MA45562B1 - Préparation pharmaceutique liquide stable - Google Patents

Préparation pharmaceutique liquide stable

Info

Publication number
MA45562B1
MA45562B1 MA45562A MA45562A MA45562B1 MA 45562 B1 MA45562 B1 MA 45562B1 MA 45562 A MA45562 A MA 45562A MA 45562 A MA45562 A MA 45562A MA 45562 B1 MA45562 B1 MA 45562B1
Authority
MA
Morocco
Prior art keywords
liquid pharmaceutical
stable liquid
pharmaceutical preparation
pharmaceutical formulation
present
Prior art date
Application number
MA45562A
Other languages
English (en)
Other versions
MA45562A (fr
Inventor
Joon Won Lee
Won Yong Han
Su Jung Kim
Jun Seok Oh
So Young Kim
Su Hyeon Hong
Yeon Kyeong Shin
Original Assignee
Celltrion Inc
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=60787364&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA45562(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Celltrion Inc filed Critical Celltrion Inc
Publication of MA45562A publication Critical patent/MA45562A/fr
Publication of MA45562B1 publication Critical patent/MA45562B1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Communicable Diseases (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une formulation pharmaceutique liquide stable contenant : un anticorps ou son fragment de liaison à l'antigène ; un tensioactif ; un sucre ou son dérivé ; et un tampon. La formulation pharmaceutique liquide stable selon la présente invention a une faible viscosité tout en contenant une teneur élevée en anticorps, présente une excellente stabilité au stockage à long terme basée sur une excellente stabilité dans des conditions accélérées et des conditions sévères, et peut être administrée par voie sous-cutanée.
MA45562A 2016-06-30 2017-06-28 Préparation pharmaceutique liquide stable MA45562B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20160083039 2016-06-30
PCT/KR2017/006855 WO2018004260A1 (fr) 2016-06-30 2017-06-28 Préparation pharmaceutique liquide stable

Publications (2)

Publication Number Publication Date
MA45562A MA45562A (fr) 2019-05-08
MA45562B1 true MA45562B1 (fr) 2024-05-31

Family

ID=60787364

Family Applications (1)

Application Number Title Priority Date Filing Date
MA45562A MA45562B1 (fr) 2016-06-30 2017-06-28 Préparation pharmaceutique liquide stable

Country Status (40)

Country Link
US (3) US11951207B2 (fr)
EP (2) EP4338752A3 (fr)
JP (2) JP7082070B2 (fr)
KR (3) KR20180003452A (fr)
CN (1) CN109310628A (fr)
AU (2) AU2017287743C1 (fr)
CA (1) CA3028238C (fr)
CL (1) CL2018003662A1 (fr)
CO (1) CO2018013689A2 (fr)
CR (1) CR20180599A (fr)
CU (1) CU24561B1 (fr)
DK (1) DK3479819T5 (fr)
DO (1) DOP2018000290A (fr)
EA (1) EA201892653A1 (fr)
EC (1) ECSP18093651A (fr)
ES (1) ES2975782T3 (fr)
FI (1) FI3479819T3 (fr)
GE (1) GEP20217249B (fr)
HR (1) HRP20240426T1 (fr)
HU (1) HUE066142T2 (fr)
IL (1) IL263630B2 (fr)
JO (1) JOP20180125B1 (fr)
LT (1) LT3479819T (fr)
MA (1) MA45562B1 (fr)
MD (1) MD3479819T2 (fr)
MX (1) MX2018015960A (fr)
NI (1) NI201800139A (fr)
PE (1) PE20190448A1 (fr)
PH (1) PH12018502670B1 (fr)
PL (1) PL3479819T3 (fr)
PT (1) PT3479819T (fr)
RS (1) RS65395B1 (fr)
SG (1) SG11201811320YA (fr)
SI (1) SI3479819T1 (fr)
SM (1) SMT202400143T1 (fr)
TN (1) TN2018000443A1 (fr)
TW (1) TWI736643B (fr)
UA (1) UA122610C2 (fr)
WO (1) WO2018004260A1 (fr)
ZA (1) ZA201808476B (fr)

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CN110585430B (zh) * 2019-09-29 2023-09-08 华博生物医药技术(上海)有限公司 一种人源化抗人il-17a单克隆抗体的药物组合物
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Also Published As

Publication number Publication date
EP3479819A4 (fr) 2020-02-26
AU2020201249B2 (en) 2021-07-15
HUE066142T2 (hu) 2024-07-28
HRP20240426T1 (hr) 2024-06-21
DK3479819T3 (da) 2024-04-15
SMT202400143T1 (it) 2024-05-14
CO2018013689A2 (es) 2019-01-18
EP4338752A2 (fr) 2024-03-20
AU2017287743C1 (en) 2020-10-01
CU24561B1 (es) 2022-01-13
NZ770076A (en) 2025-03-28
FI3479819T3 (fi) 2024-04-17
SI3479819T1 (sl) 2024-06-28
US20240269071A1 (en) 2024-08-15
KR20210042052A (ko) 2021-04-16
RS65395B1 (sr) 2024-04-30
CR20180599A (es) 2019-04-09
ECSP18093651A (es) 2019-01-31
LT3479819T (lt) 2024-04-25
PL3479819T3 (pl) 2024-07-01
PE20190448A1 (es) 2019-03-29
MX2018015960A (es) 2019-03-21
TW201806617A (zh) 2018-03-01
CU20180154A7 (es) 2019-08-06
AU2020201249A1 (en) 2020-03-12
KR20180097471A (ko) 2018-08-31
UA122610C2 (uk) 2020-12-10
ZA201808476B (en) 2020-08-26
BR112018076377A2 (pt) 2019-03-26
US20240269069A1 (en) 2024-08-15
PT3479819T (pt) 2024-04-15
SG11201811320YA (en) 2019-01-30
KR102397713B1 (ko) 2022-05-13
JP7082070B2 (ja) 2022-06-07
MA45562A (fr) 2019-05-08
JOP20180125B1 (ar) 2022-09-15
WO2018004260A1 (fr) 2018-01-04
NI201800139A (es) 2019-03-25
NZ748101A (en) 2020-11-27
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US11951207B2 (en) 2024-04-09
JP7405324B2 (ja) 2023-12-26
EA201892653A1 (ru) 2019-05-31
KR20180003452A (ko) 2018-01-09
PH12018502670A1 (en) 2019-10-07
JOP20180125A1 (ar) 2019-01-30
CA3028238A1 (fr) 2018-01-04
IL263630B2 (en) 2023-06-01
TWI736643B (zh) 2021-08-21
ES2975782T3 (es) 2024-07-15
PH12018502670B1 (en) 2023-03-24
EP3479819B1 (fr) 2024-01-24
DOP2018000290A (es) 2019-02-15
EP4338752A3 (fr) 2024-04-03
GEP20217249B (en) 2021-04-26
AU2017287743B2 (en) 2020-01-30
CL2018003662A1 (es) 2019-03-15
MD3479819T2 (ro) 2024-07-31
TN2018000443A1 (en) 2020-06-15
DK3479819T5 (da) 2024-09-09
KR102229274B1 (ko) 2021-03-18
AU2017287743A1 (en) 2018-11-22
US20210000743A1 (en) 2021-01-07
CN109310628A (zh) 2019-02-05
EP3479819A1 (fr) 2019-05-08
CA3028238C (fr) 2024-01-02
JP2019525902A (ja) 2019-09-12

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