DK2564839T3 - Farmaceutisk formulering omfattende én eller flere fumarsyreestere i en erosionsmatrix - Google Patents

Farmaceutisk formulering omfattende én eller flere fumarsyreestere i en erosionsmatrix Download PDF

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DK2564839T3
DK2564839T3 DK12193798.1T DK12193798T DK2564839T3 DK 2564839 T3 DK2564839 T3 DK 2564839T3 DK 12193798 T DK12193798 T DK 12193798T DK 2564839 T3 DK2564839 T3 DK 2564839T3
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formulation
weight
test
hours
fumaric acid
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DK12193798.1T
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Henrik Nilsson
Roland Rupp
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Forward Pharma As
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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/231—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having one or two double bonds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • 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
    • A61K9/2846—Poly(meth)acrylates
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    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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  • Animal Behavior & Ethology (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Transplantation (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (11)

1. Farmaceutisk præparat i form af en erosionsmatrixtablet omfattende: i) 35-55 vægt% dimethylfumarat; ii) 3-6 vægt% hydroxypropylcellulose; og iii) 40-60 vægt% lactose.
2. Formulering ifølge krav 1, omfattende: i) 40-50 vægt% dimethylfumarat; ii) 3-6 vægt% hydroxypropylcellulose; og iii) 45-55 vægt% lactose.
3. Formulering ifølge krav 1 eller 2, omfattende: i) 42-48 vægt% dimethylfumarat; ii) 3-5,5 vægt% hydroxypropylcellulose; og iii) 45-52 vægt% lactose.
4. Formulering ifølge krav 1, som yderligere indeholder 0,15-0,7 vægt% magnesium-stearat og eventuelt 0,05-0,25 vægt% siliciumoxid.
5. Formulering ifølge ethvert af de foregående krav, hvor formuleringen yderligere omfatter en enterisk belægning.
6. Formulering ifølge ethvert af de foregående krav, som yderligere omfatter én eller flere farmaceutisk acceptable excipienser og additiver valgt fra gruppen omfattende smøremidler, glidemidler, sprængmidler, strømningsstyrende midler, opløsningsmidler, pH-styrende midler, overfladeaktive stoffer og emulgatorer.
7. Formulering ifølge ethvert af de foregående krav, til indgivelse én gang, to gange eller tre gange dagligt.
8. Fremgangsmåde til fremstilling af formuleringen ifølge ethvert af kravene 1-7, omfattende følgende trin: a) eventuelt sigtning eller formaling af krystaller af dimethylfumarat; b) blanding af de nævnte krystaller af dimethylfumarat, hydroxypropylcellulose i form af et polymert matrixmateriale, og eventuelle farmaceutisk acceptable excipienser og additiver ved direkte komprimering for tilvejebringelse af en tabletformulering; c) eventuel film og/eller enterisk belægning af tabletformuleringen på i og for sig kendt måde; hvor de ovennævnte trin udføres ved en temperatur, der tillader en produkttemperatur, som ikke overskrider 45°C.
9. Fremgangsmåde ifølge krav 8, hvor krystallerne af dimethylfumarat sigtes eller formales således, at 90% af partiklerne har en partikelstørrelse i området 5-1000 pm.
10. Fremgangsmåde til fremstilling af formuleringen ifølge ethvert af kravene 1-7, omfattende følgende trin: a) eventuel sigtning eller formaling af krystaller af dimethylfumarat; b) blanding af de nævnte krystaller af dimethylfumarat med vilkårlige farmaceutisk acceptable excipienser og hydroxypropylcellulose i form af et polymert matrix-materiale for tilvejebringelse af en tabletformulering; c) valsekompaktering af denne blanding og sigtning/formaling deraf med henblik på at tilvejebringe granulat; d) iblanding af vilkårlige yderligere farmaceutisk acceptable excipienser til granulatet for tilvejebringelse af en endelig blanding, som er klar til tabletfremstilling; e) kompression til tabletter; f) eventuel film og/eller enterisk belægning af tabletterne.
11. Farmaceutisk formulering ifølge ethvert af kravene 1 til 7 til anvendelse ved behandling af psoriasis, arthritis psoriatika, neurodermatitis, inflammatorisk tarmsygdom, såsom Crohn's sygdom og colitis ulcerosa, polyarthritis, multipel sclerose (MS), ungdomsdiabetes mellitus, Hashimoto's thyroiditis, Grave's sygdom, SLE (systemisk lupus erythematosus), Sjogren's syndrom, perniciøs anæmi, kronisk aktiv (lupoid) hepatitis, arthritis rheumatoides (RA), lupus nephritis, myasthenia gravis, uveitis, refraktær uveitis, vernal konjunktivitis, pemphigus vulgaris, sclerodermi, optisk neuritis, smerte, såsom radikulær smerte, smerte i forbindelse med radikulopati, neuropatisk smerte eller iskialgi/iskias-smerte, organtransplantation (forebyggelse af afstødning), sarcoidose, necrobiosis lipoidica eller granuloma annulare.
DK12193798.1T 2009-01-09 2010-01-08 Farmaceutisk formulering omfattende én eller flere fumarsyreestere i en erosionsmatrix DK2564839T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14361309P 2009-01-09 2009-01-09
DKPA200900034 2009-01-09
EP10700730.4A EP2379063B2 (en) 2009-01-09 2010-01-08 Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix

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DK2564839T3 true DK2564839T3 (da) 2016-07-25

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DK12193798.1T DK2564839T3 (da) 2009-01-09 2010-01-08 Farmaceutisk formulering omfattende én eller flere fumarsyreestere i en erosionsmatrix

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US (5) US8906420B2 (da)
EP (4) EP2564839B1 (da)
JP (3) JP5788331B2 (da)
KR (1) KR101699912B1 (da)
CN (2) CN102369001A (da)
CY (2) CY1114010T1 (da)
DK (2) DK2379063T4 (da)
EA (1) EA201290596A1 (da)
ES (2) ES2586761T3 (da)
HK (1) HK1180943A1 (da)
HR (2) HRP20130480T4 (da)
HU (1) HUE030169T2 (da)
PL (2) PL2564839T3 (da)
PT (2) PT2564839T (da)
RU (2) RU2743637C2 (da)
SI (2) SI2379063T2 (da)
SM (1) SMT201300065B (da)
UA (3) UA125896C2 (da)
WO (1) WO2010079222A1 (da)

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EP2801354B1 (en) 2004-10-08 2017-02-08 Forward Pharma A/S Controlled release pharmaceutical compositions comprising a fumaric acid ester
RS55215B1 (sr) * 2007-02-08 2017-02-28 Biogen Ma Inc Neuroprotekcija kod demijelinizacionih bolesti
MX2011001341A (es) 2008-08-19 2011-03-29 Xenoport Inc Prodrogas de metil hidrogeno fumarato, sus composiciones farmaceuticas, y metodos de uso.
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MX370785B (es) 2012-02-07 2020-01-06 Biogen Ma Inc Composiciones farmacéuticas que contienen fumarato de dimetilo.
EP2692343A1 (en) 2012-08-03 2014-02-05 Forward Pharma A/S Combination therapy for treatment of multiple sclerosis
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