NO324728B1 - Fremgangsmate for fremstilling av torre, delvis amorfe produkter, stoffblanding, diagnostisk middel og preparat som omfatter stofflandingen, anvendelse av stoffblandingen til fremstilling av diagnostika og terapeutiske midler og fremgangsmate for stabilisering av biologisk eller terapeutisk aktive materialer - Google Patents
Fremgangsmate for fremstilling av torre, delvis amorfe produkter, stoffblanding, diagnostisk middel og preparat som omfatter stofflandingen, anvendelse av stoffblandingen til fremstilling av diagnostika og terapeutiske midler og fremgangsmate for stabilisering av biologisk eller terapeutisk aktive materialer Download PDFInfo
- Publication number
- NO324728B1 NO324728B1 NO19981868A NO981868A NO324728B1 NO 324728 B1 NO324728 B1 NO 324728B1 NO 19981868 A NO19981868 A NO 19981868A NO 981868 A NO981868 A NO 981868A NO 324728 B1 NO324728 B1 NO 324728B1
- Authority
- NO
- Norway
- Prior art keywords
- drying
- substances
- solution
- substance mixture
- preparation
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 90
- 238000000034 method Methods 0.000 title claims abstract description 41
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 18
- 239000011149 active material Substances 0.000 title claims abstract description 12
- 230000008569 process Effects 0.000 title claims abstract description 9
- 238000002360 preparation method Methods 0.000 title claims description 119
- 239000003814 drug Substances 0.000 title claims description 9
- 229940124597 therapeutic agent Drugs 0.000 title claims description 5
- 229940039227 diagnostic agent Drugs 0.000 title claims description 3
- 239000000032 diagnostic agent Substances 0.000 title claims description 3
- 230000000087 stabilizing effect Effects 0.000 title description 23
- 229940079593 drug Drugs 0.000 title 3
- 239000000126 substance Substances 0.000 claims abstract description 81
- 238000007710 freezing Methods 0.000 claims abstract description 15
- 230000008014 freezing Effects 0.000 claims abstract description 15
- 150000001720 carbohydrates Chemical class 0.000 claims abstract description 9
- 238000001035 drying Methods 0.000 claims description 82
- 230000009477 glass transition Effects 0.000 claims description 75
- COLNVLDHVKWLRT-QMMMGPOBSA-N phenylalanine group Chemical group N[C@@H](CC1=CC=CC=C1)C(=O)O COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 claims description 66
- 235000018102 proteins Nutrition 0.000 claims description 45
- 102000004169 proteins and genes Human genes 0.000 claims description 45
- 108090000623 proteins and genes Proteins 0.000 claims description 45
- 238000003860 storage Methods 0.000 claims description 34
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 claims description 26
- 238000001291 vacuum drying Methods 0.000 claims description 25
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical group CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims description 22
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical group NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 21
- 238000007792 addition Methods 0.000 claims description 21
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 19
- 230000006641 stabilisation Effects 0.000 claims description 18
- 238000011105 stabilization Methods 0.000 claims description 18
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical group OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 17
- 229960000310 isoleucine Drugs 0.000 claims description 17
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical group CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims description 15
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical group C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 claims description 15
- 102000004190 Enzymes Human genes 0.000 claims description 14
- 108090000790 Enzymes Proteins 0.000 claims description 14
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical group CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 14
- FSYKKLYZXJSNPZ-UHFFFAOYSA-N sarcosine Chemical group C[NH2+]CC([O-])=O FSYKKLYZXJSNPZ-UHFFFAOYSA-N 0.000 claims description 14
- 102000003886 Glycoproteins Human genes 0.000 claims description 12
- 108090000288 Glycoproteins Proteins 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 12
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 12
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 12
- 239000004475 Arginine Substances 0.000 claims description 11
- 241000700605 Viruses Species 0.000 claims description 11
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 11
- 235000009697 arginine Nutrition 0.000 claims description 11
- 239000004471 Glycine Chemical group 0.000 claims description 10
- 210000004027 cell Anatomy 0.000 claims description 10
- 238000004108 freeze drying Methods 0.000 claims description 10
- 239000011521 glass Substances 0.000 claims description 10
- 108010041986 DNA Vaccines Proteins 0.000 claims description 9
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical group C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims description 9
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical group CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 9
- 102000004895 Lipoproteins Human genes 0.000 claims description 9
- 108090001030 Lipoproteins Proteins 0.000 claims description 9
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Chemical group C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 claims description 9
- 210000003850 cellular structure Anatomy 0.000 claims description 9
- 239000005515 coenzyme Substances 0.000 claims description 9
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Chemical group OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 9
- 235000014304 histidine Nutrition 0.000 claims description 9
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Chemical group CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims description 9
- 210000000605 viral structure Anatomy 0.000 claims description 9
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Chemical group OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 8
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical group SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims description 8
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical group OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims description 8
- RHGKLRLOHDJJDR-BYPYZUCNSA-N L-citrulline Chemical group NC(=O)NCCC[C@H]([NH3+])C([O-])=O RHGKLRLOHDJJDR-BYPYZUCNSA-N 0.000 claims description 8
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical group OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims description 8
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical group NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims description 8
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Chemical group CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims description 8
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Chemical group NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims description 8
- 239000004472 Lysine Chemical group 0.000 claims description 8
- RHGKLRLOHDJJDR-UHFFFAOYSA-N Ndelta-carbamoyl-DL-ornithine Chemical group OC(=O)C(N)CCCNC(N)=O RHGKLRLOHDJJDR-UHFFFAOYSA-N 0.000 claims description 8
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Chemical group CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims description 8
- 239000000654 additive Substances 0.000 claims description 8
- 235000004279 alanine Nutrition 0.000 claims description 8
- 235000003704 aspartic acid Nutrition 0.000 claims description 8
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Chemical group OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims description 8
- 229960002173 citrulline Drugs 0.000 claims description 8
- 235000013477 citrulline Nutrition 0.000 claims description 8
- 235000018417 cysteine Nutrition 0.000 claims description 8
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Chemical group SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims description 8
- 235000013922 glutamic acid Nutrition 0.000 claims description 8
- 239000004220 glutamic acid Chemical group 0.000 claims description 8
- 235000018977 lysine Nutrition 0.000 claims description 8
- 229930182817 methionine Chemical group 0.000 claims description 8
- 239000004474 valine Chemical group 0.000 claims description 8
- AHLPHDHHMVZTML-BYPYZUCNSA-N L-Ornithine Chemical group NCCC[C@H](N)C(O)=O AHLPHDHHMVZTML-BYPYZUCNSA-N 0.000 claims description 7
- AHLPHDHHMVZTML-UHFFFAOYSA-N Orn-delta-NH2 Chemical group NCCCC(N)C(O)=O AHLPHDHHMVZTML-UHFFFAOYSA-N 0.000 claims description 7
- UTJLXEIPEHZYQJ-UHFFFAOYSA-N Ornithine Chemical group OC(=O)C(C)CCCN UTJLXEIPEHZYQJ-UHFFFAOYSA-N 0.000 claims description 7
- 108010077895 Sarcosine Chemical group 0.000 claims description 7
- YIVZYFDBEPMPNL-LBPRGKRZSA-N ethyl (2s)-2-acetamido-3-phenylpropanoate Chemical group CCOC(=O)[C@@H](NC(C)=O)CC1=CC=CC=C1 YIVZYFDBEPMPNL-LBPRGKRZSA-N 0.000 claims description 7
- 229960003104 ornithine Drugs 0.000 claims description 7
- 229940043230 sarcosine Drugs 0.000 claims description 7
- 239000000872 buffer Substances 0.000 claims description 6
- 238000006243 chemical reaction Methods 0.000 claims description 6
- 150000002016 disaccharides Chemical class 0.000 claims description 6
- 150000002772 monosaccharides Chemical class 0.000 claims description 6
- 230000001225 therapeutic effect Effects 0.000 claims description 6
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 5
- 125000000637 arginyl group Chemical group N[C@@H](CCCNC(N)=N)C(=O)* 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 239000003381 stabilizer Substances 0.000 claims description 4
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000004744 fabric Substances 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 238000002405 diagnostic procedure Methods 0.000 abstract 1
- 238000002560 therapeutic procedure Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 99
- 229940024606 amino acid Drugs 0.000 description 78
- 235000001014 amino acid Nutrition 0.000 description 75
- 150000001413 amino acids Chemical class 0.000 description 73
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 63
- 229960005190 phenylalanine Drugs 0.000 description 58
- 239000000047 product Substances 0.000 description 57
- 239000000523 sample Substances 0.000 description 50
- 235000000346 sugar Nutrition 0.000 description 42
- 230000000052 comparative effect Effects 0.000 description 33
- 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 30
- 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 30
- 230000000694 effects Effects 0.000 description 30
- 229960002160 maltose Drugs 0.000 description 30
- 229930006000 Sucrose Natural products 0.000 description 28
- 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 description 28
- 239000005720 sucrose Substances 0.000 description 28
- 102000003855 L-lactate dehydrogenase Human genes 0.000 description 27
- 108700023483 L-lactate dehydrogenases Proteins 0.000 description 27
- 238000002474 experimental method Methods 0.000 description 26
- 239000013543 active substance Substances 0.000 description 20
- 102000003951 Erythropoietin Human genes 0.000 description 19
- 108090000394 Erythropoietin Proteins 0.000 description 19
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 description 19
- 229930064664 L-arginine Natural products 0.000 description 19
- 235000014852 L-arginine Nutrition 0.000 description 19
- 239000000499 gel Substances 0.000 description 19
- 229940105423 erythropoietin Drugs 0.000 description 18
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 description 18
- 239000000178 monomer Substances 0.000 description 17
- 238000001502 gel electrophoresis Methods 0.000 description 16
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 14
- 229960003136 leucine Drugs 0.000 description 13
- 229960002885 histidine Drugs 0.000 description 12
- HBDJFVFTHLOSDW-DNDLZOGFSA-N (2r,3r,4r,5r)-2,3,5,6-tetrahydroxy-4-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;hydrate Chemical compound O.O=C[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 HBDJFVFTHLOSDW-DNDLZOGFSA-N 0.000 description 10
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 10
- 239000000539 dimer Substances 0.000 description 10
- 229960003017 maltose monohydrate Drugs 0.000 description 10
- 229960004799 tryptophan Drugs 0.000 description 10
- 208000002109 Argyria Diseases 0.000 description 9
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 9
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 9
- 229920000053 polysorbate 80 Polymers 0.000 description 9
- 229940068968 polysorbate 80 Drugs 0.000 description 9
- 239000004395 L-leucine Substances 0.000 description 8
- 229960003121 arginine Drugs 0.000 description 8
- 229960004295 valine Drugs 0.000 description 8
- 235000019454 L-leucine Nutrition 0.000 description 7
- 238000001962 electrophoresis Methods 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 230000004952 protein activity Effects 0.000 description 7
- 230000009467 reduction Effects 0.000 description 7
- 229930182844 L-isoleucine Natural products 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 229960003767 alanine Drugs 0.000 description 6
- 230000008901 benefit Effects 0.000 description 6
- 239000012620 biological material Substances 0.000 description 6
- 239000012467 final product Substances 0.000 description 6
- 238000005259 measurement Methods 0.000 description 6
- 229960004452 methionine Drugs 0.000 description 6
- QDGAVODICPCDMU-UHFFFAOYSA-N 2-amino-3-[3-[bis(2-chloroethyl)amino]phenyl]propanoic acid Chemical compound OC(=O)C(N)CC1=CC=CC(N(CCCl)CCCl)=C1 QDGAVODICPCDMU-UHFFFAOYSA-N 0.000 description 5
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 5
- 239000003708 ampul Substances 0.000 description 5
- 229960005261 aspartic acid Drugs 0.000 description 5
- 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 5
- 230000015572 biosynthetic process Effects 0.000 description 5
- 235000014633 carbohydrates Nutrition 0.000 description 5
- 229960002433 cysteine Drugs 0.000 description 5
- 238000000113 differential scanning calorimetry Methods 0.000 description 5
- 238000002270 exclusion chromatography Methods 0.000 description 5
- 238000009472 formulation Methods 0.000 description 5
- 229960002449 glycine Drugs 0.000 description 5
- 238000010438 heat treatment Methods 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 238000010186 staining Methods 0.000 description 5
- 150000008163 sugars Chemical class 0.000 description 5
- NYOGGQBMEGUVIX-WCCKRBBISA-N 2-aminoacetic acid;(2s)-2-amino-3-methylbutanoic acid Chemical compound NCC(O)=O.CC(C)[C@H](N)C(O)=O NYOGGQBMEGUVIX-WCCKRBBISA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 230000015556 catabolic process Effects 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- 239000011159 matrix material Substances 0.000 description 4
- 239000007787 solid Substances 0.000 description 4
- 108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 description 3
- 102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 description 3
- 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 description 3
- 239000000020 Nitrocellulose Substances 0.000 description 3
- FJWGYAHXMCUOOM-QHOUIDNNSA-N [(2s,3r,4s,5r,6r)-2-[(2r,3r,4s,5r,6s)-4,5-dinitrooxy-2-(nitrooxymethyl)-6-[(2r,3r,4s,5r,6s)-4,5,6-trinitrooxy-2-(nitrooxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-3,5-dinitrooxy-6-(nitrooxymethyl)oxan-4-yl] nitrate Chemical compound O([C@@H]1O[C@@H]([C@H]([C@H](O[N+]([O-])=O)[C@H]1O[N+]([O-])=O)O[C@H]1[C@@H]([C@@H](O[N+]([O-])=O)[C@H](O[N+]([O-])=O)[C@@H](CO[N+]([O-])=O)O1)O[N+]([O-])=O)CO[N+](=O)[O-])[C@@H]1[C@@H](CO[N+]([O-])=O)O[C@@H](O[N+]([O-])=O)[C@H](O[N+]([O-])=O)[C@H]1O[N+]([O-])=O FJWGYAHXMCUOOM-QHOUIDNNSA-N 0.000 description 3
- 238000004220 aggregation Methods 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 3
- 230000000368 destabilizing effect Effects 0.000 description 3
- 229960002989 glutamic acid Drugs 0.000 description 3
- 230000006872 improvement Effects 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- 229960003646 lysine Drugs 0.000 description 3
- 229920001220 nitrocellulos Polymers 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 239000008363 phosphate buffer Substances 0.000 description 3
- 239000013612 plasmid Substances 0.000 description 3
- 238000000926 separation method Methods 0.000 description 3
- 239000011550 stock solution Substances 0.000 description 3
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 description 2
- CLUOUYPICNCYNF-IPIKRLCPSA-N (2s)-2-amino-5-(diaminomethylideneamino)pentanoic acid;(2s)-2-amino-3-phenylpropanoic acid Chemical compound OC(=O)[C@@H](N)CCCNC(N)=N.OC(=O)[C@@H](N)CC1=CC=CC=C1 CLUOUYPICNCYNF-IPIKRLCPSA-N 0.000 description 2
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 241000519996 Teucrium chamaedrys Species 0.000 description 2
- -1 amino acid salts Chemical class 0.000 description 2
- UDSAIICHUKSCKT-UHFFFAOYSA-N bromophenol blue Chemical compound C1=C(Br)C(O)=C(Br)C=C1C1(C=2C=C(Br)C(O)=C(Br)C=2)C2=CC=CC=C2S(=O)(=O)O1 UDSAIICHUKSCKT-UHFFFAOYSA-N 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 239000007857 degradation product Substances 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- VHJLVAABSRFDPM-QWWZWVQMSA-N dithiothreitol Chemical compound SC[C@@H](O)[C@H](O)CS VHJLVAABSRFDPM-QWWZWVQMSA-N 0.000 description 2
- 239000012154 double-distilled water Substances 0.000 description 2
- 239000003480 eluent Substances 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 229930027945 nicotinamide-adenine dinucleotide Natural products 0.000 description 2
- BOPGDPNILDQYTO-NNYOXOHSSA-N nicotinamide-adenine dinucleotide Chemical compound C1=CCC(C(=O)N)=CN1[C@H]1[C@H](O)[C@H](O)[C@@H](COP(O)(=O)OP(O)(=O)OC[C@@H]2[C@H]([C@@H](O)[C@@H](O2)N2C3=NC=NC(N)=C3N=C2)O)O1 BOPGDPNILDQYTO-NNYOXOHSSA-N 0.000 description 2
- 230000003287 optical effect Effects 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 230000008092 positive effect Effects 0.000 description 2
- 239000008057 potassium phosphate buffer Substances 0.000 description 2
- ASHGTUMKRVIOLH-UHFFFAOYSA-L potassium;sodium;hydrogen phosphate Chemical compound [Na+].[K+].OP([O-])([O-])=O ASHGTUMKRVIOLH-UHFFFAOYSA-L 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 239000003507 refrigerant Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 235000011121 sodium hydroxide Nutrition 0.000 description 2
- 238000001694 spray drying Methods 0.000 description 2
- 238000013097 stability assessment Methods 0.000 description 2
- 238000002076 thermal analysis method Methods 0.000 description 2
- VADKRMSMGWJZCF-UHFFFAOYSA-N 2-bromophenol Chemical compound OC1=CC=CC=C1Br VADKRMSMGWJZCF-UHFFFAOYSA-N 0.000 description 1
- KXDHJXZQYSOELW-UHFFFAOYSA-N Carbamic acid Chemical class NC(O)=O KXDHJXZQYSOELW-UHFFFAOYSA-N 0.000 description 1
- QNAYBMKLOCPYGJ-UHFFFAOYSA-N D-alpha-Ala Natural products CC([NH3+])C([O-])=O QNAYBMKLOCPYGJ-UHFFFAOYSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 101000987586 Homo sapiens Eosinophil peroxidase Proteins 0.000 description 1
- 101000920686 Homo sapiens Erythropoietin Proteins 0.000 description 1
- 101000746367 Homo sapiens Granulocyte colony-stimulating factor Proteins 0.000 description 1
- 102000003839 Human Proteins Human genes 0.000 description 1
- 108090000144 Human Proteins Proteins 0.000 description 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 description 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 1
- QNAYBMKLOCPYGJ-UWTATZPHSA-N L-Alanine Natural products C[C@@H](N)C(O)=O QNAYBMKLOCPYGJ-UWTATZPHSA-N 0.000 description 1
- FFEARJCKVFRZRR-UHFFFAOYSA-N L-Methionine Natural products CSCCC(N)C(O)=O FFEARJCKVFRZRR-UHFFFAOYSA-N 0.000 description 1
- 150000008575 L-amino acids Chemical class 0.000 description 1
- 125000003440 L-leucyl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])C(C([H])([H])[H])([H])C([H])([H])[H] 0.000 description 1
- 229930195722 L-methionine Natural products 0.000 description 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 102000001938 Plasminogen Activators Human genes 0.000 description 1
- 108010001014 Plasminogen Activators Proteins 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- LCTONWCANYUPML-UHFFFAOYSA-M Pyruvate Chemical compound CC(=O)C([O-])=O LCTONWCANYUPML-UHFFFAOYSA-M 0.000 description 1
- 108010001957 Ularitide Proteins 0.000 description 1
- 238000002441 X-ray diffraction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000004931 aggregating effect Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 150000001483 arginine derivatives Chemical class 0.000 description 1
- 238000010352 biotechnological method Methods 0.000 description 1
- 244000309464 bull Species 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 230000003197 catalytic effect Effects 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- XAPOGJBFTNEIIN-JTQLQIEISA-N ethyl (2s)-2-(n-acetylanilino)propanoate Chemical compound CCOC(=O)[C@H](C)N(C(C)=O)C1=CC=CC=C1 XAPOGJBFTNEIIN-JTQLQIEISA-N 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000000855 fermentation Methods 0.000 description 1
- 230000004151 fermentation Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 150000002337 glycosamines Chemical class 0.000 description 1
- 102000044890 human EPO Human genes 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000002917 insecticide Substances 0.000 description 1
- DNHVXYDGZKWYNU-UHFFFAOYSA-N lead;hydrate Chemical compound O.[Pb] DNHVXYDGZKWYNU-UHFFFAOYSA-N 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 235000010755 mineral Nutrition 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229940097496 nasal spray Drugs 0.000 description 1
- 239000007922 nasal spray Substances 0.000 description 1
- 239000002773 nucleotide Substances 0.000 description 1
- 125000003729 nucleotide group Chemical group 0.000 description 1
- 239000003016 pheromone Substances 0.000 description 1
- 238000000053 physical method Methods 0.000 description 1
- 229940127126 plasminogen activator Drugs 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000012460 protein solution Substances 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229960001153 serine Drugs 0.000 description 1
- 150000003384 small molecules Chemical class 0.000 description 1
- IFGCUJZIWBUILZ-UHFFFAOYSA-N sodium 2-[[2-[[hydroxy-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyphosphoryl]amino]-4-methylpentanoyl]amino]-3-(1H-indol-3-yl)propanoic acid Chemical compound [Na+].C=1NC2=CC=CC=C2C=1CC(C(O)=O)NC(=O)C(CC(C)C)NP(O)(=O)OC1OC(C)C(O)C(O)C1O IFGCUJZIWBUILZ-UHFFFAOYSA-N 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000012916 structural analysis Methods 0.000 description 1
- 125000000185 sucrose group Chemical group 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 239000013638 trimer Substances 0.000 description 1
- IUCCYQIEZNQWRS-DWWHXVEHSA-N ularitide Chemical compound C([C@H]1C(=O)NCC(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@H](C(NCC(=O)N[C@@H](C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CSSC[C@@H](C(=O)N1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](C)NC(=O)[C@@H](N)[C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(O)=O)=O)[C@@H](C)CC)C1=CC=CC=C1 IUCCYQIEZNQWRS-DWWHXVEHSA-N 0.000 description 1
- 229950009436 ularitide Drugs 0.000 description 1
- 239000013598 vector Substances 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
Classifications
-
- 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
-
- 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
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/193—Colony stimulating factors [CSF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/44—Oxidoreductases (1)
- A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
-
- 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
- A61K47/16—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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Drying Of Solid Materials (AREA)
- Medicines Containing Plant Substances (AREA)
- Storage Of Fruits Or Vegetables (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Enzymes And Modification Thereof (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Materials For Medical Uses (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19539574A DE19539574A1 (de) | 1995-10-25 | 1995-10-25 | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
| PCT/EP1996/004627 WO1997015288A2 (de) | 1995-10-25 | 1996-10-24 | Zubereitungen und verfahren zur stabilisierung biologischer materialien mittels trocknungsverfahren ohne einfrieren |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO981868D0 NO981868D0 (no) | 1998-04-24 |
| NO981868L NO981868L (no) | 1998-06-25 |
| NO324728B1 true NO324728B1 (no) | 2007-12-03 |
Family
ID=7775640
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19981868A NO324728B1 (no) | 1995-10-25 | 1998-04-24 | Fremgangsmate for fremstilling av torre, delvis amorfe produkter, stoffblanding, diagnostisk middel og preparat som omfatter stofflandingen, anvendelse av stoffblandingen til fremstilling av diagnostika og terapeutiske midler og fremgangsmate for stabilisering av biologisk eller terapeutisk aktive materialer |
Country Status (25)
| Country | Link |
|---|---|
| US (3) | US7172999B2 (ru) |
| EP (1) | EP0857060B1 (ru) |
| JP (2) | JPH11513700A (ru) |
| KR (1) | KR100466670B1 (ru) |
| CN (1) | CN1130196C (ru) |
| AT (1) | ATE212541T1 (ru) |
| AU (1) | AU712489B2 (ru) |
| BR (1) | BR9611265A (ru) |
| CA (1) | CA2235243C (ru) |
| CZ (1) | CZ293456B6 (ru) |
| DE (2) | DE19539574A1 (ru) |
| DK (1) | DK0857060T3 (ru) |
| ES (1) | ES2170274T3 (ru) |
| HU (1) | HU222601B1 (ru) |
| IL (1) | IL124204A (ru) |
| MX (1) | MX9803264A (ru) |
| NO (1) | NO324728B1 (ru) |
| NZ (1) | NZ320276A (ru) |
| PL (1) | PL190657B1 (ru) |
| PT (1) | PT857060E (ru) |
| RU (1) | RU2191003C2 (ru) |
| SK (1) | SK283664B6 (ru) |
| TR (1) | TR199800715T2 (ru) |
| WO (1) | WO1997015288A2 (ru) |
| ZA (1) | ZA968930B (ru) |
Families Citing this family (48)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6582728B1 (en) | 1992-07-08 | 2003-06-24 | Inhale Therapeutic Systems, Inc. | Spray drying of macromolecules to produce inhaleable dry powders |
| DE19539574A1 (de) * | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| EP0913177A1 (de) * | 1997-11-03 | 1999-05-06 | Roche Diagnostics GmbH | Verfahren zur Herstellung trockener, amorpher Produkte enthaltend biologisch aktive Materialien mittels Konvektionstrocknung, insbesondere Sprühtrocknung |
| EP0913178A1 (en) * | 1997-11-03 | 1999-05-06 | Boehringer Mannheim Gmbh | Process for the manufacture of dry, amorphous products comprising biologically active material by means of convection drying and products obtainable by the process |
| BR9905867A (pt) * | 1998-11-06 | 2001-01-23 | Bio Sidus S A | Linhagem celular produtora de eritropoietina humana recombinante e a eritropoietina humana recombinante produzida por esta célula |
| IL145816A0 (en) * | 1999-04-09 | 2002-07-25 | Ortho Mcneil Pharm Inc | Pharmaceutical compositions of erythropoietin |
| DE10026698A1 (de) | 2000-05-30 | 2001-12-06 | Basf Ag | Selbstemulgierende Wirkstoffformulierung und Verwendung dieser Formulierung |
| AU2000264912A1 (en) * | 2000-06-07 | 2001-12-17 | Universal Preservation Technologies, Inc. | Industrial scale barrier technology for preservation of sensitive biological materials |
| GB0017999D0 (en) * | 2000-07-21 | 2000-09-13 | Smithkline Beecham Biolog | Novel device |
| EP1854454B1 (en) * | 2002-01-16 | 2013-11-06 | Boehringer Ingelheim Pharma GmbH & Co. KG | Method for the preparation of amorphous telmisartan |
| KR100556503B1 (ko) * | 2002-11-26 | 2006-03-03 | 엘지전자 주식회사 | 건조기의 건조 시간제어 방법 |
| US8377952B2 (en) * | 2003-08-28 | 2013-02-19 | Abbott Laboratories | Solid pharmaceutical dosage formulation |
| US8025899B2 (en) | 2003-08-28 | 2011-09-27 | Abbott Laboratories | Solid pharmaceutical dosage form |
| NZ550119A (en) | 2004-04-08 | 2009-10-30 | Biomatrica Inc | Method for storing biological material in a dissolvable matrix |
| US20060099567A1 (en) * | 2004-04-08 | 2006-05-11 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| US20080176209A1 (en) * | 2004-04-08 | 2008-07-24 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| GB0517688D0 (en) * | 2005-08-31 | 2005-10-05 | Cambridge Biostability Ltd | Improvements in the stabilisation of biological materials |
| GB2430880A (en) * | 2005-10-04 | 2007-04-11 | Cambridge Biostability Ltd | Pharmaceutical compositions stabilized in glassy particles |
| GB0523638D0 (en) * | 2005-11-21 | 2005-12-28 | Cambridge Biostability Ltd | Pharmaceutical device for the administration of substances to patients |
| EP1973406B1 (en) | 2005-12-28 | 2014-03-12 | Advanced Bionutrition Corporation | A delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form |
| US8968721B2 (en) | 2005-12-28 | 2015-03-03 | Advanced Bionutrition Corporation | Delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form and methods of making same |
| CA2673120C (en) | 2006-12-18 | 2012-08-07 | Advanced Bionutrition Corporation | A dry food product containing live probiotic |
| US8466187B2 (en) * | 2007-09-18 | 2013-06-18 | Thermolife International, Llc | Amino acid compositions |
| ES2908047T3 (es) | 2009-03-27 | 2022-04-27 | Intervet Int Bv | Vacunas en micropartículas para la vacunación oral o nasal y el refuerzo de animales incluidos los peces |
| EP2236520A1 (en) * | 2009-03-31 | 2010-10-06 | Leukocare Ag | Stabilizing composition for immobilized biomolecules |
| NZ597053A (en) | 2009-05-26 | 2014-02-28 | Advanced Bionutrition Corp | Stable dry powder composition comprising biologically active microorganisms and/or bioactive materials and methods of making |
| TWI609698B (zh) * | 2010-01-20 | 2018-01-01 | Chugai Pharmaceutical Co Ltd | 穩定化的含抗體溶液製劑 |
| US9504750B2 (en) | 2010-01-28 | 2016-11-29 | Advanced Bionutrition Corporation | Stabilizing composition for biological materials |
| EP2529004B1 (en) | 2010-01-28 | 2017-06-07 | Advanced Bionutrition Corporation | Dry glassy composition comprising a bioactive material |
| WO2012018639A2 (en) | 2010-07-26 | 2012-02-09 | Biomatrica, Inc. | Compositions for stabilizing dna, rna and proteins in saliva and other biological samples during shipping and storage at ambient temperatures |
| WO2012018638A2 (en) | 2010-07-26 | 2012-02-09 | Biomatrica, Inc. | Compositions for stabilizing dna, rna and proteins in blood and other biological samples during shipping and storage at ambient temperatures |
| RU2573324C2 (ru) | 2010-08-13 | 2016-01-20 | Эдванст Байоньютришн Корпорейшн | Стабилизирующая композиция для сухого хранения биологических материалов (варианты) |
| CN102408467B (zh) * | 2010-09-26 | 2014-03-05 | 海口维瑅瑷生物研究院 | 真空干燥蛋白的方法、制得的蛋白产品和试剂盒 |
| AU2012242565B2 (en) | 2011-04-13 | 2017-05-11 | Thermolife International, Llc | N-Acetyl Beta Alanine methods of use |
| EP3249054A1 (en) | 2012-12-20 | 2017-11-29 | Biomatrica, INC. | Formulations and methods for stabilizing pcr reagents |
| ES2891555T3 (es) | 2014-06-10 | 2022-01-28 | Biomatrica Inc | Estabilización de trombocitos a temperaturas ambiente |
| US9868944B2 (en) * | 2014-12-19 | 2018-01-16 | Roche Molecular Systems, Inc. | Reaction mixtures |
| WO2016127260A1 (en) * | 2015-02-11 | 2016-08-18 | Prevtec Microbia Inc | Improved dry matrix for embedding viable escherichia coli, method of making same and use thereof |
| AU2016256470B2 (en) | 2015-04-29 | 2020-10-15 | Radius Pharmaceuticals, Inc. | Methods of treating cancer |
| WO2017019273A1 (en) | 2015-07-29 | 2017-02-02 | Advanced Bionutrition Corporation | Stable dry probiotic compositions for special dietary uses |
| EP4242628A3 (en) | 2015-12-08 | 2023-11-08 | Biomatrica, INC. | Reduction of erythrocyte sedimentation rate |
| CN106831466B (zh) * | 2016-12-28 | 2018-05-22 | 安徽省虹升生物股份有限公司 | 一种β-丙氨酸的常规储存方法 |
| LT3565542T (lt) | 2017-01-05 | 2024-07-10 | Radius Pharmaceuticals, Inc. | Polimorfinės rad1901-2hcl formos |
| CN112423844B (zh) | 2018-07-04 | 2024-08-13 | 雷迪厄斯制药公司 | Rad1901-2hcl的多晶型形式 |
| IL299671A (en) * | 2020-07-13 | 2023-03-01 | Merck Patent Gmbh | Viscosity-reducing excipients and their combinations for high-concentration protein formulations |
| US11865139B2 (en) | 2020-11-12 | 2024-01-09 | Thermolife International, Llc | Method of treating migraines and headaches |
| CN114480129A (zh) * | 2022-01-13 | 2022-05-13 | 力因精准医疗产品（上海）有限公司 | 一种人粪便保存液及使用方法 |
Family Cites Families (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3714353A (en) * | 1959-08-11 | 1973-01-30 | Upjohn Co | THERAPEUTIC COMPOSITIONS COMPRISING A 6 alpha ; 9 alpha -DIFLUORO-11 beta ,17 alpha ,21-TRIHYDROXY-16 alpha -METHYL-1,4-PREGNADIENE-3,20-DIONE AND 21-ACYLATES |
| US3852461A (en) * | 1971-08-04 | 1974-12-03 | Upjohn Co | Benzodiapines used as minor tranquilizers |
| JPS5836954B2 (ja) * | 1980-03-31 | 1983-08-12 | 栄研化学株式会社 | 酵素の安定化剤 |
| JPS5967228A (ja) | 1982-10-07 | 1984-04-16 | Green Cross Corp:The | 寒冷不溶性グロブリンの凍結乾燥方法 |
| JPS6197229A (ja) * | 1984-10-18 | 1986-05-15 | Chugai Pharmaceut Co Ltd | 安定なエリトロポエチン製剤 |
| US4732889A (en) * | 1985-02-06 | 1988-03-22 | Chugai Seiyaku Kabushiki Kaisha | Pharmaceutical composition for the treatment of the anemia of rheumatoid arthritis |
| US4788072A (en) * | 1985-08-15 | 1988-11-29 | Toshimitsu Kawamura | Method of dehydrating foods |
| US4808617A (en) | 1985-12-18 | 1989-02-28 | Bristol-Myers Company | Lyophilized or precipitated cephalosporin zwitterion and salt combination |
| EP0326618A1 (en) * | 1987-03-04 | 1989-08-09 | Nippon Hypox Laboratories Incorporated | Medicinal composition containing albumin as carrier and process for its preparation |
| DE3729863A1 (de) * | 1987-09-05 | 1989-03-16 | Boehringer Mannheim Gmbh | Stabilisierte erythropoietin-lyophilisate |
| US4886742A (en) * | 1987-06-15 | 1989-12-12 | Coulter Corporation | Enzyme immunoassay for detecting HIV antigens in human sera |
| DE3801179A1 (de) | 1988-01-18 | 1989-07-27 | Hoechst Ag | Stabilisierung von cephalosporinderivaten durch trocknung mit einem stabilisator sowie stabile zubereitungsformen mit cephalosporinderivaten |
| JPH0761955B2 (ja) | 1988-04-28 | 1995-07-05 | 国立予防衛生研究所長 | 凍結乾燥ａ型肝炎ワクチン |
| US5202117A (en) | 1988-08-24 | 1993-04-13 | Koichiro Tsuji | Method of treating thrombi with g-csf |
| JPH0296536A (ja) | 1988-09-29 | 1990-04-09 | Green Cross Corp:The | プラスミノゲン乾燥製剤 |
| JP2739584B2 (ja) | 1989-01-06 | 1998-04-15 | 株式会社ミドリ十字 | ウロキナーゼ型プラスミノーゲンアクチベーター乾燥製剤 |
| US5186944A (en) * | 1989-02-15 | 1993-02-16 | Eimei Company Ltd. | Therapeutic medicament for thrombosis |
| JPH03505334A (ja) | 1989-04-11 | 1991-11-21 | イミユノバイオロジー・リサーチ・インスチチユート・インコーポレーテツド | 凍結乾燥されたペプチド製剤 |
| JPH0775519B2 (ja) | 1989-10-06 | 1995-08-16 | 東洋製罐株式会社 | ドライパック包装食品の製造方法 |
| GB9001987D0 (en) * | 1990-01-29 | 1990-03-28 | Janssen Pharmaceutica Nv | Improved cyclodextrin based erythropietin formulation |
| JPH0813750B2 (ja) | 1990-03-01 | 1996-02-14 | 持田製薬株式会社 | 経口用トロンビン製剤 |
| US5200399A (en) * | 1990-09-14 | 1993-04-06 | Boyce Thompson Institute For Plant Research, Inc. | Method of protecting biological materials from destructive reactions in the dry state |
| US5217741A (en) | 1991-01-25 | 1993-06-08 | Snow Brand Milk Products Co., Ltd. | Solution containing whey protein, whey protein gel, whey protein powder and processed food product produced by using the same |
| AU659645B2 (en) | 1991-06-26 | 1995-05-25 | Inhale Therapeutic Systems | Storage of materials |
| JP2818834B2 (ja) * | 1991-08-12 | 1998-10-30 | 大塚製薬株式会社 | ＩＬ−１α安定化医薬製剤 |
| DE4141351A1 (de) | 1991-12-14 | 1993-06-17 | Basf Ag | Stabile pulverfoermige vitamin- und/oder carotinoid-praeparate und verfahren zu deren herstellung |
| SE9201073D0 (sv) | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| IL105553A (en) | 1992-05-06 | 1998-01-04 | Janssen Pharmaceutica Inc | Solid dosage forms consisting of a porous network of matrix that releases a substance that dissipates rapidly in water |
| IT1254359B (it) | 1992-05-11 | 1995-09-14 | Serono Cesare Ist Ricerca | Composizioni farmaceutiche contenenti il-6 |
| US6582728B1 (en) | 1992-07-08 | 2003-06-24 | Inhale Therapeutic Systems, Inc. | Spray drying of macromolecules to produce inhaleable dry powders |
| JP3168550B2 (ja) * | 1992-12-02 | 2001-05-21 | 株式会社林原生物化学研究所 | 脱水剤およびそれを用いる含水物の脱水方法並びにその方法で得られる脱水物品 |
| DE4242863A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
| US5354934A (en) * | 1993-02-04 | 1994-10-11 | Amgen Inc. | Pulmonary administration of erythropoietin |
| DK0748213T3 (da) | 1994-03-07 | 2004-08-02 | Nektar Therapeutics | Fremgangsmåder og sammensætninger til pulmonal indgivelse af insulin |
| US5955448A (en) * | 1994-08-19 | 1999-09-21 | Quadrant Holdings Cambridge Limited | Method for stabilization of biological substances during drying and subsequent storage and compositions thereof |
| FR2719479B1 (fr) | 1994-05-04 | 1996-07-26 | Sanofi Elf | Formulation stable lyophilisée comprenant une protéine: kit de dosage. |
| CA2190502A1 (en) | 1994-05-18 | 1995-11-23 | Robert M. Platz | Methods and compositions for the dry powder formulation of interferons |
| IL116085A (en) | 1994-12-16 | 1999-12-31 | Ortho Pharma Corp | Spray dried erythropoietin |
| ATE287703T1 (de) | 1995-04-14 | 2005-02-15 | Nektar Therapeutics | Pulverförmige pharmazeutische formulierungen mit verbesserter dispergierbarkeit |
| US5728678A (en) | 1995-06-06 | 1998-03-17 | Nestec Ltd. | Method and composition for providing nutrition to a renal failure patient |
| DE19538687A1 (de) | 1995-10-17 | 1997-04-24 | Boehringer Mannheim Gmbh | Stabile pharmazeutische Darreichungsformen enthaltend Parathormon |
| DE19539574A1 (de) * | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
-
1995
- 1995-10-25 DE DE19539574A patent/DE19539574A1/de not_active Withdrawn
-
1996
- 1996-10-24 AU AU72984/96A patent/AU712489B2/en not_active Ceased
- 1996-10-24 ES ES96934811T patent/ES2170274T3/es not_active Expired - Lifetime
- 1996-10-24 HU HU9901314A patent/HU222601B1/hu not_active IP Right Cessation
- 1996-10-24 AT AT96934811T patent/ATE212541T1/de active
- 1996-10-24 DK DK96934811T patent/DK0857060T3/da active
- 1996-10-24 EP EP96934811A patent/EP0857060B1/de not_active Revoked
- 1996-10-24 DE DE59608684T patent/DE59608684D1/de not_active Revoked
- 1996-10-24 BR BR9611265A patent/BR9611265A/pt not_active IP Right Cessation
- 1996-10-24 SK SK509-98A patent/SK283664B6/sk not_active IP Right Cessation
- 1996-10-24 PL PL96326358A patent/PL190657B1/pl not_active IP Right Cessation
- 1996-10-24 RU RU98109886/14A patent/RU2191003C2/ru not_active IP Right Cessation
- 1996-10-24 NZ NZ320276A patent/NZ320276A/xx not_active IP Right Cessation
- 1996-10-24 KR KR10-1998-0703022A patent/KR100466670B1/ko not_active IP Right Cessation
- 1996-10-24 IL IL12420496A patent/IL124204A/en not_active IP Right Cessation
- 1996-10-24 TR TR1998/00715T patent/TR199800715T2/xx unknown
- 1996-10-24 ZA ZA9608930A patent/ZA968930B/xx unknown
- 1996-10-24 PT PT96934811T patent/PT857060E/pt unknown
- 1996-10-24 WO PCT/EP1996/004627 patent/WO1997015288A2/de not_active Application Discontinuation
- 1996-10-24 JP JP9516286A patent/JPH11513700A/ja active Pending
- 1996-10-24 CZ CZ19981179A patent/CZ293456B6/cs not_active IP Right Cessation
- 1996-10-24 US US09/051,918 patent/US7172999B2/en not_active Expired - Fee Related
- 1996-10-24 CA CA002235243A patent/CA2235243C/en not_active Expired - Fee Related
- 1996-10-24 CN CN96199329A patent/CN1130196C/zh not_active Expired - Fee Related
-
1998
- 1998-04-24 MX MX9803264A patent/MX9803264A/es not_active IP Right Cessation
- 1998-04-24 NO NO19981868A patent/NO324728B1/no not_active IP Right Cessation
-
2002
- 2002-05-10 US US10/141,960 patent/US20030059468A1/en not_active Abandoned
-
2006
- 2006-06-09 US US11/449,781 patent/US20070020289A1/en not_active Abandoned
-
2007
- 2007-05-28 JP JP2007141138A patent/JP2007236975A/ja active Pending
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| NO324728B1 (no) | Fremgangsmate for fremstilling av torre, delvis amorfe produkter, stoffblanding, diagnostisk middel og preparat som omfatter stofflandingen, anvendelse av stoffblandingen til fremstilling av diagnostika og terapeutiske midler og fremgangsmate for stabilisering av biologisk eller terapeutisk aktive materialer | |
| JP2007236975A6 (ja) | 凍結しない乾燥過程により生物材料を安定化するための調製物及び方法 | |
| Izutsu et al. | Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying | |
| KR100491281B1 (ko) | 저당함량을가지는안정한알부민무함유재조합인자Vlll의제제 | |
| EP0682944B1 (fr) | Formulation stable lyophilisée comprenant une protéine; kit de dosage | |
| WO1996033744A2 (en) | Compositions in glassy phase, stabilised by a sugar | |
| AU2005225000A1 (en) | Lyophilization method to improve excipient crystallization | |
| EP2563809B1 (en) | Stable aqueous mia/cd-rap formulations | |
| AU744777B2 (en) | Stable pharmaceutical administration forms of peptides, proteins and nucleic acids | |
| JP2009203223A (ja) | 凍結乾燥用保護剤及び生理活性物質の製造方法 | |
| US20020103126A1 (en) | Stable pharmaceutical form of administration for peptides, proteins and nucleic acids | |
| Nguyen et al. | Formulation of tablets containing lyophilized powder to improve the stability of alpha-chymotrypsin | |
| US20180133329A1 (en) | Compositions and method for stabilizing a pharmaceutical formulation, and methods of making and using the same | |
| CN1933811A (zh) | 改进赋形剂结晶作用的冷冻干燥方法 | |
| EP0391407A1 (en) | Polypeptide and antibacterial preparations containing the same | |
| Lu et al. | Solid State Characterization of Freeze-Dried Protein-Excipient Mixtures | |
| AU3541900A (en) | Stable transglutaminase preparations and process for producing them | |
| EA042954B1 (ru) | Композиция, содержащая c1-inh, и ее применение для лечения, ингибирования или профилактики наследственного ангионевротического отека |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |