JP2003504346A5 - - Google Patents
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- Publication number
- JP2003504346A5 JP2003504346A5 JP2001509214A JP2001509214A JP2003504346A5 JP 2003504346 A5 JP2003504346 A5 JP 2003504346A5 JP 2001509214 A JP2001509214 A JP 2001509214A JP 2001509214 A JP2001509214 A JP 2001509214A JP 2003504346 A5 JP2003504346 A5 JP 2003504346A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- growth hormone
- storage
- phosphate buffer
- range
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 description 26
- 238000009472 formulation Methods 0.000 description 25
- 102000018997 Growth Hormone Human genes 0.000 description 16
- 108010051696 Growth Hormone Proteins 0.000 description 16
- 239000000122 growth hormone Substances 0.000 description 16
- 239000007788 liquid Substances 0.000 description 9
- 239000008363 phosphate buffer Substances 0.000 description 9
- 238000002425 crystallisation Methods 0.000 description 6
- 230000008025 crystallization Effects 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 239000003755 preservative agent Substances 0.000 description 6
- 230000002335 preservative effect Effects 0.000 description 6
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 4
- 239000002736 nonionic surfactant Substances 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 4
- -1 NaCl Chemical class 0.000 description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 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 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 229960000686 benzalkonium chloride Drugs 0.000 description 2
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 2
- 229960001950 benzethonium chloride Drugs 0.000 description 2
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 150000002016 disaccharides Chemical class 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 229940100630 metacresol Drugs 0.000 description 2
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 2
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 2
- 229960002216 methylparaben Drugs 0.000 description 2
- 150000002772 monosaccharides Chemical class 0.000 description 2
- 230000003287 optical effect Effects 0.000 description 2
- 229960003742 phenol Drugs 0.000 description 2
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 2
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 2
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 2
- 229960003415 propylparaben Drugs 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 150000005846 sugar alcohols Chemical class 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000013011 aqueous formulation Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229940090048 pen injector Drugs 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9916252.1A GB9916252D0 (en) | 1999-07-12 | 1999-07-12 | Growth hormone formulation |
| GB9916252.1 | 1999-07-12 | ||
| GBGB9918902.9A GB9918902D0 (en) | 1999-08-12 | 1999-08-12 | Growth hormone formulation |
| GB9918902.9 | 1999-08-12 | ||
| PCT/GB2000/002664 WO2001003741A1 (en) | 1999-07-12 | 2000-07-11 | Growth hormone formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011208852A Division JP2012051891A (ja) | 1999-07-12 | 2011-09-26 | 成長ホルモン製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2003504346A JP2003504346A (ja) | 2003-02-04 |
| JP2003504346A5 true JP2003504346A5 (enExample) | 2007-08-30 |
Family
ID=26315757
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2001509214A Pending JP2003504346A (ja) | 1999-07-12 | 2000-07-11 | 成長ホルモン製剤 |
| JP2011208852A Pending JP2012051891A (ja) | 1999-07-12 | 2011-09-26 | 成長ホルモン製剤 |
| JP2014113773A Expired - Lifetime JP5941496B2 (ja) | 1999-07-12 | 2014-06-02 | 成長ホルモン製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011208852A Pending JP2012051891A (ja) | 1999-07-12 | 2011-09-26 | 成長ホルモン製剤 |
| JP2014113773A Expired - Lifetime JP5941496B2 (ja) | 1999-07-12 | 2014-06-02 | 成長ホルモン製剤 |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20060029635A1 (enExample) |
| EP (1) | EP1194170B1 (enExample) |
| JP (3) | JP2003504346A (enExample) |
| KR (1) | KR20020031388A (enExample) |
| CN (1) | CN1360506A (enExample) |
| AR (1) | AR024728A1 (enExample) |
| AT (1) | ATE386501T1 (enExample) |
| AU (1) | AU775107C (enExample) |
| BR (1) | BR0013162A (enExample) |
| CA (1) | CA2378949C (enExample) |
| CZ (1) | CZ200260A3 (enExample) |
| DE (1) | DE60038118T2 (enExample) |
| ES (1) | ES2300268T3 (enExample) |
| HK (1) | HK1046358A1 (enExample) |
| HU (1) | HUP0202189A3 (enExample) |
| IL (2) | IL147253A0 (enExample) |
| MX (1) | MXPA02000404A (enExample) |
| NO (1) | NO20020151L (enExample) |
| NZ (1) | NZ516507A (enExample) |
| PL (1) | PL353238A1 (enExample) |
| SI (1) | SI1194170T1 (enExample) |
| SK (1) | SK252002A3 (enExample) |
| TR (1) | TR200200034T2 (enExample) |
| TW (1) | TWI247608B (enExample) |
| WO (1) | WO2001003741A1 (enExample) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11738068B2 (en) | 2018-06-25 | 2023-08-29 | Jcr Pharmaceuticals Co., Ltd. | Protein-containing aqueous liquid formulation |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070179096A1 (en) * | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
| US20030162711A1 (en) * | 1996-04-24 | 2003-08-28 | Soren Bjorn | Pharmaceutical formulation |
| GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
| EP1536835A1 (en) * | 2002-07-09 | 2005-06-08 | Sandoz AG | Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol |
| WO2004082707A2 (en) * | 2003-03-18 | 2004-09-30 | Ares Trading Sa | Stabilisation of growth hormones in solution |
| JP2007506683A (ja) * | 2003-09-25 | 2007-03-22 | カンジェーン コーポレイション | ヒト成長ホルモン剤およびその調整方法と使用方法 |
| JP4845741B2 (ja) * | 2003-12-23 | 2011-12-28 | ファルマシア コーポレーション | 安定な成長ホルモン液体製剤 |
| UA89781C2 (uk) * | 2004-04-07 | 2010-03-10 | Арес Трейдінг С.А. | Рідкий склад гормона росту |
| US8293532B2 (en) | 2009-03-26 | 2012-10-23 | Dow AgroSciences, L.L.C. | Method and apparatus for tissue transfer |
| WO2011060922A1 (en) * | 2009-11-17 | 2011-05-26 | Ipsen Pharma S.A.S. | Formulation for hgh and rhigf-1 combination |
| WO2013014196A1 (en) | 2011-07-25 | 2013-01-31 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| JP2013231030A (ja) * | 2012-04-30 | 2013-11-14 | Sun Pharmaceutical Industries Ltd | リュープロリド注射剤 |
| JP6001401B2 (ja) * | 2012-09-28 | 2016-10-05 | ユニ・チャーム株式会社 | ウェットティッシュ用薬液及びウェットティッシュ |
| US10647819B2 (en) | 2015-12-10 | 2020-05-12 | Mitsubishi Gas Chemical Company, Inc. | Photocurable composition and optical material |
| WO2018142514A1 (ja) * | 2017-02-01 | 2018-08-09 | 協和発酵キリン株式会社 | ダルベポエチンを含む液体医薬組成物 |
| CN116507319A (zh) * | 2020-11-16 | 2023-07-28 | W.L.戈尔及同仁股份有限公司 | 不含浊点的制剂、方法和预填充多剂量注射装置 |
| CN112494638B (zh) * | 2020-12-22 | 2023-12-19 | 深圳科兴药业有限公司 | 一种人生长激素注射剂组合物及其制备方法 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4783441A (en) * | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| DE3325223A1 (de) * | 1983-07-13 | 1985-01-24 | Hoechst Ag, 6230 Frankfurt | Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung |
| IL79552A0 (en) * | 1985-07-30 | 1986-10-31 | Int Minerals & Chem Corp | Stabilization of growth promoting hormones |
| US4857505A (en) * | 1987-03-09 | 1989-08-15 | American Cyanamid Company | Sustained release compositions for parenteral administration and their use |
| IL86799A (en) * | 1987-07-02 | 1993-03-15 | Kabi Pharmacia Ab | Method and device for injection |
| US5151265A (en) * | 1987-11-03 | 1992-09-29 | Genentech, Inc. | Gamma interferon formulation |
| CA1331133C (en) * | 1988-03-01 | 1994-08-02 | Michael Jon Pikal | Pharmaceutical growth hormone formulations |
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| JPH0383931A (ja) * | 1989-08-29 | 1991-04-09 | Sumitomo Pharmaceut Co Ltd | 低刺激性ｇｒｆ経鼻投与製剤 |
| US5681814A (en) * | 1990-06-07 | 1997-10-28 | Genentech, Inc. | Formulated IGF-I Composition |
| US5126324A (en) * | 1990-06-07 | 1992-06-30 | Genentech, Inc. | Method of enhancing growth in patients using combination therapy |
| JP3042710B2 (ja) * | 1990-09-21 | 2000-05-22 | ノボ ノルディスク アクティーゼルスカブ | ペンシリンジアセンブリー |
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| ES2153385T5 (es) * | 1992-07-31 | 2008-09-01 | Genentech, Inc. | Composicion acuosa a base de hormona del crecimiento humana. |
| US5334162A (en) * | 1993-03-15 | 1994-08-02 | Eli Lilly And Company | Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same |
| US5496801A (en) * | 1993-12-23 | 1996-03-05 | Allelix Biopharmaceuticals Inc. | Parathyroid hormone formulation |
| US5610134A (en) * | 1994-04-15 | 1997-03-11 | Genentech, Inc. | Treatment of congestive heart failure |
| JPH0892125A (ja) * | 1994-09-21 | 1996-04-09 | Nippon Chem Res Kk | 水性医薬組成物 |
| SE9502927D0 (sv) * | 1995-08-24 | 1995-08-24 | Pharmacia Ab | Solution containing IGF-I |
| AUPN801296A0 (en) * | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
| WO1997029776A1 (en) * | 1996-02-13 | 1997-08-21 | G.D. Searle & Co. | Combinations having immunosuppressive effects, containing cyclooxygenase-2-inhibitors and 5-lipoxygenase inhibitors |
| ZA9711731B (en) * | 1996-12-31 | 1998-07-01 | Monsanto Co | Aqueous glycerol formulations of somatotropin |
| TW518235B (en) * | 1997-01-15 | 2003-01-21 | Akzo Nobel Nv | A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage |
| JP3723857B2 (ja) * | 1998-02-04 | 2005-12-07 | 日本ケミカルリサーチ株式会社 | ヒト成長ホルモン含有水性医薬組成物 |
-
2000
- 2000-07-11 MX MXPA02000404A patent/MXPA02000404A/es active IP Right Grant
- 2000-07-11 CZ CZ200260A patent/CZ200260A3/cs unknown
- 2000-07-11 IL IL14725300A patent/IL147253A0/xx not_active IP Right Cessation
- 2000-07-11 PL PL00353238A patent/PL353238A1/xx not_active Application Discontinuation
- 2000-07-11 DE DE60038118T patent/DE60038118T2/de not_active Expired - Lifetime
- 2000-07-11 JP JP2001509214A patent/JP2003504346A/ja active Pending
- 2000-07-11 CN CN00810174A patent/CN1360506A/zh active Pending
- 2000-07-11 AT AT00946088T patent/ATE386501T1/de active
- 2000-07-11 SI SI200030992T patent/SI1194170T1/sl unknown
- 2000-07-11 SK SK25-2002A patent/SK252002A3/sk unknown
- 2000-07-11 ES ES00946088T patent/ES2300268T3/es not_active Expired - Lifetime
- 2000-07-11 BR BR0013162-8A patent/BR0013162A/pt not_active IP Right Cessation
- 2000-07-11 TR TR2002/00034T patent/TR200200034T2/xx unknown
- 2000-07-11 EP EP00946088A patent/EP1194170B1/en not_active Expired - Lifetime
- 2000-07-11 HK HK02106653.3A patent/HK1046358A1/zh unknown
- 2000-07-11 CA CA2378949A patent/CA2378949C/en not_active Expired - Lifetime
- 2000-07-11 WO PCT/GB2000/002664 patent/WO2001003741A1/en not_active Ceased
- 2000-07-11 AU AU59975/00A patent/AU775107C/en not_active Expired
- 2000-07-11 HU HU0202189A patent/HUP0202189A3/hu unknown
- 2000-07-11 NZ NZ516507A patent/NZ516507A/xx unknown
- 2000-07-11 KR KR1020027000416A patent/KR20020031388A/ko not_active Ceased
- 2000-07-13 AR ARP000103593A patent/AR024728A1/es unknown
- 2000-08-24 TW TW089117050A patent/TWI247608B/zh not_active IP Right Cessation
-
2001
- 2001-12-24 IL IL147253A patent/IL147253A/en unknown
-
2002
- 2002-01-11 NO NO20020151A patent/NO20020151L/no not_active Application Discontinuation
-
2005
- 2005-10-03 US US11/242,499 patent/US20060029635A1/en not_active Abandoned
-
2011
- 2011-09-26 JP JP2011208852A patent/JP2012051891A/ja active Pending
-
2014
- 2014-06-02 JP JP2014113773A patent/JP5941496B2/ja not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11738068B2 (en) | 2018-06-25 | 2023-08-29 | Jcr Pharmaceuticals Co., Ltd. | Protein-containing aqueous liquid formulation |
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