AU2013265255B2 - Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition - Google Patents

Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition Download PDF

Info

Publication number
AU2013265255B2
AU2013265255B2 AU2013265255A AU2013265255A AU2013265255B2 AU 2013265255 B2 AU2013265255 B2 AU 2013265255B2 AU 2013265255 A AU2013265255 A AU 2013265255A AU 2013265255 A AU2013265255 A AU 2013265255A AU 2013265255 B2 AU2013265255 B2 AU 2013265255B2
Authority
AU
Australia
Prior art keywords
composition
therapeutic agent
viscosity
biologic
arginine
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
AU2013265255A
Other languages
English (en)
Other versions
AU2013265255A1 (en
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
Family has litigation
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=AU2013265255(B2) "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
Publication of AU2013265255A1 publication Critical patent/AU2013265255A1/en
Application granted granted Critical
Publication of AU2013265255B2 publication Critical patent/AU2013265255B2/en
Priority to AU2018203929A priority Critical patent/AU2018203929A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K31/13—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
    • 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)
  • 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)
AU2013265255A 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 Active AU2013265255B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2018203929A AU2018203929A1 (en) 2012-05-25 2018-06-04 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition

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)

Application Number Title Priority Date Filing Date
AU2018203929A Division AU2018203929A1 (en) 2012-05-25 2018-06-04 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
AU2013265255A1 AU2013265255A1 (en) 2014-09-25
AU2013265255B2 true AU2013265255B2 (en) 2018-03-29

Family

ID=48534372

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2013265255A Active AU2013265255B2 (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
AU2018203929A Abandoned AU2018203929A1 (en) 2012-05-25 2018-06-04 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2018203929A Abandoned AU2018203929A1 (en) 2012-05-25 2018-06-04 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition

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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004055164A2 (en) * 2002-12-13 2004-07-01 Abgenix, Inc. System and method for stabilizing antibodies with histidine
WO2008113834A2 (en) * 2007-03-22 2008-09-25 Novartis Ag C5 antigens and uses thereof
WO2011084750A1 (en) * 2009-12-21 2011-07-14 Genentech, Inc. Antibody formulation

Family Cites Families (8)

* 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
ATE547080T1 (de) 2000-08-30 2012-03-15 Univ Johns Hopkins Vorrichtungen zur intraokularen arzneimittelabgabe
US20060182783A1 (en) * 2004-04-30 2006-08-17 Allergan, Inc. Sustained release intraocular drug delivery systems
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
SI3409289T1 (sl) * 2010-02-26 2020-12-31 Novo Nordisk A/S Stabilni sestavki, ki vsebujejo protitelo

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004055164A2 (en) * 2002-12-13 2004-07-01 Abgenix, Inc. System and method for stabilizing antibodies with histidine
WO2008113834A2 (en) * 2007-03-22 2008-09-25 Novartis Ag C5 antigens and uses thereof
WO2011084750A1 (en) * 2009-12-21 2011-07-14 Genentech, Inc. Antibody formulation

Also Published As

Publication number Publication date
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
JP6250646B2 (ja) 2017-12-20
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
CN104220047A (zh) 2014-12-17
CN104220047B (zh) 2019-11-15
JP2015517556A (ja) 2015-06-22

Similar Documents

Publication Publication Date Title
US10010513B2 (en) Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition
AU2020244614B2 (en) Stable protein solution formulation containing high concentration of an anti-VEGF antibody
US20210340248A1 (en) Stabilized antibody compositions
US20240182554A1 (en) Protein solution formulation containing high concentration of an anti-vegf antibody
CA3201348A1 (en) Antibody compositions and methods of use thereof
HRP20241131T1 (hr) Visokokoncentrirane formulacije inhibitornih antitijela masp-2 niske viskoznosti, pribori i metode
EP3071181A1 (en) Pharmaceutical composition of an anti-vegf antibody
CN111683681B (zh) 包含抗ox40抗体的制剂、其制备方法及其用途
US20250332252A1 (en) Antibody compositions and methods of use thereof
EA042435B1 (ru) Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)