BRPI0809326B8 - métodos de preparação de microesfera de liberação controlada contendo exendina com camada de revestimento, composição e microesfera - Google Patents

métodos de preparação de microesfera de liberação controlada contendo exendina com camada de revestimento, composição e microesfera

Info

Publication number
BRPI0809326B8
BRPI0809326B8 BRPI0809326A BRPI0809326A BRPI0809326B8 BR PI0809326 B8 BRPI0809326 B8 BR PI0809326B8 BR PI0809326 A BRPI0809326 A BR PI0809326A BR PI0809326 A BRPI0809326 A BR PI0809326A BR PI0809326 B8 BRPI0809326 B8 BR PI0809326B8
Authority
BR
Brazil
Prior art keywords
controlled release
microsphere
active ingredient
exendin
composition
Prior art date
Application number
BRPI0809326A
Other languages
English (en)
Inventor
Lim Chae-Jin
Seol Eun-Young
Lee Hee-Yong
Choi Ho-Il
Kim Joon-Sik
Lee Ju-Han
Kim Jung-Soo
Baek Mi-Jin
Baek Mi-Young
Chae Yeon-Jin
Original Assignee
Peptron Co Ltd
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 Peptron Co Ltd filed Critical Peptron Co Ltd
Publication of BRPI0809326A2 publication Critical patent/BRPI0809326A2/pt
Publication of BRPI0809326B1 publication Critical patent/BRPI0809326B1/pt
Publication of BRPI0809326B8 publication Critical patent/BRPI0809326B8/pt

Links

Classifications

    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/2278Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
    • 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
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof

Abstract

métodos de preparação de microesfera de liberação controlada contendo exendina com camada de revestimento, composição e microesfera. são proporcionadas uma composição de liberação controlada e microesferas de liberação controlada contendo exendina como ingrediente ativo e um método de preparação da mesma. mais especificamente, são proporcionados uma composição de liberação controlada contendo exendina como ingrediente ativo, um polímero biodegradável como uma viscosidade especifica e materiais de revestimento, tendo elevada biodisponibilidade e exibindo liberação sustentada do ingrediente ativo numa concentração efetiva para um certo período sem uma explosão inicial excessiva do ingrediente ativo: microesferas de liberação controlada contendo um núcleo incluindo exendina como ingrediente ativo e um polímero biodegradável e uma camada de revestimento que recobre o núcleo; e um método de preparação de microesferas de liberação controlada incluindo as etapas de misturar uma exendina, um polímero biodegradável e um solvente, remover o solvente a partir da mistura para preparar a microesferas endurecidas e revestimento sobre a superfície de cada microesfera.
BRPI0809326A 2007-03-27 2008-01-22 métodos de preparação de microesfera de liberação controlada contendo exendina com camada de revestimento, composição e microesfera BRPI0809326B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020070029586A KR100805208B1 (ko) 2007-03-27 2007-03-27 엑센딘 함유 서방성 제제 조성물, 엑센딘 함유 서방성미립구 및 이의 제조 방법
PCT/KR2008/000397 WO2008117927A1 (en) 2007-03-27 2008-01-22 Composition and microsphere for controlled-release of exendin, and method of preparing the same
KR10-2007-0029586 2008-03-27

Publications (3)

Publication Number Publication Date
BRPI0809326A2 BRPI0809326A2 (pt) 2014-09-23
BRPI0809326B1 BRPI0809326B1 (pt) 2020-10-13
BRPI0809326B8 true BRPI0809326B8 (pt) 2021-05-25

Family

ID=39382592

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0809326A BRPI0809326B8 (pt) 2007-03-27 2008-01-22 métodos de preparação de microesfera de liberação controlada contendo exendina com camada de revestimento, composição e microesfera

Country Status (16)

Country Link
US (1) US9155702B2 (pt)
EP (1) EP2134329B1 (pt)
JP (1) JP5135428B2 (pt)
KR (1) KR100805208B1 (pt)
CN (1) CN101646424B (pt)
AU (1) AU2008230297B2 (pt)
BR (1) BRPI0809326B8 (pt)
CA (1) CA2682499C (pt)
ES (1) ES2528282T3 (pt)
IL (1) IL201024A (pt)
MX (1) MX2009010280A (pt)
MY (1) MY150087A (pt)
PL (1) PL2134329T3 (pt)
RU (1) RU2463040C2 (pt)
WO (1) WO2008117927A1 (pt)
ZA (1) ZA200906381B (pt)

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US20100183876A1 (en) * 2008-12-23 2010-07-22 Hell Andre Process for the Preparation of a Peptide Powder Form
CN102370611B (zh) * 2010-08-17 2013-09-18 东莞太力生物工程有限公司 一种包含exendin-4的温度敏感型水凝胶及其注射剂
WO2012098188A1 (en) * 2011-01-19 2012-07-26 Novo Nordisk A/S Glp-1 particles and compositions
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CN105688188A (zh) * 2011-11-18 2016-06-22 瑞泽恩制药公司 聚合物蛋白微粒
CN102688198B (zh) * 2012-06-19 2015-04-15 广州帝奇医药技术有限公司 多肽药物缓释微球制剂及其制备方法
US10568975B2 (en) 2013-02-05 2020-02-25 The Johns Hopkins University Nanoparticles for magnetic resonance imaging tracking and methods of making and using thereof
CN104107165B (zh) * 2013-04-17 2018-11-30 长春百益制药有限责任公司 一种艾塞那肽微球制剂、其制备方法及其应用
CN104840415B (zh) 2014-02-19 2019-03-15 香港浸会大学 含有降血糖活性成分的长效控释脂质体凝胶组合物及其制备方法
JP2017511371A (ja) * 2014-04-16 2017-04-20 シャンドン ルイ ファーマシューティカル カンパニー リミテッド エクセナチド含有組成物及びその製造方法
WO2015175545A1 (en) 2014-05-12 2015-11-19 The Johns Hopkins University Highly stable biodegradable gene vector platforms for overcoming biological barriers
US9480640B2 (en) * 2014-09-24 2016-11-01 Hongkai Zhang Nano freeze dry process of preparation of highly bioactive agent and its method of use
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AU2016338410B2 (en) 2015-10-14 2021-07-15 X-Therma, Inc. Compositions and methods for reducing ice crystal formation
CN107405307B (zh) * 2015-12-22 2020-11-10 四川科伦药物研究院有限公司 一种艾塞那肽微球制剂及其制备方法
EP3528836A1 (en) 2016-10-20 2019-08-28 Peptron, Inc. Methods of delivering a neuroprotective polypeptide to the central nervous system
EP3600258A1 (en) 2017-03-20 2020-02-05 Teva Pharmaceuticals International GmbH Sustained release olanzapine formulaitons
US20200353127A1 (en) * 2018-01-10 2020-11-12 G2Gbio, Inc. Collagen peptide-containing polycaprolactone microsphere filler and preparation method therefor
AU2019401868B2 (en) * 2018-12-17 2023-07-27 G2Gbio, Inc. Sustained-release injection comprising deslorelin, and preparation method therefor
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CN114206374A (zh) * 2019-07-29 2022-03-18 佩特通公司 用于治疗左旋多巴诱导的运动障碍或用于抑制其进展的药物组合物
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Also Published As

Publication number Publication date
IL201024A (en) 2014-01-30
EP2134329A4 (en) 2013-07-10
AU2008230297A1 (en) 2008-10-02
CA2682499C (en) 2013-01-08
JP5135428B2 (ja) 2013-02-06
IL201024A0 (en) 2010-05-17
MX2009010280A (es) 2009-10-12
RU2463040C2 (ru) 2012-10-10
RU2009136655A (ru) 2011-05-10
US9155702B2 (en) 2015-10-13
ES2528282T3 (es) 2015-02-06
CN101646424A (zh) 2010-02-10
CA2682499A1 (en) 2008-10-02
PL2134329T3 (pl) 2015-07-31
WO2008117927A1 (en) 2008-10-02
AU2008230297B2 (en) 2010-07-29
BRPI0809326B1 (pt) 2020-10-13
EP2134329B1 (en) 2015-01-07
JP2010522743A (ja) 2010-07-08
CN101646424B (zh) 2013-03-20
BRPI0809326A2 (pt) 2014-09-23
EP2134329A1 (en) 2009-12-23
ZA200906381B (en) 2010-11-24
MY150087A (en) 2013-11-29
US20100136126A1 (en) 2010-06-03
KR100805208B1 (ko) 2008-02-21

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