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AR079127A1 - Composiciones de daptomicina y metodos relacionados - Google Patents

Composiciones de daptomicina y metodos relacionados

Info

Publication number
AR079127A1
AR079127A1 ARP100104318A AR079127A1 AR 079127 A1 AR079127 A1 AR 079127A1 AR P100104318 A ARP100104318 A AR P100104318A AR 079127 A1 AR079127 A1 AR 079127A1
Authority
AR
Argentina
Prior art keywords
daptomycin
preparation
solid
sucrose
powdered
Prior art date
Application number
Other languages
English (en)
Inventor
Sandra O'connor
Original Assignee
Cubist Pharm Inc
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=44060422&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR079127(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cubist Pharm Inc filed Critical Cubist Pharm Inc
Publication of AR079127A1 publication Critical patent/AR079127A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10Peptides having 12 to 20 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K11/00Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K11/02Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof cyclic, e.g. valinomycins ; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Formulaciones de daptomicina en polvo que tienen estabilidad mejorada y tiempos de reconstitucion más rápidos cuando están en estado solido. Algunos ejemplos de las composiciones comprenden daptomicina y sacarosa. Reivindicacion 1: Una preparacion de daptomicina solida con reconstitucion aumentada y estabilidad de daptomicina aumentada en formas en polvo y reconstituida, caracterizada porque la preparacion de daptomicina solida comprende daptomicina, sacarosa, y un agente amortiguador fosfato; en donde: a) la preparacion de daptomicina solida es al menos 92% daptomicina pura, segun se calcula mediante la proporcion de absorbancia (área bajo la curva) a 214 nm para la daptomicina dividido por el área total bajo la curva medida mediante cromatografía líquida de alto rendimiento (HPLC) de la solucion de daptomicina reconstituida a 214 nm de acuerdo a la Tabla 3; y b) la preparacion de daptomicina se puede obtener mediante los pasos de: i) formar una solucion acuosa de daptomicina que comprende 105 mg/ml (10,5% peso en volumen) de daptomicina, 7,1 mg/ml (50 mM) de un agente amortiguador fosfato dibásico de sodio y 150 mg/mI (15% peso en volumen) de sacarosa a un pH de aproximadamente 7,0; y ii) convertir la formulacion de daptomicina acuosa a la preparacion de daptomicina solida.
ARP100104318 2009-11-23 2010-11-23 Composiciones de daptomicina y metodos relacionados AR079127A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US26378409P 2009-11-23 2009-11-23

Publications (1)

Publication Number Publication Date
AR079127A1 true AR079127A1 (es) 2011-12-28

Family

ID=44060422

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP100104318 AR079127A1 (es) 2009-11-23 2010-11-23 Composiciones de daptomicina y metodos relacionados
ARP210102879A AR123846A2 (es) 2009-11-23 2021-10-19 Composición farmacéutica sólida liofilizada de daptomicina

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP210102879A AR123846A2 (es) 2009-11-23 2021-10-19 Composición farmacéutica sólida liofilizada de daptomicina

Country Status (33)

Country Link
US (3) US8835382B2 (es)
EP (2) EP3417849A1 (es)
JP (3) JP6041673B2 (es)
CN (3) CN104056250A (es)
AR (2) AR079127A1 (es)
AU (1) AU2010321531C1 (es)
BR (1) BR112012012406B1 (es)
CA (1) CA2781666C (es)
CL (2) CL2012001336A1 (es)
CO (1) CO6541585A2 (es)
CR (1) CR20120271A (es)
CY (1) CY1120854T1 (es)
DK (1) DK2504353T4 (es)
DO (1) DOP2012000140A (es)
EC (1) ECSP12011939A (es)
ES (1) ES2686331T5 (es)
FI (1) FI2504353T4 (es)
HR (1) HRP20181380T4 (es)
HU (1) HUE039967T2 (es)
IL (1) IL219891B (es)
LT (1) LT2504353T (es)
MX (1) MX2012005993A (es)
NZ (1) NZ600118A (es)
PE (2) PE20151717A1 (es)
PL (1) PL2504353T5 (es)
PT (1) PT2504353T (es)
RS (1) RS57566B2 (es)
RU (1) RU2607526C2 (es)
SG (1) SG10201407724YA (es)
SI (1) SI2504353T2 (es)
TR (1) TR201812823T4 (es)
TW (2) TWI548414B (es)
WO (1) WO2011063419A2 (es)

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CN110339341A (zh) * 2018-04-03 2019-10-18 江苏恒瑞医药股份有限公司 一种达托霉素或其盐的组合物
CN110548130A (zh) * 2018-06-04 2019-12-10 浙江医药股份有限公司新昌制药厂 含达托霉素的喷雾干粉及其工业化制备方法
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JP7582205B2 (ja) * 2019-12-26 2024-11-13 ニプロ株式会社 ダプトマイシンを含有する安定した凍結乾燥製剤
AU2021227095B2 (en) 2020-02-28 2024-02-22 Xellia Pharmaceuticals Aps Daptomycin formulation
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CN114788814B (zh) * 2021-01-26 2023-10-13 浙江创新生物有限公司 一种高稳定性的注射用达托霉素组合物及其制备方法和其应用
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Also Published As

Publication number Publication date
NZ600118A (en) 2014-08-29
EP2504353A4 (en) 2014-04-02
US8835382B2 (en) 2014-09-16
SI2504353T1 (sl) 2018-10-30
LT2504353T (lt) 2018-09-25
US9138456B2 (en) 2015-09-22
CL2015002412A1 (es) 2016-02-05
IL219891A0 (en) 2012-07-31
JP2017075186A (ja) 2017-04-20
DK2504353T4 (da) 2023-11-20
US20140364380A1 (en) 2014-12-11
TW201141506A (en) 2011-12-01
CY1120854T1 (el) 2019-12-11
CN104056250A (zh) 2014-09-24
WO2011063419A3 (en) 2011-10-13
ECSP12011939A (es) 2012-07-31
TWI548414B (zh) 2016-09-11
PE20121517A1 (es) 2012-11-26
CN108785654A (zh) 2018-11-13
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BR112012012406B1 (pt) 2021-11-16
FI2504353T4 (fi) 2023-11-30
CN102712677A (zh) 2012-10-03
US20160030577A1 (en) 2016-02-04
AU2010321531B2 (en) 2016-11-03
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EP2504353A2 (en) 2012-10-03
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RU2012126076A (ru) 2013-12-27
AU2010321531A1 (en) 2012-06-14
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RS57566B1 (sr) 2018-10-31
CA2781666C (en) 2017-02-21
RU2607526C2 (ru) 2017-01-10
AU2010321531C1 (en) 2020-10-01
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BR112012012406A2 (pt) 2019-12-03
RS57566B2 (sr) 2023-12-29
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US9662397B2 (en) 2017-05-30
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JP6088681B2 (ja) 2017-03-01
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SI2504353T2 (sl) 2023-11-30
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