CN110664780B - 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 - Google Patents

延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 Download PDF

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Publication number
CN110664780B
CN110664780B CN201910990909.9A CN201910990909A CN110664780B CN 110664780 B CN110664780 B CN 110664780B CN 201910990909 A CN201910990909 A CN 201910990909A CN 110664780 B CN110664780 B CN 110664780B
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cysteamine
range
beads
dosage form
pharmaceutical dosage
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CN110664780A (zh
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K.波维尔
R.穆特塔瓦拉普
R.多西勒
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Haolian Treatment Usa Holdings Ltd
University of California, San Diego
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University of California, San Diego
Horizon Orphan LLC
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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Psychology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Fodder In General (AREA)
  • Cosmetics (AREA)
CN201910990909.9A 2013-06-17 2014-06-17 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 Active CN110664780B (zh)

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US201361835965P 2013-06-17 2013-06-17
US61/835965 2013-06-17
PCT/US2014/042607 WO2014204881A1 (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation
CN201480034647.4A CN105492000B (zh) 2013-06-17 2014-06-17 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法

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CN110664780B true CN110664780B (zh) 2022-09-27

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CN201480034647.4A Active CN105492000B (zh) 2013-06-17 2014-06-17 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法

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UA (1) UA117833C2 (enExample)
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TWI649100B (zh) 2013-06-17 2019-02-01 地平線罕見醫學製藥有限責任公司 延遲釋放型半胱胺珠粒調配物，以及其製備及使用方法
TWI659209B (zh) * 2013-06-17 2019-05-11 地平線罕見醫學製藥有限責任公司 分析半胱胺組合物的方法
WO2017087532A1 (en) * 2015-11-16 2017-05-26 The Regents Of The University Of California Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine compounds
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ITUA20161799A1 (it) * 2016-03-18 2017-09-18 Recordati Ind Chimica E Farmaceutica S P A Composizione farmaceutica a rilascio prolungato comprendente cisteamina o un suo sale
EP3308773A1 (en) * 2016-10-11 2018-04-18 Recordati Industria Chimica E Farmaceutica SPA Formulations of cysteamine and cysteamine derivatives
WO2018093364A1 (en) * 2016-11-16 2018-05-24 The Regents Of The University Of California Formulations of cysteamine and cystamine
US10251850B2 (en) 2017-01-11 2019-04-09 Lupin Limited Process for preparation of cysteamine bitartrate
EA201992178A1 (ru) * 2017-03-15 2020-05-22 Сересин Инк. Фармацевтические композиции с высоким содержанием лекарственного средства из среднецепочечных триглицеридов и способы, связанные c ними
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CN1527670A (zh) * 2000-12-13 2004-09-08 �����ﶯ��Ƽ�(I.P.2)���޹�˾ 调节动物生长的组合物,其制备方法和用途
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CN101932238A (zh) * 2007-11-30 2010-12-29 加利福尼亚大学董事会 使用半胱胺制品治疗非酒精性脂肪性肝炎(nash)的方法
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BR112015031417A8 (pt) 2021-06-22
ZA201508783B (en) 2019-09-25
KR20210094140A (ko) 2021-07-28
US20170319513A1 (en) 2017-11-09
NI201500177A (es) 2016-02-15
CU20150178A7 (es) 2016-07-29
PH12015502783A1 (en) 2016-03-21
US20160095827A1 (en) 2016-04-07
UA117833C2 (uk) 2018-10-10
US9233077B2 (en) 2016-01-12
SG11201510126QA (en) 2016-01-28
WO2014204881A8 (en) 2016-02-18
CN105492000B (zh) 2019-11-15
CA2914770C (en) 2016-09-27
JP6468661B2 (ja) 2019-02-13
AR096628A1 (es) 2016-01-20
EP3010491A4 (en) 2016-05-18
AR128816A2 (es) 2024-06-19
US20170319514A1 (en) 2017-11-09
KR102281747B1 (ko) 2021-07-26
TWI649100B (zh) 2019-02-01
AU2014281702B2 (en) 2019-11-07
EP3010491A1 (en) 2016-04-27
HK1218066A1 (zh) 2017-02-03
BR112015031417B1 (pt) 2022-12-27
KR20160045053A (ko) 2016-04-26
JP2016523250A (ja) 2016-08-08
US11090279B2 (en) 2021-08-17
EP3939574A1 (en) 2022-01-19
NZ714517A (en) 2018-10-26
BR112015031417A2 (pt) 2017-07-25
CA2914770A1 (en) 2014-12-24
MX2015017366A (es) 2016-07-13
CN105492000A (zh) 2016-04-13
CA2938644C (en) 2019-08-27
WO2014204881A1 (en) 2014-12-24
EA201690036A1 (ru) 2016-09-30
MX375377B (es) 2025-03-06
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US20160331704A1 (en) 2016-11-17
CL2015003662A1 (es) 2016-08-05
EA031255B1 (ru) 2018-12-28
US20170319512A1 (en) 2017-11-09
US20190298665A1 (en) 2019-10-03
TW201534357A (zh) 2015-09-16
AU2014281702C1 (en) 2020-05-14
KR102466253B1 (ko) 2022-11-10
AU2014281702A1 (en) 2015-12-10
US20160158170A1 (en) 2016-06-09
TN2015000549A1 (en) 2017-04-06
US9173851B1 (en) 2015-11-03
EA031255B8 (ru) 2019-11-29
US20140370085A1 (en) 2014-12-18
AP2015008925A0 (en) 2015-12-31
CN110664780A (zh) 2020-01-10
US20150290139A1 (en) 2015-10-15
IL284823A (en) 2021-08-31

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