ZA201406403B - 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

Info

Publication number
ZA201406403B
ZA201406403B ZA2014/06403A ZA201406403A ZA201406403B ZA 201406403 B ZA201406403 B ZA 201406403B ZA 2014/06403 A ZA2014/06403 A ZA 2014/06403A ZA 201406403 A ZA201406403 A ZA 201406403A ZA 201406403 B ZA201406403 B ZA 201406403B
Authority
ZA
South Africa
Prior art keywords
guanidine
therapeutic agent
aqueous pharmaceutical
pharmaceutical composition
composition containing
Prior art date
Application number
ZA2014/06403A
Other languages
English (en)
Inventor
Schmitt David
Wallny Hans-Joachim
Original Assignee
Novartis Ag A Swiss Company
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=ZA201406403(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag A Swiss Company filed Critical Novartis Ag A Swiss Company
Publication of ZA201406403B publication Critical patent/ZA201406403B/en

Links

Classifications

    • 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, ocular 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [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)
  • 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)
ZA2014/06403A 2012-05-25 2014-09-01 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition ZA201406403B (en)

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
ZA201406403B true ZA201406403B (en) 2019-01-30

Family

ID=48534372

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA2014/06403A ZA201406403B (en) 2012-05-25 2014-09-01 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 (OSRAM)
EP (1) EP2854760B1 (OSRAM)
JP (3) JP6250646B2 (OSRAM)
KR (1) KR20150024301A (OSRAM)
CN (1) CN104220047B (OSRAM)
AR (1) AR091155A1 (OSRAM)
AU (2) AU2013265255B2 (OSRAM)
CA (1) CA2866232A1 (OSRAM)
CL (1) CL2014003148A1 (OSRAM)
CO (1) CO7270463A2 (OSRAM)
ES (1) ES2706059T3 (OSRAM)
MX (1) MX2014014318A (OSRAM)
PH (1) PH12014502352A1 (OSRAM)
RU (1) RU2014152803A (OSRAM)
WO (1) WO2013174936A1 (OSRAM)
ZA (1) ZA201406403B (OSRAM)

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
MX391067B (es) * 2014-10-01 2025-03-21 Eagle Biologics Inc Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad.
CA3014030C (en) * 2015-02-09 2023-10-03 Ori Braun 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
MY196006A (en) 2016-06-14 2023-03-06 Regeneron Pharma Anti-C5 Antibodies and Uses Thereof
TWI656882B (zh) 2016-08-10 2019-04-21 南韓商賽特瑞恩股份有限公司 穩定的液體抗流感病毒抗體醫藥調配物
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
KR20200098528A (ko) 2017-12-13 2020-08-20 리제너론 파아마슈티컬스, 인크. 항-c5 항체 조합물 및 이의 용도

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
DK1313415T3 (da) 2000-08-30 2008-10-13 Univ Johns Hopkins Indretninger til intraokulær lægemiddeladministration
US20040191243A1 (en) * 2002-12-13 2004-09-30 Bei Chen System and method for stabilizing antibodies with histidine
US20060182783A1 (en) * 2004-04-30 2006-08-17 Allergan, Inc. Sustained release intraocular drug delivery systems
KR20100015773A (ko) * 2007-03-22 2010-02-12 노파르티스 아게 Ｃ５ 항원 및 그의 용도
MX2011001371A (es) 2008-08-05 2011-06-16 Novartis Ag Composiciones y metodos para anticuerpos que se dirigen a la proteina de complementos c5.
PL2515941T3 (pl) 2009-12-21 2020-04-30 F. Hoffmann-La Roche Ag Preparat farmaceutyczny zawierający bewacyzumab
BR112012021576A2 (pt) * 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.

Also Published As

Publication number Publication date
AU2018203929A1 (en) 2018-06-21
PH12014502352A1 (en) 2015-01-12
CA2866232A1 (en) 2013-11-28
JP6250646B2 (ja) 2017-12-20
JP6405406B2 (ja) 2018-10-17
EP2854760B1 (en) 2018-10-17
KR20150024301A (ko) 2015-03-06
CO7270463A2 (es) 2015-05-19
CN104220047B (zh) 2019-11-15
WO2013174936A1 (en) 2013-11-28
ES2706059T3 (es) 2019-03-27
US10010513B2 (en) 2018-07-03
AR091155A1 (es) 2015-01-14
JP2017122123A (ja) 2017-07-13
AU2013265255A1 (en) 2014-09-25
MX2014014318A (es) 2015-02-12
CN104220047A (zh) 2014-12-17
JP2015517556A (ja) 2015-06-22
CL2014003148A1 (es) 2015-02-27
AU2013265255B2 (en) 2018-03-29
JP2018193406A (ja) 2018-12-06
RU2014152803A (ru) 2016-07-20
EP2854760A1 (en) 2015-04-08
US20130317457A1 (en) 2013-11-28

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