JP6250646B2 - 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤 - Google Patents

生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤 Download PDF

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JP6250646B2
JP6250646B2 JP2015513185A JP2015513185A JP6250646B2 JP 6250646 B2 JP6250646 B2 JP 6250646B2 JP 2015513185 A JP2015513185 A JP 2015513185A JP 2015513185 A JP2015513185 A JP 2015513185A JP 6250646 B2 JP6250646 B2 JP 6250646B2
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composition
viscosity
arginine
therapeutic agent
guanidine
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JP2015517556A5 (enExample
JP2015517556A (ja
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デイビッド シュミット，
デイビッド シュミット，
ハンス−ヨアヒム ウォルニー，
ハンス−ヨアヒム ウォルニー，
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ノバルティス アーゲー
ノバルティス アーゲー
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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

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  • 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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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)
JP2015513185A 2012-05-25 2013-05-23 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤 Active JP6250646B2 (ja)

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

Related Child Applications (1)

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JP2017071601A Division JP6405406B2 (ja) 2012-05-25 2017-03-31 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤

Publications (3)

Publication Number Publication Date
JP2015517556A JP2015517556A (ja) 2015-06-22
JP2015517556A5 JP2015517556A5 (enExample) 2016-05-12
JP6250646B2 true JP6250646B2 (ja) 2017-12-20

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JP2015513185A Active JP6250646B2 (ja) 2012-05-25 2013-05-23 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤
JP2017071601A Expired - Fee Related JP6405406B2 (ja) 2012-05-25 2017-03-31 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤
JP2018172328A Pending JP2018193406A (ja) 2012-05-25 2018-09-14 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤

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JP2017071601A Expired - Fee Related JP6405406B2 (ja) 2012-05-25 2017-03-31 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤
JP2018172328A Pending JP2018193406A (ja) 2012-05-25 2018-09-14 生物学的治療薬およびグアニジンまたはグアニジン誘導体を含む水性医薬組成物、並びに該組成物を含む注射剤

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 (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016501931A (ja) 2012-11-21 2016-01-21 ユニバーシティー オブ ルイヴィル リサーチ ファウンデーション，インコーポレーテッドＵｎｉｖｅｒｓｉｔｙ Ｏｆ Ｌｏｕｉｓｖｉｌｌｅ Ｒｅｓｅａｒｃｈ Ｆｏｕｎｄａｔｉｏｎ，Ｉｎｃ． 酸化的損傷を減じるための組成物および方法
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
EP3118210B1 (en) * 2014-03-11 2019-11-13 Green Cross Holdings Corporation Method for purifying immunoglobulin
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog 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
WO2017094507A1 (ja) * 2015-11-30 2017-06-08 ロート製薬株式会社 眼科組成物
IL263481B2 (en) 2016-06-14 2024-06-01 Regeneron Pharma Anti-c5 antibodies and uses thereof
US12065482B2 (en) 2016-08-10 2024-08-20 Celltrion Inc. Stable liquid pharmaceutical formulation of 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
AU2018383751B2 (en) 2017-12-13 2025-05-08 Regeneron Pharmaceuticals, Inc. Anti-C5 antibody combinations and uses thereof
FI4185318T3 (fi) 2021-05-17 2025-10-13 Regeneron Pharma Pitkäaikaisia, suuren annoksen VEGF-antagonistihoitoja angiogeenisten silmäsairauksien hoitoon

Family Cites Families (11)

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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
WO2008113834A2 (en) * 2007-03-22 2008-09-25 Novartis Ag C5 antigens and uses thereof
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
CN107095846A (zh) 2009-12-21 2017-08-29 霍夫曼-拉罗奇有限公司 抗体配制剂
SI3409289T1 (sl) * 2010-02-26 2020-12-31 Novo Nordisk A/S Stabilni sestavki, ki vsebujejo protitelo

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ES2706059T3 (es) 2019-03-27
CO7270463A2 (es) 2015-05-19
JP6405406B2 (ja) 2018-10-17
CL2014003148A1 (es) 2015-02-27
AU2018203929A1 (en) 2018-06-21
WO2013174936A1 (en) 2013-11-28
MX2014014318A (es) 2015-02-12
JP2018193406A (ja) 2018-12-06
JP2017122123A (ja) 2017-07-13
AU2013265255A1 (en) 2014-09-25
US20130317457A1 (en) 2013-11-28
EP2854760B1 (en) 2018-10-17
ZA201406403B (en) 2019-01-30
US10010513B2 (en) 2018-07-03
RU2014152803A (ru) 2016-07-20
PH12014502352A1 (en) 2015-01-12
AR091155A1 (es) 2015-01-14
KR20150024301A (ko) 2015-03-06
CA2866232A1 (en) 2013-11-28
EP2854760A1 (en) 2015-04-08
AU2013265255B2 (en) 2018-03-29
CN104220047A (zh) 2014-12-17
CN104220047B (zh) 2019-11-15
JP2015517556A (ja) 2015-06-22

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