BR112012012406B1 - Composições farmacêuticas sólidas de daptomicina, seu produto farmacêutico e seus métodos de fabricação - Google Patents
Composições farmacêuticas sólidas de daptomicina, seu produto farmacêutico e seus métodos de fabricação Download PDFInfo
- Publication number
- BR112012012406B1 BR112012012406B1 BR112012012406-4A BR112012012406A BR112012012406B1 BR 112012012406 B1 BR112012012406 B1 BR 112012012406B1 BR 112012012406 A BR112012012406 A BR 112012012406A BR 112012012406 B1 BR112012012406 B1 BR 112012012406B1
- Authority
- BR
- Brazil
- Prior art keywords
- daptomycin
- solid
- sucrose
- pharmaceutical
- aqueous
- Prior art date
Links
- DOAKLVKFURWEDJ-QCMAZARJSA-N daptomycin Chemical group C([C@H]1C(=O)O[C@H](C)[C@@H](C(NCC(=O)N[C@@H](CCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H](C)C(=O)N[C@@H](CC(O)=O)C(=O)NCC(=O)N[C@H](CO)C(=O)N[C@H](C(=O)N1)[C@H](C)CC(O)=O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](CC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)CCCCCCCCC)C(=O)C1=CC=CC=C1N DOAKLVKFURWEDJ-QCMAZARJSA-N 0.000 title claims abstract description 621
- 108010013198 Daptomycin Proteins 0.000 title claims abstract description 619
- 229960005484 daptomycin Drugs 0.000 title claims abstract description 612
- 239000007787 solid Substances 0.000 title claims abstract description 185
- 239000000825 pharmaceutical preparation Substances 0.000 title claims description 80
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 67
- 238000004519 manufacturing process Methods 0.000 title claims description 5
- 229940127557 pharmaceutical product Drugs 0.000 title claims description 3
- 229930006000 Sucrose Natural products 0.000 claims abstract description 86
- 239000005720 sucrose Substances 0.000 claims abstract description 86
- 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 abstract description 85
- 238000000034 method Methods 0.000 claims abstract description 65
- 239000000243 solution Substances 0.000 claims description 88
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 84
- 239000003085 diluting agent Substances 0.000 claims description 54
- 239000011780 sodium chloride Substances 0.000 claims description 42
- 239000006172 buffering agent Substances 0.000 claims description 38
- 238000004108 freeze drying Methods 0.000 claims description 36
- 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 33
- 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 33
- 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 32
- 239000007864 aqueous solution Substances 0.000 claims description 25
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 17
- 238000001694 spray drying Methods 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 2
- 239000000203 mixture Substances 0.000 abstract description 203
- 238000009472 formulation Methods 0.000 abstract description 86
- 239000000126 substance Substances 0.000 abstract description 78
- 108010028921 Lipopeptides Proteins 0.000 abstract description 57
- 239000000843 powder Substances 0.000 abstract description 13
- 235000000346 sugar Nutrition 0.000 description 114
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 102
- 238000002360 preparation method Methods 0.000 description 85
- 229960004793 sucrose Drugs 0.000 description 80
- 239000004471 Glycine Substances 0.000 description 50
- 239000007788 liquid Substances 0.000 description 50
- 238000004128 high performance liquid chromatography Methods 0.000 description 34
- 239000000594 mannitol Substances 0.000 description 32
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 31
- 229930195725 Mannitol Natural products 0.000 description 31
- 235000010355 mannitol Nutrition 0.000 description 31
- 150000008163 sugars Chemical class 0.000 description 28
- 239000000047 product Substances 0.000 description 27
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 24
- 238000005259 measurement Methods 0.000 description 16
- 238000003860 storage Methods 0.000 description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 16
- 239000008227 sterile water for injection Substances 0.000 description 14
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 13
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 12
- -1 daptomycin lactone Chemical class 0.000 description 12
- 230000007062 hydrolysis Effects 0.000 description 12
- 238000006460 hydrolysis reaction Methods 0.000 description 12
- 229910019142 PO4 Inorganic materials 0.000 description 11
- 239000008186 active pharmaceutical agent Substances 0.000 description 11
- 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 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 description 10
- 229930091371 Fructose Natural products 0.000 description 10
- 239000005715 Fructose Substances 0.000 description 10
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 10
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 10
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 10
- 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 description 10
- 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 description 10
- 239000008121 dextrose Substances 0.000 description 10
- 239000008101 lactose Substances 0.000 description 10
- 238000007911 parenteral administration Methods 0.000 description 10
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 10
- 239000010452 phosphate Substances 0.000 description 10
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 9
- 229940061607 dibasic sodium phosphate Drugs 0.000 description 9
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 8
- 150000001875 compounds Chemical class 0.000 description 8
- 239000013068 control sample Substances 0.000 description 8
- 229910052708 sodium Inorganic materials 0.000 description 8
- 239000011734 sodium Substances 0.000 description 8
- 239000001488 sodium phosphate Substances 0.000 description 8
- 229910000162 sodium phosphate Inorganic materials 0.000 description 8
- 235000011008 sodium phosphates Nutrition 0.000 description 8
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 8
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 7
- 238000002347 injection Methods 0.000 description 7
- 239000007924 injection Substances 0.000 description 7
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
- 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 description 6
- 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 description 6
- 229940021392 cubicin Drugs 0.000 description 6
- 229940126534 drug product Drugs 0.000 description 6
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 229910052757 nitrogen Inorganic materials 0.000 description 6
- 239000008024 pharmaceutical diluent Substances 0.000 description 6
- 239000000523 sample Substances 0.000 description 6
- 239000002904 solvent Substances 0.000 description 6
- 239000000600 sorbitol Substances 0.000 description 6
- 238000010257 thawing Methods 0.000 description 6
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 6
- 238000002835 absorbance Methods 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 5
- 230000015556 catabolic process Effects 0.000 description 5
- 238000006731 degradation reaction Methods 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- 229910000397 disodium phosphate Inorganic materials 0.000 description 4
- 235000019800 disodium phosphate Nutrition 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000000855 fermentation Methods 0.000 description 4
- 230000004151 fermentation Effects 0.000 description 4
- 239000013022 formulation composition Substances 0.000 description 4
- 238000001990 intravenous administration Methods 0.000 description 4
- 235000020061 kirsch Nutrition 0.000 description 4
- 239000006193 liquid solution Substances 0.000 description 4
- 239000008176 lyophilized powder Substances 0.000 description 4
- 229960001855 mannitol Drugs 0.000 description 4
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 239000007983 Tris buffer Substances 0.000 description 3
- 238000013019 agitation Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 239000000872 buffer Substances 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 3
- 239000000693 micelle Substances 0.000 description 3
- 239000012299 nitrogen atmosphere Substances 0.000 description 3
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical compound CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 description 2
- 208000031729 Bacteremia Diseases 0.000 description 2
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- LFVGISIMTYGQHF-UHFFFAOYSA-N ammonium dihydrogen phosphate Chemical compound [NH4+].OP(O)([O-])=O LFVGISIMTYGQHF-UHFFFAOYSA-N 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 239000008228 bacteriostatic water for injection Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
- GHVNFZFCNZKVNT-UHFFFAOYSA-N decanoic acid Chemical compound CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 description 2
- 239000007857 degradation product Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 238000012417 linear regression Methods 0.000 description 2
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 description 2
- 238000010979 pH adjustment Methods 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 206010040872 skin infection Diseases 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 229940074410 trehalose Drugs 0.000 description 2
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 description 1
- JCIIKRHCWVHVFF-UHFFFAOYSA-N 1,2,4-thiadiazol-5-amine;hydrochloride Chemical compound Cl.NC1=NC=NS1 JCIIKRHCWVHVFF-UHFFFAOYSA-N 0.000 description 1
- AZUYLZMQTIKGSC-UHFFFAOYSA-N 1-[6-[4-(5-chloro-6-methyl-1H-indazol-4-yl)-5-methyl-3-(1-methylindazol-5-yl)pyrazol-1-yl]-2-azaspiro[3.3]heptan-2-yl]prop-2-en-1-one Chemical compound ClC=1C(=C2C=NNC2=CC=1C)C=1C(=NN(C=1C)C1CC2(CN(C2)C(C=C)=O)C1)C=1C=C2C=NN(C2=CC=1)C AZUYLZMQTIKGSC-UHFFFAOYSA-N 0.000 description 1
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 description 1
- OCKGFTQIICXDQW-ZEQRLZLVSA-N 5-[(1r)-1-hydroxy-2-[4-[(2r)-2-hydroxy-2-(4-methyl-1-oxo-3h-2-benzofuran-5-yl)ethyl]piperazin-1-yl]ethyl]-4-methyl-3h-2-benzofuran-1-one Chemical compound C1=C2C(=O)OCC2=C(C)C([C@@H](O)CN2CCN(CC2)C[C@H](O)C2=CC=C3C(=O)OCC3=C2C)=C1 OCKGFTQIICXDQW-ZEQRLZLVSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- RJQXTJLFIWVMTO-TYNCELHUSA-N Methicillin Chemical compound COC1=CC=CC(OC)=C1C(=O)N[C@@H]1C(=O)N2[C@@H](C(O)=O)C(C)(C)S[C@@H]21 RJQXTJLFIWVMTO-TYNCELHUSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000958215 Streptomyces filamentosus Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 238000005349 anion exchange Methods 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000003125 aqueous solvent Substances 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 125000003164 beta-aspartyl group Chemical group 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 1
- 239000004327 boric acid Substances 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 125000005587 carbonate group Chemical group 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical compound OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 229960002242 chlorocresol Drugs 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 238000011026 diafiltration Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 206010014665 endocarditis Diseases 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 239000002809 glycine agent Substances 0.000 description 1
- 229960003446 histidine monohydrochloride Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 201000007119 infective endocarditis Diseases 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 description 1
- 238000006317 isomerization reaction Methods 0.000 description 1
- 150000002596 lactones Chemical class 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 239000013541 low molecular weight contaminant Substances 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 150000002689 maleic acids Chemical class 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 1
- 229960002216 methylparaben Drugs 0.000 description 1
- 229960003085 meticillin Drugs 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 150000002840 non-reducing disaccharides Chemical group 0.000 description 1
- 239000008063 pharmaceutical solvent Substances 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- 229960005323 phenoxyethanol Drugs 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical group O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- 229940096826 phenylmercuric acetate Drugs 0.000 description 1
- PDTFCHSETJBPTR-UHFFFAOYSA-N phenylmercuric nitrate Chemical compound [O-][N+](=O)O[Hg]C1=CC=CC=C1 PDTFCHSETJBPTR-UHFFFAOYSA-N 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- KKCBUQHMOMHUOY-UHFFFAOYSA-N sodium oxide Chemical compound [O-2].[Na+].[Na+] KKCBUQHMOMHUOY-UHFFFAOYSA-N 0.000 description 1
- 229910001948 sodium oxide Inorganic materials 0.000 description 1
- 239000012064 sodium phosphate buffer Substances 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 239000008247 solid mixture Substances 0.000 description 1
- 239000007790 solid phase Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 125000000185 sucrose group Chemical group 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
- 229940033663 thimerosal Drugs 0.000 description 1
- 125000000647 trehalose group Chemical group 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
Images
Classifications
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- 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
- A61K2121/00—Preparations for use in therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
-
- 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
- A61K9/08—Solutions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K11/00—Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K11/02—Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof cyclic, e.g. valinomycins ; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26378409P | 2009-11-23 | 2009-11-23 | |
| US61/263,784 | 2009-11-23 | ||
| PCT/US2010/057910 WO2011063419A2 (en) | 2009-11-23 | 2010-11-23 | Lipopeptide compositions and related methods |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112012012406A2 BR112012012406A2 (pt) | 2019-12-03 |
| BR112012012406B1 true BR112012012406B1 (pt) | 2021-11-16 |
Family
ID=44060422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112012012406-4A BR112012012406B1 (pt) | 2009-11-23 | 2010-11-23 | Composições farmacêuticas sólidas de daptomicina, seu produto farmacêutico e seus métodos de fabricação |
Country Status (33)
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6696412B1 (en) | 2000-01-20 | 2004-02-24 | Cubist Pharmaceuticals, Inc. | High purity lipopeptides, Lipopeptide micelles and processes for preparing same |
| US20060014674A1 (en) * | 2000-12-18 | 2006-01-19 | Dennis Keith | Methods for preparing purified lipopeptides |
| TWI606838B (zh) | 2009-11-23 | 2017-12-01 | 庫比斯特製藥有限責任公司 | 達托黴素(daptomycin)組合物及相關方法 |
| CN103429228B (zh) | 2011-01-05 | 2016-10-26 | 赫士睿股份有限公司 | 万古霉素的喷雾干燥 |
| KR20140037877A (ko) * | 2011-05-26 | 2014-03-27 | 큐비스트 파마슈티컬즈 인코포레이티드 | Cb-183,315 조성물 및 관련 방법 |
| MX2014008390A (es) * | 2012-01-12 | 2014-09-22 | Celgene Corp | Formulaciones de romidepsina y sus usos. |
| CA2881121A1 (en) * | 2012-08-23 | 2014-03-27 | Agila Specialties Private Limited | Improved daptomycin injectable formulation |
| EP4066849B1 (en) * | 2012-09-11 | 2025-03-05 | Hospira Australia Pty Ltd | Daptomycin formulations and uses thereof |
| CN104027791B (zh) * | 2013-03-06 | 2016-08-10 | 浙江海正药业股份有限公司 | 药物组合物 |
| CN104511011A (zh) * | 2013-09-29 | 2015-04-15 | 山东新时代药业有限公司 | 一种达托霉素无菌粉末及其制备方法 |
| US10647746B2 (en) | 2016-04-08 | 2020-05-12 | Versitech Limited | Antibacterial cyclic lipopeptides |
| US11667674B2 (en) | 2016-04-08 | 2023-06-06 | Versitech Limited | Antibacterial cyclic lipopeptides |
| ES2946600T3 (es) | 2016-10-21 | 2023-07-21 | Xellia Pharmaceuticals Aps | Formulaciones líquidas de daptomicina |
| EP3675815A1 (en) | 2017-08-31 | 2020-07-08 | Xellia Pharmaceuticals ApS | Daptomycin formulations |
| CN110339341A (zh) * | 2018-04-03 | 2019-10-18 | 江苏恒瑞医药股份有限公司 | 一种达托霉素或其盐的组合物 |
| CN110548130A (zh) * | 2018-06-04 | 2019-12-10 | 浙江医药股份有限公司新昌制药厂 | 含达托霉素的喷雾干粉及其工业化制备方法 |
| US11058745B1 (en) | 2018-10-04 | 2021-07-13 | Good Health, Llc | Stable liquid pharmaceutical compositions of daptomycin |
| CN111840511A (zh) * | 2019-04-30 | 2020-10-30 | 江苏恒瑞医药股份有限公司 | 一种含有精氨酸的达托霉素或其盐的组合物 |
| JP7582205B2 (ja) * | 2019-12-26 | 2024-11-13 | ニプロ株式会社 | ダプトマイシンを含有する安定した凍結乾燥製剤 |
| CN118873500A (zh) | 2020-02-28 | 2024-11-01 | 埃克斯利亚制药有限公司 | 达托霉素制剂 |
| CA3170514A1 (en) | 2020-03-12 | 2021-09-16 | Baxter International Inc. | Daptomycin formulations containing a combination of sorbitol and mannitol |
| US11362190B2 (en) | 2020-05-22 | 2022-06-14 | Raytheon Company | Depletion mode high electron mobility field effect transistor (HEMT) semiconductor device having beryllium doped Schottky contact layers |
| CN114788814B (zh) * | 2021-01-26 | 2023-10-13 | 浙江创新生物有限公司 | 一种高稳定性的注射用达托霉素组合物及其制备方法和其应用 |
| RU2770481C1 (ru) * | 2021-06-25 | 2022-04-18 | федеральное государственное автономное образовательное учреждение высшего образования «Казанский (Приволжский) федеральный университет» (ФГАОУ ВО КФУ) | Способ получения суммарной фракции липопептидов бактерий Bacillus subtilis MG-8 ВКПМ В-12476 и его использование в качестве профилактического средства от болезней сельскохозяйственных птиц |
Family Cites Families (71)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4331594A (en) | 1978-10-16 | 1982-05-25 | Eli Lilly And Company | A-21978 Antibiotics and process for their production |
| EP0014815A3 (de) | 1978-12-20 | 1980-10-29 | Ciba-Geigy Ag | Peptidderivate, Verfahren zu deren Herstellung und Zwischenprodukte sowie pharmazeutische Präparate mit einer dieser Verbindungen |
| US4432487A (en) | 1982-01-18 | 1984-02-21 | Chugai Denki Kogyo Kabushiki Kaisha | Method of overlaying stainless steel material for decorative articles and ornaments with a precious metal alloy |
| US4537717A (en) | 1982-05-21 | 1985-08-27 | Eli Lilly And Company | Derivatives of A-21978C cyclic peptides |
| US4482487A (en) | 1982-05-21 | 1984-11-13 | Eli Lilly And Company | A-21978C cyclic peptides |
| CN1051200A (zh) | 1984-10-09 | 1991-05-08 | 伊莱利利公司 | 制备抗菌素a-21978c复合物或因子的方法 |
| CA1319886C (en) | 1987-02-03 | 1993-07-06 | Alberto Ferro | Mixed micelle solutions |
| US4874843A (en) * | 1987-12-03 | 1989-10-17 | Eli Lilly And Company | Chromatographic purification process |
| EP0294990A3 (en) | 1987-06-10 | 1990-05-09 | Eli Lilly And Company | Chromatographic purification process |
| CA1315229C (en) | 1987-06-10 | 1993-03-30 | Patrick J. Baker | Chromatographic purification process |
| US5271935A (en) | 1988-02-05 | 1993-12-21 | Hoechst Aktiengesellschaft | Antibiotic, cammunocin, a process for the preparation thereof, and the use thereof as a pharmaceutical |
| CA2011365A1 (en) * | 1989-03-06 | 1990-09-06 | Eugene L. Inman | Diluent formulation for daptomycin |
| DE69031730T2 (de) | 1990-01-26 | 1998-04-23 | Hoechst Ag | Neues Antibiotikum, Deoxymulündocandin, Verfahren zu seiner Produktion und Verwendung als Medikament |
| JPH04224197A (ja) | 1990-12-26 | 1992-08-13 | Fujitsu Ltd | 生体高分子結晶化方法および装置 |
| US5336756A (en) | 1991-05-01 | 1994-08-09 | Merck & Co., Inc. | Process for crystalline cyclic lipopeptides |
| TW213468B (enExample) | 1991-06-29 | 1993-09-21 | Hoechst Ag | |
| JP2948708B2 (ja) | 1991-11-27 | 1999-09-13 | ニューヨーク・ブラッド・センター・インコーポレーテッド | フィブロネクチン含有点眼液 |
| CA2133644C (en) | 1992-04-20 | 2008-09-09 | Alexander H. T. Chu | Process for making vancomycin |
| TW455591B (en) | 1993-06-08 | 2001-09-21 | Hoechst Ag | Lipopeptides from actinoplanes sp. with pharmacological action, process for their production and the use thereof |
| DE4411025A1 (de) | 1994-03-30 | 1995-10-05 | Hoechst Ag | Lipopeptid-Derivate, Verfahren zu ihrer Herstellung und ihre Verwendung |
| US5952300A (en) | 1996-04-19 | 1999-09-14 | Merck & Co., Inc. | Antifungal compositions |
| US5955509A (en) | 1996-05-01 | 1999-09-21 | Board Of Regents, The University Of Texas System | pH dependent polymer micelles |
| JPH10212241A (ja) | 1996-05-27 | 1998-08-11 | Sumitomo Pharmaceut Co Ltd | Bdnfを安定に含有する製剤 |
| WO1999027957A1 (en) | 1997-12-03 | 1999-06-10 | The Immune Response Corporation | Vaccination and methods against multiple sclerosis using specific tcr vbeta peptides |
| FR2771640B1 (fr) | 1997-12-03 | 2000-02-11 | Inst Nat Sante Rech Med | Micelles mixtes de lipopeptides pour l'induction d'une reponse immunitaire et leurs utilisations a des fins therapeutiques |
| FR2774687B1 (fr) | 1998-02-06 | 2002-03-22 | Inst Nat Sante Rech Med | Lipopeptides contenant un fragment de l'interferon gamma, et leur utilisation dans des compositions pharmaceutiques |
| DE19807972A1 (de) | 1998-02-25 | 1999-08-26 | Hoechst Marion Roussel De Gmbh | Lipopeptidantibiotika-Calciumsalze, Verfahren zu ihrer Herstellung und Verwendung |
| EP1674107B8 (en) | 1998-09-25 | 2017-01-25 | Cubist Pharmaceuticals LLC | Use of daptomycin |
| US7129274B1 (en) | 1999-11-05 | 2006-10-31 | Emisphere Technologies Inc. | Phenoxy carboxylic acid compounds and compositions for delivering active agents |
| US7279597B1 (en) | 1999-11-05 | 2007-10-09 | Emisphere Technologies, Inc. | Phenyl amine carboxylic acid compounds and compositions for delivering active agents |
| CA2394350A1 (en) | 1999-12-15 | 2001-06-21 | Cubist Pharmaceuticals, Inc. | Lipopeptides as antibacterial agents |
| US6696412B1 (en) | 2000-01-20 | 2004-02-24 | Cubist Pharmaceuticals, Inc. | High purity lipopeptides, Lipopeptide micelles and processes for preparing same |
| AU2001267011B2 (en) * | 2000-06-21 | 2006-02-02 | Cubist Pharmaceuticals, Inc. | Compositions and methods to improve the oral absorption of antimicrobial agents |
| US6716962B2 (en) | 2000-07-17 | 2004-04-06 | Micrologix Biotech Inc. | Extractive purification of lipopeptide antibiotics |
| WO2002056829A2 (en) * | 2000-12-18 | 2002-07-25 | Cubist Pharmaceuticals, Inc. | Methods for preparing purified daptomycin |
| US20060014674A1 (en) | 2000-12-18 | 2006-01-19 | Dennis Keith | Methods for preparing purified lipopeptides |
| WO2002059145A1 (en) | 2000-12-18 | 2002-08-01 | Cubist Pharmaceuticals, Inc. | Methods for preparing purified lipopeptides |
| US20080220441A1 (en) | 2001-05-16 | 2008-09-11 | Birnbaum Eva R | Advanced drug development and manufacturing |
| JP3932272B2 (ja) * | 2001-06-28 | 2007-06-20 | 明治乳業株式会社 | 多重t細胞エピトープポリペプチドの酢酸塩組成物 |
| CA2454587C (en) | 2001-07-25 | 2012-11-13 | Protein Design Labs, Inc. | Stable lyophilized pharmaceutical formulation of igg antibodies |
| IL160169A0 (en) | 2001-08-06 | 2004-07-25 | Cubist Pharm Inc | Nucleic acid molecules that encode a daptomycin non-ribosomal peptide synthetase and methods for the production thereof |
| DE60304992T2 (de) | 2002-01-17 | 2007-01-18 | Arkema France | Supramolekularpolymere |
| IL166156A0 (en) | 2002-07-09 | 2006-01-15 | Point Therapeutics Inc | Boroproline compound combination therapy |
| US8216609B2 (en) | 2002-08-05 | 2012-07-10 | Torrent Pharmaceuticals Limited | Modified release composition of highly soluble drugs |
| US7985422B2 (en) | 2002-08-05 | 2011-07-26 | Torrent Pharmaceuticals Limited | Dosage form |
| US8268352B2 (en) | 2002-08-05 | 2012-09-18 | Torrent Pharmaceuticals Limited | Modified release composition for highly soluble drugs |
| US9211259B2 (en) | 2002-11-29 | 2015-12-15 | Foamix Pharmaceuticals Ltd. | Antibiotic kit and composition and uses thereof |
| US8912174B2 (en) | 2003-04-16 | 2014-12-16 | Mylan Pharmaceuticals Inc. | Formulations and methods for treating rhinosinusitis |
| JP2005060377A (ja) * | 2003-07-28 | 2005-03-10 | Yamanouchi Pharmaceut Co Ltd | インターロイキン−11含有凍結乾燥製剤 |
| US20050152979A1 (en) * | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
| US20050196418A1 (en) | 2004-03-04 | 2005-09-08 | Yu Ruey J. | Bioavailability and improved delivery of alkaline pharmaceutical drugs |
| CN1616083A (zh) * | 2004-09-01 | 2005-05-18 | 魏雪纹 | 注射用达托霉素冻干制剂及制备方法 |
| BRPI0607168A2 (pt) * | 2005-02-14 | 2009-08-11 | Venus Remedies Ltd | terapia de combinação parenteral, composição farmacêutica, processo para preparar uma composição farmacêutica e método de tratamento |
| WO2006130629A2 (en) | 2005-05-31 | 2006-12-07 | Cubist Pharmaceuticals, Inc. | Daptomycin for the treatment of biofilm and catheter salvage |
| WO2007099396A2 (en) | 2005-06-07 | 2007-09-07 | Foamix Ltd. | Antibiotic kit and composition and uses thereof |
| US8158152B2 (en) * | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| KR101536781B1 (ko) * | 2006-07-26 | 2015-07-14 | 산도즈 아게 | 카스포펀진 제형 |
| EP2511844B1 (en) | 2006-10-10 | 2015-08-12 | XRpro Sciences, Inc. | X-ray microscope |
| DE102007004968B4 (de) * | 2007-01-26 | 2011-03-10 | Heraeus Kulzer Gmbh | Revisions-Polymethylmethacrylat-Knochenzement |
| WO2008102452A1 (ja) * | 2007-02-22 | 2008-08-28 | Kringle Pharma Inc. | Hgf製剤 |
| JP2010530846A (ja) * | 2007-06-01 | 2010-09-16 | アコロジックス インコーポレイティッド | 高温で安定なペプチド製剤 |
| EP2170362B1 (en) | 2007-06-26 | 2015-11-04 | Merck Sharp & Dohme Corp. | Lyophilized anti-fungal composition |
| US20100287884A1 (en) * | 2007-10-25 | 2010-11-18 | Sangita Seshadri | Powder conditioning of unit dose drug packages |
| WO2009144739A1 (en) * | 2008-05-26 | 2009-12-03 | Biocon Limited | Amorphous daptomycin and a method of purification thereof |
| US8901072B2 (en) | 2009-08-12 | 2014-12-02 | The Medicines Company | Glycopeptide and lipoglycopeptide antibiotics with improved solubility |
| US8431539B2 (en) | 2009-09-17 | 2013-04-30 | Eagle Pharmaceuticals, Inc. | Formulations of daptomycin |
| JP2013511522A (ja) | 2009-11-23 | 2013-04-04 | イーグル・ファーマシューティカルズ・インコーポレーテッド | ダプトマイシン製剤 |
| TWI606838B (zh) | 2009-11-23 | 2017-12-01 | 庫比斯特製藥有限責任公司 | 達托黴素(daptomycin)組合物及相關方法 |
| CA2816077C (en) | 2010-11-01 | 2021-08-10 | Rib-X Pharmaceuticals, Inc. | Antimicrobial compositions comprising an emulsifier and dissolution aid |
| CA2822447C (en) | 2010-12-23 | 2018-05-01 | Alkermes Pharma Ireland Limited | Multi-api loading prodrugs |
| CN103347532A (zh) | 2011-02-04 | 2013-10-09 | 爱奇司治疗公司 | 口服可生物利用肽药物组合物及其方法 |
-
2010
- 2010-11-23 TW TW105116907A patent/TWI606838B/zh active
- 2010-11-23 AU AU2010321531A patent/AU2010321531C1/en active Active
- 2010-11-23 RU RU2012126076A patent/RU2607526C2/ru active
- 2010-11-23 JP JP2012540161A patent/JP6041673B2/ja active Active
- 2010-11-23 SI SI201031736T patent/SI2504353T2/sl unknown
- 2010-11-23 RS RS20180974A patent/RS57566B2/sr unknown
- 2010-11-23 FI FIEP10832379.1T patent/FI2504353T4/fi active
- 2010-11-23 WO PCT/US2010/057910 patent/WO2011063419A2/en not_active Ceased
- 2010-11-23 HR HRP20181380TT patent/HRP20181380T4/hr unknown
- 2010-11-23 CN CN201410208415.8A patent/CN104056250A/zh active Pending
- 2010-11-23 PT PT10832379T patent/PT2504353T/pt unknown
- 2010-11-23 AR ARP100104318 patent/AR079127A1/es not_active Application Discontinuation
- 2010-11-23 TW TW099140485A patent/TWI548414B/zh active
- 2010-11-23 MX MX2012005993A patent/MX2012005993A/es unknown
- 2010-11-23 HU HUE10832379A patent/HUE039967T2/hu unknown
- 2010-11-23 TR TR2018/12823T patent/TR201812823T4/tr unknown
- 2010-11-23 PL PL10832379.1T patent/PL2504353T5/pl unknown
- 2010-11-23 LT LTEP10832379.1T patent/LT2504353T/lt unknown
- 2010-11-23 CN CN201810651754.1A patent/CN108785654A/zh active Pending
- 2010-11-23 NZ NZ600118A patent/NZ600118A/en unknown
- 2010-11-23 CN CN201080062122.3A patent/CN102712677B/zh active Active
- 2010-11-23 PE PE2015002039A patent/PE20151717A1/es unknown
- 2010-11-23 EP EP10832379.1A patent/EP2504353B2/en active Active
- 2010-11-23 SG SG10201407724YA patent/SG10201407724YA/en unknown
- 2010-11-23 DK DK10832379.1T patent/DK2504353T4/da active
- 2010-11-23 US US13/511,246 patent/US8835382B2/en active Active
- 2010-11-23 ES ES10832379T patent/ES2686331T5/es active Active
- 2010-11-23 CA CA2781666A patent/CA2781666C/en active Active
- 2010-11-23 EP EP18181723.0A patent/EP3417849A1/en not_active Withdrawn
- 2010-11-23 PE PE2012000703A patent/PE20121517A1/es active IP Right Grant
- 2010-11-23 BR BR112012012406-4A patent/BR112012012406B1/pt active IP Right Grant
-
2012
- 2012-05-18 DO DO2012000140A patent/DOP2012000140A/es unknown
- 2012-05-20 IL IL219891A patent/IL219891B/en not_active IP Right Cessation
- 2012-05-22 CR CR20120271A patent/CR20120271A/es unknown
- 2012-05-23 CL CL2012001336A patent/CL2012001336A1/es unknown
- 2012-05-31 EC ECSP12011939 patent/ECSP12011939A/es unknown
- 2012-06-08 CO CO12097444A patent/CO6541585A2/es unknown
-
2013
- 2013-12-04 US US14/096,346 patent/US9138456B2/en active Active
-
2015
- 2015-08-12 US US14/824,272 patent/US9662397B2/en active Active
- 2015-08-27 CL CL2015002412A patent/CL2015002412A1/es unknown
-
2016
- 2016-03-02 JP JP2016039505A patent/JP6088681B2/ja active Active
-
2017
- 2017-02-03 JP JP2017018290A patent/JP6239167B2/ja active Active
-
2018
- 2018-09-04 CY CY181100923T patent/CY1120854T1/el unknown
-
2021
- 2021-10-19 AR ARP210102879A patent/AR123846A2/es not_active Application Discontinuation
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| BR112012012406B1 (pt) | Composições farmacêuticas sólidas de daptomicina, seu produto farmacêutico e seus métodos de fabricação | |
| JP6063064B2 (ja) | 安定したノカチアシン凍結乾燥製剤 | |
| US5972912A (en) | Method for lyophilizing ifosfamide | |
| ES2292122T3 (es) | Procedimiento de estabilizacion de sal sodica de cefovecina desordenada. | |
| HK1176367B (en) | Lipopeptide compositions and related methods | |
| HK1176367A (en) | Lipopeptide compositions and related methods |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B25F | Entry of change of name and/or headquarter and transfer of application, patent and certif. of addition of invention: change of name on requirement |
Owner name: CUBIST PHARMACEUTICALS, INC. (US) Free format text: A FIM DE ATENDER A ALTERACAO DE NOME REQUERIDA ATRAVES DA PETICAO NO 870160065938, DE 08/11/2016, E NECESSARIO APRESENTAR A TRADUCAO JURAMENTADA DO DOCUMENTO, ALEM DA GUIA DE CUMPRIMENTO DE EXIGENCIA. |
|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B25D | Requested change of name of applicant approved |
Owner name: CUBIST PHARMACEUTICALS LLC (CH) |
|
| B25G | Requested change of headquarter approved |
Owner name: CUBIST PHARMACEUTICALS LLC (CH) |
|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |