HRP20211056T1 - Pripravci i postupci za stabilizaciju formulacija koje sadrže proteine - Google Patents
Pripravci i postupci za stabilizaciju formulacija koje sadrže proteine Download PDFInfo
- Publication number
- HRP20211056T1 HRP20211056T1 HRP20211056TT HRP20211056T HRP20211056T1 HR P20211056 T1 HRP20211056 T1 HR P20211056T1 HR P20211056T T HRP20211056T T HR P20211056TT HR P20211056 T HRP20211056 T HR P20211056T HR P20211056 T1 HRP20211056 T1 HR P20211056T1
- Authority
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- Croatia
- Prior art keywords
- alkylglycoside
- antibody
- preparation according
- substance preparation
- temperature
- Prior art date
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- 238000000034 method Methods 0.000 title claims 9
- 239000000203 mixture Substances 0.000 title 2
- 238000009472 formulation Methods 0.000 title 1
- 102000004169 proteins and genes Human genes 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 title 1
- 230000000087 stabilizing effect Effects 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 12
- 239000000126 substance Substances 0.000 claims 10
- 239000003053 toxin Substances 0.000 claims 7
- 231100000765 toxin Toxicity 0.000 claims 7
- 239000007864 aqueous solution Substances 0.000 claims 6
- 230000003647 oxidation Effects 0.000 claims 6
- 238000007254 oxidation reaction Methods 0.000 claims 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 6
- 238000004220 aggregation Methods 0.000 claims 4
- 230000002776 aggregation Effects 0.000 claims 4
- 238000013019 agitation Methods 0.000 claims 3
- MASIZQYHVMQQKI-OIIXUNCGSA-N (2r,3r,4s,5s,6r)-2-[(2r,3s,4r,5r,6r)-4,5-dihydroxy-2-(hydroxymethyl)-6-octoxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@@H]1[C@@H](O)[C@H](OCCCCCCCC)O[C@H](CO)[C@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 MASIZQYHVMQQKI-OIIXUNCGSA-N 0.000 claims 1
- RHXPDNGQJSXOMW-OIIXUNCGSA-N (2r,3r,4s,5s,6r)-2-[(2r,3s,4r,5r,6r)-6-(2-cyclohexylethoxy)-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)O[C@@H](OCCC2CCCCC2)[C@H](O)[C@H]1O RHXPDNGQJSXOMW-OIIXUNCGSA-N 0.000 claims 1
- JVAZJLFFSJARQM-RMPHRYRLSA-N (2r,3r,4s,5s,6r)-2-hexoxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound CCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O JVAZJLFFSJARQM-RMPHRYRLSA-N 0.000 claims 1
- QFAPUKLCALRPLH-UXXRCYHCSA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-nonoxyoxane-3,4,5-triol Chemical compound CCCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O QFAPUKLCALRPLH-UXXRCYHCSA-N 0.000 claims 1
- JVAZJLFFSJARQM-UHFFFAOYSA-N O-n-hexyl beta-D-glucopyranoside Natural products CCCCCCOC1OC(CO)C(O)C(O)C1O JVAZJLFFSJARQM-UHFFFAOYSA-N 0.000 claims 1
- -1 alkyl glycosides Chemical class 0.000 claims 1
- RVTGFZGNOSKUDA-ZNGNCRBCSA-N cyclohexyl-pentyl-maltoside Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)O[C@@H](OCCCCCC2CCCCC2)[C@H](O)[C@H]1O RVTGFZGNOSKUDA-ZNGNCRBCSA-N 0.000 claims 1
- JDRSMPFHFNXQRB-IBEHDNSVSA-N decyl glucoside Chemical compound CCCCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O JDRSMPFHFNXQRB-IBEHDNSVSA-N 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 229930182470 glycoside Natural products 0.000 claims 1
- NIDYWHLDTIVRJT-UJPOAAIJSA-N heptyl-β-d-glucopyranoside Chemical compound CCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O NIDYWHLDTIVRJT-UJPOAAIJSA-N 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 239000012931 lyophilized formulation Substances 0.000 claims 1
- JVAZJLFFSJARQM-YBXAARCKSA-N n-Hexyl-beta-D-glucopyranoside Natural products CCCCCCO[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O JVAZJLFFSJARQM-YBXAARCKSA-N 0.000 claims 1
- HEGSGKPQLMEBJL-UHFFFAOYSA-N n-octyl beta-D-glucopyranoside Natural products CCCCCCCCOC1OC(CO)C(O)C(O)C1O HEGSGKPQLMEBJL-UHFFFAOYSA-N 0.000 claims 1
- HEGSGKPQLMEBJL-RKQHYHRCSA-N octyl beta-D-glucopyranoside Chemical compound CCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HEGSGKPQLMEBJL-RKQHYHRCSA-N 0.000 claims 1
- 125000000430 tryptophan group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C2=C([H])C([H])=C([H])C([H])=C12 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
- 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
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- 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
- C07K16/2803—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 immunoglobulin superfamily
-
- 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
- C07K16/2845—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 against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
-
- 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
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3076—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
- C07K16/3092—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated mucins
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Cell Biology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preventing Corrosion Or Incrustation Of Metals (AREA)
- Anti-Oxidant Or Stabilizer Compositions (AREA)
- Saccharide Compounds (AREA)
Claims (15)
1. Pripravak tvari, naznačen time, da sadrži konjugat protutijela i toksina i alkilglikozida koji ima CMC vrijednost od 1,0 mM ili veću u vodi pri temperaturi od 25 °C, gdje je alkilglikozid prisutan u pripravku tvari u koncentraciji koja je niža od CMC vrijednosti alkilglikozida u vodi pri temperaturi od 25 °C.
2. Pripravak tvari prema patentnom zahtjevu 1, naznačen time, da sadrži količinu spomenutog alkilglikozida koja inhibira agregaciju izazvanu agitacijom.
3. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 2, naznačen time, da sadrži količinu spomenutog alkilglikozida koja sprječava oksidaciju.
4. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da je stabilan pri temperaturi od 2 do 8 °C barem godinu dana.
5. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da je stabilan pri temperaturi od 30 °C barem mjesec dana.
6. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da nije liofiliziran te nije bio predmet prethodne liofilizacije.
7. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da je rekonstituirana liofilizirana formulacija.
8. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da je konjugat protutijela i toksina podložan agregaciji.
9. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da je konjugat protutijela i toksina podložan oksidaciji.
10. Postupak sprječavanja oksidacije konjugata protutijela i toksina prisutnog u prvoj vodenoj otopini, naznačen time, da spomenuti postupak obuhvaća korakdodavanja spomenutoj prvoj vodenoj otopini količine alkilglikozida koja sprječava oksidaciju te ima CMC vrijednost od 1,0 mM ili veću u vodi pri temperaturi od 25 °C, gdje se alkilglikozid dodaje do konačne koncentracije koja je niža od CMC vrijednosti alkilglikozida u vodi pri temperaturi od 25 °C čime se dobiva druga vodena otopina.
11. Postupak prema patentnom zahtjevu 10, naznačen time, da je spomenuta oksidacija inducirana svjetlošću.
12. Postupak prema patentnom zahtjevu 10 ili 11, naznačen time, da se spomenuta svjetlošću inducirana oksidacija odnosi na ostatak triptofana u spomenutom konjugatu protutijela i toksina.
13. Postupak inhibicije agregacije izazvane agitacijom konjugata protutijela i toksina prisutnog u prvoj vodenoj otopini, naznačen time, da spomenuti postupak obuhvaća korak dodavanja spomenutoj prvoj vodenoj otopini količine alkilglikozida koja inhibira agitacijom izazvanu agregaciju te koja ima CMC vrijednost 1,0 mM ili veću u vodi pri temperaturi od 25 °C, gdje se alkilglikozid dodaje do konačne koncentracije koja je niža od CMC vrijednosti alkilglikozida u vodi pri temperaturi od 25 °C, čime se dobiva druga vodena otopina.
14. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 9 ili postupak prema bilo kojem od patentnih zahtjeva 10 do 13, naznačeni time, da je protutijelo sadržano u navedenom konjugatu protutijela i toksina monoklonsko protutijelo.
15. Pripravak tvari prema bilo kojem od patentnih zahtjeva 1 do 9 i 14 ili postupak prema bilo kojem od patentnih zahtjeva 10 do 14, naznačeni time, da je alkilglikozid odabran iz skupine koja se sastoji od n-heksil-β-D-glukopiranozida, n-heptil-β-D-glukopiranozida, n-oktil-β-D-glukopiranozida, n-nonil-β-D-glukopiranozida, n-decil-β-D-glukopiranozida, 3-cikloheksil-1-propil-β-D-glukozida, 3-cikloheksil-1-butil-β-D-glukozida, n-heksil-β-D-maltopiranozida, n-oktil-β-D-maltopiranozida, n-nonil-β-D-maltopiranozida, n-decil-β-D-maltopirazonida, cikloheksil-metil-β-D-maltozida, 2-cikloheksil-etil-β-D-maltozida, 3-cikloheksil-propil-β-D-maltozida, 4-cikloheksil-butil-β-D-maltozida te 5-cikloheksil-pentil-β-D-maltozida.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US35810510P | 2010-06-24 | 2010-06-24 | |
| EP19167191.6A EP3586826B1 (en) | 2010-06-24 | 2011-06-23 | Compositions and methods for stabilizing protein-containing formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211056T1 true HRP20211056T1 (hr) | 2021-10-01 |
Family
ID=44628056
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191878TT HRP20191878T1 (hr) | 2010-06-24 | 2019-10-16 | Pripravci i postupci koji sadrže alkilglikozide te koji su korisni za stabilizaciju formulacija koje sadrže proteine |
| HRP20211056TT HRP20211056T1 (hr) | 2010-06-24 | 2021-07-02 | Pripravci i postupci za stabilizaciju formulacija koje sadrže proteine |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191878TT HRP20191878T1 (hr) | 2010-06-24 | 2019-10-16 | Pripravci i postupci koji sadrže alkilglikozide te koji su korisni za stabilizaciju formulacija koje sadrže proteine |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US9254321B2 (hr) |
| EP (3) | EP2585045B1 (hr) |
| JP (1) | JP5894154B2 (hr) |
| KR (2) | KR101924653B1 (hr) |
| CN (1) | CN103068367B (hr) |
| AU (1) | AU2011270828B2 (hr) |
| BR (1) | BR112012033002B1 (hr) |
| CA (2) | CA3111727C (hr) |
| ES (2) | ES2751381T3 (hr) |
| HR (2) | HRP20191878T1 (hr) |
| IL (2) | IL223651A (hr) |
| MX (1) | MX339666B (hr) |
| MY (2) | MY184736A (hr) |
| NZ (1) | NZ605147A (hr) |
| PL (2) | PL3586826T3 (hr) |
| SG (1) | SG186783A1 (hr) |
| SI (2) | SI3586826T1 (hr) |
| WO (1) | WO2011163458A2 (hr) |
| ZA (1) | ZA201209539B (hr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MY184736A (en) | 2010-06-24 | 2021-04-20 | Genentech Inc | Compositions and methods containing alkylglycosides for stabilizing protein-containing formulations |
| ES2688895T3 (es) * | 2013-03-13 | 2018-11-07 | F. Hoffmann-La Roche Ag | Formulaciones con oxidación reducida |
| US20140314778A1 (en) | 2013-03-13 | 2014-10-23 | Genentech, Inc. | Formulations with reduced oxidation |
| WO2015032972A1 (en) * | 2013-09-09 | 2015-03-12 | Lek Pharmaceuticals D.D. | Nanoformulation of g-csf for non-parenteral delivery |
| WO2015032981A1 (en) * | 2013-09-09 | 2015-03-12 | Lek Pharmaceuticals D.D. | Erythropoietin conjugates having oral bioavailability |
| JP2016535811A (ja) * | 2013-09-30 | 2016-11-17 | エンサ バイオテック アクチエボラグＥｎｚａ Ｂｉｏｔｅｃｈ Ａｂ | 界面活性剤組成物 |
| CN104707146B (zh) * | 2013-12-16 | 2019-04-16 | 浙江海正药业股份有限公司 | 一种含有阿达木单抗的药物组合物 |
| US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| EP3484520A4 (en) | 2016-07-13 | 2020-07-29 | Reform Biologics, LLC | STABILIZING EXCIPIENTS FOR THERAPEUTIC PROTEIN FORMULATIONS |
| WO2019036619A1 (en) * | 2017-08-18 | 2019-02-21 | Reform Biologics, Llc | STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN |
| MX2021012032A (es) * | 2019-04-01 | 2021-11-03 | Genentech Inc | Composiciones y metodos para estabilizar formulaciones que contienen proteinas. |
| JP7217364B2 (ja) * | 2019-11-29 | 2023-02-02 | 千寿製薬株式会社 | 医薬組成物 |
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| US4515893A (en) | 1979-04-26 | 1985-05-07 | Ortho Pharmaceutical Corporation | Hybrid cell line for producing complement-fixing monoclonal antibody to human T cells |
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