ME02858B - Formulacija za anti- 4 7 antitelo - Google Patents
Formulacija za anti- 4 7 antiteloInfo
- Publication number
- ME02858B ME02858B MEP-2017-227A MEP2017227A ME02858B ME 02858 B ME02858 B ME 02858B ME P2017227 A MEP2017227 A ME P2017227A ME 02858 B ME02858 B ME 02858B
- Authority
- ME
- Montenegro
- Prior art keywords
- seq
- stable liquid
- pharmaceutical formulation
- liquid pharmaceutical
- formulation according
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title claims 2
- 239000000203 mixture Substances 0.000 title claims 2
- 239000007788 liquid Substances 0.000 claims 27
- 239000008194 pharmaceutical composition Substances 0.000 claims 27
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 11
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 9
- 239000004094 surface-active agent Substances 0.000 claims 9
- 235000001014 amino acid Nutrition 0.000 claims 7
- 150000001413 amino acids Chemical class 0.000 claims 7
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 7
- 229920000053 polysorbate 80 Polymers 0.000 claims 7
- 229940068968 polysorbate 80 Drugs 0.000 claims 7
- 239000003963 antioxidant agent Substances 0.000 claims 5
- 230000003078 antioxidant effect Effects 0.000 claims 5
- 239000002738 chelating agent Substances 0.000 claims 5
- 239000004475 Arginine Substances 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000012669 liquid formulation Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- 229960000502 poloxamer Drugs 0.000 claims 2
- 229920001983 poloxamer Polymers 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 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 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- 235000004279 alanine Nutrition 0.000 claims 1
- 235000013922 glutamic acid Nutrition 0.000 claims 1
- 239000004220 glutamic acid Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 229960004914 vedolizumab Drugs 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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Claims (31)
1. Stabilna tečna farmaceutska formulacija koja obuhvata anti-α4β7 antitelo, citrat, i najmanje jednu slobodnu aminokiselinu, pri čemu anti-α4β7 antitelo obuhvata varijabilan region lakog lanca koji obuhvata region 1 koji određuje komplementarnost (CDR1) koji obuhvata SEQ ID NO:11, CDR2 koji obuhvata SEQ ID NO:12, i CDR3 koji obuhvata SEQ ID NO:13, i obuhvata varijabilan region teškog lanca koji obuhvata CDR1 koji obuhvata SEQ ID NO:8, CDR2 koji obuhvata SEQ ID NO:9, i CDR3 koji obuhvata SEQ ID NO:10.
2. Stabilna tečna farmaceutska formulacija prema zahtevu 1, u kojoj je molarni odnos anti-α4β7 antitela prema citratu oko 1:4 do oko 1:100.
3. Stabilna tečna farmaceutska formulacija prema zahtevu 1 ili 2, u kojoj je pomenuta slobodna aminokiselina odabrana iz grupe koju čine histidin, alanin, arginin, glicin, glutaminska kiselina i njihove kombinacije.
4. Stabilna tečna formulacija prema bilo kom od prethodnih zahteva, koja dalje obuhvata neki surfaktant.
5. Stabilna tečna farmaceutska formulacija prema zahtevu 4, u kojoj je molarni odnos citrata prema surfaktantu oko 3:1 do oko 156:1.
6. Stabilna tečna formulacija prema zahtevu 4 ili 5, u kojoj surfaktant predstavlja polisorbat 20, polisorbat 80, poloksamer i njihove kombinacije.
7. Stabilna tečna formulacija prema zahtevu 6, u kojoj surfaktant predstavlja polisorbat 80, a koncentracija polisorbata 80 je 0,01% do 0,5%.
8. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 1-7, u kojoj je koncentracija citrata 5 mM do 50 mM.
9. Stabilna tečna farmaceutska formulacija koja obuhvata najmanje oko 60 mg/ml do oko 190 mg/ml anti-α4β7 antitela, antioksidans ili helator, i najmanje jednu slobodnu aminokiselinu, pri čemu anti-α4β7 antitelo obuhvata varijabilan region lakog lanca koji obuhvata region 1 koji određuje komplementarnost (CDR1) koji obuhvata SEQ ID NO:11, CDR2 koji obuhvata SEQ ID NO:12, i CDR3 koji obuhvata SEQ ID NO:13, i obuhvata varijabilan region teškog lanca koji obuhvata CDR1 koji obuhvata SEQ ID NO:8, CDR2 koji obuhvata SEQ ID NO:9, i CDR3 koji obuhvata SEQ ID NO:10.
10. Stabilna tečna farmaceutska formulacija koja obuhvata anti-α4β7 antitelo, antioksidans ili helator, i najmanje jednu slobodnu aminokiselinu, pri čemu anti-α4β7 antitelo obuhvata varijabilan region lakog lanca koji obuhvata region1 koji određuje komplementarnost (CDR1) koji obuhvata SEQ ID NO:11, CDR2 koji obuhvata SEQ ID NO:12, i CDR3 koji obuhvata SEQ ID NO:13, i obuhvata varijabilan region teškog lanca koji obuhvata CDR1 koji obuhvata SEQ ID NO:8, CDR2 koji obuhvata SEQ ID NO:9, i CDR3 koji obuhvata SEQ ID NO:10, i gde formulacija ima pH od 6,1 do 7,0.
11. Stabilna tečna farmaceutska formulacija prema zahtevu 9 ili 10, koja obuhvata oko 150 mg/ml do oko 180 mg/ml anti-α4β7 antitela.
12. Stabilna tečna farmaceutska formulacija prema zahtevu 9 ili 10, u kojoj antioksidans ili helator predstavlja citrat ili EDTA.
13. Stabilna tečna farmaceutska formulacija prema zahtevu 12, u kojoj antioksidans ili helator predstavlja citrat.
14. Stabilna tečna farmaceutska formulacija prema zahtevu 13, u kojoj je koncentracija citrata 5 mM do 50 mM.
15. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 9-15, koja dalje obuhvata neki surfaktant.
16. Stabilna tečna farmaceutska formulacija prema zahtevu 15, u kojoj je molarni odnos surfaktant:antitelo od oko 0,7:1 do oko 2,0:1.
17. Stabilna tečna farmaceutska formulacija prema zahtevu 15, u kojoj je molarni odnos antioksidansa ili helatora prema surfaktantu oko 3:1 do oko 156:1.
18. Stabilna tečna farmaceutska formulacija prema zahtevu 15, u kojoj surfaktant predstavlja polisorbat 20, polisorbat 80, poloksamer i njihove kombinacije.
19. Stabilna tečna farmaceutska formulacija prema zahtevu 18, u kojoj surfaktant predstavlja polisorbat 80, a koncentracija polisorbata 80 je 0,01% do 0,5%.
20. Stabilna tečna farmaceutska formulacija prema zahtevu 9 ili 10, koja obuhvata anti-α4β7 antitelo, citrat, histidin, arginin, i polisorbat 80, pri čemu anti-α4β7 antitelo obuhvata varijabilan region lakog lanca koji obuhvata region1 koji određuje komplementarnost (CDR1) koji obuhvata SEQ ID NO:11, CDR2 koji obuhvata SEQ ID NO:12, i CDR3 koji obuhvata SEQ ID NO:13, i obuhvata varijabilan region teškog lanca koji obuhvata CDR1 koji obuhvata SEQ ID NO:8, CDR2 koji obuhvata SEQ ID NO:9, i CDR3 koji obuhvata SEQ ID NO:10.
21. Stabilna tečna farmaceutska formulacija prema zahtevu 20, u kojoj je koncentracija anti-α4β7 antitela najmanje oko 140 mg/ml.
22. Stabilna tečna farmaceutska formulacija prema zahtevu 20 ili 21, u kojoj je koncentracija histidina 10 mM do 75 mM.
23. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 20-21, u kojoj je koncentracija arginina 50 mM do 150 mM.
24. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 20 - 23, u kojoj je koncentracija citrata 5 mM do 50 mM.
25. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 1-24, u kojoj antitelo obuhvata varijabilan region teškog lanca koji obuhvata aminokiseline 20-140 iz SEQ ID NO: 2 i varijabilan region lakog lanca koji obuhvata aminokiseline 20-131 iz SEQ ID NO:4 ili aminokiseline 21-132 iz SEQ ID NO:5.
26. Stabilna tečna farmaceutska formulacija prema bilo kom od prethodnih zahteva, u kojoj pomenuto antitelo predstavlja vedolizumab.
27. Proizvod proizvodnje koji obuhvata kontejner, stabilnu tečnu farmaceutsku formulaciju prema bilo kom od zahteva 1-26, i instrukcije za njenu upotrebu.
28. Proizvod prema zahtevu 27, u kom pomenuta stabilna tečna farmaceutska formulacija obuhvata 108 mg antitela.
29. Proizvod prema zahtevu 27, pri čemu proizvod predstavlja prethodno napunjen špric.
30. Stabilna tečna farmaceutska formulacija prema bilo kom od zahteva 1-26 ili proizvod proizvodnje prema bilo kom od zahteva 27 do 29 za upotrebu u lečenju zapaljenske bolesti creva.
31. Stabilna tečna farmaceutska formulacija ili proizvod proizvodnje prema zahtevu 30, pri čemu zapaljenska bolest creva predstavlja Kronovu bolest ili ulcerozni kolitis.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161481522P | 2011-05-02 | 2011-05-02 | |
| US201161544054P | 2011-10-06 | 2011-10-06 | |
| EP12722973.0A EP2704742B1 (en) | 2011-05-02 | 2012-05-02 | Formulation for anti- 4 7 antibody |
| PCT/US2012/036069 WO2012151247A2 (en) | 2011-05-02 | 2012-05-02 | FORMULATION FOR ANTI-α4β7 ANTIBODY |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02858B true ME02858B (me) | 2018-04-20 |
Family
ID=46147702
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2017-227A ME02858B (me) | 2011-05-02 | 2012-05-02 | Formulacija za anti- 4 7 antitelo |
Country Status (38)
| Country | Link |
|---|---|
| US (7) | US10040855B2 (me) |
| EP (5) | EP3311834A1 (me) |
| JP (5) | JP6190359B2 (me) |
| KR (7) | KR101875155B1 (me) |
| CN (4) | CN107998388B (me) |
| AR (1) | AR086238A1 (me) |
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