ES2706059T3 - Composición farmacéutica acuosa que contiene un agente terapéutico biológico y derivado de L-arginina y una inyección que incluye la composición - Google Patents

Composición farmacéutica acuosa que contiene un agente terapéutico biológico y derivado de L-arginina y una inyección que incluye la composición Download PDF

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Publication number
ES2706059T3
ES2706059T3 ES13725348T ES13725348T ES2706059T3 ES 2706059 T3 ES2706059 T3 ES 2706059T3 ES 13725348 T ES13725348 T ES 13725348T ES 13725348 T ES13725348 T ES 13725348T ES 2706059 T3 ES2706059 T3 ES 2706059T3
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ES
Spain
Prior art keywords
composition
arginine
typically
injection
concentration
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES13725348T
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English (en)
Spanish (es)
Inventor
David Schmitt
Hans-Joachim Wallny
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Original Assignee
Novartis AG
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48534372&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2706059(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Application granted granted Critical
Publication of ES2706059T3 publication Critical patent/ES2706059T3/es
Active legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • A61K9/0051Ocular inserts, ocular implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
ES13725348T 2012-05-25 2013-05-23 Composición farmacéutica acuosa que contiene un agente terapéutico biológico y derivado de L-arginina y una inyección que incluye la composición Active ES2706059T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261651588P 2012-05-25 2012-05-25
PCT/EP2013/060649 WO2013174936A1 (en) 2012-05-25 2013-05-23 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition

Publications (1)

Publication Number Publication Date
ES2706059T3 true ES2706059T3 (es) 2019-03-27

Family

ID=48534372

Family Applications (1)

Application Number Title Priority Date Filing Date
ES13725348T Active ES2706059T3 (es) 2012-05-25 2013-05-23 Composición farmacéutica acuosa que contiene un agente terapéutico biológico y derivado de L-arginina y una inyección que incluye la composición

Country Status (16)

Country Link
US (1) US10010513B2 (enExample)
EP (1) EP2854760B1 (enExample)
JP (3) JP6250646B2 (enExample)
KR (1) KR20150024301A (enExample)
CN (1) CN104220047B (enExample)
AR (1) AR091155A1 (enExample)
AU (2) AU2013265255B2 (enExample)
CA (1) CA2866232A1 (enExample)
CL (1) CL2014003148A1 (enExample)
CO (1) CO7270463A2 (enExample)
ES (1) ES2706059T3 (enExample)
MX (1) MX2014014318A (enExample)
PH (1) PH12014502352A1 (enExample)
RU (1) RU2014152803A (enExample)
WO (1) WO2013174936A1 (enExample)
ZA (1) ZA201406403B (enExample)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105164204A (zh) 2012-11-21 2015-12-16 路易斯维尔大学研究基金会 用于降低氧化损伤的组合物和方法
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
ES2769783T3 (es) * 2014-03-11 2020-06-29 Green Cross Holdings Corp Procedimiento de purificación de inmunoglobulina
AU2015325055B2 (en) * 2014-10-01 2021-02-25 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
EP3256136A4 (en) 2015-02-09 2018-11-21 University Of Louisville Research Foundation, Inc. Ophthalmic compositions and methods for reducing oxidative damage to an eye lens
TW201722437A (zh) * 2015-11-30 2017-07-01 Rohto Pharma 眼科組成物
MY191668A (en) 2016-06-14 2022-07-06 Regeneron Pharma Anti-c5 antibodies and uses thereof
ES2968923T3 (es) 2016-08-10 2024-05-14 Celltrion Inc Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe
KR102262743B1 (ko) 2017-07-07 2021-06-09 에이치케이이노엔 주식회사 주사용 조성물
GB201713660D0 (en) * 2017-08-25 2017-10-11 Kalvista Pharmaceuticals Ltd Pharmaceutical compositions
JP2021506241A (ja) 2017-12-13 2021-02-22 リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. 抗c5抗体組み合わせ物およびその使用

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5364884A (en) * 1993-01-21 1994-11-15 Baylor College Of Medicine Arginine compounds as ocular hypotensive agents
US5658948A (en) * 1994-03-02 1997-08-19 Allergan Enhancement of benzalkonium chloride preservative activity in formulations containing an incompatible drug using amino acids having net positive charge
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US6462071B1 (en) * 2000-03-02 2002-10-08 Vitreo-Retinal Technologies, Inc. Agents for intravitreal administration to treat or prevent disorders of the eye
AU2001271417B2 (en) 2000-08-30 2006-10-05 Johns Hopkins University Devices for intraocular drug delivery
AU2003293543A1 (en) * 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
US20060182783A1 (en) * 2004-04-30 2006-08-17 Allergan, Inc. Sustained release intraocular drug delivery systems
EP2129681A2 (en) * 2007-03-22 2009-12-09 Novartis Ag C5 antigens and uses thereof
WO2010015608A1 (en) 2008-08-05 2010-02-11 Novartis Ag Compositions and methods for antibodies targeting complement protein c5
ES2765657T3 (es) * 2009-12-21 2020-06-10 Hoffmann La Roche Formulación farmacéutica de bevacizumab
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions

Also Published As

Publication number Publication date
US20130317457A1 (en) 2013-11-28
AU2013265255B2 (en) 2018-03-29
JP2018193406A (ja) 2018-12-06
PH12014502352A1 (en) 2015-01-12
CN104220047A (zh) 2014-12-17
CO7270463A2 (es) 2015-05-19
AU2013265255A1 (en) 2014-09-25
WO2013174936A1 (en) 2013-11-28
EP2854760A1 (en) 2015-04-08
KR20150024301A (ko) 2015-03-06
ZA201406403B (en) 2019-01-30
JP6405406B2 (ja) 2018-10-17
EP2854760B1 (en) 2018-10-17
AU2018203929A1 (en) 2018-06-21
AR091155A1 (es) 2015-01-14
US10010513B2 (en) 2018-07-03
CL2014003148A1 (es) 2015-02-27
CA2866232A1 (en) 2013-11-28
RU2014152803A (ru) 2016-07-20
CN104220047B (zh) 2019-11-15
JP6250646B2 (ja) 2017-12-20
JP2017122123A (ja) 2017-07-13
JP2015517556A (ja) 2015-06-22
MX2014014318A (es) 2015-02-12

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