HRP20171931T1 - Farmaceutska formulacija koja obuhvaća biofarmaceutski lijek - Google Patents
Farmaceutska formulacija koja obuhvaća biofarmaceutski lijek Download PDFInfo
- Publication number
- HRP20171931T1 HRP20171931T1 HRP20171931TT HRP20171931T HRP20171931T1 HR P20171931 T1 HRP20171931 T1 HR P20171931T1 HR P20171931T T HRP20171931T T HR P20171931TT HR P20171931 T HRP20171931 T HR P20171931T HR P20171931 T1 HRP20171931 T1 HR P20171931T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation
- formulation according
- antibody
- seq
- adipate
- Prior art date
Links
Classifications
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Endocrinology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurosurgery (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (14)
1. Farmaceutska formulacija, naznačena time, da je za parenteralnu primjenu, pri čemu formulacija obuhvaća monoklonsko IgG-protutijelo sa sačuvanim kapacitetom ciljanog vezanja, gdje navedeni formulacijski sastav dodatno obuhvaća adipinsku kiselinu ili jednu adipatnu sol, pri čemu adipinska kiselina ili adipat djeluju kao pufer, i pritom je jaki lanac monoklonskog IgG-protutijela, definiran s aminokiselinskom sekvencom od SEQ ID NO: 3, a njegov slabi lanac je definiran s aminokiselinskom sekvencom od SEQ ID NO: 4.
2. Formulacija prema zahtjevu 1, naznačena time, da se adipinska kiselina ili adipat nalaze u vodenom obliku farmaceutske formulacije u koncentraciji od između ≥ 2 i ≤ 50 mM.
3. Formulacija prema zahtjevu 2, naznačena time, da se adipinska kiselina ili adipat nalaze u vodenom obliku farmaceutske formulacije u koncentraciji od između ≥ 5 i ≤ 25 mM.
4. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time, da se jaki lanac monoklonskog IgG-protutijela kodira putem nukleinske kiseline od
SEQ ID NO: 1, i pritom se njegov slabi lanac kodira putem nukleinske kiseline od SEQ ID NO: 2.
5. Formulacija prema bilo kojem od prethodno navedenih zahtjeva, naznačena time, da formulacija dodatno obuhvaća limunsku kiselinu ili citrat, gdje limunska kiselina ili citrat djeluju kao pufer.
6. Formulacija prema bilo kojem od prethodno navedenih zahtjeva, naznačena time, da formulacija dodatno obuhvaća najmanje jedan stabilizator odabran iz skupine koju čine: aminokiselina, šećerni poliol, disaharid i/ili polisaharid.
7. Formulacija prema zahtjevu 6, naznačena time, da je navedeni disaharid takvo sredstvo koje je odabrano iz skupine koja se sastoji od sukroze i/ili trehaloze.
8. Formulacija prema zahtjevu 6 ili 7, naznačena time, da je navedeni šećerni poliol takvo sredstvo koje je odabrano iz skupine koja se sastoji od manitola i/ili sorbitola.
9. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time, da formulacija ima pH-vrijednost između ≥4 i ≤8.
10. Formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time, da formulacija ima pH-vrijednost između ≥5 i ≤8.
11. Formulacija prema bilo kojem od prethodno navedenih zahtjeva, naznačena time, da navedeno monoklonsko IgG-protutijelo je sljedeće:
• protutijelo izvedeno iz hibridoma,
• kimerizirano protutijelo,
• humanizirano protutijelo, i/ili
• ljudsko protutijelo.
12. Prethodno napunjena brizgalica ili olovka, ampula ili infuzijska vrećica, naznačena time, da navedena brizgalica ili olovka, ampula ili infuzijska vrećica, sadrže formulaciju prema bilo kojem od zahtjeva 1 do 11.
13. Farmaceutska formulacija prema bilo kojem od zahtjeva 1 do 11, naznačena time, da se upotrebljava u liječenju patološkog stanja, pri čemu je patološko stanje barem jedno od sljedećih:
• autoimune bolesti,
• infektivne bolesti,
• neoplastične i/ili maligne bolesti (rak), i/ili
• bolesti nervnog sustava,
i pri čemu liječenje uključuje parenteralnu primjenu.
14. Formulacija za uporabu prema zahtjevu 13, naznačena time, da liječenje uključuje intravenoznu, intramuskularnu i/ili potkožnu primjenu.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10197122A EP2471554A1 (en) | 2010-12-28 | 2010-12-28 | Pharmaceutical formulation comprising a biopharmaceutical drug |
| PCT/EP2011/074181 WO2012089778A1 (en) | 2010-12-28 | 2011-12-28 | Pharmaceutical formulation comprising a biopharmaceutical drug |
| EP11807947.4A EP2658575B1 (en) | 2010-12-28 | 2011-12-28 | Pharmaceutical formulation comprising a biopharmaceutical drug |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20171931T1 true HRP20171931T1 (hr) | 2018-02-23 |
Family
ID=43982272
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171931TT HRP20171931T1 (hr) | 2010-12-28 | 2011-12-28 | Farmaceutska formulacija koja obuhvaća biofarmaceutski lijek |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9480743B2 (hr) |
| EP (2) | EP2471554A1 (hr) |
| JP (2) | JP5767340B2 (hr) |
| KR (1) | KR101808367B1 (hr) |
| CN (1) | CN103269718B (hr) |
| AR (2) | AR084627A1 (hr) |
| AU (1) | AU2011351414B2 (hr) |
| BR (1) | BR112013016770A2 (hr) |
| CA (1) | CA2822859C (hr) |
| DK (1) | DK2658575T3 (hr) |
| ES (1) | ES2659981T3 (hr) |
| HR (1) | HRP20171931T1 (hr) |
| HU (1) | HUE035707T2 (hr) |
| MX (1) | MX352245B (hr) |
| NO (1) | NO2658575T3 (hr) |
| PL (1) | PL2658575T3 (hr) |
| PT (1) | PT2658575T (hr) |
| RU (1) | RU2587056C2 (hr) |
| SI (1) | SI2658575T1 (hr) |
| TW (1) | TWI530295B (hr) |
| WO (1) | WO2012089778A1 (hr) |
| ZA (2) | ZA201304446B (hr) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| JP2015509526A (ja) | 2012-03-07 | 2015-03-30 | カディラ ヘルスケア リミティド | 医薬製剤 |
| US20130236505A1 (en) | 2012-03-09 | 2013-09-12 | Basf Se | Production Of Pharmaceutical Protective Coatings With Good Resistance In A Neutral Environment |
| WO2013186230A1 (en) * | 2012-06-12 | 2013-12-19 | Boehringer Ingelheim International Gmbh | Pharmaceutical formulation for a therapeutic antibody |
| AU2013312300A1 (en) | 2012-09-07 | 2015-04-16 | Coherus Biosciences, Inc. | Stable aqueous formulations of adalimumab |
| WO2014100143A2 (en) * | 2012-12-20 | 2014-06-26 | Medimmune, Llc | Liquid antibody formulation with improved aggregation properties |
| CN103446583B (zh) * | 2013-03-21 | 2015-11-18 | 百奥泰生物科技(广州)有限公司 | 一种治疗TNF-α相关疾病的人抗体制剂 |
| EP3021833B2 (en) * | 2013-07-19 | 2022-03-30 | Hexal Aktiengesellschaft | Methods and formulations which allow the modulation of immune responses related to the administration of a biopharmaceutical drug |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| HUE029849T2 (en) | 2014-05-23 | 2017-04-28 | Ares Trading Sa | Liquid pharmaceutical composition |
| HUP1400510A1 (hu) | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
| SG11202108627SA (en) | 2019-02-18 | 2021-09-29 | Lilly Co Eli | Therapeutic antibody formulation |
| JP2026501288A (ja) | 2022-12-21 | 2026-01-14 | フォーマイコン アーゲー | 抗ｐｄ１抗体の製剤 |
| WO2025149960A1 (en) * | 2024-01-11 | 2025-07-17 | Lupin Limited | Pharmaceutical formulation of anti-il-5 antibody |
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| US6548640B1 (en) | 1986-03-27 | 2003-04-15 | Btg International Limited | Altered antibodies |
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| FI903489A0 (fi) | 1988-11-11 | 1990-07-10 | Medical Res Council | Ligander med en enda sektion, receptorer innehaollande naemnda ligander, foerfaranden foer deras framstaellning samt anvaendning av liganderna och receptorerna. |
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| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
-
2010
- 2010-12-28 EP EP10197122A patent/EP2471554A1/en not_active Withdrawn
-
2011
- 2011-12-28 JP JP2013546703A patent/JP5767340B2/ja active Active
- 2011-12-28 MX MX2013007537A patent/MX352245B/es active IP Right Grant
- 2011-12-28 HR HRP20171931TT patent/HRP20171931T1/hr unknown
- 2011-12-28 AR ARP110104977A patent/AR084627A1/es not_active Application Discontinuation
- 2011-12-28 CA CA2822859A patent/CA2822859C/en not_active Expired - Fee Related
- 2011-12-28 RU RU2013133953/15A patent/RU2587056C2/ru active
- 2011-12-28 WO PCT/EP2011/074181 patent/WO2012089778A1/en not_active Ceased
- 2011-12-28 PL PL11807947T patent/PL2658575T3/pl unknown
- 2011-12-28 NO NO11807947A patent/NO2658575T3/no unknown
- 2011-12-28 EP EP11807947.4A patent/EP2658575B1/en active Active
- 2011-12-28 CN CN201180062372.1A patent/CN103269718B/zh not_active Expired - Fee Related
- 2011-12-28 HU HUE11807947A patent/HUE035707T2/en unknown
- 2011-12-28 AU AU2011351414A patent/AU2011351414B2/en not_active Ceased
- 2011-12-28 KR KR1020137016504A patent/KR101808367B1/ko not_active Expired - Fee Related
- 2011-12-28 ES ES11807947.4T patent/ES2659981T3/es active Active
- 2011-12-28 PT PT118079474T patent/PT2658575T/pt unknown
- 2011-12-28 US US13/995,556 patent/US9480743B2/en active Active
- 2011-12-28 SI SI201131399T patent/SI2658575T1/en unknown
- 2011-12-28 BR BR112013016770A patent/BR112013016770A2/pt not_active IP Right Cessation
- 2011-12-28 TW TW100149158A patent/TWI530295B/zh active
- 2011-12-28 DK DK11807947.4T patent/DK2658575T3/en active
-
2013
- 2013-06-06 ZA ZA2013/04446A patent/ZA201304446B/en unknown
- 2013-11-25 ZA ZA2013/08841A patent/ZA201308841B/en unknown
-
2015
- 2015-03-09 JP JP2015045482A patent/JP2015131832A/ja not_active Abandoned
-
2022
- 2022-01-18 AR ARP220100101A patent/AR124676A2/es unknown
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