JP6468661B2 - 遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法 - Google Patents

遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法 Download PDF

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JP6468661B2
JP6468661B2 JP2016521489A JP2016521489A JP6468661B2 JP 6468661 B2 JP6468661 B2 JP 6468661B2 JP 2016521489 A JP2016521489 A JP 2016521489A JP 2016521489 A JP2016521489 A JP 2016521489A JP 6468661 B2 JP6468661 B2 JP 6468661B2
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beads
cysteamine
pharmaceutical composition
weight
range
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JP2016523250A5 (enExample
JP2016523250A (ja
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キャスリーン パウエル
キャスリーン パウエル
ラメシュ ムタヴァラプ
ラメシュ ムタヴァラプ
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ホライズン オーファン リミテッド ライアビリティ カンパニー
ホライズン オーファン リミテッド ライアビリティ カンパニー
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Application filed by ホライズン オーファン リミテッド ライアビリティ カンパニー, ホライズン オーファン リミテッド ライアビリティ カンパニー filed Critical ホライズン オーファン リミテッド ライアビリティ カンパニー
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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
    • A61K9/0012—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
    • 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
    • A61K9/48—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
    • 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)
JP2016521489A 2013-06-17 2014-06-17 遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法 Active JP6468661B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361835965P 2013-06-17 2013-06-17
US61/835,965 2013-06-17
PCT/US2014/042607 WO2014204881A1 (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation

Publications (3)

Publication Number Publication Date
JP2016523250A JP2016523250A (ja) 2016-08-08
JP2016523250A5 JP2016523250A5 (enExample) 2017-08-03
JP6468661B2 true JP6468661B2 (ja) 2019-02-13

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ID=52019418

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016521489A Active JP6468661B2 (ja) 2013-06-17 2014-06-17 遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法

Country Status (25)

Country Link
US (9) US9233077B2 (enExample)
EP (2) EP3939574A1 (enExample)
JP (1) JP6468661B2 (enExample)
KR (2) KR102281747B1 (enExample)
CN (2) CN110664780B (enExample)
AP (1) AP2015008925A0 (enExample)
AR (2) AR096628A1 (enExample)
AU (1) AU2014281702C1 (enExample)
BR (1) BR112015031417B1 (enExample)
CA (2) CA2938644C (enExample)
CL (1) CL2015003662A1 (enExample)
CU (1) CU20150178A7 (enExample)
EA (1) EA031255B8 (enExample)
HK (1) HK1218066A1 (enExample)
IL (2) IL302141A (enExample)
MX (1) MX375377B (enExample)
NI (1) NI201500177A (enExample)
NZ (1) NZ714517A (enExample)
PH (2) PH12020552266A1 (enExample)
SG (1) SG11201510126QA (enExample)
TN (1) TN2015000549A1 (enExample)
TW (1) TWI649100B (enExample)
UA (1) UA117833C2 (enExample)
WO (1) WO2014204881A1 (enExample)
ZA (1) ZA201508783B (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
US10143665B2 (en) 2015-11-17 2018-12-04 Horizon Orphan Llc Methods for storing cysteamine formulations and related methods of treatment
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
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PH12020552266A1 (en) 2022-04-25
IL302141A (en) 2023-06-01
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
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
CN110664780B (zh) 2022-09-27
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
CA2938644A1 (en) 2014-12-24
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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