JP2010523501A5 - - Google Patents

Info

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

2008-04-04

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

• Espacenet
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• 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