CY1120681T1 - Υγρη φαρμακευτικη συνθεση - Google Patents
Υγρη φαρμακευτικη συνθεσηInfo
- Publication number
- CY1120681T1 CY1120681T1 CY181100952T CY181100952T CY1120681T1 CY 1120681 T1 CY1120681 T1 CY 1120681T1 CY 181100952 T CY181100952 T CY 181100952T CY 181100952 T CY181100952 T CY 181100952T CY 1120681 T1 CY1120681 T1 CY 1120681T1
- Authority
- CY
- Cyprus
- Prior art keywords
- adalimumab
- acetic acid
- pharmaceutical composition
- ingredients
- liquid pharmaceutical
- Prior art date
Links
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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- A61K47/10—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
- 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
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- 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
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
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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
- C07K16/24—Immunoglobulins [IGs], 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- 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
Abstract
Η παρούσα εφεύρεση αναφέρεται σε νέες υγρές φαρμακευτικές συνθέσεις αδαλιμουμάμπης, οι οποίες περιλαμβάνουν αδαλιμουμάμπη ή ένα βιοομοειδές αυτής, έναν ρυθμιστικό παράγοντα/σύστημα οξικού οξέος όπως οξικό νάτριο/οξικό οξύ και έναν σταθεροποιητή σακχάρου όπως η τρεαλόζη. Ένας τέτοιος συνδυασμός συστατικών παρέχει σκευάσματα που έχουν σταθερότητα (π.χ. κατά την αποθήκευση και την έκθεση σε καταπόνηση), η οποία είναι συγκρίσιμη ή βελτιωμένη με όσα είναι γνωστά στην τεχνική, και λιγότερα συστατικά. Τέτοιες πρόοδοι συμβάλλουν στο να γίνουν οι θεραπείες της αδαλιμουμάμπης ευρέως διαθέσιμες με χαμηλότερο κόστος και να παρατείνουν τη βιωσιμότητα των προ-φορτωμένων συσκευών χορήγησης (πχ. προγεμισμένες σύριγγες) για τη μείωση των περισσευμάτων φαρμάκου.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14169753.2A EP2946765B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
PCT/EP2015/060816 WO2015177057A1 (en) | 2014-05-23 | 2015-05-15 | Liquid pharmaceutical composition |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1120681T1 true CY1120681T1 (el) | 2019-12-11 |
Family
ID=50774704
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY181100952T CY1120681T1 (el) | 2014-05-23 | 2018-09-14 | Υγρη φαρμακευτικη συνθεση |
Country Status (24)
Country | Link |
---|---|
US (7) | US10426832B2 (el) |
EP (4) | EP2946765B1 (el) |
JP (1) | JP6334819B2 (el) |
KR (4) | KR102296766B1 (el) |
CN (2) | CN106456538A (el) |
AU (3) | AU2015263340B2 (el) |
BR (2) | BR112016026879A8 (el) |
CA (2) | CA3073703A1 (el) |
CY (1) | CY1120681T1 (el) |
DK (2) | DK2946765T3 (el) |
ES (2) | ES2600488T3 (el) |
HR (2) | HRP20161311T1 (el) |
HU (2) | HUE029849T2 (el) |
IL (3) | IL249115B (el) |
LT (2) | LT2946765T (el) |
MX (1) | MX361061B (el) |
NZ (1) | NZ725360A (el) |
PL (2) | PL2946765T3 (el) |
PT (2) | PT2946765T (el) |
RS (2) | RS55548B1 (el) |
RU (2) | RU2719431C2 (el) |
SG (3) | SG11201608745QA (el) |
SI (2) | SI2946765T1 (el) |
WO (1) | WO2015177057A1 (el) |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2014337263B2 (en) | 2013-10-16 | 2019-12-12 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
IN2014MU01248A (el) | 2014-04-02 | 2015-10-09 | Intas Pharmaceuticals Ltd | |
EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP2946765B1 (en) * | 2014-05-23 | 2016-08-31 | Ares Trading S.A. | Liquid pharmaceutical composition |
ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
EP3247718B1 (en) | 2015-01-21 | 2021-09-01 | Outlook Therapeutics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
EP3411401A1 (en) | 2016-02-03 | 2018-12-12 | Oncobiologics, Inc. | Buffer formulations for enhanced antibody stability |
DK3479819T3 (da) * | 2016-06-30 | 2024-04-15 | Celltrion Inc | Stabilt væskeformigt farmaceutisk præparat |
EP3558363A1 (en) * | 2016-12-21 | 2019-10-30 | Amgen Inc. | Anti-tnf alpha antibody formulations |
WO2018131893A1 (ko) * | 2017-01-11 | 2018-07-19 | ㈜셀트리온 | 안정한 액체 제제 |
IT201700004019A1 (it) * | 2017-01-16 | 2018-07-16 | Gk Pharma Consultans Sa | Composizione comprendente carnitina, colato di sodio, acetato di sodio ed eventualmente argento per uso nel trattamento di psoriasi, vitiligine e rosacea |
KR20180106974A (ko) * | 2017-03-16 | 2018-10-01 | 주식회사 엘지화학 | 항-tnf 알파 항체의 액상 제제 |
CN110831621A (zh) * | 2017-04-18 | 2020-02-21 | 雷迪博士实验室有限公司 | 稳定的液体药物组合物 |
US20210070850A1 (en) * | 2017-09-20 | 2021-03-11 | Alvotech Hf | Pharmaceutical formulations for adalimumab |
CN110151988A (zh) * | 2018-02-11 | 2019-08-23 | 百奥泰生物制药股份有限公司 | 一种靶向治疗TNF-α相关疾病的人抗体制剂 |
WO2020138517A1 (ko) * | 2018-12-24 | 2020-07-02 | 삼성바이오에피스 주식회사 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
EP3909607A4 (en) * | 2019-01-11 | 2022-10-26 | Samsung Bioepis Co., Ltd. | PHARMACEUTICAL COMPOSITION WITH ANTIBODIES, DEVICE CONTAINING THIS AND USE THEREOF |
AU2020364480A1 (en) * | 2019-10-08 | 2022-03-31 | Samsung Bioepis Co., Ltd. | Stable liquid composition, method for preparing same, and formulation comprising same |
AU2022270665A1 (en) * | 2021-05-05 | 2023-12-07 | I2O Therapeutics, Inc. | Ionic liquid formulations for treating inflammatory and autoimmune diseases |
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SG11201405475UA (en) * | 2012-03-07 | 2014-10-30 | Cadila Healthcare Ltd | Pharmaceutical formulations of tnf-alpha antibodies |
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PE20191815A1 (es) * | 2012-09-07 | 2019-12-27 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
KR20150070384A (ko) | 2012-10-25 | 2015-06-24 | 메디뮨 엘엘씨 | 안정한 저점도 항체 제제 |
EP2727602A1 (en) | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
AR093297A1 (es) | 2012-10-31 | 2015-05-27 | Amgen Res (Munich) Gmbh | Formulacion liquida que comprende un compuesto neutralizante de gm-csf |
US9833410B2 (en) | 2012-10-31 | 2017-12-05 | Takeda Gmbh | Lyophilized formulation comprising GM-CSF neutralizing compound |
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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 |
IN2014MU01248A (el) | 2014-04-02 | 2015-10-09 | Intas Pharmaceuticals Ltd | |
ES2607489T3 (es) * | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
EP2946765B1 (en) | 2014-05-23 | 2016-08-31 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
WO2018131893A1 (ko) | 2017-01-11 | 2018-07-19 | ㈜셀트리온 | 안정한 액체 제제 |
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2014
- 2014-05-23 EP EP14169753.2A patent/EP2946765B1/en active Active
- 2014-05-23 RS RS20161050A patent/RS55548B1/sr unknown
- 2014-05-23 HU HUE14169753A patent/HUE029849T2/en unknown
- 2014-05-23 EP EP16160760.1A patent/EP3050557A1/en not_active Withdrawn
- 2014-05-23 DK DK14169753.2T patent/DK2946765T3/en active
- 2014-05-23 ES ES14169753.2T patent/ES2600488T3/es active Active
- 2014-05-23 PT PT141697532T patent/PT2946765T/pt unknown
- 2014-05-23 SI SI201430077A patent/SI2946765T1/sl unknown
- 2014-05-23 PL PL14169753T patent/PL2946765T3/pl unknown
- 2014-05-23 LT LTEP14169753.2T patent/LT2946765T/lt unknown
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2015
- 2015-05-15 ES ES15722541.8T patent/ES2687600T3/es active Active
- 2015-05-15 EP EP18185220.3A patent/EP3476386B1/en active Active
- 2015-05-15 KR KR1020207003849A patent/KR102296766B1/ko active Application Filing
- 2015-05-15 SI SI201530373T patent/SI3145487T1/sl unknown
- 2015-05-15 MX MX2016015304A patent/MX361061B/es active IP Right Grant
- 2015-05-15 PT PT15722541T patent/PT3145487T/pt unknown
- 2015-05-15 BR BR112016026879A patent/BR112016026879A8/pt active Search and Examination
- 2015-05-15 RU RU2016150640A patent/RU2719431C2/ru active
- 2015-05-15 KR KR1020167035624A patent/KR20170005864A/ko active Application Filing
- 2015-05-15 CA CA3073703A patent/CA3073703A1/en not_active Abandoned
- 2015-05-15 BR BR122021022508-7A patent/BR122021022508B1/pt active IP Right Grant
- 2015-05-15 AU AU2015263340A patent/AU2015263340B2/en active Active
- 2015-05-15 KR KR1020227045384A patent/KR20230004960A/ko active Application Filing
- 2015-05-15 DK DK15722541.8T patent/DK3145487T3/en active
- 2015-05-15 SG SG11201608745QA patent/SG11201608745QA/en unknown
- 2015-05-15 PL PL15722541T patent/PL3145487T3/pl unknown
- 2015-05-15 NZ NZ72536015A patent/NZ725360A/en unknown
- 2015-05-15 WO PCT/EP2015/060816 patent/WO2015177057A1/en active Application Filing
- 2015-05-15 SG SG10201806300VA patent/SG10201806300VA/en unknown
- 2015-05-15 RS RS20181063A patent/RS57780B1/sr unknown
- 2015-05-15 CN CN201580026719.5A patent/CN106456538A/zh active Pending
- 2015-05-15 SG SG10202000517YA patent/SG10202000517YA/en unknown
- 2015-05-15 JP JP2017513322A patent/JP6334819B2/ja not_active Expired - Fee Related
- 2015-05-15 CN CN201810926988.2A patent/CN109248315B/zh active Active
- 2015-05-15 CA CA2946953A patent/CA2946953C/en active Active
- 2015-05-15 KR KR1020217027325A patent/KR20210108504A/ko not_active Application Discontinuation
- 2015-05-15 LT LTEP15722541.8T patent/LT3145487T/lt unknown
- 2015-05-15 RU RU2020112952A patent/RU2020112952A/ru unknown
- 2015-05-15 HU HUE15722541A patent/HUE040237T2/hu unknown
- 2015-05-15 US US15/313,470 patent/US10426832B2/en active Active
- 2015-05-15 EP EP15722541.8A patent/EP3145487B1/en active Active
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2016
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2018
- 2018-08-22 AU AU2018220051A patent/AU2018220051B2/en active Active
- 2018-09-14 CY CY181100952T patent/CY1120681T1/el unknown
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- 2018-12-04 IL IL263473A patent/IL263473B/en active IP Right Grant
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2019
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2020
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2021
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