit esterleri (polisorbat), fosfolipitler, setrimid veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, sürfaktan polisorbat 80 veya gliseril monostearat veya sodyum lauril sülfat veya bunlarin karisimlaridir. Farmasötik ürünlerde anyonik sürfaktan olarak yaygin olarak kullanilan sentetik bir organik bilesiktir. Mevcut bulusta istenen profili saglar. Ayrica istenen akiskanligin saglanmasina da yardimci olur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda sürfaktan miktari agirlikça %0.1 ile Mevcut bulusun bir düzenlemesine göre, sürfaktanlar çekirdek tablette veya enterik kaplamada veya her ikisinde bulunur. Uygun pH ayarlayici maddeler, alüminyum potasyum sülfat, susuz sitrik asit, susuz disodyum hidrojen fosfat, potasyum karbonat, susuz sodyum dihidrojen fosfat, dibazik potasyum sülfat, kalsiyum karbonat, seyreltik hidroklorik asit, monobazik potasyum fosfat, fosforik asit, adipik asit, sodyum asetat, sodyum bikarbonat, sodyum karbonat , sodyum sitrat, sodyum dihidrojen fosfat dihidrat, tribazik sodyum fosfat veya bunlarin karisimlarini içeren gruptan seçilir. Ph ayarlayici madde kullanilmasi, düsük pH degerlerinde stabil olmayan lansoprazolün uzun kosullar altinda istenen stabilitede kalmasini saglamaktadir. Mevcut bulusun bir düzenlemesine göre, pH ayarlayici madde sodyum bikarbonattir. Mevcut bulusun bir düzenlemesine göre, pH ayarlayici madde enterik kaplamada bulunur. Uygun lubrikantlar, magnezyum stearat, sodyum stearil fumarat, kalsiyum stearat, stearik asit, polietilen glikol, sodyum lauril sülfat, magnezyum lauril sülfat, fumarik asit, gliseril palmito sülfat, hidrojene bitkisel yag, çinko stearat veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, lubrikant magnezyum stearat veya sodyum stearil fumarat veya bunlarin karisimlaridir. Mevcut bulusun bir düzenlemesine göre, lubrikantlar çekirdek tablette veya enterik kaplamada veya her ikisinde bulunur. Mevcut bulusun bir düzenlemesine göre, toplam kompozisyonda lubrikant miktari agirlikça %1.0 ile Mevcut bulusun bir düzenlemesine göre çekirdek tablet, lansoprazol, D-mannitol, Düsük ikameli HPC, sodyum stearil fumarat, kroskarmeloz sodyum ve hidroksipropil selüloz içerir. Mevcut bulusun bir düzenlemesine göre, çekirdek tablet, lansoprazol, mikrokristalin selüloz, magnezyum karbonat ve magnezyum stearat içerir. Mevcut bulusun bir düzenlemesine göre, iç kaplama HPMC, triasetin ve talk içerir. Mevcut bulusun bir düzenlemesine göre, iç kaplama HPMC ve talk içerir. Mevcut bulusun bir düzenlemesine göre enterik kaplama, metakrilik asit etil akrilat kopolimer (1.1) tip A, talk, trietil sitrat, susuz kolloidal silika, SLS ve sodyum bikarbonat içerir. Mevcut bulusun bir düzenlemesine göre enterik kaplama, Eudragit 5100, Eudragit L100, talk, trietil sitrat, gliseril monostearat ve Polisorbat 80 içerir. Bilesenler Miktar (toplam formülasyonun agirlikça %) Lansoprazol 5.0 - 20.0 4; Kroskarmeloz sodyum 1.0 - 8.0 33 HPC 0.1 - 5.0 Sodyum stearil fumarat 1.0 - 6.0 .2 2 Talk Eudragit S100 g Eudragit L100 20.0 - 40.0 *E Gliseril monostearat Polisorbat 80 Toplam Enterik kapli mini veya 100 mikro tablet Örnek 1 için bir proses; Çekirdek tablet o Lansoprazol, D-mannitol, HPC, kroskarmelloz sodyum, düsük ikameli HPC tartilarak kompakt silindirde 15 dakika süreyle karistirilir (silindir araligi 2.0 mm, silindir basinci 15.0 mPa, besleme vidasi hizi 10:1, besleme vidasi hizi 25 dev/dak, hiz 2.5 dev/dak) o Granüllerin elenmesi, 0 Kuru karisima sodyum stearil fumarat ilave edilerek 5 dakika süreyle karistirilmasi, o Karisimin tablet halinde basilmasi, Iç kaplama o HPMC ve talk ile enterik kaplama yapilmasi, Enterik kaplama o Metakrilik asit kopolimer dispersiyonu ile enterik kaplama yapilmasi, Iç ve enterik kaplamaya sahip mikro veya mini tabletlerin kapsüllere doldurulmasi. Bilesenler Miktar (toplam formülasyonun agirlikça %) Lansoprazol 5.0 - 20.0 D-Mannitol DC derecesi 25.0 - 37.0 .g Kroskarmeloz sodyum 1.0 - 8.0 Magnezyum stearat 1.0 - 6.0 .3 S Talk Eudragit S100 g Eudragit L100 TE Trietil sitrat 20.0 - 40.0 *E Gliseril monostearat Polisorbat 80 Toplam Enterik kapli mini tablet 100 Örnek 2 için bir proses; Çekirdek tablet o Lansoprazol, D-mannitol, HPC, kroskarmelloz sodyum, düsük ikameli HPC'nin tartilarak 15 o Sodyum stearil fumarat ve talk ilave edilerek 5 dakika süreyle karistirilmasi, 0 Kuru karisima Magnezyum stearat ilave edilerek 3 dakika süreyle karistirilmasi, o Karisimin tablet halinde basilmasi, Iç kaplama o HPMC ve talk ile enterik kaplama yapilmasi, Enterik kaplama o Metakrilik asit kopolimer dispersiyonu ile enterik kaplama yapilmasi, Iç ve enterik kaplamaya sahip mikro veya mini tabletlerin kapsüllere doldurulmasi. Bilesenler Miktar (toplam formülasyonun agirlikça %) Lansoprazol 5.0 - 20.0 s Magnezyum karbonat 2.0 - 20.0 3 Misir nisastasi 2.0 - 10.0 .E Polisorbat 80 0.1 - 3.0 E Kroskarmeloz sodyum 1.0 - 6.0 Magnezyum stearat 0.1 - 5.0 g Triasetin 1.0 - 10.0 Metakrilik asit etil akrilat I kopolimer (1.1) tip A 2 Trietil sitrat 15.0 - 35.0 Toplam Enterik kapli mini tablet 100 Örnek 3 için bir proses; Çekirdek tablet o Lansoprazol, magnezyum karbonat, laktoz, V2 kroskarmeloz sodyumun tartilarak 15 dakika süreyle karistirilmasi, 0 Kuru karisimin su solüsyonunda HPC ve polisorbat 80 ile granüllestirilmesi, 0 Yas granüllerin 2.0 mm elenmesi, o Granüllerin firinda kurutulmasi, 0 Kuru granüllerin 0.85 mm elenmesi, o V2 kroskarmeloz sodyum ilave edilerek 5 dakika süreyle karistirilmasi, 0 Kuru karisima tartilmis ve 0.6 mm elenmis Magnezyum stearat ilave edilerek 3 dakika süreyle karistirilmasi, o Karisimin tablet halinde basilmasi, Iç kaplama o HPMC, triasetin ve talk ile enterik kaplama yapilmasi, Enterik kaplama o Metakrilik asit kopolimer dispersiyonu ile enterik kaplama yapilmasi, Iç ve enterik kaplamaya sahip mikro veya mini tabletlerin kapsüllere doldurulmasi. Bilesenler Miktar (toplam formülasyonun agirlikça %) Lansoprazol 5.0 - 20.0 g KoIIoidaI silikon dioksit 0.1-3.0 Magnezyum stearat 0.1 - 3.0 g Triasetin 1.0 - 10.0 .3 S Talk Metakrilik asit etil akrilat kopolimer (1.1) 7 tip A 2 Trietil sitrat 15.0 - 35.0 Toplam Enterik kapli mini tablet 100 Örnek 4 için bir proses; Çekirdek Lansoprazol, Magnezyum karbonat, V2 MCC 112, kolloidal silikon dioksit, PVP K-30'un tartilarak 10 dakika süreyle karistirilmasi, Kuru karisima tartilmis ve 0.6 mm elenmis Magnezyum stearat ilave edilerek 3 dakika süreyle karistirilmasi, Kompaktörde slug granülasyonu yapilmasi, Kuru granüllerin 1.2 mm elenmesi, V2 MCC pH 112, Krospovidon CL ilave edilerek 5 dakika süreyle karistirilmasi 0.6 mm elenmis V2 Mg-stearat ilave edilerek 3 dakika süreyle karistirilmasi o Karisimin tablet halinde basilmasi, Iç kaplama o HPMC, triasetin ve talk ile enterik kaplama yapilmasi, Enterik kaplama o Metakrilik asit kopolimer dispersiyonu ile enterik kaplama yapilmasi, Iç ve enterik kaplamaya sahip mikro veya mini tabletlerin kapsüllere doldurulmasi. Bilesenler Miktar (toplam formülasyonun agirlikça %) Lansoprazol 5.0 - 20.0 g Misir nisastasi 1.0 - 10.0 E kroskarmeloz sodyum 1.0 - 6.0 Susuz koIIoidaI silika 0.1 - 3.0 Magnezyum stearat 0.1 - 3.0 g Triasetin 1.0 - 10.0 .3 S Talk Metakrilik asit etil akrilat T kopolimer (1.1) tip A 2 Trietil sitrat 15.0 - 35.0 nci Susuz koIIoidaI silika Toplam Enterik kapli mini 100 Örnek 5 için bir proses; Çekirdek tablet o Lansoprazol, Magnezyum karbonat, MCC 112, HPC, misir nisastasi, kroskarmeloz, sodyum, susuz koloidal silika, talkin tartilarak 15 dakika süreyle karistirilmasi, 0 Kuru karisima tartilmis ve 0.6 mm elenmis Magnezyum stearat ilave edilerek 3 dakika süreyle karistirilmasi, o Karisimin tablet halinde basilmasi, Iç kaplama o HPMC, triasetin ve talk ile enterik kaplama yapilmasi, Enterik kaplama o Metakrilik asit kopolimer dispersiyonu ile enterik kaplama yapilmasi, Iç ve enterik kaplamaya sahip mikro veya mini tabletlerin kapsüllere doldurulmasi. TR TR TR TR DESCRIPTION TABLETS IN CAPSULE CONTAINING LANSOPRAZOL Field of the Invention The present invention relates to a pharmaceutical composition in capsule form having micro or mini tablets, the tablets comprising a tablet core containing lansoprazole and an inner coating comprising at least one water-soluble polymer and at least one anti-adhesive agent and an enteric coating comprising at least one enteric coating polymer. The capsules are prepared by a simple, rapid, cost-effective, time-saving and industrially suitable process. Background of the Invention Lansoprazole has the chemical name 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)-1H-benzoyl Imidazole, is a brownish white crystalline powder which is readily soluble in dimethylamide, soluble in methanol, insoluble in ethanol and ether, and practically insoluble in water. It has the chemical structure shown in Formula I: Formula I Lansoprazole is the second proton pump inhibitor anti-ulcer drug developed by Takeda Corporation of Japan after omeprazole. In 1992, the Japanese Takeda Pharmaceutical Co., Ltd. and Houde Company first officially launched it in France and was approved by the United States Food and Drug Administration (FDA) for listing in the United States in May 1995. Lansoprazole is extremely unstable under acidic conditions and is quickly degraded into inactive components in a low pH environment, so it is easily degraded in the environment of gastric acid. In order to increase the bioavailability of the drug, it should be prepared as an enteric-coated preparation. discloses a lansoprazole enteric capsule formulation and preparation method using cross-linked polyvinylpyrrolidone and acrylic resin as enteric coating agent. discloses an orally dispersible lansoprazole tablet containing granules. Therefore, it is still necessary to prepare a pharmaceutical composition in capsule form having the desired stability, the desired dissolution profile and micro or mini tablet suitable for industrial production. Detailed Description of the Invention The main purpose of the present invention is to eliminate the problems caused by the active substance and to provide additional advantages to the related prior art. To be explained in more detail, the main purpose is to provide a pharmaceutical composition in capsule form having enteric coated micro or mini tablets having high physical and chemical stability and a long shelf life by means of the selection of excipients. Another object of the present invention is to obtain a pharmaceutical composition in capsule form having enteric-coated micro or mini tablets providing improved dissolution profile and at the same time being cost-effective. Another object of the present invention is to obtain a pharmaceutical composition in capsule form having enteric-coated micro or mini tablets providing improved excellent pharmacomechanical properties such as flowability, compressibility and content uniformity. In particular, there is a need for an acid labile physiologically active substance to be combined with basic inorganic salts and the like for stability purposes and further coated with coating layers such as an enteric layer. The production of small enteric-coated micro or mini tablets despite containing small amounts of acid labile physiologically active substance is an important problem. The present invention uses a pharmaceutical composition in capsule form having both an inner coating and a micro or mini tablet having an enteric coating. The composition provides the desired stability and the desired profile. According to one embodiment of the present invention, the tablets in the capsule may be microtablets or minitablets, this varies according to the size of the tablets. The tablets in the capsule are cylindrical in shape with flat or concave top and bottom edges and preferably have a diameter and height that are approximately equal and have a tablet size independently of each other, preferably from about 1 mm to about 4 mm, more preferably from about 1.5 mm to about 4.5 mm. According to one embodiment of the present invention, a pharmaceutical composition in capsule form comprising micro or minitablets, wherein the tablets comprise; - a core tablet containing lansoprazole, - an inner coating comprising at least one water-soluble polymer and at least one anti-adhesive agent, - an enteric coating comprising at least one enteric coating polymer, wherein the weight ratio of the core tablet to the enteric coating is 6.0-1.5. According to one embodiment of the present invention, the weight ratio of the core tablet to the enteric coating is between 6.0 and 1.5. Preferably, it is between 4.0 and 2.0. This ratio provides the desired dissolution profile as well as helps to provide the pharmacomechanical properties. According to one embodiment of the present invention, the amount of lansoprazole in the total composition is 4.0% by weight. According to one embodiment of the present invention, the amount of the core tablet in the total composition is 4.0% by weight. According to one embodiment of the present invention, the core tablet contains lansoprazole, further comprising at least one diluent or at least one binder or at least one disintegrant or at least one lubricant or at least one glidant or at least one surfactant or mixtures thereof. According to one embodiment of the present invention, the inner coating of the present composition is designed to disperse rapidly in an aqueous medium. In the present invention, the inner coating comprises at least one water-soluble polymer and at least one anti-adhesive agent. Since it is between two layers, it is very important from the perspective of the composition that this layer is effective. The use of these excipients in the inner coating provides an excellent coating surface for the enteric coating and improves enteric coating effectiveness while preventing degradation due to enteric coating and tablet core interactions. Suitable water-soluble polymers are selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, hydroxypropylcellulose, hydroxypropyl methylcellulose or mixtures thereof. According to one embodiment of the present invention, the water-soluble polymer is hydroxypropyl methylcellulose. According to one embodiment of the present invention, the amount of water-soluble polymer is by weight of the total composition. Suitable anti-adhesive agents are selected from the group consisting of talc, starch, kaolin, lactose or dextrose or mixtures thereof. According to one embodiment of the present invention, the anti-adhesive agent is talc. According to one embodiment of the present invention, the amount of anti-adhesive agents is between 0.005% and 1.0% by weight of the total composition. According to one embodiment of the present invention, the anti-sticking agents are present in the inner coating or the enteric coating or both. According to one embodiment of the present invention, the inner coating includes HPMC as the water-soluble polymer and talc as the anti-sticking agent. Using both in the inner coating has provided surprisingly high stability, apart from the dissolution profile and ease of fabrication. According to one embodiment of the present invention, the inner coating may also include at least one plasticizer. Suitable plasticizers are selected from the group consisting of triethyl citrate, polyethylene glycol, triacetin, alpha tocopherol, docusate sodium, glyceryl monooleate, glyceryl monostearate, tributyl citrate, acetyl triethyl citrate, acetyl tributyl citrate, butyl stearate, stearyl alcohol, propylene glycol, diethyl phthalate, dioctyl phosphate, sodium lauryl sulfate, sorbitan esters, potassium cetylphosphate, ethylene glycol distearate, sodium dodecanoate, dioctyl sodium sulfosuccinate, sodium stearate, benzalkonium chlorides, polysorbates, poloxamers or mixtures thereof. According to one embodiment of the present invention, the plasticizer is triethyl citrate or triacetin or mixtures thereof. According to one embodiment of the present invention, the plasticizer in the enteric coating is triethyl citrate. According to one embodiment of the present invention, the plasticizer is triacetin in the inner coating. According to one embodiment of the present invention, the amount of plasticizers in the total composition is between 1.0% and 10.0% by weight. Preferably, it is between 1.0% and 5.0% by weight in the total composition. According to one embodiment of the present invention, the enteric coating helps protect lansoprazole from acidic degradation as the dosage form passes through the stomach. The enteric coating comprises at least one enteric coating polymer or at least one anti-adherent agent or at least one plasticizer or at least one surfactant or at least one lubricant or at least one pH adjusting agent or mixtures thereof. Suitable enteric coating polymers are selected from the group consisting of methacrylic acid-methyl methacrylate copolymer (1:2) (Eudragit 5100), methacrylic acid-methyl methacrylate copolymer (, glyceryl behenate, hydroxyethyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl ethylcellulose, ethylcellulose, methacrylic acid - ethyl acrylate copolymer, polymethylmethacrylate, polyvinyl acetate, polyvinyl alcohol, polyvinylpyrrolidine, glyceryl dibehenate, polyethylene oxide, polyethylene glycol, cellulose acetate, vinyl acetate/crotonic acid copolymers, maleic anhydride/methyl vinyl ether copolymers, acrylic copolymer or methacrylic acid esters, polyoxyethylene-alkyl ethers or mixtures thereof. Used only in enteric coating. According to one embodiment of the present invention, the enteric coating The polymer is methacrylic acid-methyl methacrylate or methacrylic acid - ethyl acrylate copolymer (Eudragit L 30 D-55 or Kollicoat MAE 30DP) or mixtures thereof. The methacrylic acid copolymer is used alone or in combination with other enteric polymers to achieve the desired delayed release profile. It also helps provide stability. According to one embodiment of the present invention, the amount of enteric coating polymers is between 10.0% and 250% by weight of the total composition. According to one embodiment of the present invention, the amount of enteric coating is by weight in the total composition. Suitable diluents are selected from the group consisting of D-mannitol, lactose, microcrystalline cellulose, corn starch, lactose monohydrate, spray-dried mannitol, lactose, starch, dextrose, sucrose, fructose, maltose, sorbitol, xylitol, inorganic salts, calcium salts, polysaccharides, dicalcium phosphate, sodium chloride, maltodextrin, sucrose-maltodextrin mixture, trehalose, magnesium carbonate, or mixtures thereof. According to one embodiment of the present invention, the diluent is D-mannitol or lactose or microcrystalline cellulose or corn starch or magnesium carbonate, or mixtures thereof. According to one embodiment of the present invention, the diluent is D-mannitol. According to one embodiment of the present invention, the diluent is lactose or microcrystalline cellulose or corn starch or magnesium carbonate or mixtures thereof. According to one embodiment of the present invention, the amount of diluents in the total composition is between 25.0% and 70.0% by weight. The amount provides the desired content uniformity. Since the amount of active ingredient is low relative to the entire composition, it is important to ensure content uniformity. According to one embodiment of the present invention, the diluents are contained in the core tablet. Suitable disintegrants are selected from the group consisting of croscarmellose sodium, low substituted hydroxypropyl cellulose, crospovidone, ion exchange resins, magnesium aluminum silica, sodium carboxymethyl cellulose, calcium silicate, sodium starch glycolate, carboxymethyl cellulose, calcium carboxymethyl cellulose, docusate sodium, polyacryline potassium, poloxamer, povidone, sodium alginate, sodium glycine carbonate or mixtures thereof. According to one embodiment of the present invention, the disintegrant is croscarmellose sodium or low substituted hydroxypropyl cellulose or crospovidone or mixtures thereof. According to one embodiment of the present invention, the amount of disintegrant in the total composition is 1.0% by weight. According to one embodiment of the present invention, the disintegrants are present in the core tablet. Suitable binders are selected from the group consisting of hydroxypropyl cellulose, polyvinylpyrrolidone, natural gums, gelatin, alginates, sodium alginate, gum, guar gum, starch mucilage, acacia mucilage, cetostearyl alcohol, pullulan, polydextrose, polyethylene oxide, pectin, aluminum hydroxide, hyaluronic acid or mixtures thereof. According to one embodiment of the present invention, the binder is hydroxypropyl cellulose or polyvinylpyrrolidone or mixtures thereof. According to one embodiment of the present invention, the binders are present in the core tablet. According to one embodiment of the present invention, the amount of binder in the total composition is 0.5% by weight. Suitable glidants are selected from the group consisting of talc, anhydrous colloidal silica, colloidal silicon dioxide, calcium silicate, aluminum silicate, magnesium silicate, magnesium oxide, starch or mixtures thereof. According to one embodiment of the present invention, the glidant is talc or anhydrous colloidal silica or mixtures thereof. According to one embodiment of the present invention, when talc is used in the core tablet, it acts as a glidant. When talc is used in the inner coating or enteric coating, it acts as an anti-adhesive agent. According to one embodiment of the present invention, the glidants are present in the core tablet. According to one embodiment of the present invention, the amount of glidant in the total composition is between 0.1% and 4.0% by weight. Suitable surfactants are selected from the group consisting of polysorbate 80, glyceryl monostearate, sodium dodecyl sulfate, sodium lauryl sulfate, cetylpyridinium chloride, docusate sodium, lauric acid, polyoxyethylene sorbitan fatty acid esters (polysorbate), phospholipids, cetrimide or mixtures thereof. According to one embodiment of the present invention, the surfactant is polysorbate 80 or glyceryl monostearate or sodium lauryl sulfate or mixtures thereof. It is a synthetic organic compound commonly used as an anionic surfactant in pharmaceutical products. It provides the desired profile in the present invention. It also helps to provide the desired flowability. According to one embodiment of the present invention, the amount of surfactant in the total composition is 0.1% by weight. According to one embodiment of the present invention, the surfactants are present in the tablet core or in the enteric coating or both. Suitable pH adjusting agents are selected from the group consisting of aluminum potassium sulfate, anhydrous citric acid, anhydrous disodium hydrogen phosphate, potassium carbonate, anhydrous sodium dihydrogen phosphate, dibasic potassium sulfate, calcium carbonate, dilute hydrochloric acid, monobasic potassium phosphate, phosphoric acid, adipic acid, sodium acetate, sodium bicarbonate, sodium carbonate, sodium citrate, sodium dihydrogen phosphate dihydrate, tribasic sodium phosphate or mixtures thereof. The use of the pH adjusting agent ensures that lansoprazole, which is unstable at low pH values, maintains the desired stability under long conditions. According to one embodiment of the present invention, the pH adjusting agent is sodium bicarbonate. According to one embodiment of the present invention, the pH adjusting agent is present in the enteric coating. Suitable lubricants are selected from the group consisting of magnesium stearate, sodium stearyl fumarate, calcium stearate, stearic acid, polyethylene glycol, sodium lauryl sulfate, magnesium lauryl sulfate, fumaric acid, glyceryl palmito sulfate, hydrogenated vegetable oil, zinc stearate or mixtures thereof. According to one embodiment of the present invention, the lubricant is magnesium stearate or sodium stearyl fumarate or mixtures thereof. According to one embodiment of the present invention, the lubricants are present in the core tablet or the enteric coating or both. According to one embodiment of the present invention, the amount of lubricant in the total composition is 1.0% by weight. According to one embodiment of the present invention, the core tablet comprises lansoprazole, D-mannitol, Low substituted HPC, sodium stearyl fumarate, croscarmellose sodium and hydroxypropyl cellulose. According to one embodiment of the present invention, the core tablet comprises lansoprazole, microcrystalline cellulose, magnesium carbonate and magnesium stearate. According to one embodiment of the present invention, the inner coating comprises HPMC, triacetin and talc. According to one embodiment of the present invention, the inner coating comprises HPMC and talc. According to one embodiment of the present invention, the enteric coating comprises methacrylic acid ethyl acrylate copolymer (1.1) type A, talc, triethyl citrate, anhydrous colloidal silica, SLS, and sodium bicarbonate. According to one embodiment of the present invention, the enteric coating comprises Eudragit 5100, Eudragit L100, talc, triethyl citrate, glyceryl monostearate, and Polysorbate 80. Ingredients Amount (% by weight of total formulation) Lansoprazole 5.0 - 20.0 4; Croscarmellose sodium 1.0 - 8.0 33 HPC 0.1 - 5.0 Sodium stearyl fumarate 1.0 - 6.0 .2 2 Talc Eudragit S100 g Eudragit L100 20.0 - 40.0 *E Glyceryl monostearate Polysorbate 80 Total Enteric-coated mini or 100 micro tablets A process for Example 1; Core tablet o Weigh lansoprazole, D-mannitol, HPC, croscarmellose sodium, low substituted HPC and mix in a compact cylinder for 15 minutes (cylinder gap 2.0 mm, cylinder pressure 15.0 mPa, feed screw speed 10:1, feed screw speed 25 rpm, speed 2.5 rpm) o Sifting the granules, 0 Adding sodium stearyl fumarate to the dry mixture and mixing for 5 minutes, o Compressing the mixture into tablets, Inner coating o Enteric coating with HPMC and talc, Enteric coating o Enteric coating with methacrylic acid copolymer dispersion, Filling the micro or mini tablets with inner and enteric coating into capsules. Components Amount (% by weight of total formulation) Lansoprazole 5.0 - 20.0 D-Mannitol DC grade 25.0 - 37.0 .g Croscarmellose sodium 1.0 - 8.0 Magnesium stearate 1.0 - 6.0 .3 S Talc Eudragit S100 g Eudragit L100 TE Triethyl citrate 20.0 - 40.0 *E Glyceryl monostearate Polysorbate 80 Total Enteric-coated minitablets 100 One process for example 2; Core tablet o Weighing lansoprazole, D-mannitol, HPC, croscarmellose sodium, low substituted HPC and mixing for 15 o Adding sodium stearyl fumarate and talc and mixing for 5 minutes, 0 Adding magnesium stearate to the dry mixture and mixing for 3 minutes, o Compressing the mixture into tablets, Inner coating o Enteric coating with HPMC and talc, Enteric coating o Enteric coating with methacrylic acid copolymer dispersion, Filling micro or mini tablets with inner and enteric coating into capsules. Ingredients Amount (% of total formulation by weight) Lansoprazole 5.0 - 20.0 s Magnesium carbonate 2.0 - 20.0 3 Corn starch 2.0 - 10.0 . E Polysorbate 80 0.1 - 3.0 E Croscarmellose sodium 1.0 - 6.0 Magnesium stearate 0.1 - 5.0 g Triacetin 1.0 - 10.0 Methacrylic acid ethyl acrylate I copolymer (1.1) type A 2 Triethyl citrate 15.0 - 35.0 Total Enteric-coated minitablets 100 A process for example 3; Core tablet o Weighing lansoprazole, magnesium carbonate, lactose, V2 croscarmellose sodium and mixing for 15 minutes, 0 Granulating the dry mixture with HPC and polysorbate 80 in water solution, 0 Sifting the wet granules to 2.0 mm, o Drying the granules in the oven, 0 Sifting the dry granules to 0.85 mm, o Adding V2 croscarmellose sodium and mixing for 5 minutes, 0 Adding weighed and 0.6 mm sieved magnesium stearate to the dry mixture and mixing for 3 minutes, o Compressing the mixture into tablets, Inner coating o Enteric coating with HPMC, triacetin and talc, Enteric coating o Enteric coating with methacrylic acid copolymer dispersion, Filling the micro or mini tablets with inner and enteric coating into capsules. Components Amount (% by weight of total formulation) Lansoprazole 5.0 - 20.0 g Colloidal silicon dioxide 0.1-3.0 Magnesium stearate 0.1 - 3.0 g Triacetin 1.0 - 10.0 .3 S Talc Methacrylic acid ethyl acrylate copolymer (1.1) 7 type A 2 Triethyl citrate 15.0 - 35.0 Total Enteric-coated minitablets 100 A process for Example 4; Weighing core Lansoprazole, Magnesium carbonate, V2 MCC 112, colloidal silicon dioxide, PVP K-30 and mixing for 10 minutes, Adding weighed and 0.6 mm sieved Magnesium stearate to the dry mixture and mixing for 3 minutes, Granulating slug in a compactor, Sieving dry granules to 1.2 mm, Adding V2 MCC pH 112, Crospovidone CL and mixing for 5 minutes, Adding 0.6 mm sieved V2 Mg-stearate and mixing for 3 minutes o Compressing the mixture into tablets, Inner coating o Enteric coating with HPMC, triacetin and talc, Enteric coating o Enteric coating with methacrylic acid copolymer dispersion, Filling micro or mini tablets with inner and enteric coating into capsules. Components Amount (% by weight of total formulation) Lansoprazole 5.0 - 20.0 g Corn starch 1.0 - 10.0 E croscarmellose sodium 1.0 - 6.0 Anhydrous colloidal silica 0.1 - 3.0 Magnesium stearate 0.1 - 3.0 g Triacetin 1.0 - 10.0 .3 S Talc Methacrylic acid ethyl acrylate T copolymer (1.1) type A 2 Triethyl citrate 15.0 - 35.0 nci Anhydrous colloidal silica Total Enteric-coated mini 100 A process for Example 5; Core tablet o Weighing lansoprazole, magnesium carbonate, MCC 112, HPC, corn starch, croscarmellose, sodium, anhydrous colloidal silica, talc and mixing for 15 minutes, 0 Adding weighed and 0.6 mm sieved magnesium stearate to the dry mixture and mixing for 3 minutes, o Compressing the mixture into tablets, Inner coating o Enteric coating with HPMC, triacetin and talc, Enteric coating o Enteric coating with methacrylic acid copolymer dispersion, Filling the micro or mini tablets with inner and enteric coating into capsules.TR TR TR TR
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| Publication Number | Publication Date |
|---|---|
| TR2022015882A2 true TR2022015882A2 (en) | 2024-04-22 |
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