AR074054A1 - Formulaciones farmaceuticas de factor de von willebrand recombinante liofilizado - Google Patents
Formulaciones farmaceuticas de factor de von willebrand recombinante liofilizadoInfo
- Publication number
- AR074054A1 AR074054A1 ARP090104052A ARP090104052A AR074054A1 AR 074054 A1 AR074054 A1 AR 074054A1 AR P090104052 A ARP090104052 A AR P090104052A AR P090104052 A ARP090104052 A AR P090104052A AR 074054 A1 AR074054 A1 AR 074054A1
- Authority
- AR
- Argentina
- Prior art keywords
- group
- formulation
- agents
- seq
- rvwf
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 4
- 150000001413 amino acids Chemical class 0.000 abstract 4
- 238000009472 formulation Methods 0.000 abstract 4
- 239000000203 mixture Substances 0.000 abstract 4
- 239000003381 stabilizer Substances 0.000 abstract 4
- 239000004094 surface-active agent Substances 0.000 abstract 4
- 235000001014 amino acid Nutrition 0.000 abstract 3
- 102000040430 polynucleotide Human genes 0.000 abstract 3
- 108091033319 polynucleotide Proteins 0.000 abstract 3
- 239000002157 polynucleotide Substances 0.000 abstract 3
- 229920001184 polypeptide Polymers 0.000 abstract 3
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 3
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 3
- 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 abstract 2
- 239000004471 Glycine Substances 0.000 abstract 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 abstract 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 2
- 239000006172 buffering agent Substances 0.000 abstract 2
- 239000012634 fragment Substances 0.000 abstract 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 2
- 239000008101 lactose Substances 0.000 abstract 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 1
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 abstract 1
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 abstract 1
- 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 abstract 1
- IDOQDZANRZQBTP-UHFFFAOYSA-N 2-[2-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol Chemical compound CC(C)(C)CC(C)(C)C1=CC=CC=C1OCCO IDOQDZANRZQBTP-UHFFFAOYSA-N 0.000 abstract 1
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 abstract 1
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 abstract 1
- 239000004475 Arginine Substances 0.000 abstract 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 abstract 1
- GUBGYTABKSRVRQ-CUHNMECISA-N D-Cellobiose 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)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-CUHNMECISA-N 0.000 abstract 1
- 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 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 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 abstract 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 abstract 1
- QRLVDLBMBULFAL-UHFFFAOYSA-N Digitonin Natural products CC1CCC2(OC1)OC3C(O)C4C5CCC6CC(OC7OC(CO)C(OC8OC(CO)C(O)C(OC9OCC(O)C(O)C9OC%10OC(CO)C(O)C(OC%11OC(CO)C(O)C(O)C%11O)C%10O)C8O)C(O)C7O)C(O)CC6(C)C5CCC4(C)C3C2C QRLVDLBMBULFAL-UHFFFAOYSA-N 0.000 abstract 1
- 229930091371 Fructose Natural products 0.000 abstract 1
- 239000005715 Fructose Substances 0.000 abstract 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 abstract 1
- 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 abstract 1
- 239000007995 HEPES buffer Substances 0.000 abstract 1
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 abstract 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 1
- 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 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 abstract 1
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 abstract 1
- MTCFGRXMJLQNBG-UHFFFAOYSA-N Serine Natural products OCC(N)C(O)=O MTCFGRXMJLQNBG-UHFFFAOYSA-N 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 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 abstract 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 1
- 239000007983 Tris buffer Substances 0.000 abstract 1
- 239000013504 Triton X-100 Substances 0.000 abstract 1
- 229920004890 Triton X-100 Polymers 0.000 abstract 1
- 229920004929 Triton X-114 Polymers 0.000 abstract 1
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 abstract 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 abstract 1
- 235000004279 alanine Nutrition 0.000 abstract 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 1
- PYMYPHUHKUWMLA-WDCZJNDASA-N arabinose Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)C=O PYMYPHUHKUWMLA-WDCZJNDASA-N 0.000 abstract 1
- PYMYPHUHKUWMLA-UHFFFAOYSA-N arabinose Natural products OCC(O)C(O)C(O)C=O PYMYPHUHKUWMLA-UHFFFAOYSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- SRBFZHDQGSBBOR-UHFFFAOYSA-N beta-D-Pyranose-Lyxose Natural products OC1COC(O)C(O)C1O SRBFZHDQGSBBOR-UHFFFAOYSA-N 0.000 abstract 1
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 abstract 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 abstract 1
- 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 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- UVYVLBIGDKGWPX-KUAJCENISA-N digitonin Chemical compound O([C@@H]1[C@@H]([C@]2(CC[C@@H]3[C@@]4(C)C[C@@H](O)[C@H](O[C@H]5[C@@H]([C@@H](O)[C@@H](O[C@H]6[C@@H]([C@@H](O[C@H]7[C@@H]([C@@H](O)[C@H](O)CO7)O)[C@H](O)[C@@H](CO)O6)O[C@H]6[C@@H]([C@@H](O[C@H]7[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O7)O)[C@@H](O)[C@@H](CO)O6)O)[C@@H](CO)O5)O)C[C@@H]4CC[C@H]3[C@@H]2[C@@H]1O)C)[C@@H]1C)[C@]11CC[C@@H](C)CO1 UVYVLBIGDKGWPX-KUAJCENISA-N 0.000 abstract 1
- UVYVLBIGDKGWPX-UHFFFAOYSA-N digitonine Natural products CC1C(C2(CCC3C4(C)CC(O)C(OC5C(C(O)C(OC6C(C(OC7C(C(O)C(O)CO7)O)C(O)C(CO)O6)OC6C(C(OC7C(C(O)C(O)C(CO)O7)O)C(O)C(CO)O6)O)C(CO)O5)O)CC4CCC3C2C2O)C)C2OC11CCC(C)CO1 UVYVLBIGDKGWPX-UHFFFAOYSA-N 0.000 abstract 1
- -1 gentiobious Chemical compound 0.000 abstract 1
- 229960002442 glucosamine Drugs 0.000 abstract 1
- 239000008103 glucose Substances 0.000 abstract 1
- 238000009396 hybridization Methods 0.000 abstract 1
- 239000000905 isomalt Substances 0.000 abstract 1
- 235000010439 isomalt Nutrition 0.000 abstract 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 abstract 1
- 239000006179 pH buffering agent Substances 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
- 229920000053 polysorbate 80 Polymers 0.000 abstract 1
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose 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[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 abstract 1
- 239000000600 sorbitol Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 abstract 1
- 108010047303 von Willebrand Factor Proteins 0.000 abstract 1
- 102100036537 von Willebrand factor Human genes 0.000 abstract 1
- 229960001134 von willebrand factor Drugs 0.000 abstract 1
- 239000000811 xylitol Substances 0.000 abstract 1
- 235000010447 xylitol Nutrition 0.000 abstract 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 abstract 1
- 229960002675 xylitol Drugs 0.000 abstract 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
- 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
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- 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
-
- 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
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K47/06—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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
Reivindicacion 1: Una formulacion farmacéutica estable liofilizada de un factor de von Willebrand recombinante (rVWF) caracterizada porque comprende: (a) un rVWF; (b) uno o más agentes amortiguadores; (c) uno o más aminoácidos; (d) uno o más agentes estabilizantes; y (e) uno o más agentes tensioactivos; donde dicho rVWF comprende un polipéptido seleccionado del grupo que consiste de: la secuencia de aminoácidos de la SEQ ID N°:3; un análogo, fragmento o variante biologicamente activo de a); un polipéptido codificado por el polinucleotido indicado en la SEQ ID N° 1; un análogo, fragmento o variante biologicamente activo de c); y un polipéptido codificado por un polinucleotido que se hibridiza con el polinucleotido indicado en la SEQ ID N°:1 bajo condiciones de hibridacion moderadamente severas; donde dicha solucion amortiguadora está compuesta por un agente amortiguador de pH en un rango de aproximadamente 0,1 mM a aproximadamente 500 mM y dicho pH se encuentra en un rango de aproximadamente 2,0 a aproximadamente 12,0; dicho aminoácido está a una concentracion de aproximadamente 1 a aproximadamente 500mM; dicho agente estabilizante está a una concentracion de aproximadamente 0,1 a aproximadamente 1000 mM; y dicho agente tensioactivo está a una concentracion de aproximadamente 0,01 g/l a aproximadamente 0,5 g/l. Reivindicacion 3: La formulacion de la reivindicacion 1, caracterizada porque el agente amortiguador se selecciona del grupo que consiste de citrato, glicina, histidina, HEPES, Tris y combinaciones de estos agentes. Reivindicacion 9: La formulacion de la reivindicacion 1, caracterizada porque el aminoácido se selecciona del grupo que consiste de glicina, histidina, prolina, serina, alanina y arginina. Reivindicacion 13: La formulacion de la reivindicacion 1, caracterizada porque dichos uno o más agentes estabilizantes se selecciona del grupo que consiste de manitol, lactosa, sorbitol, xilitol, sacarosa, trehalosa, manosa, maltosa, lactosa, glucosa, rafinosa, celobiosa, gentiobiosa, isomaltosa, arabinosa, glucosamina, fructosa y combinaciones de estos agentes estabilizantes. Reivindicacion 15: La formulacion de la reivindicacion 1, caracterizada porque el agente tensioactivo se selecciona del grupo que consiste de digitonina, Triton X-100, Triton X-114, TWEEN-20, TWEEN-80 y combinaciones de estos agentes tensioactivos.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10727308P | 2008-10-21 | 2008-10-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR074054A1 true AR074054A1 (es) | 2010-12-22 |
Family
ID=42109151
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP090104052A AR074054A1 (es) | 2008-10-21 | 2009-10-21 | Formulaciones farmaceuticas de factor de von willebrand recombinante liofilizado |
| ARP200100313A AR118012A2 (es) | 2008-10-21 | 2020-02-05 | Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP200100313A AR118012A2 (es) | 2008-10-21 | 2020-02-05 | Una composición farmacéutica estable liofilizada de un factor von willebrand recombinante |
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| US (4) | US20100099603A1 (es) |
| EP (2) | EP2349314B1 (es) |
| JP (6) | JP5781931B2 (es) |
| KR (2) | KR101953494B1 (es) |
| CN (2) | CN103919736A (es) |
| AR (2) | AR074054A1 (es) |
| AU (1) | AU2009307648C1 (es) |
| BR (1) | BRPI0919693A2 (es) |
| CA (1) | CA2740919A1 (es) |
| CY (1) | CY1113869T1 (es) |
| DK (1) | DK2349314T3 (es) |
| ES (1) | ES2409032T3 (es) |
| HR (1) | HRP20130414T1 (es) |
| MX (1) | MX2011004247A (es) |
| NZ (1) | NZ592704A (es) |
| PL (1) | PL2349314T3 (es) |
| PT (1) | PT2349314E (es) |
| SI (1) | SI2349314T1 (es) |
| SM (1) | SMT201300093B (es) |
| TW (3) | TWI508735B (es) |
| WO (1) | WO2010048275A2 (es) |
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| WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| CA2814054A1 (en) * | 2010-10-12 | 2012-04-19 | Merz Pharma Gmbh & Co. Kgaa | Formulation suitable for stabilizing proteins, which is free of mammalian excipients |
| AR086904A1 (es) * | 2011-06-10 | 2014-01-29 | Baxter Int | Tratamiento de trastornos de la coagulacion por medio de la administracion de factor recombinante de von willebrand (vwf) |
| EP2698162A1 (en) | 2012-08-15 | 2014-02-19 | Credentis AG | Method for producing a composition for treating a tooth lesion |
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| NL1040254C2 (en) * | 2013-05-17 | 2014-11-24 | Ablynx Nv | Stable formulations of immunoglobulin single variable domains and uses thereof. |
| AU2015274238B2 (en) | 2014-06-13 | 2020-11-05 | Csl Limited | Improved production of recombinant von Willebrand factor in a bioreactor |
| JP6866296B2 (ja) * | 2015-02-27 | 2021-04-28 | ボード オブ リージェンツ, ザ ユニバーシティ オブ テキサス システムBoard Of Regents, The University Of Texas System | ポリペプチド治療及びその使用 |
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| CA3069256A1 (en) | 2017-07-07 | 2019-01-10 | Baxalta Incorporated | Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf |
| WO2019010497A1 (en) | 2017-07-07 | 2019-01-10 | Baxalta Incorporated | TREATMENT OF GASTROINTESTINAL BLEEDING IN PATIENTS WITH A SEVERE FORM OF VON WILLEBRAND'S DISEASE BY RECOMBINANT VWF ADMINISTRATION |
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| WO2019183290A1 (en) | 2018-03-21 | 2019-09-26 | Baxalta Incorporated | Separation of vwf and vwf propeptide by chromatographic methods |
| CN112739367A (zh) | 2018-09-10 | 2021-04-30 | 肺疾治疗公司 | Cav-1蛋白的修饰的肽片段及其在纤维化治疗中的用途 |
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| CN111789867B (zh) * | 2020-08-27 | 2022-01-11 | 中国人民解放军军事科学院军事医学研究院 | 一种适用于提高血浆干粉功能的适配液 |
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2009
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- 2009-10-21 KR KR1020177011494A patent/KR101953494B1/ko active Active
- 2009-10-21 JP JP2011532347A patent/JP5781931B2/ja active Active
- 2009-10-21 ES ES09740822T patent/ES2409032T3/es active Active
- 2009-10-21 CN CN201410067147.2A patent/CN103919736A/zh active Pending
- 2009-10-21 MX MX2011004247A patent/MX2011004247A/es active IP Right Grant
- 2009-10-21 DK DK09740822.3T patent/DK2349314T3/da active
- 2009-10-21 CN CN200980142453.5A patent/CN102387784B/zh active Active
- 2009-10-21 PL PL09740822T patent/PL2349314T3/pl unknown
- 2009-10-21 BR BRPI0919693-5A patent/BRPI0919693A2/pt not_active Application Discontinuation
- 2009-10-21 KR KR1020117011539A patent/KR101772674B1/ko active Active
- 2009-10-21 SI SI200930558T patent/SI2349314T1/sl unknown
- 2009-10-21 TW TW098135542A patent/TWI508735B/zh active
- 2009-10-21 US US12/603,064 patent/US20100099603A1/en not_active Abandoned
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- 2009-10-21 WO PCT/US2009/061470 patent/WO2010048275A2/en active Application Filing
- 2009-10-21 EP EP13150822.8A patent/EP2601932A1/en active Pending
- 2009-10-21 AU AU2009307648A patent/AU2009307648C1/en active Active
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- 2013-04-02 CY CY20131100272T patent/CY1113869T1/el unknown
- 2013-05-10 HR HRP20130414AT patent/HRP20130414T1/hr unknown
- 2013-08-16 SM SM201300093T patent/SMT201300093B/xx unknown
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2015
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2016
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2020
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2021
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