CA2900114C - Stable nocathiacin lyophilized injection agent - Google Patents

Stable nocathiacin lyophilized injection agent Download PDF

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Publication number
CA2900114C
CA2900114C CA2900114A CA2900114A CA2900114C CA 2900114 C CA2900114 C CA 2900114C CA 2900114 A CA2900114 A CA 2900114A CA 2900114 A CA2900114 A CA 2900114A CA 2900114 C CA2900114 C CA 2900114C
Authority
CA
Canada
Prior art keywords
nocathiacin
stable
pharmaceutical agent
agent containing
lyophilized pharmaceutical
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.)
Expired - Fee Related
Application number
CA2900114A
Other languages
English (en)
French (fr)
Other versions
CA2900114A1 (en
Inventor
Yijun Chen
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.)
NANJING BIOTICA PHARMACEUTICAL Co
Original Assignee
NANJING BIOTICA PHARMACEUTICAL Co
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
Application filed by NANJING BIOTICA PHARMACEUTICAL Co filed Critical NANJING BIOTICA PHARMACEUTICAL Co
Publication of CA2900114A1 publication Critical patent/CA2900114A1/en
Application granted granted Critical
Publication of CA2900114C publication Critical patent/CA2900114C/en
Expired - Fee Related 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Inorganic Chemistry (AREA)
CA2900114A 2013-02-05 2013-09-12 Stable nocathiacin lyophilized injection agent Expired - Fee Related CA2900114C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2013100448189A CN103040769A (zh) 2013-02-05 2013-02-05 一种稳定的诺卡沙星粉针冻干剂
CN201310044818.9 2013-02-05
PCT/CN2013/083366 WO2014121611A1 (zh) 2013-02-05 2013-09-12 一种稳定的诺卡沙星粉针冻干剂

Publications (2)

Publication Number Publication Date
CA2900114A1 CA2900114A1 (en) 2014-08-14
CA2900114C true CA2900114C (en) 2017-06-13

Family

ID=48053782

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2900114A Expired - Fee Related CA2900114C (en) 2013-02-05 2013-09-12 Stable nocathiacin lyophilized injection agent

Country Status (11)

Country Link
US (1) US9616125B2 (enExample)
EP (1) EP2954894B1 (enExample)
JP (1) JP6063064B2 (enExample)
KR (1) KR101801177B1 (enExample)
CN (1) CN103040769A (enExample)
AU (1) AU2013377601B2 (enExample)
CA (1) CA2900114C (enExample)
DK (1) DK2954894T3 (enExample)
ES (1) ES2749474T3 (enExample)
RU (1) RU2015137828A (enExample)
WO (1) WO2014121611A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103040769A (zh) * 2013-02-05 2013-04-17 南京碧迪可医药科技有限公司 一种稳定的诺卡沙星粉针冻干剂
CN104771359A (zh) * 2015-04-02 2015-07-15 南京正大天晴制药有限公司 一种稳定的盐酸莫西沙星注射液
CN107469068B (zh) * 2017-08-04 2021-06-22 南京碧迪可医药科技有限公司 一种硫肽环素的药物组合物
KR20230141971A (ko) * 2022-03-24 2023-10-10 주식회사 엘지화학 이소옥사졸린 유도체를 포함하는 주사용 제제 및 이의 제조방법

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020055465A1 (en) * 2000-08-14 2002-05-09 Wenying Li Nocathiacin antibiotics prepared by biotransformation or chemical methods
WO2003086443A1 (en) * 2002-04-11 2003-10-23 Medimmune Vaccines, Inc. Spray freeze dry of compositions for intranasal administration
US8436190B2 (en) * 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
US8158152B2 (en) * 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
US20080132500A1 (en) * 2006-10-20 2008-06-05 Kun Liu Antibiotic compounds
GB0821806D0 (en) * 2008-11-28 2009-01-07 Circassia Ltd Compositions with reduced dimer formation
DK2525830T3 (en) * 2010-01-22 2016-08-15 Ascendis Pharma As DIPEPTID-BASED PRODRUG LINKERS TO ALIFATIC AMINE-CONTAINING MEDICINES
CN102018953B (zh) * 2010-11-18 2013-05-01 南京碧迪可医药科技有限公司 含诺卡沙星抗生素的药物组合物
CN103040769A (zh) * 2013-02-05 2013-04-17 南京碧迪可医药科技有限公司 一种稳定的诺卡沙星粉针冻干剂
CN103040770B (zh) * 2013-02-05 2016-08-17 南京碧迪可医药科技有限公司 一种诺卡沙星冻干粉针剂的制备方法

Also Published As

Publication number Publication date
EP2954894A1 (en) 2015-12-16
EP2954894B1 (en) 2019-08-14
CA2900114A1 (en) 2014-08-14
DK2954894T3 (da) 2019-08-26
AU2013377601A1 (en) 2015-08-27
KR20150113201A (ko) 2015-10-07
WO2014121611A1 (zh) 2014-08-14
KR101801177B1 (ko) 2017-11-24
EP2954894A4 (en) 2016-06-15
JP2016507535A (ja) 2016-03-10
US20150374824A1 (en) 2015-12-31
ES2749474T3 (es) 2020-03-20
AU2013377601B2 (en) 2017-02-02
JP6063064B2 (ja) 2017-01-18
RU2015137828A (ru) 2017-03-10
CN103040769A (zh) 2013-04-17
US9616125B2 (en) 2017-04-11

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Effective date: 20150804

EEER Examination request

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Effective date: 20220912