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MX2009012964A - Formulacion de peptido estable a alta temperatura. - Google Patents

Formulacion de peptido estable a alta temperatura.

Info

Publication number
MX2009012964A
MX2009012964A MX2009012964A MX2009012964A MX2009012964A MX 2009012964 A MX2009012964 A MX 2009012964A MX 2009012964 A MX2009012964 A MX 2009012964A MX 2009012964 A MX2009012964 A MX 2009012964A MX 2009012964 A MX2009012964 A MX 2009012964A
Authority
MX
Mexico
Prior art keywords
peptide
stability
lyophilized
lyophilized product
months
Prior art date
Application number
MX2009012964A
Other languages
English (en)
Inventor
Byeong Chang
Dennis Chen
Russell Wayne Blacher
Original Assignee
Acologix 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
Application filed by Acologix Inc filed Critical Acologix Inc
Publication of MX2009012964A publication Critical patent/MX2009012964A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • A61K47/26—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
    • A61K9/08—Solutions
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4702—Regulators; Modulating activity
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se describe en la presente una composición farmacéutica estabilizada en forma de producto liofilizado que se reconstituirá posteriormente para generar un producto fármaco acuoso. El ingrediente terapéuticamente activo en forma de péptido de la secuencia TDLQERGDNDISPFSGDGQPFKD se estabiliza con un amortiguador, estabilizador de carbohidrato, un agente de carga no iónico y un tensioactivo para facilitar la reconstitución. La preparación preferida contiene un péptido de la secuencia TDLQERGDNDISPFSGDGQPFKD, el amortiguador de histidina, mariitol o glicina, sucrosa y/o polisorbato 20. Esta combinación de excipientes ha demostrado estabilidad excepcional como un producto liofilizado cuando se almacena a temperatura elevada de 40 °C por lo menos durante 6 meses y por lo menos 3 meses a 50 °C. La mezcla liofilizada formada así se reconstituye a una alta concentración de péptido sin la pérdida evidente de estabilidad del péptido y también ha permitido la capacidad terminal de esterilizar el producto liofilizado usando la irradiación de rayos gamma sin afectar la estabilidad.
MX2009012964A 2007-06-01 2008-05-29 Formulacion de peptido estable a alta temperatura. MX2009012964A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US94155607P 2007-06-01 2007-06-01
US96908007P 2007-08-30 2007-08-30
PCT/US2008/006898 WO2008150479A2 (en) 2007-06-01 2008-05-29 High temperature stable peptide formulation

Publications (1)

Publication Number Publication Date
MX2009012964A true MX2009012964A (es) 2010-01-14

Family

ID=40094334

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2009012964A MX2009012964A (es) 2007-06-01 2008-05-29 Formulacion de peptido estable a alta temperatura.

Country Status (7)

Country Link
US (1) US7879805B2 (es)
EP (1) EP2150537A4 (es)
JP (1) JP2010530846A (es)
AU (1) AU2008260483A1 (es)
CA (1) CA2687246A1 (es)
MX (1) MX2009012964A (es)
WO (1) WO2008150479A2 (es)

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US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
CN104398471A (zh) * 2008-11-28 2015-03-11 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
CN102458469B (zh) * 2009-05-04 2014-12-24 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
NZ600118A (en) * 2009-11-23 2014-08-29 Cubist Pharm Inc Lipopeptide compositions and related methods
ES2617921T3 (es) 2010-03-31 2017-06-20 Stabilitech Ltd. Excipientes para estabilizar partículas virales
HUE026885T2 (en) 2010-03-31 2016-08-29 Stabilitech Ltd Stabilize virus fragments
AU2011234268B2 (en) 2010-03-31 2015-07-02 Stabilitech Ltd. Method for preserving alum adjuvants and alum-adjuvanted vaccines
DK2603600T3 (da) 2010-08-13 2019-03-04 Aileron Therapeutics Inc Peptidomimetiske makrocyklusser
JP5919606B2 (ja) 2010-11-11 2016-05-18 アッヴィ バイオテクノロジー リミテッド 改良型高濃度抗ｔｎｆアルファ抗体液体製剤
CN102488889B (zh) * 2011-09-26 2014-01-22 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103315969B (zh) * 2011-09-26 2016-05-18 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
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RU2019138024A (ru) * 2014-05-28 2019-12-05 Ноно Инк. ХЛОРИДНАЯ СОЛЬ ПЕПТИДА TAT-NR2B9c, КОМПОЗИЦИЯ НА ЕГО ОСНОВЕ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ
MX389354B (es) * 2014-09-24 2025-03-20 Aileron Therapeutics Inc Macrociclos peptidomimeticos y formulaciones de los mismos.
CA2961258A1 (en) 2014-09-24 2016-03-31 Aileron Therapeutics, Inc. Peptidomimetic macrocycles and uses thereof
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
CA2979847A1 (en) 2015-03-20 2016-09-29 Aileron Therapeutics, Inc. Peptidomimetic macrocycles and uses thereof
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Also Published As

Publication number Publication date
WO2008150479A3 (en) 2009-02-19
EP2150537A2 (en) 2010-02-10
JP2010530846A (ja) 2010-09-16
EP2150537A4 (en) 2010-09-22
US20090054331A1 (en) 2009-02-26
US7879805B2 (en) 2011-02-01
WO2008150479A2 (en) 2008-12-11
CA2687246A1 (en) 2008-12-11
AU2008260483A1 (en) 2008-12-11

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