DK2473527T3 - Stabile formuleringer af polypeptider og anvendelser deraf - Google Patents
Stabile formuleringer af polypeptider og anvendelser deraf Download PDFInfo
- Publication number
- DK2473527T3 DK2473527T3 DK10747895.0T DK10747895T DK2473527T3 DK 2473527 T3 DK2473527 T3 DK 2473527T3 DK 10747895 T DK10747895 T DK 10747895T DK 2473527 T3 DK2473527 T3 DK 2473527T3
- Authority
- DK
- Denmark
- Prior art keywords
- formulation
- weeks
- hplc
- polypeptide
- storage
- Prior art date
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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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physical Education & Sports Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Claims (22)
1. Formulering, der omfatter et vandigt bæremateriale, en buffer og et polypeptid med SEQ ID NO: 1, hvilken formulering er formuleret til administration til et menneske, hvor polypeptidet har en koncentration på mindst 30 mg/ml, hvor bufferen er dinatriumhydrogenphosphat (Na2HP04) , pH 7,0 ved en koncentration på 10 mM.
2. Formulering ifølge krav 1, hvor polypeptidet har en koncentration på mindst 60 mg/ml.
3. Formulering ifølge krav 2, hvor polypeptidet har en koncentration på mindst 80 mg/ml.
4. Formulering ifølge krav 1, hvor polypeptidet har en bifasiske smeltetemperaturprofil, hvor én Tml er mindst 60 °C eller mere, fortrinsvis mindst 61 °C eller mere, mere fortrinsvis mindst 62 °C eller mere, og Tm2 er mindst 65 °C eller mere, fortrinsvis mindst 66 °C eller mere, mere fortrinsvis mindst 67 °C eller mere målt ved hjælp af termisk skift analyse og/eller differentiel scanningskalorimetri (DSC).
5. Formulering ifølge et hvilket som helst af kravene 1 til 4, hvor polypeptidet: - er stabilt under opbevaring ved en temperatur på 37 ± 5 °C op til mindst 2 uger (fortrinsvis mindst 4 uger, mere fortrinsvis mindst 6 uger, mest fortrinsvis mindst 8 uger eller mere), hvilken stabilitet bestemmes ved det faktum, at mindre end 25 % af polypeptiderne danner dimerer målt ved hjælp af SE-HPLC.
6. Formulering ifølge et hvilket som helst af kravene 1 til 5, hvor ikke mere end 5 % af polypeptiderne danner aggregater målt ved hjælp af SE-HPLC, sub-synlig partikeltælling, analytisk ultracentrifugering og/eller dynamisk lysspredning.
7. Formulering ifølge et hvilket som helst af kravene 1 til 6, hvor - mindst 80 % (fortrinsvis 90 %) of polypeptiderne bevarer deres bindingsaktivitet til RANKL efter opbevaring ved 37 + 5 °C op til mindst 2 uger (fortrinsvis mindst 4 uger, mere fortrinsvis mindst 6 uger, mest fortrinsvis mindst 8 uger eller mere) sammenlignet med bindingsaktiviteten før opbevaring, hvilken bindingsaktivitet måles ved hjælp af ELISA og/eller Biacore; og/eller - mindst 80 % (fortrinsvis 90 %) af polypeptiderne bevarer deres bindingsaktivitet til HSA efter opbevaring ved 37 ± 5 °C op til mindst 2 uger (fortrinsvis mindst 4 uger, mere fortrinsvis mindst 6 uger, mest fortrinsvis mindst 8 uger eller mere) sammenlignet med bindingsaktiviteten før opbevaring, hvilken bindingsaktivitet måles ved hjælp af ELISA og/eller Biacore.
8. Formulering ifølge et hvilket som helst af kravene 1 til 7, der har en osmolalitet på 290 ± 60 mOsm/kg.
9. Formulering ifølge et hvilket som helst af kravene 1 til 8, der yderligere omfatter et salt.
10. Formulering ifølge krav 9, hvor saltet er NaCl ved en koncentration på 115 mM.
11. Formulering ifølge et hvilket som helst af kravene 1 til 10, hvor formuleringen omfatter et overfladeaktivt stof udvalgt blandt Tween20 eller Tween80 ved en koncentration op til 0,01 % (volumen/volumen).
12. Formulering ifølge krav 11, hvor SEQ ID NO: 1 er stabil under mekanisk belastning udvalgt blandt: - omrystning i 10 sekunder til 1 minut - presning gennem en kanyle (25G, 26G, 27G, 28G, 29G eller mere) med en sprøjte, - rotering i to dage ved 10 rpm og - omrøring i 1 time ved stuetemperatur og 2 dage ved 4 °C ved mindst 10 rpm (såsom 50 rpm, 100 rpm eller mere).
13. Formulering ifølge et hvilket som helst af kravene 1 til 12, der omfatter - 65 mg/ml af SEQ ID NO: 1; - 10 mM dinatriumhydrogenphosphat (Na2HP04) ; - 115 mM natriumchlorid (NaCl); - 0,01 % Tween80 (volumen/volumen) .
14. Fremgangsmåde til fremstilling af en formulering ifølge et hvilket som helst af kravene 1 til 13, der omfatter trinet opkoncentrering af polypeptidet med SEQ ID NO: 1 og skift af den med en buffer.
15. Formulering, der er dannet ved hjælp af lyofilisering eller sprøjtetørring af formuleringen ifølge et hvilket som helst af kravene 1 til 13.
16. Fremgangsmåde til fremstilling af den lyofiliserede eller sprøjtetørrede formulering ifølge krav 15, som omfatter trinet frysetørring eller sprøjtetørring af en opløsning ifølge et hvilket som helst af kravene 1 til 13.
17. Forseglet beholder, der indeholder en formulering ifølge et hvilket som helst af kravene 1 til 13 eller 15.
18. Farmaceutisk enhedsdosisform, der er egnet til parenteral administration til et menneske, som omfatter en formulering ifølge et hvilket som helst af kravene 1 til 13 eller 15 i en egnet beholder.
19. Farmaceutisk enhedsdosisform ifølge krav 18, der er egnet til subkutan administration.
20. Kit, der omfatter én eller flere af de forseglede beholdere ifølge krav 17 og/eller farmaceutiske enhedsfosisformer ifølge et hvilket som helst af kravene 18 eller 19 og instruktioner i anvendelse af formuleringen.
21. Formulering, beholder, farmaceutisk enhedsdosis eller kit ifølge et hvilket som helst af kravene 1 til 13, 15 eller 17 til 20 til anvendelse til terapi.
22. Formulering, beholder, farmaceutisk enhedsdosis eller kit ifølge krav 21, hvor sygdommen eller forstyrrelsen er osteoporose, cancerrelaterede knoglesygdomme og/eller knogletab i forbindelse med autoimmunitet og/eller virusinfektion.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US27581609P | 2009-09-03 | 2009-09-03 | |
| US28450209P | 2009-12-18 | 2009-12-18 | |
| PCT/EP2010/062972 WO2011026945A1 (en) | 2009-09-03 | 2010-09-03 | Stable formulations of polypeptides and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2473527T3 true DK2473527T3 (da) | 2017-03-06 |
Family
ID=42797362
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10747895.0T DK2473527T3 (da) | 2009-09-03 | 2010-09-03 | Stabile formuleringer af polypeptider og anvendelser deraf |
| DK10747896T DK2473528T3 (da) | 2009-09-03 | 2010-09-03 | Stabile formuleringer af polypeptider og anvendelser deraf |
| DK20176028.7T DK3725330T3 (da) | 2009-09-03 | 2010-09-03 | Stabile formuleringer af polypeptider og anvendelser heraf |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10747896T DK2473528T3 (da) | 2009-09-03 | 2010-09-03 | Stabile formuleringer af polypeptider og anvendelser deraf |
| DK20176028.7T DK3725330T3 (da) | 2009-09-03 | 2010-09-03 | Stabile formuleringer af polypeptider og anvendelser heraf |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US9884117B2 (da) |
| EP (5) | EP3438126B1 (da) |
| CY (1) | CY1121411T1 (da) |
| DK (3) | DK2473527T3 (da) |
| ES (4) | ES2531083T3 (da) |
| FI (1) | FI3725330T3 (da) |
| HR (2) | HRP20251316T1 (da) |
| HU (1) | HUE073438T2 (da) |
| LT (2) | LT2805731T (da) |
| PL (3) | PL3725330T3 (da) |
| PT (4) | PT3438126T (da) |
| SI (2) | SI3725330T1 (da) |
| WO (2) | WO2011026945A1 (da) |
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| KR101593285B1 (ko) | 2008-10-29 | 2016-02-11 | 아블린쓰 엔.브이. | 단일 도메인 항원 결합 분자의 제형 |
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| US9265834B2 (en) | 2009-03-05 | 2016-02-23 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| US10618964B2 (en) | 2009-04-10 | 2020-04-14 | Ablynx N.V. | Nanobody against IL-6R |
| US8748581B2 (en) * | 2009-04-10 | 2014-06-10 | Ablynx N.V. | Anti-IL-6R polypeptides and pharmaceutical compositions thereof |
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