JP2010523501A5 - - Google Patents
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- Publication number
- JP2010523501A5 JP2010523501A5 JP2010501341A JP2010501341A JP2010523501A5 JP 2010523501 A5 JP2010523501 A5 JP 2010523501A5 JP 2010501341 A JP2010501341 A JP 2010501341A JP 2010501341 A JP2010501341 A JP 2010501341A JP 2010523501 A5 JP2010523501 A5 JP 2010523501A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- ghrh
- seq
- amino acid
- reducing sugar
- 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
- 238000009472 formulation Methods 0.000 claims description 53
- 239000000203 mixture Substances 0.000 claims description 53
- 101710142969 Somatoliberin Proteins 0.000 claims description 19
- 239000008194 pharmaceutical composition Substances 0.000 claims description 18
- 239000007788 liquid Substances 0.000 claims description 14
- 102100022831 Somatoliberin Human genes 0.000 claims description 13
- 239000002736 nonionic surfactant Substances 0.000 claims description 12
- 239000007864 aqueous solution Substances 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 10
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 10
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 10
- 239000007787 solid Substances 0.000 claims description 10
- 229940068977 polysorbate 20 Drugs 0.000 claims description 9
- 239000004094 surface-active agent Substances 0.000 claims description 8
- 239000012931 lyophilized formulation Substances 0.000 claims description 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 5
- 125000005907 alkyl ester group Chemical group 0.000 claims description 5
- 239000012669 liquid formulation Substances 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims 16
- 108090000765 processed proteins & peptides Proteins 0.000 claims 12
- 125000003275 alpha amino acid group Chemical group 0.000 claims 9
- 229930006000 Sucrose Natural products 0.000 claims 8
- 239000005720 sucrose Substances 0.000 claims 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 7
- 229930195725 Mannitol Natural products 0.000 claims 7
- 239000000872 buffer Substances 0.000 claims 7
- 239000000594 mannitol Substances 0.000 claims 7
- 235000010355 mannitol Nutrition 0.000 claims 7
- 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 claims 6
- 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 6
- 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 claims 6
- 239000004067 bulking agent Substances 0.000 claims 6
- 229920001184 polypeptide Polymers 0.000 claims 6
- 102000004196 processed proteins & peptides Human genes 0.000 claims 6
- 150000001408 amides Chemical class 0.000 claims 5
- 125000003903 2-propenyl group Chemical group [H]C([*])([H])C([H])=C([H])[H] 0.000 claims 4
- 150000001413 amino acids Chemical class 0.000 claims 4
- 239000003963 antioxidant agent Substances 0.000 claims 4
- 230000003078 antioxidant effect Effects 0.000 claims 4
- 230000001684 chronic effect Effects 0.000 claims 4
- 230000007812 deficiency Effects 0.000 claims 4
- 238000012217 deletion Methods 0.000 claims 4
- 230000037430 deletion Effects 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 230000002209 hydrophobic effect Effects 0.000 claims 4
- 230000007774 longterm Effects 0.000 claims 4
- 125000000647 trehalose group Chemical group 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000008223 sterile water Substances 0.000 claims 3
- 125000005913 (C3-C6) cycloalkyl group Chemical group 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 2
- 208000004611 Abdominal Obesity Diseases 0.000 claims 2
- 206010065941 Central obesity Diseases 0.000 claims 2
- 206010049287 Lipodystrophy acquired Diseases 0.000 claims 2
- 208000002720 Malnutrition Diseases 0.000 claims 2
- 125000000217 alkyl group Chemical group 0.000 claims 2
- 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 claims 2
- 208000010877 cognitive disease Diseases 0.000 claims 2
- 125000000753 cycloalkyl group Chemical group 0.000 claims 2
- 238000007918 intramuscular administration Methods 0.000 claims 2
- 238000007912 intraperitoneal administration Methods 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 208000006132 lipodystrophy Diseases 0.000 claims 2
- 230000001071 malnutrition Effects 0.000 claims 2
- 235000000824 malnutrition Nutrition 0.000 claims 2
- 229930182817 methionine Natural products 0.000 claims 2
- 125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 claims 2
- 208000027061 mild cognitive impairment Diseases 0.000 claims 2
- 208000015380 nutritional deficiency disease Diseases 0.000 claims 2
- 229920006395 saturated elastomer Polymers 0.000 claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 2
- 239000008362 succinate buffer Substances 0.000 claims 2
- 125000000185 sucrose group Chemical group 0.000 claims 2
- 206010020880 Hypertrophy Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 125000000625 hexosyl group Chemical group 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 230000007863 steatosis Effects 0.000 claims 1
- 231100000240 steatosis hepatitis Toxicity 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US90998507P | 2007-04-04 | 2007-04-04 | |
| PCT/CA2008/000637 WO2008122118A1 (en) | 2007-04-04 | 2008-04-04 | Pharmaceutical formulations of ghrh molecules |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2010523501A JP2010523501A (ja) | 2010-07-15 |
| JP2010523501A5 true JP2010523501A5 (https=) | 2011-05-19 |
Family
ID=39827484
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010501341A Pending JP2010523501A (ja) | 2007-04-04 | 2008-04-04 | Ｇｈｒｈ分子の医薬製剤 |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US20080249017A1 (https=) |
| EP (1) | EP2142207A4 (https=) |
| JP (1) | JP2010523501A (https=) |
| KR (1) | KR20090130044A (https=) |
| CN (1) | CN101678083A (https=) |
| AU (1) | AU2008235215A1 (https=) |
| BR (1) | BRPI0809441A2 (https=) |
| CA (1) | CA2680329A1 (https=) |
| IL (1) | IL200810A0 (https=) |
| MX (1) | MX2009010675A (https=) |
| RU (1) | RU2009140731A (https=) |
| WO (1) | WO2008122118A1 (https=) |
| ZA (1) | ZA200906179B (https=) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4778053B2 (ja) * | 2005-07-14 | 2011-09-21 | リセラ，インコーポレイテッド | 局所的脂肪組織処置のための徐放性増強脂肪分解処方物 |
| PL2077830T3 (pl) * | 2006-10-17 | 2013-04-30 | Lithera Inc | Sposoby, kompozycje i formulacje do leczenia orbitopatii tarczycowej |
| US9132084B2 (en) | 2009-05-27 | 2015-09-15 | Neothetics, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
| GB2487868B (en) * | 2010-01-15 | 2014-12-10 | Neothetics Inc | Lyophilized cake formulations |
| JP5582983B2 (ja) * | 2010-11-24 | 2014-09-03 | 楠本化成株式会社 | 水系沈降防止剤 |
| US9597531B2 (en) | 2010-11-24 | 2017-03-21 | Neothetics, Inc. | Selective, lipophilic, and long-acting beta agonist monotherapeutic formulations and methods for the cosmetic treatment of adiposity and contour bulging |
| JP2016027003A (ja) * | 2012-11-20 | 2016-02-18 | 大蔵製薬株式会社 | 長期間安定なオランザピンの水性医薬製剤 |
| US8871713B2 (en) * | 2013-03-01 | 2014-10-28 | Theratechnologies Inc. | Formulations of growth hormone releasing factor (GRF) molecules with improved stability |
| CN113646327A (zh) | 2019-03-29 | 2021-11-12 | 综合医院公司 | 用于治疗肝脏疾病的ghrh或其类似物 |
| US20230270865A1 (en) * | 2020-07-05 | 2023-08-31 | Theratechnologies Inc. | Low-dose pharmaceutical compositions of ghrh analogs and uses thereof |
| WO2024133908A1 (en) * | 2022-12-23 | 2024-06-27 | Syna Therapeutics, S.L. | Stable pharmaceutical compositions comprising romiplostim |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5137872A (en) * | 1989-09-18 | 1992-08-11 | Pitman-Moore, Inc. | Growth hormone-releasing factor analogs |
| DE4242863A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
| US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| US5876992A (en) * | 1996-07-03 | 1999-03-02 | Molecular Biology Resources, Inc. | Method and formulation for stabilization of enzymes |
| EP0880969A1 (en) * | 1997-05-28 | 1998-12-02 | Applied Research Systems ARS Holdings N.V. | Pharmaceutical compositions of peptides having low solubility in physiological medium |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6991790B1 (en) * | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
| FR2776520B1 (fr) * | 1998-03-25 | 2000-05-05 | Sod Conseils Rech Applic | Nouvelles compositions pharmaceutiques destinees a la liberation prolongee de peptides et leur procede de preparation |
| WO2000006124A2 (en) * | 1998-07-30 | 2000-02-10 | Point Biomedical Corporation | A novel excipient for the lyophilization of aqueous suspensions of microparticles |
| EP1064934A1 (en) * | 1999-06-30 | 2001-01-03 | Applied Research Systems ARS Holding N.V. | GRF-containing lyophilized pharmaceutical composition |
| WO2001087322A2 (en) * | 2000-05-17 | 2001-11-22 | Bionebraska, Inc. | Peptide pharmaceutical formulations |
| AU9558901A (en) * | 2000-10-05 | 2002-04-15 | Ares Trading Sa | Regioselective liquid phase pegylation |
| CA2454587C (en) * | 2001-07-25 | 2012-11-13 | Protein Design Labs, Inc. | Stable lyophilized pharmaceutical formulation of igg antibodies |
| CA2472956A1 (en) * | 2002-02-14 | 2003-08-21 | Bayer Pharmaceuticals Corporation | Formulation strategies in stabilizing peptides in organic solvents and in dried states |
| WO2004027064A2 (en) * | 2002-09-18 | 2004-04-01 | Centre Hospitalier De L'universite De Montreal (Chum) | Ghrh analogues |
| AU2003229222B2 (en) * | 2003-05-29 | 2009-11-12 | Theratechnologies Inc. | GRF analog compositions and their use |
| US7662393B2 (en) * | 2004-04-07 | 2010-02-16 | Ares Trading S.A. | Liquid growth hormone formulation and method of use |
| EP1812048A4 (en) * | 2004-10-20 | 2012-01-18 | Theratechnologies Inc | GH SECRETAGOGA AND ITS USE |
| CA2593112A1 (en) * | 2005-01-21 | 2006-07-27 | Alza Corporation | Therapeutic peptide formulations for coating microneedles with improved stability containing at least one counterion |
-
2008
- 2008-04-04 BR BRPI0809441-1A patent/BRPI0809441A2/pt not_active IP Right Cessation
- 2008-04-04 AU AU2008235215A patent/AU2008235215A1/en not_active Abandoned
- 2008-04-04 EP EP08733718A patent/EP2142207A4/en not_active Withdrawn
- 2008-04-04 MX MX2009010675A patent/MX2009010675A/es not_active Application Discontinuation
- 2008-04-04 CN CN200880010959A patent/CN101678083A/zh active Pending
- 2008-04-04 KR KR1020097021319A patent/KR20090130044A/ko not_active Withdrawn
- 2008-04-04 RU RU2009140731/15A patent/RU2009140731A/ru not_active Application Discontinuation
- 2008-04-04 WO PCT/CA2008/000637 patent/WO2008122118A1/en not_active Ceased
- 2008-04-04 JP JP2010501341A patent/JP2010523501A/ja active Pending
- 2008-04-04 CA CA002680329A patent/CA2680329A1/en not_active Abandoned
- 2008-04-04 US US12/098,298 patent/US20080249017A1/en not_active Abandoned
-
2009
- 2009-09-07 ZA ZA200906179A patent/ZA200906179B/xx unknown
- 2009-09-08 IL IL200810A patent/IL200810A0/en unknown
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