MX2016015304A - Composicion farmaceutica liquida. - Google Patents

Composicion farmaceutica liquida.

Info

Publication number
MX2016015304A
MX2016015304A MX2016015304A MX2016015304A MX2016015304A MX 2016015304 A MX2016015304 A MX 2016015304A MX 2016015304 A MX2016015304 A MX 2016015304A MX 2016015304 A MX2016015304 A MX 2016015304A MX 2016015304 A MX2016015304 A MX 2016015304A
Authority
MX
Mexico
Prior art keywords
adalimumab
liquid pharmaceutical
pharmaceutical composition
acetate
biosimilar
Prior art date
Application number
MX2016015304A
Other languages
English (en)
Other versions
MX361061B (es
Inventor
Rio Alessandra Del
Rinaldi Gianluca
FRATARCANGELI Silvia
Original Assignee
Ares Trading Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774704&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016015304(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ares Trading Sa filed Critical Ares Trading Sa
Publication of MX2016015304A publication Critical patent/MX2016015304A/es
Publication of MX361061B publication Critical patent/MX361061B/es

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
    • 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
    • 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

La presente invención se relaciona con las composiciones farmacéuticas líquidas novedosas de adalimumab, que incluyen adalimumab o un biosimilar del mismo, un agente/sistema regulador de pH de acetato como acetato de sodio/ácido acético, y un estabilizador de azúcar como trehalosa; tal combinación de componentes incluye formulaciones que tienen una estabilidad (por ejemplo, al almacenarse o cuando se exponen a estrés) que es comparable con o una mejoría sobre las conocidas en la técnica, y con menos ingredientes; tales avances ayudarán a que los tratamientos con adalimumab se vuelvan disponibles más ampliamente a un costo inferior, y prolongar la viabilidad de dispositivos de suministro precargados (por ejemplo, jeringas prellenadas) para reducir el desecho innecesario del fármaco.
MX2016015304A 2014-05-23 2015-05-15 Composicion farmaceutica liquida. MX361061B (es)

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 (2)

Publication Number Publication Date
MX2016015304A true MX2016015304A (es) 2017-02-22
MX361061B MX361061B (es) 2018-11-23

Family

ID=50774704

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016015304A MX361061B (es) 2014-05-23 2015-05-15 Composicion farmaceutica liquida.

Country Status (24)

Country Link
US (7) US10426832B2 (es)
EP (4) EP2946765B1 (es)
JP (1) JP6334819B2 (es)
KR (4) KR102296766B1 (es)
CN (2) CN106456538A (es)
AU (3) AU2015263340B2 (es)
BR (2) BR112016026879A8 (es)
CA (2) CA3073703A1 (es)
CY (1) CY1120681T1 (es)
DK (2) DK2946765T3 (es)
ES (2) ES2600488T3 (es)
HR (2) HRP20161311T1 (es)
HU (2) HUE029849T2 (es)
IL (3) IL249115B (es)
LT (2) LT2946765T (es)
MX (1) MX361061B (es)
NZ (1) NZ725360A (es)
PL (2) PL2946765T3 (es)
PT (2) PT2946765T (es)
RS (2) RS55548B1 (es)
RU (2) RU2719431C2 (es)
SG (3) SG11201608745QA (es)
SI (2) SI2946765T1 (es)
WO (1) WO2015177057A1 (es)

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EP2946765B1 (en) 2014-05-23 2016-08-31 Ares Trading S.A. Liquid pharmaceutical composition
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WO2018131893A1 (ko) 2017-01-11 2018-07-19 ㈜셀트리온 안정한 액체 제제

Also Published As

Publication number Publication date
US20210322551A1 (en) 2021-10-21
EP3050557A1 (en) 2016-08-03
US20210196824A1 (en) 2021-07-01
BR122021022508B1 (pt) 2023-04-11
DK2946765T3 (en) 2016-10-31
RU2020112952A (ru) 2020-06-03
SG10202000517YA (en) 2020-03-30
AU2020203119A1 (en) 2020-05-28
PL2946765T3 (pl) 2017-08-31
US20210308262A1 (en) 2021-10-07
KR102296766B1 (ko) 2021-09-03
RU2719431C2 (ru) 2020-04-17
HUE040237T2 (hu) 2019-02-28
PT3145487T (pt) 2018-10-19
SI3145487T1 (sl) 2018-10-30
US10426832B2 (en) 2019-10-01
KR20200017553A (ko) 2020-02-18
CN109248315B (zh) 2021-11-09
CA2946953C (en) 2021-05-18
IL249115A0 (en) 2017-01-31
HRP20181479T1 (hr) 2018-11-02
CA3073703A1 (en) 2015-11-26
KR20230004960A (ko) 2023-01-06
US11712471B2 (en) 2023-08-01
US11707524B2 (en) 2023-07-25
EP3145487A1 (en) 2017-03-29
RS55548B1 (sr) 2017-05-31
KR20210108504A (ko) 2021-09-02
BR112016026879A2 (pt) 2017-08-15
WO2015177057A1 (en) 2015-11-26
PT2946765T (pt) 2016-11-10
SG10201806300VA (en) 2018-08-30
LT2946765T (lt) 2016-11-25
KR20170005864A (ko) 2017-01-16
HRP20161311T1 (hr) 2016-12-02
IL263473B (en) 2021-05-31
US10729769B2 (en) 2020-08-04
EP3145487B1 (en) 2018-08-22
AU2018220051B2 (en) 2020-06-04
IL282481A (en) 2021-06-30
IL263473A (en) 2019-01-31
CN109248315A (zh) 2019-01-22
PL3145487T3 (pl) 2018-11-30
NZ725360A (en) 2019-09-27
RS57780B1 (sr) 2018-12-31
EP3476386B1 (en) 2024-01-24
IL249115B (en) 2018-12-31
EP2946765B1 (en) 2016-08-31
EP3476386C0 (en) 2024-01-24
RU2016150640A (ru) 2018-06-26
ES2600488T3 (es) 2017-02-09
CA2946953A1 (en) 2015-11-26
LT3145487T (lt) 2018-09-25
CY1120681T1 (el) 2019-12-11
AU2018220051A1 (en) 2018-09-06
SI2946765T1 (sl) 2016-11-30
EP3476386A1 (en) 2019-05-01
CN106456538A (zh) 2017-02-22
EP2946765A1 (en) 2015-11-25
SG11201608745QA (en) 2016-11-29
AU2015263340A1 (en) 2016-11-03
US20170196974A1 (en) 2017-07-13
AU2015263340B2 (en) 2018-08-09
DK3145487T3 (en) 2018-10-01
JP6334819B2 (ja) 2018-05-30
MX361061B (es) 2018-11-23
JP2017516846A (ja) 2017-06-22
US20210030871A1 (en) 2021-02-04
ES2687600T3 (es) 2018-10-26
HUE029849T2 (en) 2017-04-28
US20210121566A1 (en) 2021-04-29
BR112016026879A8 (pt) 2021-06-29
US20200016268A1 (en) 2020-01-16
RU2016150640A3 (es) 2018-12-07

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