JP2016539921A5 - - Google Patents

Info

Publication number

JP2016539921A5

JP2016539921A5 JP2016524503A JP2016524503A JP2016539921A5 JP 2016539921 A5 JP2016539921 A5 JP 2016539921A5 JP 2016524503 A JP2016524503 A JP 2016524503A JP 2016524503 A JP2016524503 A JP 2016524503A JP 2016539921 A5 JP2016539921 A5 JP 2016539921A5

Authority

JP

Japan

Prior art keywords

aqueous pharmaceutical

pharmaceutical formulation

formulation according

diabetes mellitus

type

Prior art date

2014-10-24

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.)

Granted

Links

• Espacenet
• Global Dossier
• Discuss

• 239000008194 pharmaceutical composition Substances 0.000 claims 29
• NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 14
• 102000004877 Insulin Human genes 0.000 claims 7
• 108090001061 Insulin Proteins 0.000 claims 7
• 229940125396 insulin Drugs 0.000 claims 7
• 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 4
• 238000009472 formulation Methods 0.000 claims 4
• PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 4
• RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 4
• 239000000203 mixture Substances 0.000 claims 4
• 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 4
• 239000002736 nonionic surfactant Substances 0.000 claims 3
• 239000000825 pharmaceutical preparation Substances 0.000 claims 3
• HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 2
• 150000001413 amino acids Chemical class 0.000 claims 2
• 235000011187 glycerol Nutrition 0.000 claims 2
• 238000002347 injection Methods 0.000 claims 2
• 239000007924 injection Substances 0.000 claims 2
• 238000000034 method Methods 0.000 claims 2
• ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 2
• 239000003755 preservative agent Substances 0.000 claims 2
• 239000000126 substance Substances 0.000 claims 2
• LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical group OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 2
• 229960000281 trometamol Drugs 0.000 claims 2
• 239000011701 zinc Substances 0.000 claims 2
• 229910052725 zinc Inorganic materials 0.000 claims 2
• 239000004475 Arginine Substances 0.000 claims 1
• VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
• ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
• FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
• 229910019142 PO4 Inorganic materials 0.000 claims 1
• RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
• 229920001213 Polysorbate 20 Polymers 0.000 claims 1
• ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
• 239000012928 buffer substance Substances 0.000 claims 1
• 239000003795 chemical substances by application Substances 0.000 claims 1
• 206010012601 diabetes mellitus Diseases 0.000 claims 1
• 239000003814 drug Substances 0.000 claims 1
• 238000004519 manufacturing process Methods 0.000 claims 1
• 229930182817 methionine Natural products 0.000 claims 1
• NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
• 239000010452 phosphate Substances 0.000 claims 1
• 229960000502 poloxamer Drugs 0.000 claims 1
• 229920001983 poloxamer Polymers 0.000 claims 1
• 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
• 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
• 229940068977 polysorbate 20 Drugs 0.000 claims 1
• 229920000053 polysorbate 80 Polymers 0.000 claims 1
• 229940068968 polysorbate 80 Drugs 0.000 claims 1
• 230000002335 preservative effect Effects 0.000 claims 1
• 239000012929 tonicity agent Substances 0.000 claims 1