CA2938644C - Delayed release cysteamine bead formulation, and methods of making and using same - Google Patents

Delayed release cysteamine bead formulation, and methods of making and using same Download PDF

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Publication number
CA2938644C
CA2938644C CA2938644A CA2938644A CA2938644C CA 2938644 C CA2938644 C CA 2938644C CA 2938644 A CA2938644 A CA 2938644A CA 2938644 A CA2938644 A CA 2938644A CA 2938644 C CA2938644 C CA 2938644C
Authority
CA
Canada
Prior art keywords
cysteamine
dosage form
pharmaceutical dosage
beads
stable pharmaceutical
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2938644A
Other languages
English (en)
French (fr)
Other versions
CA2938644A1 (en
Inventor
Kathlene Powell
Ramesh Muttavarapu
Ranjan Dohil
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Horizon Therapeutics US Holding LLC
University of California, San Diego
Original Assignee
University of California, San Diego
Horizon Orphan LLC
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=52019418&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2938644(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by University of California, San Diego, Horizon Orphan LLC filed Critical University of California, San Diego
Publication of CA2938644A1 publication Critical patent/CA2938644A1/en
Application granted granted Critical
Publication of CA2938644C publication Critical patent/CA2938644C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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

Landscapes

  • 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)
CA2938644A 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same Active CA2938644C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361835965P 2013-06-17 2013-06-17
US61/835,965 2013-06-17
CA2914770A CA2914770C (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2914770A Division CA2914770C (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same

Publications (2)

Publication Number Publication Date
CA2938644A1 CA2938644A1 (en) 2014-12-24
CA2938644C true CA2938644C (en) 2019-08-27

Family

ID=52019418

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2938644A Active CA2938644C (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same
CA2914770A Active CA2914770C (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2914770A Active CA2914770C (en) 2013-06-17 2014-06-17 Delayed release cysteamine bead formulation, and methods of making and using same

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)

Families Citing this family (10)

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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
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EP4545069A4 (en) * 2022-06-24 2026-06-10 Sunsho Pharmaceutical Co Ltd PHARMACEUTICAL COMPOSITION AND ITS PRODUCTION PROCESS

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Publication number Publication date
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
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
CN110664780B (zh) 2022-09-27
CN105492000A (zh) 2016-04-13
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
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US20150290139A1 (en) 2015-10-15
IL284823A (en) 2021-08-31

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