PH12014502352A1 - 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
PH12014502352A1
PH12014502352A1 PH12014502352A PH12014502352A PH12014502352A1 PH 12014502352 A1 PH12014502352 A1 PH 12014502352A1 PH 12014502352 A PH12014502352 A PH 12014502352A PH 12014502352 A PH12014502352 A PH 12014502352A PH 12014502352 A1 PH12014502352 A1 PH 12014502352A1
Authority
PH
Philippines
Prior art keywords
guanidine
composition
therapeutic agent
aqueous pharmaceutical
pharmaceutical composition
Prior art date
Application number
PH12014502352A
Other languages
English (en)
Inventor
Schmitt David
Wallny Hans-Joachim
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=PH12014502352(A1) "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 PH12014502352A1 publication Critical patent/PH12014502352A1/en

Links

Classifications

    • 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
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (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)
PH12014502352A 2012-05-25 2014-10-21 Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition PH12014502352A1 (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
PH12014502352A1 true PH12014502352A1 (en) 2015-01-12

Family

ID=48534372

Family Applications (1)

Application Number Title Priority Date Filing Date
PH12014502352A PH12014502352A1 (en) 2012-05-25 2014-10-21 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 (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
CN106414476B (zh) * 2014-03-11 2019-12-31 株式会社绿十字控股 用于纯化免疫球蛋白的方法
WO2016054259A1 (en) * 2014-10-01 2016-04-07 Arsia Therapeutics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
US11406591B2 (en) * 2015-02-09 2022-08-09 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
EP4374922A3 (en) 2016-06-14 2024-08-28 Regeneron Pharmaceuticals, Inc. Anti-c5 antibodies and uses thereof
WO2018030777A1 (ko) * 2016-08-10 2018-02-15 ㈜셀트리온 항-인플루엔자 바이러스 항체의 안정한 액체 약제학적 제제
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
SG11202004662RA (en) 2017-12-13 2020-06-29 Regeneron Pharma Anti-c5 antibody combinations and uses thereof

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
WO2004055164A2 (en) * 2002-12-13 2004-07-01 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
EA200901211A1 (ru) * 2007-03-22 2010-04-30 Новартис Аг Антигены белка с5 и их применение
PT2328616E (pt) 2008-08-05 2015-08-26 Novartis Ag Composições e métodos para anticorpos dirigidos à proteína c5 do complemento
CN102770158B (zh) * 2009-12-21 2016-10-19 霍夫曼-拉罗奇有限公司 抗体配制剂
EP3216462A3 (en) * 2010-02-26 2017-12-20 Novo Nordisk A/S Stable antibody containing compositions

Also Published As

Publication number Publication date
EP2854760B1 (en) 2018-10-17
AU2013265255B2 (en) 2018-03-29
CN104220047A (zh) 2014-12-17
RU2014152803A (ru) 2016-07-20
JP6250646B2 (ja) 2017-12-20
KR20150024301A (ko) 2015-03-06
US20130317457A1 (en) 2013-11-28
CN104220047B (zh) 2019-11-15
JP2017122123A (ja) 2017-07-13
MX2014014318A (es) 2015-02-12
AU2013265255A1 (en) 2014-09-25
WO2013174936A1 (en) 2013-11-28
CA2866232A1 (en) 2013-11-28
EP2854760A1 (en) 2015-04-08
JP6405406B2 (ja) 2018-10-17
JP2015517556A (ja) 2015-06-22
ZA201406403B (en) 2019-01-30
AR091155A1 (es) 2015-01-14
CL2014003148A1 (es) 2015-02-27
CO7270463A2 (es) 2015-05-19
AU2018203929A1 (en) 2018-06-21
US10010513B2 (en) 2018-07-03
ES2706059T3 (es) 2019-03-27
JP2018193406A (ja) 2018-12-06

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