HRP20181028T1 - Dugodjelujuće formulacije inzulina - Google Patents
Dugodjelujuće formulacije inzulina Download PDFInfo
- Publication number
- HRP20181028T1 HRP20181028T1 HRP20181028TT HRP20181028T HRP20181028T1 HR P20181028 T1 HRP20181028 T1 HR P20181028T1 HR P20181028T T HRP20181028T T HR P20181028TT HR P20181028 T HRP20181028 T HR P20181028T HR P20181028 T1 HRP20181028 T1 HR P20181028T1
- Authority
- HR
- Croatia
- Prior art keywords
- insulin glargine
- aqueous
- aqueous formulation
- insulin
- type
- Prior art date
Links
- 102000004877 Insulin Human genes 0.000 title claims 2
- 108090001061 Insulin Proteins 0.000 title claims 2
- 238000009472 formulation Methods 0.000 title 1
- 239000004026 insulin derivative Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 108010057186 Insulin Glargine Proteins 0.000 claims 19
- COCFEDIXXNGUNL-RFKWWTKHSA-N Insulin glargine Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(=O)NCC(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 COCFEDIXXNGUNL-RFKWWTKHSA-N 0.000 claims 19
- 229960002869 insulin glargine Drugs 0.000 claims 19
- 239000013011 aqueous formulation Substances 0.000 claims 18
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 17
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 14
- XVVOERDUTLJJHN-UHFFFAOYSA-N Lixisenatide Chemical compound C=1NC2=CC=CC=C2C=1CC(C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)NCC(=O)NCC(=O)N1C(CCC1)C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1C(CCC1)C(=O)N1C(CCC1)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)CC)NC(=O)C(NC(=O)C(CC(C)C)NC(=O)C(CCCNC(N)=N)NC(=O)C(NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(CCC(O)=O)NC(=O)C(CCC(O)=O)NC(=O)C(CCSC)NC(=O)C(CCC(N)=O)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CC(O)=O)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC=1C=CC=CC=1)NC(=O)C(NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)CNC(=O)C(N)CC=1NC=NC=1)C(C)O)C(C)O)C(C)C)CC1=CC=CC=C1 XVVOERDUTLJJHN-UHFFFAOYSA-N 0.000 claims 8
- 229960001093 lixisenatide Drugs 0.000 claims 8
- 108010004367 lixisenatide Proteins 0.000 claims 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims 8
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 239000011701 zinc Substances 0.000 claims 7
- 229910052725 zinc Inorganic materials 0.000 claims 7
- 229920001213 Polysorbate 20 Polymers 0.000 claims 6
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 6
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 6
- 229940068977 polysorbate 20 Drugs 0.000 claims 6
- 101000976075 Homo sapiens Insulin Proteins 0.000 claims 5
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 5
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 5
- PBGKTOXHQIOBKM-FHFVDXKLSA-N insulin (human) Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 PBGKTOXHQIOBKM-FHFVDXKLSA-N 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 5
- 239000011734 sodium Substances 0.000 claims 5
- 229910052708 sodium Inorganic materials 0.000 claims 5
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 5
- 108010011459 Exenatide Proteins 0.000 claims 2
- 108010092217 Long-Acting Insulin Proteins 0.000 claims 2
- 102000016261 Long-Acting Insulin Human genes 0.000 claims 2
- 229940100066 Long-acting insulin Drugs 0.000 claims 2
- 229960001519 exenatide Drugs 0.000 claims 2
- 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 2
- HTQBXNHDCUEHJF-XWLPCZSASA-N Exenatide Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 HTQBXNHDCUEHJF-XWLPCZSASA-N 0.000 claims 1
- 208000013016 Hypoglycemia Diseases 0.000 claims 1
- YSDQQAXHVYUZIW-QCIJIYAXSA-N Liraglutide Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)NCC(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCNC(=O)CC[C@H](NC(=O)CCCCCCCCCCCCCCC)C(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=C(O)C=C1 YSDQQAXHVYUZIW-QCIJIYAXSA-N 0.000 claims 1
- 108010019598 Liraglutide Proteins 0.000 claims 1
- JUFFVKRROAPVBI-PVOYSMBESA-N chembl1210015 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(=O)N[C@H]1[C@@H]([C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@]3(O[C@@H](C[C@H](O)[C@H](O)CO)[C@H](NC(C)=O)[C@@H](O)C3)C(O)=O)O2)O)[C@@H](CO)O1)NC(C)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 JUFFVKRROAPVBI-PVOYSMBESA-N 0.000 claims 1
- 230000002218 hypoglycaemic effect Effects 0.000 claims 1
- 229940125396 insulin Drugs 0.000 claims 1
- 229960002701 liraglutide Drugs 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/2278—Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
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- A—HUMAN NECESSITIES
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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Claims (25)
1. Vodena farmaceutska formulacija sa pH između 3.4 i 4.6 koja sadrži inzulin glargin, naznačena time da je koncentracija inzulin glargina 200-500 U/mL ekvimolarna prema 200-500 IU ljudskog inzulina.
2. Vodena farmaceutska formulacija prema zahtjevu 1 naznačena time da sadrži 200 U/mL inzulin glargina.
3. Vodena farmaceutska formulacija prema zahtjevu 1 naznačena time da sadrži 500 U/mL inzulin glargina.
4. Vodena formulacija prema bilo kojem od zahtjeva 1 do 3 naznačena time da sadrži analog eksendin-4 odabran iz skupine koja sadrži liksisenatid, eksenatid i liraglutid.
5. Vodena formulacija prema zahtjevu 4 naznačena time da sadrži 0.1 µg do 10 µg liksisenatida po jedinici inzulin glargina.
6. Vodena formulacija prema zahtjevu 5 naznačena time da sadrži 0.2 do 1 µg liksisenatida po jedinici inzulin glargina.
7. Vodena formulacija prema zahtjevu 6 naznačena time da sadrži 0.25 µg do 0.7 µg liksisenatida po jedinici inzulin glargina.
8. Vodena formulacija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time da sadrži jedan ili više ekscipijenata odabranih iz skupine koja sadrži cink, m-krezol, glicerol, polisorbat 20 i natrij.
9. Vodena formulacija prema zahtjevu 8 naznačena time da sadrži 90 µg/mL cinka, 2.7 mg/mL m-krezola i 20 mg/mL glicerola 85%.
10. Vodena formulacija prema zahtjevu 8 naznačena time da sadrži 90 µg/mL cinka, 2.7 mg/mL m-krezola, 20 µg/mL polisorbata 20 i 20 mg/mL glicerola 85%.
11. Vodena formulacija prema bilo kojem od zahtjeva 1 do 10, naznačena time da pH je 4.
12. Vodena formulacija prema bilo kojem od zahtjeva 1 do 10, naznačena time da pH je 4.5.
13. Vodena farmaceutska formulacija sa pH između 3.4 i 4.6 koja sadrži inzulin glargin naznačena time da je za uporabu za liječenje dijabetes melitusa tipa I i tipa II kod pacijenta, pri čemu je koncentracija inzulin glargina 200-500 U/mL ekvimolarna prema 200-500 IU ljudskog inzulina.
14. Vodena formulacija za uporabu prema zahtjevu 13 naznačena time da navedeni farmaceutski pripravak nadalje sadrži pomoćne tvari koje se biraju iz skupine koja sadrži cink, m-krezol, glicerol, polisorbat 20 i natrij.
15. Vodena formulacija za uporabu prema zahtjevu 13 naznačena time da navedeni farmaceutski pripravak nadalje sadrži 0.1 µg do 10 µg liksisenatida po jedinici inzulin glargina.
16. Vodena farmaceutska formulacija sa pH između 3.4 i 4.6 koja sadrži inzulin glargin naznačena time da je za uporabu za produljenje trajanja izlaganja dugodjelujućem inzulinu u liječenju dijabetes melitusa tipa I i tipa II kod pacijenta, pri čemu je koncentracija inzulin glargina 200-500 U/mL ekvimolarna prema 200-500 IU ljudskog inzulina.
17. Vodena formulacija za uporabu prema zahtjevu 16 naznačena time da navedeni farmaceutski pripravak nadalje sadrži ekscipijente odabrane iz skupine koju čine cink, m-krezol, glicerol, polisorbat 20 i natrij.
18. Vodena formulacija za uporabu prema zahtjevu 16 naznačena time da navedeni farmaceutski pripravak nadalje sadrži 0.1 µg do 10 µg liksisenatida po jedinici inzulin glargina.
19. Vodena farmaceutska formulacija sa pH između 3.4 i 4.6 koja sadrži inzulin glargin naznačena time da je za uporabu za u smanjenju učestalosti hipoglikemije u liječenju dijabetes melitusa tipa I i tipa II kod pacijenta s dugodjelujućim inzulinom, pri čemu je koncentracija inzulin glargina 200-500 U/mL ekvimolarna prema 200-500 IU ljudskog inzulina.
20. Vodena formulacija za uporabu prema zahtjevu 19 naznačena time da navedeni farmaceutski pripravak nadalje sadrži ekscipijente odabrane iz skupine koju čine cink, m-krezol, glicerol, polisorbat 20 i natrij.
21. Vodena formulacija za uporabu prema zahtjevu 19 naznačena time da navedeni farmaceutski pripravak nadalje sadrži 0.1 µg do 10 µg liksisenatida po jedinici inzulin glargina.
22. Vodena farmaceutska formulacija sa pH između 3.4 i 4.6 koja sadrži inzulin glargin za upotrebu u osiguravanju dugodjelujućeg bazalnog inzulina bez vrhunca u liječenje dijabetes melitusa tipa I i tipa II kod pacijenta, pri čemu je koncentracija inzulin glargina 200-500 U/mL ekvimolarna prema 200-500 IU ljudskog inzulina.
23. Vodena formulacija za uporabu prema zahtjevu 22 naznačena time da navedeni farmaceutski pripravak nadalje sadrži ekscipijente odabrane iz skupine koju čine cink, m-krezol, glicerol, polisorbat 20 i natrij.
24. Vodena formulacija za uporabu prema zahtjevu 22 naznačena time da navedeni farmaceutski pripravak nadalje sadrži 0.1 µg do 10 µg liksisenatida po jedinici inzulin glargina.
25. Vodena formulacija prema bilo kojem od prethodnih zahtjeva naznačena time da je za uporabu za liječenje dijabetes melitusa tipa I i tipa II.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| EP10305532 | 2010-05-19 | ||
| EP10305780 | 2010-07-13 | ||
| EP11305140 | 2011-02-10 | ||
| EP11720115.2A EP2571517B2 (en) | 2010-05-19 | 2011-05-18 | Long - acting formulations of insulins |
| PCT/EP2011/058079 WO2011144673A2 (en) | 2010-05-19 | 2011-05-18 | Long - acting formulations of insulins |
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| HRP20181028T1 true HRP20181028T1 (hr) | 2018-08-24 |
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| HRP20140860AT HRP20140860T1 (hr) | 2010-05-19 | 2014-09-11 | Dugodjelujuä†e formulacije inzulina |
| HRP20181028TT HRP20181028T1 (hr) | 2010-05-19 | 2018-07-04 | Dugodjelujuće formulacije inzulina |
| HRP20181026TT HRP20181026T1 (hr) | 2010-05-19 | 2018-07-04 | Dugodjelujuće formulacije inzulina |
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| HRP20140860AT HRP20140860T1 (hr) | 2010-05-19 | 2014-09-11 | Dugodjelujuä†e formulacije inzulina |
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| HRP20181026TT HRP20181026T1 (hr) | 2010-05-19 | 2018-07-04 | Dugodjelujuće formulacije inzulina |
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