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DK1615646T3 - Farmaceutiske formuleringer indeholdende methylnaltrexon - Google Patents

Farmaceutiske formuleringer indeholdende methylnaltrexon Download PDF

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Publication number
DK1615646T3
DK1615646T3 DK04759349.6T DK04759349T DK1615646T3 DK 1615646 T3 DK1615646 T3 DK 1615646T3 DK 04759349 T DK04759349 T DK 04759349T DK 1615646 T3 DK1615646 T3 DK 1615646T3
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DK
Denmark
Prior art keywords
methylnaltrexone
solution
agent
preparation
pharmaceutical composition
Prior art date
Application number
DK04759349.6T
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English (en)
Other versions
DK1615646T4 (da
Inventor
Suketu P Sanghvi
Thomas A Boyd
Original Assignee
Progenics Pharm Inc
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Publication date
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Application filed by Progenics Pharm Inc filed Critical Progenics Pharm Inc
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Publication of DK1615646T3 publication Critical patent/DK1615646T3/da
Publication of DK1615646T4 publication Critical patent/DK1615646T4/da

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    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Virology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
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  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
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Claims (13)

1. Farmaceutisk præparat omfattende en opløsning af metylnaltrexon eller et salt deraf og et chelateringsmiddel, hvor chelateringsmidlet er ethylendiamintetraeddikesyre (EDTA) eller et derivat deraf, niacinamid eller et derivat deraf eller natriumdesoxycholat eller et derivat deraf.
2. Farmaceutisk præparat ifølge krav 1, hvor chelateringsmidlet er ethylendiamintetraeddikesyre (EDTA) eller et derivat deraf.
3. Farmaceutisk præparat ifølge krav 2, hvor derivatet er dikaliumedetat, dinatriumedetat, edetat-calciumdinatrium, natriumedetat, trinatriumedetat eller kaliumedetat.
4. Farmaceutisk præparat ifølge krav 3, hvor EDTA eller derivatet deraf er til stede i en koncentration fra 0,001 til 100,0 mg/ml.
5. Farmaceutisk præparat ifølge krav 4, hvor EDTA eller derivatet deraf er til stede i en koncentration fra 0,05 til 25,0 mg/ml.
6. Farmaceutisk præparat ifølge krav 5, hvor EDTA eller derivatet deraf er til stede i en koncentration fra 0,1 til 2,5 mg/ml.
7. Farmaceutisk præparat ifølge et hvilket som helst af de foregående krav, hvor opløsningen har et pH fra 2 til 6.
8. Farmaceutisk præparat ifølge et hvilket som helst af de foregående krav, hvor pH’et ikke overstiger 4,25.
9. Farmaceutisk præparat ifølge krav 8, hvor pH’et er fra 2,0 til 4,0.
10. Farmaceutisk præparat ifølge krav 9, hvor pH’et er fra 3,0 til 4,0.
11. Farmaceutisk præparat ifølge krav 10, hvor pH’et er fra 3,0 til 3,5.
12. Farmaceutisk præparat ifølge krav 1, hvor methylnaltrexonsaltet er udvalgt fra gruppen bestående af et bromidsalt, et chloridsalt, et iodidsalt, et carbonatsalt og et sulfatsalt.
13. Farmaceutisk præparat ifølge krav 12, hvor præparatet indeholder en oplosning af methylnaltrexonbromidsalt.
DK04759349.6T 2003-04-08 2004-04-08 Farmaceutiske formuleringer, der indeholder methylnaltrexon DK1615646T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46161103P 2003-04-08 2003-04-08
PCT/US2004/010997 WO2004091623A1 (en) 2003-04-08 2004-04-08 Pharmaceutical formulations containing methylnaltrexone

Publications (2)

Publication Number Publication Date
DK1615646T3 true DK1615646T3 (da) 2015-02-02
DK1615646T4 DK1615646T4 (da) 2022-10-10

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ID=33299842

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Application Number Title Priority Date Filing Date
DK04759349.6T DK1615646T4 (da) 2003-04-08 2004-04-08 Farmaceutiske formuleringer, der indeholder methylnaltrexon
DK10184575.8T DK2368553T3 (da) 2003-04-08 2004-04-08 Lægemiddelsammensætning der omfatter methylnaltrexon
DK10184684.8T DK2368554T3 (da) 2003-04-08 2004-04-08 En lægemiddelsammensætning omfattende methylnaltrexon

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Application Number Title Priority Date Filing Date
DK10184575.8T DK2368553T3 (da) 2003-04-08 2004-04-08 Lægemiddelsammensætning der omfatter methylnaltrexon
DK10184684.8T DK2368554T3 (da) 2003-04-08 2004-04-08 En lægemiddelsammensætning omfattende methylnaltrexon

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US (8) US20040266806A1 (da)
EP (3) EP2368553B1 (da)
JP (3) JP2006522818A (da)
CN (2) CN104383542B (da)
AU (2) AU2004229463B2 (da)
BR (1) BRPI0409133B8 (da)
CA (2) CA2521379C (da)
CY (3) CY1116272T1 (da)
DK (3) DK1615646T4 (da)
ES (3) ES2527870T5 (da)
HK (2) HK1082181A1 (da)
HR (3) HRP20150037T4 (da)
IL (1) IL171228A (da)
MX (1) MXPA05010817A (da)
PL (3) PL2368554T3 (da)
PT (3) PT2368554E (da)
RU (1) RU2362560C2 (da)
SI (3) SI2368553T1 (da)
WO (1) WO2004091623A1 (da)

Families Citing this family (92)

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US20030158220A1 (en) * 1997-11-03 2003-08-21 Foss Joseph F. Use of methylnaltrexone and related compounds to treat chronic opioid use side effects
US6274591B1 (en) * 1997-11-03 2001-08-14 Joseph F. Foss Use of methylnaltrexone and related compounds
BR9813827A (pt) 1997-12-22 2000-10-10 Euro Celtique Sa Analgésico opióide aplicável em mamìferos e método para impedir o uso oral abusivo de uma formulação opióide oral
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
ES2361148T3 (es) 2001-05-11 2011-06-14 Endo Pharmaceuticals Inc. Forma de dosificación de opioides de liberación controlada resistente al abuso.
EP2316429A1 (en) 2002-04-05 2011-05-04 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US7407955B2 (en) 2002-08-21 2008-08-05 Boehringer Ingelheim Pharma Gmbh & Co., Kg 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
WO2004091665A1 (en) * 2003-04-08 2004-10-28 Progenics Pharmaceuticals, Inc. Combination therapy for constipation comprising a laxative and a peripheral opioid antagonist
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