DK1919458T5 - Enterisk overtrukket cysteamin, cystamin og derivater deraf - Google Patents

Enterisk overtrukket cysteamin, cystamin og derivater deraf Download PDF

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Publication number
DK1919458T5
DK1919458T5 DK07762690.1T DK07762690T DK1919458T5 DK 1919458 T5 DK1919458 T5 DK 1919458T5 DK 07762690 T DK07762690 T DK 07762690T DK 1919458 T5 DK1919458 T5 DK 1919458T5
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Prior art keywords
cysteamine
composition
cystamine
use according
cystinosis
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DK07762690.1T
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English (en)
Other versions
DK1919458T6 (da
DK1919458T3 (da
Inventor
Ranjan Dohil
Jerry Schneider
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Univ California
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    • 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
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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    • A61K9/2806—Coating materials
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K9/5005—Wall or coating material
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    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K9/5052—Proteins, e.g. albumin
    • A61K9/5057—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
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    • 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
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Claims (10)

1. Sammensætning omfattende enterisk overtrukket cystamin eller cystea-min, i form af et farmakologisk acceptabelt salt, en ester eller amid, til anvendelse ved behandling af cystinose ved en dosis på to gange dagligt.
2. Sammensætning til anvendelse ifølge krav 1, omfattende en enterisk coating, som frigiver cystaminen eller cysteaminen ved en pH-værdi, der er større end 4,5.
3. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 eller 2, hvor sammensætningen øger afgivelsen af cystamin eller cysteamin, i for af et farmakologisk acceptabelt salt, en ester eller amid, til tyndtarmen.
4. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor den enteriske coating er udvalgt fra gruppen bestående af polymerise-ret gelatine, shellak, methacrylsyrecopolymer type C NF, cellulosebutyratphtha-lat, cellulosehydrogenphthalat, cellulosepropionatphthalat polyvinylacetatphtha-lat (PVAP), celluloseacetatphthalat (CAP), celluloseacetattrimellitat (CAT), hy-droxypropylmethylcellulosephthalat, hydroxypropylmethylcelluloseacetat, dio-xypropylmethylcellulosesuccinat, carboxymethylethylcellulose (CMEC), hydro-xypropylmethylcelluloseacetatsuccinat (HPMCAS) og acrylsyrepolymerer og copolymerer, typisk dannet ud fra methylacrylat, ethylacrylat, methylnethacrylat og/eller ethylmethacrylat med copolymerer af acryl- og methacrylsyreestere.
5. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 4, omfattende en farmaceutisk acceptabel bærer eller stabilisator.
6. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 5, til indgivelse ved en samlet daglig dosis på ca. 0,5 til 1,0 g/m2 kropsoverfladeområde.
7. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 6, til tilvejebringelse af et 12 timers leukocytcystinniveau på under 1 nmol/1/2 cystin/mg protein.
8. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 7, hvor den enteriske coating tilvejebringer en øget absorption i tyndtarmen.
9. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 8, hvilken er i form af en tablet, eller er granuleret og fyldt i en kapsel.
10. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 9, hvor sammensætningen er i stand til at øge afgivelsen af cystaminen eller cysteaminen eller farmaceutisk acceptable salte deraf til tyndtarmen.
DK07762690.1T 2006-01-27 2007-01-26 Syreresistent coatet cysteamin, cystamin og derivater deraf DK1919458T6 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US76271506P 2006-01-27 2006-01-27
PCT/US2007/002325 WO2007089670A2 (en) 2006-01-27 2007-01-26 Enterically coated cysteamine, cystamine and derivatives thereof

Publications (3)

Publication Number Publication Date
DK1919458T3 DK1919458T3 (da) 2012-08-20
DK1919458T5 true DK1919458T5 (da) 2014-03-17
DK1919458T6 DK1919458T6 (da) 2017-03-27

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ID=38327943

Family Applications (2)

Application Number Title Priority Date Filing Date
DK07762690.1T DK1919458T6 (da) 2006-01-27 2007-01-26 Syreresistent coatet cysteamin, cystamin og derivater deraf
DK12169866.6T DK2535044T3 (da) 2006-01-27 2007-01-26 Enterisk coatet cysteaminbitartrat og cystamin

Family Applications After (1)

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DK12169866.6T DK2535044T3 (da) 2006-01-27 2007-01-26 Enterisk coatet cysteaminbitartrat og cystamin

Country Status (20)

Country Link
US (15) US8026284B2 (da)
EP (3) EP3659588A1 (da)
AU (1) AU2007210005C1 (da)
BR (1) BRPI0707277B1 (da)
CA (1) CA2640531C (da)
CY (1) CY1122943T1 (da)
DK (2) DK1919458T6 (da)
EA (2) EA201600089A1 (da)
ES (2) ES2388310T7 (da)
FR (1) FR14C0018I1 (da)
HU (1) HUE049307T2 (da)
IL (1) IL193044A (da)
LT (1) LT2535044T (da)
LU (1) LU92389I2 (da)
MX (1) MX2008009647A (da)
NL (1) NL300649I2 (da)
PL (2) PL1919458T6 (da)
PT (2) PT2535044T (da)
SI (2) SI1919458T1 (da)
WO (1) WO2007089670A2 (da)

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JP5583022B2 (ja) 2007-11-30 2014-09-03 ザ レジェンツ オブ ザ ユニヴァースティ オブ カリフォルニア システアミン生成物を用いる非アルコール性脂肪性肝炎（ｎａｓｈ）の治療方法
US9023798B2 (en) 2009-07-24 2015-05-05 The Regents Of The University Of Michigan Cystinosin replacement factor
US8815942B2 (en) 2010-10-20 2014-08-26 The Royal Institution For The Advancement Of Learning/Mcgill University Combination therapy and uses thereof for treatment and prevention of parasitic infection and disease
CA2732440C (en) * 2011-02-23 2017-10-31 Universite Laval Cystamine analogues for the treatment of parkinson`s disease
AU2011379972B2 (en) 2011-10-26 2016-05-12 Seattle Children's Research Institute Cysteamine in the treatment of fibrotic disease
US20140314841A1 (en) 2013-04-19 2014-10-23 The United States Of America, As Represented By The Secretary, Department Of Health And Human Serv Use of Cysteamine and Derivatives Thereof to Suppress Tumor Metastases
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
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
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