CN104220047B - 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 - Google Patents

含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 Download PDF

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Publication number
CN104220047B
CN104220047B CN201380020203.0A CN201380020203A CN104220047B CN 104220047 B CN104220047 B CN 104220047B CN 201380020203 A CN201380020203 A CN 201380020203A CN 104220047 B CN104220047 B CN 104220047B
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composition
viscosity
biopharmaceuticals
arginine
guanidine
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Chinese (zh)
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CN104220047A (zh
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D·斯奇米特
H-J·沃尔尼
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Novartis AG
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Novartis AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic 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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts or implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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

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)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
CN201380020203.0A 2012-05-25 2013-05-23 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 Active CN104220047B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261651588P 2012-05-25 2012-05-25
US61/651,588 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 (2)

Publication Number Publication Date
CN104220047A CN104220047A (zh) 2014-12-17
CN104220047B true CN104220047B (zh) 2019-11-15

Family

ID=48534372

Family Applications (1)

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CN201380020203.0A Active CN104220047B (zh) 2012-05-25 2013-05-23 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂

Country Status (16)

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

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
CA2941232C (en) * 2014-03-11 2020-08-25 Green Cross Holdings Corporation Method for purifying immunoglobulin
EP3200804A4 (en) * 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
WO2016130478A1 (en) 2015-02-09 2016-08-18 University Of Louisville Research Foundation, Inc. Ophthalmic compositions and methods for reducing oxidative damage to an eye lens
JP6560764B2 (ja) * 2015-11-30 2019-08-14 ロート製薬株式会社 眼科組成物
ES2984352T3 (es) 2016-06-14 2024-10-29 Regeneron Pharma Anticuerpos anti-C5 y usos de los mismos
EP3498263B1 (en) 2016-08-10 2023-11-29 Celltrion Inc. Stable liquid pharmaceutical preparation for anti-influenza virus antibody
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
MA51147A (fr) 2017-12-13 2021-03-24 Regeneron Pharma Associations d'anticorps anti-c5 et utilisations associées

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2011084750A1 (en) * 2009-12-21 2011-07-14 Genentech, Inc. Antibody formulation

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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
ATE547080T1 (de) 2000-08-30 2012-03-15 Univ Johns Hopkins Vorrichtungen zur intraokularen arzneimittelabgabe
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
JP2010521194A (ja) * 2007-03-22 2010-06-24 ノバルティス アーゲー Ｃ５抗原およびその使用
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
BR112012021576A2 (pt) * 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011084750A1 (en) * 2009-12-21 2011-07-14 Genentech, Inc. Antibody formulation

Also Published As

Publication number Publication date
CL2014003148A1 (es) 2015-02-27
CO7270463A2 (es) 2015-05-19
PH12014502352A1 (en) 2015-01-12
MX2014014318A (es) 2015-02-12
JP6250646B2 (ja) 2017-12-20
JP2017122123A (ja) 2017-07-13
EP2854760B1 (en) 2018-10-17
AU2013265255B2 (en) 2018-03-29
ZA201406403B (en) 2019-01-30
JP2015517556A (ja) 2015-06-22
WO2013174936A1 (en) 2013-11-28
JP6405406B2 (ja) 2018-10-17
US20130317457A1 (en) 2013-11-28
KR20150024301A (ko) 2015-03-06
CN104220047A (zh) 2014-12-17
US10010513B2 (en) 2018-07-03
AR091155A1 (es) 2015-01-14
EP2854760A1 (en) 2015-04-08
CA2866232A1 (en) 2013-11-28
AU2013265255A1 (en) 2014-09-25
AU2018203929A1 (en) 2018-06-21
RU2014152803A (ru) 2016-07-20
ES2706059T3 (es) 2019-03-27
JP2018193406A (ja) 2018-12-06

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