HU198627B - Process for producing stable pharmaceutical composition comprising granulocyte colony stimulating factor - Google Patents

Process for producing stable pharmaceutical composition comprising granulocyte colony stimulating factor Download PDF

Info

Publication number: HU198627B
Authority: HU; Hungary
Prior art keywords: acid; csf; molecular weight; weight; carboxylic acid
Prior art date: 1986-07-18

Application number

HU873268A

Other languages

English (en)

Hungarian (hu)

Other versions

HUT44941A (en

Inventor

Minoru Machida

Original Assignee

Chugai Pharmaceutical Co Ltd

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1986-07-18

Filing date

1987-07-17

Publication date

1989-11-28

1987-07-17 Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd

1988-05-30 Publication of HUT44941A publication Critical patent/HUT44941A/hu

1989-11-28 Publication of HU198627B publication Critical patent/HU198627B/hu

Links

239000008194 pharmaceutical composition Substances 0.000 title claims description 23
238000000034 method Methods 0.000 title claims description 15
108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 title description 79
102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 title description 79
PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 21
-1 aliphatic carboxylic acid carboxylic acid ester Chemical class 0.000 claims description 21
108090000623 proteins and genes Proteins 0.000 claims description 18
102000004169 proteins and genes Human genes 0.000 claims description 16
239000004094 surface-active agent Substances 0.000 claims description 16
150000001720 carbohydrates Chemical class 0.000 claims description 15
239000000126 substance Substances 0.000 claims description 12
102000008100 Human Serum Albumin Human genes 0.000 claims description 11
108091006905 Human Serum Albumin Proteins 0.000 claims description 11
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 10
108010010803 Gelatin Proteins 0.000 claims description 10
229930195725 Mannitol Natural products 0.000 claims description 10
150000007933 aliphatic carboxylic acids Chemical class 0.000 claims description 10
239000008273 gelatin Substances 0.000 claims description 10
229920000159 gelatin Polymers 0.000 claims description 10
235000019322 gelatine Nutrition 0.000 claims description 10
235000011852 gelatine desserts Nutrition 0.000 claims description 10
239000000594 mannitol Substances 0.000 claims description 10
235000010355 mannitol Nutrition 0.000 claims description 10
IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 claims description 9
239000002253 acid Substances 0.000 claims description 9
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239000002202 Polyethylene glycol Substances 0.000 claims description 8
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150000003839 salts Chemical class 0.000 claims description 8
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JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical compound OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 claims description 5
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108010045362 Serum Globulins Proteins 0.000 claims description 5
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KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 4
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RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims description 4
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DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
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AEMOLEFTQBMNLQ-AQKNRBDQSA-N D-glucopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-AQKNRBDQSA-N 0.000 claims description 3
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HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 3
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CERZMXAJYMMUDR-QBTAGHCHSA-N 5-amino-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid Chemical compound N[C@@H]1[C@@H](O)CC(O)(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO CERZMXAJYMMUDR-QBTAGHCHSA-N 0.000 claims description 2
SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims description 2
229920002101 Chitin Polymers 0.000 claims description 2
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RGHNJXZEOKUKBD-MGCNEYSASA-N D-galactonic acid Chemical compound OC[C@@H](O)[C@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-MGCNEYSASA-N 0.000 claims description 2
AEMOLEFTQBMNLQ-YMDCURPLSA-N D-galactopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-YMDCURPLSA-N 0.000 claims description 2
FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 claims description 2
AEMOLEFTQBMNLQ-VANFPWTGSA-N D-mannopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H]1O AEMOLEFTQBMNLQ-VANFPWTGSA-N 0.000 claims description 2
239000004386 Erythritol Substances 0.000 claims description 2
UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims description 2
AEMOLEFTQBMNLQ-HNFCZKTMSA-N L-idopyranuronic acid Chemical compound OC1O[C@@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-HNFCZKTMSA-N 0.000 claims description 2
MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 claims description 2
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235000019414 erythritol Nutrition 0.000 claims description 2
UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims description 2
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CERZMXAJYMMUDR-UHFFFAOYSA-N neuraminic acid Natural products NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO CERZMXAJYMMUDR-UHFFFAOYSA-N 0.000 claims description 2
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102000007644 Colony-Stimulating Factors Human genes 0.000 claims 1
108010071942 Colony-Stimulating Factors Proteins 0.000 claims 1
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102000007651 Macrophage Colony-Stimulating Factor Human genes 0.000 claims 1
108010046938 Macrophage Colony-Stimulating Factor Proteins 0.000 claims 1
210000003714 granulocyte Anatomy 0.000 claims 1
JYJIGFIDKWBXDU-MNNPPOADSA-N inulin Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)OC[C@]1(OC[C@]2(OC[C@]3(OC[C@]4(OC[C@]5(OC[C@]6(OC[C@]7(OC[C@]8(OC[C@]9(OC[C@]%10(OC[C@]%11(OC[C@]%12(OC[C@]%13(OC[C@]%14(OC[C@]%15(OC[C@]%16(OC[C@]%17(OC[C@]%18(OC[C@]%19(OC[C@]%20(OC[C@]%21(OC[C@]%22(OC[C@]%23(OC[C@]%24(OC[C@]%25(OC[C@]%26(OC[C@]%27(OC[C@]%28(OC[C@]%29(OC[C@]%30(OC[C@]%31(OC[C@]%32(OC[C@]%33(OC[C@]%34(OC[C@]%35(OC[C@]%36(O[C@@H]%37[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O%37)O)[C@H]([C@H](O)[C@@H](CO)O%36)O)[C@H]([C@H](O)[C@@H](CO)O%35)O)[C@H]([C@H](O)[C@@H](CO)O%34)O)[C@H]([C@H](O)[C@@H](CO)O%33)O)[C@H]([C@H](O)[C@@H](CO)O%32)O)[C@H]([C@H](O)[C@@H](CO)O%31)O)[C@H]([C@H](O)[C@@H](CO)O%30)O)[C@H]([C@H](O)[C@@H](CO)O%29)O)[C@H]([C@H](O)[C@@H](CO)O%28)O)[C@H]([C@H](O)[C@@H](CO)O%27)O)[C@H]([C@H](O)[C@@H](CO)O%26)O)[C@H]([C@H](O)[C@@H](CO)O%25)O)[C@H]([C@H](O)[C@@H](CO)O%24)O)[C@H]([C@H](O)[C@@H](CO)O%23)O)[C@H]([C@H](O)[C@@H](CO)O%22)O)[C@H]([C@H](O)[C@@H](CO)O%21)O)[C@H]([C@H](O)[C@@H](CO)O%20)O)[C@H]([C@H](O)[C@@H](CO)O%19)O)[C@H]([C@H](O)[C@@H](CO)O%18)O)[C@H]([C@H](O)[C@@H](CO)O%17)O)[C@H]([C@H](O)[C@@H](CO)O%16)O)[C@H]([C@H](O)[C@@H](CO)O%15)O)[C@H]([C@H](O)[C@@H](CO)O%14)O)[C@H]([C@H](O)[C@@H](CO)O%13)O)[C@H]([C@H](O)[C@@H](CO)O%12)O)[C@H]([C@H](O)[C@@H](CO)O%11)O)[C@H]([C@H](O)[C@@H](CO)O%10)O)[C@H]([C@H](O)[C@@H](CO)O9)O)[C@H]([C@H](O)[C@@H](CO)O8)O)[C@H]([C@H](O)[C@@H](CO)O7)O)[C@H]([C@H](O)[C@@H](CO)O6)O)[C@H]([C@H](O)[C@@H](CO)O5)O)[C@H]([C@H](O)[C@@H](CO)O4)O)[C@H]([C@H](O)[C@@H](CO)O3)O)[C@H]([C@H](O)[C@@H](CO)O2)O)[C@@H](O)[C@H](O)[C@@H](CO)O1 JYJIGFIDKWBXDU-MNNPPOADSA-N 0.000 claims 1
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229940049954 penicillin Drugs 0.000 description 1
150000003014 phosphoric acid esters Chemical class 0.000 description 1
229920003023 plastic Polymers 0.000 description 1
239000004033 plastic Substances 0.000 description 1
229920000573 polyethylene Polymers 0.000 description 1
229920000223 polyglycerol Polymers 0.000 description 1
229920000259 polyoxyethylene lauryl ether Polymers 0.000 description 1
235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
235000010988 polyoxyethylene sorbitan tristearate Nutrition 0.000 description 1
239000001816 polyoxyethylene sorbitan tristearate Substances 0.000 description 1
210000004896 polypeptide structure Anatomy 0.000 description 1
229920001451 polypropylene glycol Polymers 0.000 description 1
229920001282 polysaccharide Polymers 0.000 description 1
239000005017 polysaccharide Substances 0.000 description 1
150000004804 polysaccharides Chemical class 0.000 description 1
229920001296 polysiloxane Polymers 0.000 description 1
239000011591 potassium Substances 0.000 description 1
229910052700 potassium Inorganic materials 0.000 description 1
230000003389 potentiating effect Effects 0.000 description 1
230000002035 prolonged effect Effects 0.000 description 1
108700042769 prolyl-leucyl-glycine Proteins 0.000 description 1
230000001737 promoting effect Effects 0.000 description 1
238000000746 purification Methods 0.000 description 1
DCBSHORRWZKAKO-UHFFFAOYSA-N rac-1-monomyristoylglycerol Chemical compound CCCCCCCCCCCCCC(=O)OCC(O)CO DCBSHORRWZKAKO-UHFFFAOYSA-N 0.000 description 1
230000002829 reductive effect Effects 0.000 description 1
238000004007 reversed phase HPLC Methods 0.000 description 1
230000002441 reversible effect Effects 0.000 description 1
210000002966 serum Anatomy 0.000 description 1
239000011734 sodium Substances 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
235000017557 sodium bicarbonate Nutrition 0.000 description 1
229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 description 1
238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 1
235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
229940057950 sodium laureth sulfate Drugs 0.000 description 1
235000019983 sodium metaphosphate Nutrition 0.000 description 1
229940048086 sodium pyrophosphate Drugs 0.000 description 1
235000010265 sodium sulphite Nutrition 0.000 description 1
AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
235000019345 sodium thiosulphate Nutrition 0.000 description 1
SXHLENDCVBIJFO-UHFFFAOYSA-M sodium;2-[2-(2-dodecoxyethoxy)ethoxy]ethyl sulfate Chemical compound [Na+].CCCCCCCCCCCCOCCOCCOCCOS([O-])(=O)=O SXHLENDCVBIJFO-UHFFFAOYSA-M 0.000 description 1
230000003381 solubilizing effect Effects 0.000 description 1
235000011067 sorbitan monolaureate Nutrition 0.000 description 1
239000001590 sorbitan monolaureate Substances 0.000 description 1
230000006641 stabilisation Effects 0.000 description 1
238000011105 stabilization Methods 0.000 description 1
230000004936 stimulating effect Effects 0.000 description 1
238000010254 subcutaneous injection Methods 0.000 description 1
239000007929 subcutaneous injection Substances 0.000 description 1
150000005846 sugar alcohols Chemical class 0.000 description 1
150000008163 sugars Chemical class 0.000 description 1
239000006228 supernatant Substances 0.000 description 1
229920001059 synthetic polymer Polymers 0.000 description 1
239000003826 tablet Substances 0.000 description 1
235000019818 tetrasodium diphosphate Nutrition 0.000 description 1
239000001577 tetrasodium phosphonato phosphate Substances 0.000 description 1
229940124597 therapeutic agent Drugs 0.000 description 1
YODZTKMDCQEPHD-UHFFFAOYSA-N thiodiglycol Chemical compound OCCSCCO YODZTKMDCQEPHD-UHFFFAOYSA-N 0.000 description 1
229950006389 thiodiglycol Drugs 0.000 description 1
229940035024 thioglycerol Drugs 0.000 description 1
125000003396 thiol group Chemical group [H]S* 0.000 description 1
210000001519 tissue Anatomy 0.000 description 1
229960001295 tocopherol Drugs 0.000 description 1
239000011732 tocopherol Substances 0.000 description 1
229940042585 tocopherol acetate Drugs 0.000 description 1
239000003204 tranquilizing agent Substances 0.000 description 1
230000002936 tranquilizing effect Effects 0.000 description 1
210000004881 tumor cell Anatomy 0.000 description 1

Classifications

- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- 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
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
- 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

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Public Health (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Veterinary Medicine (AREA)
Engineering & Computer Science (AREA)
Oil, Petroleum & Natural Gas (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Inorganic Chemistry (AREA)
Bioinformatics & Cheminformatics (AREA)
Immunology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)

HU873268A 1986-07-18 1987-07-17 Process for producing stable pharmaceutical composition comprising granulocyte colony stimulating factor HU198627B (en)

Applications Claiming Priority (4)

Application Number	Priority Date	Filing Date	Title
JP16948886		1986-07-18
JP16948986		1986-07-18
JP16948786		1986-07-18
JP16948686		1986-07-18

Publications (2)

Publication Number	Publication Date
HUT44941A HUT44941A (en)	1988-05-30
HU198627B true HU198627B (en)	1989-11-28

Family

ID=27474266

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
HU873268A HU198627B (en)	1986-07-18	1987-07-17	Process for producing stable pharmaceutical composition comprising granulocyte colony stimulating factor

Country Status (24)

Country	Link
KR (1)	KR930004597B1 (da)
CN (1)	CN1033738C (da)
AT (1)	AT402259B (da)
AU (1)	AU611856B2 (da)
BE (1)	BE1000253A3 (da)
CA (1)	CA1297007C (da)
CH (1)	CH671157A5 (da)
DE (1)	DE3723781C2 (da)
DK (1)	DK171308B1 (da)
ES (1)	ES2010226A6 (da)
FR (1)	FR2601591B1 (da)
GB (1)	GB2193631B (da)
GR (1)	GR871067B (da)
HK (1)	HK64893A (da)
HU (1)	HU198627B (da)
IE (1)	IE60290B1 (da)
IL (1)	IL83220A (da)
IT (1)	IT1218927B (da)
NL (1)	NL192917C (da)
NO (1)	NO171828C (da)
PT (1)	PT85343B (da)
SE (1)	SE503312C2 (da)
SG (1)	SG64393G (da)
YU (1)	YU47543B (da)

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US4847325A (en) *	1988-01-20	1989-07-11	Cetus Corporation	Conjugation of polymer to colony stimulating factor-1
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US5981485A (en)	1997-07-14	1999-11-09	Genentech, Inc.	Human growth hormone aqueous formulation
US5349052A (en) *	1988-10-20	1994-09-20	Royal Free Hospital School Of Medicine	Process for fractionating polyethylene glycol (PEG)-protein adducts and an adduct for PEG and granulocyte-macrophage colony stimulating factor
US6132763A (en) *	1988-10-20	2000-10-17	Polymasc Pharmaceuticals Plc	Liposomes
GB8824591D0 (en)	1988-10-20	1988-11-23	Royal Free Hosp School Med	Fractionation process
US5104651A (en) *	1988-12-16	1992-04-14	Amgen Inc.	Stabilized hydrophobic protein formulations of g-csf
JP2911496B2 (ja)	1989-09-11	1999-06-23	帝國製薬株式会社	生理活性ポリペプチド含有高吸収性経膣剤
JP3249147B2 (ja) *	1990-06-01	2002-01-21	キリン−アムジエン・インコーポレーテツド	生理活性蛋白含有経口製剤
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FR2686900B1 (fr) *	1992-01-31	1995-07-21	Rhone Poulenc Rorer Sa	Nouveaux polypeptides ayant une activite de stimulation des colonies de granulocytes, leur preparation et compositions pharmaceutiques les contenant.
FR2686899B1 (fr)	1992-01-31	1995-09-01	Rhone Poulenc Rorer Sa	Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
FR2693907B1 (fr) *	1992-07-23	1994-09-02	Rhone Poulenc Rorer Sa	Procédé d'administration de solutions de facteur de stimulation des colonies granulocytaires.
EP0582932A1 (de) *	1992-08-11	1994-02-16	F. Hoffmann-La Roche Ag	Therapeutisches System zur parenteralen Verabreichung von hämatopoetischen Wachstumsfaktoren
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DE4242863A1 (de) *	1992-12-18	1994-06-23	Boehringer Mannheim Gmbh	Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
US20030053982A1 (en)	1994-09-26	2003-03-20	Kinstler Olaf B.	N-terminally chemically modified protein compositions and methods
US5824784A (en)	1994-10-12	1998-10-20	Amgen Inc.	N-terminally chemically modified protein compositions and methods
JP2000510813A (ja) *	1995-02-06	2000-08-22	ジェネテイックス・インスティテュート・インコーポレイテッド	Ｉｌ−１２用処方
TW434021B (en) *	1995-03-15	2001-05-16	Kirin Brewery	Methods for preventing adsorption of thrombopoietin (TPO), and stable TPO-containing compositions
TW434020B (en) *	1995-03-15	2001-05-16	Kirin Brewery	Methods for preventing adsorption of thrombopoietin (TPO), and stable top-containing compositions
GB9526733D0 (en)	1995-12-30	1996-02-28	Delta Biotechnology Ltd	Fusion proteins
US20030190307A1 (en)	1996-12-24	2003-10-09	Biogen, Inc.	Stable liquid interferon formulations
JP3895109B2 (ja) *	1998-03-06	2007-03-22	中外製薬株式会社	蛋白非添加製剤
US6979442B1 (en) *	1998-08-17	2005-12-27	Pfizer Inc.	Stabilized protein compositions
EP1232753B1 (en) *	1999-09-08	2008-03-19	Chugai Seiyaku Kabushiki Kaisha	Stable protein solution filled in a container made from a hydrophobic resin and method of stabilizing the same
AU2001236005A1 (en) *	2000-02-29	2001-09-12	Chugai Seiyaku Kabushiki Kaisha	Preparations stabilized over long time
PT1129720E (pt) *	2000-02-29	2004-08-31	Pfizer Prod Inc	Factor estimulador de colonias de granulocitos estabilizado
EP2206720A1 (en)	2000-04-12	2010-07-14	Human Genome Sciences, Inc.	Albumin fusion proteins
US6946134B1 (en)	2000-04-12	2005-09-20	Human Genome Sciences, Inc.	Albumin fusion proteins
EP1930024A3 (en) *	2000-09-01	2008-08-06	Chugai Seiyaku Kabushiki Kaisha	G-CSF solution formulations having long-term stability
US8435939B2 (en)	2000-09-05	2013-05-07	Biokine Therapeutics Ltd.	Polypeptide anti-HIV agent containing the same
US7507413B2 (en)	2001-04-12	2009-03-24	Human Genome Sciences, Inc.	Albumin fusion proteins
EP2261250B1 (en)	2001-12-21	2015-07-01	Human Genome Sciences, Inc.	GCSF-Albumin fusion proteins
WO2004020462A1 (ja)	2002-08-27	2004-03-11	Fujii, Nobutaka	Ｃｘｃｒ４拮抗薬およびその用途
CA2513213C (en)	2003-01-22	2013-07-30	Human Genome Sciences, Inc.	Albumin fusion proteins
KR101235507B1 (ko)	2003-02-28	2013-02-20	추가이 세이야쿠 가부시키가이샤	단백질을 함유하는 안정화 제제
DE202006020194U1 (de)	2006-03-01	2007-12-06	Bioceuticals Arzneimittel Ag	G-CSF-Flüssigformulierung
CA2673719C (en)	2006-12-21	2018-07-24	Biokine Therapeutics Ltd.	T-140 peptide analogs having cxcr4 super-agonist activity for bone marrow recovery
US9155780B2 (en)	2009-02-11	2015-10-13	Yeda Research And Development Co. Ltd.	Short beta-defensin-derived peptides
CN107412737A (zh)	2010-01-19	2017-12-01	韩美科学株式会社	长效g‑csf缀合物的液体制剂
EP2399572A1 (en)	2010-06-22	2011-12-28	Sandoz AG	Long-term storage of non-glycosylated recombinant human G-CSF
IL274572B2 (en)	2015-07-16	2024-01-01	Biolinerx Ltd	Compositions and methods for treating cancer
CN109310733A (zh)	2016-02-23	2019-02-05	百欧林纳克斯有限公司	治疗急性骨髓性白血病的方法
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1987
- 1987-07-08 GR GR871067A patent/GR871067B/el unknown
- 1987-07-10 IT IT67594/87A patent/IT1218927B/it active
- 1987-07-13 NL NL8701640A patent/NL192917C/nl not_active IP Right Cessation
- 1987-07-14 AT AT0177587A patent/AT402259B/de not_active IP Right Cessation
- 1987-07-15 AU AU75665/87A patent/AU611856B2/en not_active Expired
- 1987-07-15 DK DK368387A patent/DK171308B1/da not_active IP Right Cessation
- 1987-07-15 BE BE8700787A patent/BE1000253A3/fr not_active IP Right Cessation
- 1987-07-15 CA CA000542239A patent/CA1297007C/en not_active Expired - Lifetime
- 1987-07-16 NO NO872966A patent/NO171828C/no not_active IP Right Cessation
- 1987-07-16 PT PT85343A patent/PT85343B/pt unknown
- 1987-07-16 CH CH2727/87A patent/CH671157A5/de not_active IP Right Cessation
- 1987-07-17 SE SE8702907A patent/SE503312C2/sv not_active IP Right Cessation
- 1987-07-17 IE IE193387A patent/IE60290B1/en not_active IP Right Cessation
- 1987-07-17 ES ES8702106A patent/ES2010226A6/es not_active Expired
- 1987-07-17 YU YU134287A patent/YU47543B/sh unknown
- 1987-07-17 DE DE3723781A patent/DE3723781C2/de not_active Expired - Lifetime
- 1987-07-17 IL IL83220A patent/IL83220A/xx not_active IP Right Cessation
- 1987-07-17 HU HU873268A patent/HU198627B/hu unknown
- 1987-07-17 GB GB8716904A patent/GB2193631B/en not_active Expired - Lifetime
- 1987-07-17 FR FR878710156A patent/FR2601591B1/fr not_active Expired - Lifetime
- 1987-07-18 CN CN87104963A patent/CN1033738C/zh not_active Expired - Lifetime
- 1987-07-18 KR KR1019870007804A patent/KR930004597B1/ko not_active Expired - Fee Related
1993
- 1993-05-18 SG SG64393A patent/SG64393G/en unknown
- 1993-07-08 HK HK648/93A patent/HK64893A/xx not_active IP Right Cessation

Also Published As

Publication number	Publication date
KR880001297A (ko)	1988-04-22
CH671157A5 (de)	1989-08-15
CN1033738C (zh)	1997-01-08
ATA177587A (de)	1996-08-15
SG64393G (en)	1993-08-06
CN87104963A (zh)	1988-02-24
HUT44941A (en)	1988-05-30
NO171828B (no)	1993-02-01
GB8716904D0 (en)	1987-08-26
DE3723781C2 (de)	1999-09-02
AU7566587A (en)	1988-01-21
GR871067B (en)	1987-11-19
NL8701640A (nl)	1988-02-16
DK368387A (da)	1988-01-19
NO872966D0 (no)	1987-07-16
SE8702907D0 (sv)	1987-07-17
NL192917B (nl)	1998-01-05
SE503312C2 (sv)	1996-05-13
IT1218927B (it)	1990-04-24
BE1000253A3 (fr)	1988-09-27
FR2601591B1 (fr)	1991-04-26
NO171828C (no)	1993-05-12
CA1297007C (en)	1992-03-10
PT85343A (en)	1987-08-01
DK368387D0 (da)	1987-07-15
GB2193631A (en)	1988-02-17
YU134287A (en)	1989-06-30
GB2193631B (en)	1990-11-21
AU611856B2 (en)	1991-06-27
DE3723781A1 (de)	1988-01-21
ES2010226A6 (es)	1989-11-01
HK64893A (en)	1993-07-16
IL83220A0 (en)	1987-12-31
NO872966L (no)	1988-01-19
IT8767594A0 (it)	1987-07-10
DK171308B1 (da)	1996-09-02
NL192917C (nl)	1998-05-07
IL83220A (en)	1993-01-31
AT402259B (de)	1997-03-25
YU47543B (sh)	1995-10-03
FR2601591A1 (fr)	1988-01-22
KR930004597B1 (ko)	1993-06-01
PT85343B (pt)	1990-04-30
SE8702907L (sv)	1988-01-19
IE871933L (en)	1988-01-18
IE60290B1 (en)	1994-06-29

Legal Events

Date	Code	Title	Description
1990-06-28	HU90	Patent valid on 900628

Publication	Publication Date	Title
HU198627B (en)	1989-11-28	Process for producing stable pharmaceutical composition comprising granulocyte colony stimulating factor
ES2326498T3 (es)	2009-10-13	Formulacion liquida de g-csf.
KR100731559B1 (ko)	2007-06-22	장기 안정화 제제
JP3927248B2 (ja)	2007-06-06	Ｈｇｆ凍結乾燥製剤
JPWO2001064241A1 (ja)	2003-07-02	長期安定化製剤
AU2001282607B2 (en)	2006-08-17	Solution preparations stabilized over long time
JP2577744B2 (ja)	1997-02-05	安定な顆粒球コロニ−刺激因子含有製剤
JP5349452B2 (ja)	2013-11-20	安定な水性ｇ‐ｃｓｆ製剤
WO1993005799A1 (en)	1993-04-01	Lyophilized stable pharmaceutical compositions containing a granulocyte macrophage colony stimulating factor
JP2577742B2 (ja)	1997-02-05	安定な顆粒球コロニ−刺激因子含有製剤
JP2577743B2 (ja)	1997-02-05	安定な顆粒球コロニ−刺激因子含有製剤
US5534251A (en)	1996-07-09	Stabilized il-1α medicinal composition
JPS63146828A (ja)	1988-06-18	安定な顆粒球コロニ−刺激因子含有製剤
JP2629000B2 (ja)	1997-07-09	安定な顆粒球コロニー刺激因子含有製剤
HK1056122A (en)	2004-02-06	Solution formulations having long-term stability