JP2010513309A5 - - Google Patents
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- JP2010513309A5 JP2010513309A5 JP2009541592A JP2009541592A JP2010513309A5 JP 2010513309 A5 JP2010513309 A5 JP 2010513309A5 JP 2009541592 A JP2009541592 A JP 2009541592A JP 2009541592 A JP2009541592 A JP 2009541592A JP 2010513309 A5 JP2010513309 A5 JP 2010513309A5
- Authority
- JP
- Japan
- Prior art keywords
- hgh
- preparation
- item
- buffer
- crystals
- 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
- 238000002360 preparation method Methods 0.000 claims description 207
- 239000013078 crystal Substances 0.000 claims description 51
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 34
- 239000007983 Tris buffer Substances 0.000 claims description 32
- 238000000034 method Methods 0.000 claims description 31
- 239000000872 buffer Substances 0.000 claims description 27
- 229920001223 polyethylene glycol Polymers 0.000 claims description 18
- 239000008118 PEG 6000 Substances 0.000 claims description 17
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims description 17
- 239000011780 sodium chloride Substances 0.000 claims description 17
- 239000002202 Polyethylene glycol Substances 0.000 claims description 16
- 239000000725 suspension Substances 0.000 claims description 16
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 claims description 15
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 12
- 239000003755 preservative agent Substances 0.000 claims description 12
- 230000002335 preservative effect Effects 0.000 claims description 12
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 12
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 10
- 150000003839 salts Chemical class 0.000 claims description 10
- 239000001632 sodium acetate Substances 0.000 claims description 10
- 235000017281 sodium acetate Nutrition 0.000 claims description 10
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 9
- 102000002265 Human Growth Hormone Human genes 0.000 claims description 8
- 108010000521 Human Growth Hormone Proteins 0.000 claims description 8
- 239000000854 Human Growth Hormone Substances 0.000 claims description 8
- 229920000724 poly(L-arginine) polymer Polymers 0.000 claims description 8
- 108010011110 polyarginine Proteins 0.000 claims description 8
- 239000000375 suspending agent Substances 0.000 claims description 8
- 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 6
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 6
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 6
- 229910019142 PO4 Inorganic materials 0.000 claims description 6
- 239000000337 buffer salt Substances 0.000 claims description 6
- 229920002674 hyaluronan Polymers 0.000 claims description 6
- 229960003160 hyaluronic acid Drugs 0.000 claims description 6
- RAXXELZNTBOGNW-UHFFFAOYSA-N imidazole Natural products C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 6
- 239000010452 phosphate Substances 0.000 claims description 6
- 229920000867 polyelectrolyte Polymers 0.000 claims description 6
- 229920001296 polysiloxane Polymers 0.000 claims description 6
- 102000004169 proteins and genes Human genes 0.000 claims description 6
- 108090000623 proteins and genes Proteins 0.000 claims description 6
- 229920002562 Polyethylene Glycol 3350 Polymers 0.000 claims description 5
- 229920002594 Polyethylene Glycol 8000 Polymers 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- QKNYBSVHEMOAJP-UHFFFAOYSA-N 2-amino-2-(hydroxymethyl)propane-1,3-diol;hydron;chloride Chemical compound Cl.OCC(N)(CO)CO QKNYBSVHEMOAJP-UHFFFAOYSA-N 0.000 claims description 4
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 4
- 239000004809 Teflon Substances 0.000 claims description 4
- 229920006362 Teflon® Polymers 0.000 claims description 4
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims description 4
- 150000001875 compounds Chemical class 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 229940121366 growth hormone derivative Drugs 0.000 claims description 4
- 239000004615 ingredient Substances 0.000 claims description 4
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims description 4
- 239000008363 phosphate buffer Substances 0.000 claims description 4
- 229940050929 polyethylene glycol 3350 Drugs 0.000 claims description 4
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 4
- 229940085678 polyethylene glycol 8000 Drugs 0.000 claims description 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 3
- 229930006000 Sucrose Natural products 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 2
- FKNQFGJONOIPTF-UHFFFAOYSA-N Sodium cation Chemical compound [Na+] FKNQFGJONOIPTF-UHFFFAOYSA-N 0.000 claims description 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 2
- -1 amino acid salt Chemical class 0.000 claims description 2
- 235000019445 benzyl alcohol Nutrition 0.000 claims description 2
- 229960004926 chlorobutanol Drugs 0.000 claims description 2
- 238000009826 distribution Methods 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 230000007935 neutral effect Effects 0.000 claims description 2
- 239000002245 particle Substances 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 229920005862 polyol Polymers 0.000 claims description 2
- 150000003077 polyols Chemical class 0.000 claims description 2
- 229940071643 prefilled syringe Drugs 0.000 claims description 2
- 239000001509 sodium citrate Substances 0.000 claims description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 2
- 229910001415 sodium ion Inorganic materials 0.000 claims description 2
- 239000001488 sodium phosphate Substances 0.000 claims description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 2
- 239000012064 sodium phosphate buffer Substances 0.000 claims description 2
- 159000000000 sodium salts Chemical class 0.000 claims description 2
- WUWHFEHKUQVYLF-UHFFFAOYSA-M sodium;2-aminoacetate Chemical compound [Na+].NCC([O-])=O WUWHFEHKUQVYLF-UHFFFAOYSA-M 0.000 claims description 2
- 239000003381 stabilizer Substances 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical group [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 2
- 239000004599 antimicrobial Substances 0.000 claims 1
- 239000008181 tonicity modifier Substances 0.000 claims 1
- 239000011734 sodium Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 2
- 229960005486 vaccine Drugs 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US87060506P | 2006-12-18 | 2006-12-18 | |
| PCT/US2007/087417 WO2008076819A2 (en) | 2006-12-18 | 2007-12-13 | Human growth hormone formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015153650A Division JP6106722B2 (ja) | 2006-12-18 | 2015-08-03 | ヒト成長ホルモン製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2010513309A JP2010513309A (ja) | 2010-04-30 |
| JP2010513309A5 true JP2010513309A5 (enExample) | 2011-01-27 |
Family
ID=39402753
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009541592A Pending JP2010513309A (ja) | 2006-12-18 | 2007-12-13 | ヒト成長ホルモン製剤 |
| JP2015153650A Expired - Fee Related JP6106722B2 (ja) | 2006-12-18 | 2015-08-03 | ヒト成長ホルモン製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015153650A Expired - Fee Related JP6106722B2 (ja) | 2006-12-18 | 2015-08-03 | ヒト成長ホルモン製剤 |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US8071544B2 (enExample) |
| EP (2) | EP2120869A2 (enExample) |
| JP (2) | JP2010513309A (enExample) |
| AU (1) | AU2007333959A1 (enExample) |
| CA (1) | CA2672284C (enExample) |
| DK (1) | DK2486916T3 (enExample) |
| WO (1) | WO2008076819A2 (enExample) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG10201604530SA (en) | 2008-01-22 | 2016-07-28 | Araim Pharmaceuticals Inc | Tissue protective peptides and peptide analogs for preventing and treating diseases and disorders associated with tissue damage |
| TW201023912A (en) | 2008-12-05 | 2010-07-01 | Alcon Res Ltd | Pharmaceutical suspension |
| WO2010101989A1 (en) | 2009-03-03 | 2010-09-10 | Alcon Research, Ltd. | PHARMACEUTICAL COMPOSITION FOR DELIVERY OF RECEPTOR TYROSINE KINASE INHIBITING (RTKi) COMPOUNDS TO THE EYE |
| WO2010115728A2 (en) * | 2009-03-30 | 2010-10-14 | F. Hoffmann-La Roche Ag | A method for avoiding glass fogging |
| EP2453874A2 (en) * | 2009-07-14 | 2012-05-23 | Biogen Idec MA Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| EP2473191B1 (en) * | 2009-09-04 | 2017-08-23 | XOMA Technology Ltd. | Antibody coformulations |
| FR2966044B1 (fr) | 2010-10-18 | 2012-11-02 | Sanofi Pasteur | Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium |
| WO2012125809A1 (en) * | 2011-03-15 | 2012-09-20 | Biogen Idec Inc. | Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen |
| WO2013014196A1 (en) | 2011-07-25 | 2013-01-31 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| EP2782590A4 (en) * | 2011-11-23 | 2016-08-03 | Durect Corp | BIODEGRADABLE AND MEDIUM-RADIATED STERILIZED MEDICAMENTAL COMPOSITIONS |
| EP2949336B1 (en) | 2013-01-28 | 2018-09-05 | National University Corporation Kumamoto University | Stabilized protein gel preparation |
| EP3064213A4 (en) * | 2013-10-28 | 2017-04-26 | Terumo Kabushiki Kaisha | Protein aqueous suspension |
| CN105764491A (zh) | 2013-12-09 | 2016-07-13 | 度瑞公司 | 药物活性剂复合物、聚合物复合物，以及包括其的组合物和方法 |
| CN113425835B (zh) * | 2020-03-23 | 2024-03-19 | 常州健益生物制药有限公司 | 一种生长激素原料药溶液、水针剂及其制备方法 |
| 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 (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4342832A (en) | 1979-07-05 | 1982-08-03 | Genentech, Inc. | Method of constructing a replicable cloning vehicle having quasi-synthetic genes |
| US5618697A (en) | 1982-12-10 | 1997-04-08 | Novo Nordisk A/S | Process for preparing a desired protein |
| NL9000634A (nl) * | 1990-03-20 | 1991-10-16 | Catharina Ziekenhuis Stichting | Suspensie-injectiepreparaat op waterbasis, werkwijze voor de bereiding daarvan en toepassing van dit preparaat voor pijnbestrijding. |
| DK168790D0 (enExample) | 1990-07-13 | 1990-07-13 | Novo Nordisk As | |
| ATE227583T1 (de) * | 1991-12-20 | 2002-11-15 | Novo Nordisk As | Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält |
| ES2153385T5 (es) * | 1992-07-31 | 2008-09-01 | Genentech, Inc. | Composicion acuosa a base de hormona del crecimiento humana. |
| CZ296649B6 (cs) * | 1993-02-23 | 2006-05-17 | Genentech, Inc. | Zpusob výroby stabilizovaného polypeptidového prostredku zahrnující stabilizování polypeptidu protidenaturaci organickými rozpoustedly, jeho príprava a prostredek pro regulované uvolnování polypeptidu |
| US5439643A (en) * | 1993-11-03 | 1995-08-08 | Liebert; Richard T. | Method and apparatus for terminal sterilization |
| JP3829991B2 (ja) * | 1994-06-17 | 2006-10-04 | アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ | Ｈｇｈ含有医薬組成物 |
| US7276251B2 (en) * | 1997-04-01 | 2007-10-02 | Lg Life Sciences, Ltd., Inc. | Sustained-release composition of drugs encapsulated in microparticles of hyaluronic acid |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| US6541606B2 (en) * | 1997-12-31 | 2003-04-01 | Altus Biologics Inc. | Stabilized protein crystals formulations containing them and methods of making them |
| US7582311B1 (en) * | 1999-10-15 | 2009-09-01 | Genentech, Inc. | Injection vehicle for polymer-based formulations |
| CN1606620A (zh) * | 2000-01-28 | 2005-04-13 | 因菲米德治疗有限公司 | 缓慢释放的蛋白质聚合物 |
| BR0317896A (pt) | 2002-12-31 | 2005-12-06 | Altus Pharmaceuticals Inc | Complexos de cristais de proteìna e polìmeros iÈnicos |
| BR0317888A (pt) * | 2002-12-31 | 2005-12-06 | Altus Pharmaceuticals Inc | Cristais do hormÈnio do crescimento humano e processos para preparação dos mesmos |
| US20090023629A1 (en) * | 2005-12-23 | 2009-01-22 | Altus Pharmaceuticals Inc. | Compositions comprising polycation-complexed protein crystals and methods of treatment using them |
-
2007
- 2007-12-13 JP JP2009541592A patent/JP2010513309A/ja active Pending
- 2007-12-13 DK DK11010051.8T patent/DK2486916T3/en active
- 2007-12-13 EP EP07869230A patent/EP2120869A2/en not_active Withdrawn
- 2007-12-13 CA CA2672284A patent/CA2672284C/en not_active Expired - Fee Related
- 2007-12-13 EP EP11010051.8A patent/EP2486916B1/en not_active Not-in-force
- 2007-12-13 WO PCT/US2007/087417 patent/WO2008076819A2/en not_active Ceased
- 2007-12-13 US US12/519,720 patent/US8071544B2/en not_active Expired - Fee Related
- 2007-12-13 AU AU2007333959A patent/AU2007333959A1/en not_active Abandoned
-
2011
- 2011-10-10 US US13/270,136 patent/US20120088724A1/en not_active Abandoned
-
2015
- 2015-08-03 JP JP2015153650A patent/JP6106722B2/ja not_active Expired - Fee Related
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