DK2268282T3 - Flydende formulering af deferipron med behagelig smag - Google Patents

Flydende formulering af deferipron med behagelig smag Download PDF

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Publication number
DK2268282T3
DK2268282T3 DK08748186.7T DK08748186T DK2268282T3 DK 2268282 T3 DK2268282 T3 DK 2268282T3 DK 08748186 T DK08748186 T DK 08748186T DK 2268282 T3 DK2268282 T3 DK 2268282T3
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DK
Denmark
Prior art keywords
formulation
approx
per liter
grams
deferiprone
Prior art date
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DK08748186.7T
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English (en)
Inventor
Michael Spino
Anita Hui
Cihua Yang
Mohammed N Kabir
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Apotex Technologies Inc
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Publication of DK2268282T3 publication Critical patent/DK2268282T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/04Chelating agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Toxicology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (14)

1. Oral, farmaceutisk, flydende formulering, omfattende deferipron i en mængde på mellem ca. 20 og ca. 200 gram per liter af formuleringen og en smagsmaskeringsammensætning, hvor smagsmaskeringsammensætning omfatter en virksom mængde af et sødemiddel per liter af flydende formulering, hvor sødemidlet er udvalgt fra gruppen bestående af aspartam, saccharin, saccharin-natrium, sucralose og blandinger deraf, en virksom mængde af fortykkelses- og suspensionsmiddel per liter af flydende formulering, hvor fortykkelses- og suspensionsmidlet er hydroxyethyl-cellulose, og hvor mængden af hydroxyethylcellulose ligger mellem ca. 0,5 og ca. 3 gram per liter af formuleringen, en virksom mængde af et fugtighedsbevarende stof per liter af flydende formulering, hvor det fugtighedsbevarende stof er glycerin, og hvor mængden af glycerin ligger mellem ca. 100 og ca. 900 gram per liter af formuleringen, og en virksom mængde af mindst ét smagsstof, hvor smagsstoffet er udvalgt fra gruppen bestående af naturlige smagsstoffer, naturlige frugtsmagsstoffer, kunstige smagsstoffer, kunstige frugtsmagsstoffer, pebermynte, pebermynteolier og blandinger deraf, hvor en endelig form af den orale, flydende, farmaceutiske formulering har en i det væsentlige ikke-bitter og behagelig smag.
2. Formulering ifølge krav 1, hvor smagsstoffet er udvalgt fra gruppen bestående af kirsebær, druer, jordbær, blodappelsin, melon, banan og citronvanilje og blandinger deraf.
3. Formulering ifølge krav 1, omfattende mere end et smagsstof.
4. Formulering ifølge krav 1, hvor sødemidlet er sucralose.
5. Formulering ifølge krav 4, hvor sucralose foreligger i en mængde på mellem ca. 5 gram og ca. 30 gram per liter af formuleringen.
6. Formulering ifølge krav 1, hvor den flydende, farmaceutiske formulering har en pFI-værdi på mellem ca. 2,5 og ca. 5,0.
7. Formulering ifølge krav 6, yderligere omfattende koncentreret saltsyre.
8. Formulering ifølge krav 1, hvor sødemidlet er udvalgt fra gruppen bestående af de højintensive, kunstige sødemidler aspartam, sucralose og saccharin.
9. Formulering ifølge krav 1, hvor sødemidlet foreligger i en mængde på mellem ca. 0,1 og ca. 3 vægtprocent.
10. Formulering ifølge krav 1, hvor deferipron foreligger i en mængde på mellem ca. 50 gram og ca. 200 gram per liter af formuleringen.
11. Formulering ifølge krav 2, hvor smagsstoffet omfatter kunstig kirsebærsmag.
12. Formulering ifølge krav 11, hvor pebermynteolie tilsættes som et yderligere smagsstof.
13. Behagelig, flydende, farmaceutisk formulering ifølge krav 1, omfattende: ca. 50-200 gram deferipron per liter af formuleringen, ca. 15 gram sucralose per liter af formuleringen, ca. 500 gram glycerin per liter af formuleringen, ca. 1 gram hydroxyethylcellulose per liter af formuleringen, ca. 59 gram koncentreret saltsyre per liter af formuleringen, ca. 0,40 gram FD&C Yellow No. 6 per liter af formuleringen, ca. 2 gram kunstig kirsebærsmag per liter af formuleringen, ca. 0,10 gram pebermynteolie per liter af formuleringen og en tilstrækkelig mængde af renset vand for at give 1 liter af formuleringen.
14. Formulering ifølge et af kravene 1 til 13, hvor formuleringen er til anvendelse i behandling af jernoverbelastningstilstande af hjertet, mitokondrie eller centralnervesystemet, herunder hjernen.
DK08748186.7T 2008-04-25 2008-04-25 Flydende formulering af deferipron med behagelig smag DK2268282T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CA2008/000784 WO2009129592A1 (en) 2008-04-25 2008-04-25 Liquid formulation for deferiprone with palatable taste

Publications (1)

Publication Number Publication Date
DK2268282T3 true DK2268282T3 (da) 2014-11-24

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ID=41216357

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Application Number Title Priority Date Filing Date
DK08748186.7T DK2268282T3 (da) 2008-04-25 2008-04-25 Flydende formulering af deferipron med behagelig smag

Country Status (25)

Country Link
US (1) US8703156B2 (da)
EP (1) EP2268282B1 (da)
KR (1) KR101490721B1 (da)
CN (1) CN102014904B (da)
AP (1) AP2010005454A0 (da)
AU (1) AU2008355464C1 (da)
BR (1) BRPI0822206B8 (da)
CA (1) CA2722393A1 (da)
CR (1) CR11744A (da)
CY (1) CY1116146T1 (da)
DK (1) DK2268282T3 (da)
EA (1) EA022751B1 (da)
ES (1) ES2539414T3 (da)
HK (1) HK1152871A1 (da)
HR (1) HRP20150083T1 (da)
IL (1) IL208876A (da)
MX (1) MX2010011701A (da)
NZ (1) NZ588602A (da)
PL (1) PL2268282T3 (da)
PT (1) PT2268282E (da)
RS (1) RS53689B1 (da)
SI (1) SI2268282T1 (da)
UA (1) UA102254C2 (da)
WO (1) WO2009129592A1 (da)
ZA (1) ZA201008374B (da)

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CA3077514C (en) 2017-10-25 2022-10-11 Chiesi Farmaceutici S.P.A. Delayed release deferiprone tablets and methods of using the same
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Also Published As

Publication number Publication date
US8703156B2 (en) 2014-04-22
NZ588602A (en) 2012-08-31
UA102254C2 (ru) 2013-06-25
IL208876A (en) 2015-02-26
US20110039897A1 (en) 2011-02-17
CR11744A (es) 2011-01-10
AU2008355464B2 (en) 2014-04-10
HK1152871A1 (en) 2012-03-16
MX2010011701A (es) 2010-12-06
HRP20150083T1 (hr) 2015-03-13
AU2008355464C1 (en) 2014-11-20
PT2268282E (pt) 2015-02-05
KR20100135316A (ko) 2010-12-24
BRPI0822206B1 (pt) 2019-03-19
EP2268282B1 (en) 2014-10-29
KR101490721B1 (ko) 2015-02-06
CY1116146T1 (el) 2017-02-08
EP2268282A1 (en) 2011-01-05
IL208876A0 (en) 2011-01-31
CA2722393A1 (en) 2009-10-29
EP2268282A4 (en) 2011-06-22
ES2539414T3 (es) 2015-06-30
PL2268282T3 (pl) 2015-04-30
CN102014904A (zh) 2011-04-13
EA201071235A1 (ru) 2011-06-30
BRPI0822206B8 (pt) 2021-05-25
AP2010005454A0 (en) 2010-12-31
ZA201008374B (en) 2012-01-25
SI2268282T1 (sl) 2015-01-30
AU2008355464A1 (en) 2009-10-29
BRPI0822206A2 (pt) 2015-06-23
WO2009129592A1 (en) 2009-10-29
RS53689B1 (en) 2015-04-30
CN102014904B (zh) 2013-02-06
EA022751B1 (ru) 2016-02-29

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