HRP20230437T1 - Formulacija afabicina, postupak izrade iste - Google Patents
Formulacija afabicina, postupak izrade iste Download PDFInfo
- Publication number
- HRP20230437T1 HRP20230437T1 HRP20230437TT HRP20230437T HRP20230437T1 HR P20230437 T1 HRP20230437 T1 HR P20230437T1 HR P20230437T T HRP20230437T T HR P20230437TT HR P20230437 T HRP20230437 T HR P20230437T HR P20230437 T1 HRP20230437 T1 HR P20230437T1
- Authority
- HR
- Croatia
- Prior art keywords
- solid pharmaceutical
- pharmaceutical preparation
- preparation according
- granulate
- pharmaceutically acceptable
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 9
- HFYMDQMXVPJNTH-VQHVLOKHSA-N afabicin Chemical compound OP(=O)(O)OCN1C(=O)CCC2=CC(/C=C/C(=O)N(CC3=C(C4=CC=CC=C4O3)C)C)=CN=C21 HFYMDQMXVPJNTH-VQHVLOKHSA-N 0.000 title claims 5
- 229950006578 afabicin Drugs 0.000 title claims 5
- 238000000034 method Methods 0.000 title claims 4
- 238000009472 formulation Methods 0.000 title 1
- 239000007787 solid Substances 0.000 claims 13
- 239000000825 pharmaceutical preparation Substances 0.000 claims 12
- 239000008187 granular material Substances 0.000 claims 7
- -1 histidine compound Chemical class 0.000 claims 5
- 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 4
- DLRVVLDZNNYCBX-UHFFFAOYSA-N Polydextrose Polymers OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(O)O1 DLRVVLDZNNYCBX-UHFFFAOYSA-N 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 208000035143 Bacterial infection Diseases 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- 208000022362 bacterial infectious disease Diseases 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 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 2
- 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 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- 239000004375 Dextrin Substances 0.000 claims 2
- 229920001353 Dextrin Polymers 0.000 claims 2
- 229920002907 Guar gum Polymers 0.000 claims 2
- 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 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 2
- 241000124008 Mammalia Species 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 229920001100 Polydextrose Polymers 0.000 claims 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 2
- HZVVJJIYJKGMFL-UHFFFAOYSA-N almasilate Chemical compound O.[Mg+2].[Al+3].[Al+3].O[Si](O)=O.O[Si](O)=O HZVVJJIYJKGMFL-UHFFFAOYSA-N 0.000 claims 2
- 230000001580 bacterial effect Effects 0.000 claims 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 2
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims 2
- 239000007891 compressed tablet Substances 0.000 claims 2
- 229940096516 dextrates Drugs 0.000 claims 2
- 235000019425 dextrin Nutrition 0.000 claims 2
- 239000008121 dextrose Substances 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000000665 guar gum Substances 0.000 claims 2
- 235000010417 guar gum Nutrition 0.000 claims 2
- 229960002154 guar gum Drugs 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 229920001983 poloxamer Polymers 0.000 claims 2
- 239000001259 polydextrose Substances 0.000 claims 2
- 235000013856 polydextrose Nutrition 0.000 claims 2
- 229940035035 polydextrose Drugs 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- 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 1
- 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 1
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 1
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 208000008960 Diabetic foot Diseases 0.000 claims 1
- 229930091371 Fructose Natural products 0.000 claims 1
- 239000005715 Fructose Substances 0.000 claims 1
- 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 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 240000007472 Leucaena leucocephala Species 0.000 claims 1
- 235000010643 Leucaena leucocephala Nutrition 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 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 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 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 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 229920001531 copovidone Polymers 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 229960003964 deoxycholic acid Drugs 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 238000007908 dry granulation Methods 0.000 claims 1
- 238000007580 dry-mixing Methods 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 229960001031 glucose Drugs 0.000 claims 1
- 235000001727 glucose Nutrition 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims 1
- 239000000905 isomalt Substances 0.000 claims 1
- 235000010439 isomalt Nutrition 0.000 claims 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 1
- 239000000832 lactitol Substances 0.000 claims 1
- 235000010448 lactitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 1
- 229960003451 lactitol Drugs 0.000 claims 1
- 239000000787 lecithin Substances 0.000 claims 1
- 235000010445 lecithin Nutrition 0.000 claims 1
- 229940067606 lecithin Drugs 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 1
- FHHPUSMSKHSNKW-SMOYURAASA-M sodium deoxycholate Chemical compound [Na+].C([C@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC([O-])=O)C)[C@@]2(C)[C@@H](O)C1 FHHPUSMSKHSNKW-SMOYURAASA-M 0.000 claims 1
- 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 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
- 241000894007 species Species 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- MDYZKJNTKZIUSK-UHFFFAOYSA-N tyloxapol Chemical compound O=C.C1CO1.CC(C)(C)CC(C)(C)C1=CC=C(O)C=C1 MDYZKJNTKZIUSK-UHFFFAOYSA-N 0.000 claims 1
- 229920001664 tyloxapol Polymers 0.000 claims 1
- 229960004224 tyloxapol Drugs 0.000 claims 1
- 239000001993 wax Substances 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- Animal Behavior & Ethology (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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- Dermatology (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (16)
1. Kruti farmaceutski pripravak u obliku jedinične doze koji sadrži afabicin ili njegovu farmaceutski prihvatljivu sol i jedan ili više farmaceutski prihvatljivih ekscipijenata, naznačen time što pripravak sadrži histidinski spoj.
2. Kruti farmaceutski pripravak prema zahtjevu 1, koji sadrži afabicin ili njegovu farmaceutski prihvatljivu sol u količini od 20 mg do 480 mg.
3. Kruti farmaceutski pripravak prema zahtjevu 1 ili 2, koji sadrži histidin.
4. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 3, koji je u obliku tablete, tableta poželjno sadrži unutarnju fazu i vanjsku fazu, pri čemu je afabicin ili njegova farmaceutski prihvatljiva sol poželjno sadržan samo u unutarnjoj fazi.
5. Kruti farmaceutski pripravak prema zahtjevu 4, koji sadrži histidinski spoj samo u unutarnjoj fazi.
6. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 5, koji sadrži vezivo odabrano iz skupine koju čine povidon, kopovidon, poloksamer, polietilen glikol, magnezijev aluminosilikat, želatina, akacija, dekstrin, dekstrati, dekstroza, polidekstroza, guar guma, hidrogenirano biljno ulje, tekuća glukoza, vosak, maltoza, saharoza, laktoza, vosak, i njihove mješavine.
7. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, koji sadrži razrjeđivač odabran iz skupine koju čine manitol, izomalt, laktoza, kalcijev fosfat, kalcijev karbonat, kalcijev sulfat, saharoza, fruktoza, maltoza, ksilitol, maltitol, laktitol, trehaloza , aluminijev silikat, ciklodekstrin, dekstroza, polidekstroza, glukoza, dekstrin, dekstrati, magnezijev karbonat i njihove mješavine.
8. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7, koji sadrži surfaktant odabran iz skupine koju čine natrijev lauril sulfat, poloksameri, natrijev dokuzat, natrijev deoksikolat, sorbitan esteri, saharozni esteri masne kiseline, tiloksapol, lecitin i polisorbat i njihove mješavine.
9. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 8, koji sadrži dezintegrator odabran iz skupine koju čine krospovidon, magnezijev aluminosilikat, koloidni silicij dioksid, guar guma i njihove mješavine.
10. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 3 i 6 do 9, koji je u obliku kapsule koja sadrži afabicin ili njegovu farmaceutski prihvatljivu sol i jedan ili više farmaceutski prihvatljivih ekscipijenata u obliku praha ili granulata.
11. Postupak proizvodnje krutog pripravka prema bilo kojem od zahtjeva 1 do 9, koji uključuje sljedeće korake navedenim redoslijedom:
(i) suho miješanje nekih ili svih komponenti pripravka;
(ii) granuliranje dobivene mješavine da se dobije granulat;
(iii) miješanje bilo koje preostale komponente pripravka u granulat;
(iv) kompresija dobivene mješavine da se dobije komprimirana tableta; i
(v) izborno oblaganje dobivene komprimirane tablete.
12. Postupak prema zahtjevu 11, naznačen time što se korak granulacije izvodi mokrom granulacijom ili suhom granulacijom.
13. Postupak prema zahtjevu 11 ili 12, naznačen time što je ispunjen najmanje jedan od sljedećih uvjeta:
(a) prisutan je razrjeđivač i dio razrjeđivača je pomiješan s granulatom iz koraka (ii);
(b) sredstvo za raspadanje je prisutno i dio sredstva za raspadanje je pomiješano s granulatom iz koraka (ii);
(c) klizno sredstvo je prisutno i dio ili cijelo klizno sredstvo je pomiješano s granulatom iz koraka (ii); i/ili
(d) lubrikant je prisutan i dio ili cijeli lubrikant je pomiješan s granulatom iz koraka (ii).
14. Kruti farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 10 za uporabu u postupku liječenja bakterijskih infekcija kod sisavaca.
15. Kruti farmaceutski pripravak za uporabu prema zahtjevu 14, naznačen time što je sisavac čovjek.
16. Kruti farmaceutski pripravak za uporabu prema točki 14 ili 15, naznačen time što je bakterijska infekcija uzrokovana bakterijskom vrstom S. aureus, takve infekcije su npr. akutna bakterijska infekcija kože i strukture kože (ABSSI) ili bakterijske infekcije povezane sa sindromom dijabetičkog stopala.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP19157255 | 2019-02-14 | ||
| PCT/EP2020/053882 WO2020165407A1 (en) | 2019-02-14 | 2020-02-14 | Afabicin formulation, method for making the same |
| EP20704307.6A EP3923914B1 (en) | 2019-02-14 | 2020-02-14 | Afabicin formulation, method for making the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230437T1 true HRP20230437T1 (hr) | 2023-07-07 |
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ID=65440901
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230437TT HRP20230437T1 (hr) | 2019-02-14 | 2020-02-14 | Formulacija afabicina, postupak izrade iste |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US20220142993A1 (hr) |
| EP (1) | EP3923914B1 (hr) |
| JP (1) | JP7383715B2 (hr) |
| KR (1) | KR20210127187A (hr) |
| CN (2) | CN116327781A (hr) |
| AU (1) | AU2020223515A1 (hr) |
| BR (1) | BR112021015825B1 (hr) |
| CA (1) | CA3129508A1 (hr) |
| CL (1) | CL2021002149A1 (hr) |
| CY (1) | CY1126077T1 (hr) |
| DK (1) | DK3923914T3 (hr) |
| EA (1) | EA202192246A1 (hr) |
| ES (1) | ES2944535T3 (hr) |
| FI (1) | FI3923914T3 (hr) |
| HR (1) | HRP20230437T1 (hr) |
| HU (1) | HUE062061T2 (hr) |
| IL (1) | IL285204A (hr) |
| LT (1) | LT3923914T (hr) |
| MA (1) | MA54009B1 (hr) |
| MX (1) | MX2021009799A (hr) |
| PL (1) | PL3923914T3 (hr) |
| PT (1) | PT3923914T (hr) |
| RS (1) | RS64158B1 (hr) |
| SG (1) | SG11202108591PA (hr) |
| SI (1) | SI3923914T1 (hr) |
| TN (1) | TN2021000159A1 (hr) |
| WO (1) | WO2020165407A1 (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2022515775A (ja) | 2018-12-21 | 2022-02-22 | アクルクス ファーマシューティカルズ エルエルシー | Ｄｎａポリメラーゼｉｉｉｃ阻害剤及びその使用 |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2444597A1 (en) | 2001-04-06 | 2002-10-06 | Affinium Pharmaceuticals, Inc. | Fab i inhibitors |
| CN101415701A (zh) * | 2005-12-05 | 2009-04-22 | Affinium医药公司 | 作为fabi抑制剂的杂环丙烯酰胺化合物和抗菌剂 |
| JP6085026B2 (ja) | 2012-06-19 | 2017-02-22 | デビオファーム インターナショナル エスエーＤｅｂｉｏｐｈａｒｍ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｓａ | （ｅ）−ｎ−メチル−ｎ−（（３−メチルベンゾフラン−２−イル）メチル）−３−（７−オキソ−５，６，７，８−テトラヒドロ−１，８−ナフチリジン−３−イル）アクリルアミドのプロドラッグ誘導体 |
| CA3014541A1 (en) * | 2016-02-26 | 2017-08-31 | Debiopharm International S.A. | Medicament for treatment of diabetic foot infections |
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2020
- 2020-02-14 LT LTEPPCT/EP2020/053882T patent/LT3923914T/lt unknown
- 2020-02-14 AU AU2020223515A patent/AU2020223515A1/en active Pending
- 2020-02-14 HU HUE20704307A patent/HUE062061T2/hu unknown
- 2020-02-14 ES ES20704307T patent/ES2944535T3/es active Active
- 2020-02-14 RS RS20230315A patent/RS64158B1/sr unknown
- 2020-02-14 EA EA202192246A patent/EA202192246A1/ru unknown
- 2020-02-14 SG SG11202108591PA patent/SG11202108591PA/en unknown
- 2020-02-14 EP EP20704307.6A patent/EP3923914B1/en active Active
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- 2020-02-14 MA MA54009A patent/MA54009B1/fr unknown
- 2020-02-14 PL PL20704307.6T patent/PL3923914T3/pl unknown
- 2020-02-14 CN CN202310544746.8A patent/CN116327781A/zh active Pending
- 2020-02-14 KR KR1020217028702A patent/KR20210127187A/ko unknown
- 2020-02-14 JP JP2021545458A patent/JP7383715B2/ja active Active
- 2020-02-14 CA CA3129508A patent/CA3129508A1/en active Pending
- 2020-02-14 WO PCT/EP2020/053882 patent/WO2020165407A1/en active Application Filing
- 2020-02-14 BR BR112021015825-1A patent/BR112021015825B1/pt active IP Right Grant
- 2020-02-14 FI FIEP20704307.6T patent/FI3923914T3/fi active
- 2020-02-14 TN TNP/2021/000159A patent/TN2021000159A1/en unknown
- 2020-02-14 CN CN202080014005.3A patent/CN113423390B/zh active Active
- 2020-02-14 DK DK20704307.6T patent/DK3923914T3/da active
- 2020-02-14 SI SI202030183T patent/SI3923914T1/sl unknown
- 2020-02-14 PT PT207043076T patent/PT3923914T/pt unknown
- 2020-02-14 US US17/430,616 patent/US20220142993A1/en active Pending
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2021
- 2021-07-28 IL IL285204A patent/IL285204A/en unknown
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Also Published As
| Publication number | Publication date |
|---|---|
| DK3923914T3 (da) | 2023-05-01 |
| FI3923914T3 (fi) | 2023-04-27 |
| CA3129508A1 (en) | 2020-08-20 |
| LT3923914T (lt) | 2023-07-25 |
| CY1126077T1 (el) | 2023-11-15 |
| WO2020165407A1 (en) | 2020-08-20 |
| RS64158B1 (sr) | 2023-05-31 |
| ES2944535T3 (es) | 2023-06-22 |
| SG11202108591PA (en) | 2021-09-29 |
| SI3923914T1 (sl) | 2023-08-31 |
| PL3923914T3 (pl) | 2023-08-07 |
| MA54009B1 (fr) | 2022-10-31 |
| MX2021009799A (es) | 2021-09-08 |
| AU2020223515A1 (en) | 2021-08-19 |
| CL2021002149A1 (es) | 2022-03-04 |
| HUE062061T2 (hu) | 2023-09-28 |
| CN116327781A (zh) | 2023-06-27 |
| EP3923914A1 (en) | 2021-12-22 |
| US20220142993A1 (en) | 2022-05-12 |
| CN113423390B (zh) | 2023-05-23 |
| MA54009A1 (fr) | 2022-05-31 |
| BR112021015825B1 (pt) | 2024-03-12 |
| BR112021015825A2 (pt) | 2021-10-13 |
| KR20210127187A (ko) | 2021-10-21 |
| IL285204A (en) | 2021-09-30 |
| CN113423390A (zh) | 2021-09-21 |
| JP2022520170A (ja) | 2022-03-29 |
| EP3923914B1 (en) | 2023-04-12 |
| EA202192246A1 (ru) | 2021-11-18 |
| TN2021000159A1 (en) | 2023-04-04 |
| JP7383715B2 (ja) | 2023-11-20 |
| PT3923914T (pt) | 2023-05-04 |
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