HRP20160982T1 - Farmaceutska formulacija koja sadrži jedan ili više estera fumarne kiseline na erozijskom matriksu - Google Patents
Farmaceutska formulacija koja sadrži jedan ili više estera fumarne kiseline na erozijskom matriksu Download PDFInfo
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- HRP20160982T1 HRP20160982T1 HRP20160982TT HRP20160982T HRP20160982T1 HR P20160982 T1 HRP20160982 T1 HR P20160982T1 HR P20160982T T HRP20160982T T HR P20160982TT HR P20160982 T HRP20160982 T HR P20160982T HR P20160982 T1 HRP20160982 T1 HR P20160982T1
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 5
- 239000011159 matrix material Substances 0.000 title claims 3
- 230000003628 erosive effect Effects 0.000 title claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 9
- LDCRTTXIJACKKU-ONEGZZNKSA-N dimethyl fumarate Chemical compound COC(=O)\C=C\C(=O)OC LDCRTTXIJACKKU-ONEGZZNKSA-N 0.000 claims 8
- 229960004419 dimethyl fumarate Drugs 0.000 claims 8
- 238000009472 formulation Methods 0.000 claims 7
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 5
- 239000013078 crystal Substances 0.000 claims 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 3
- 208000002193 Pain Diseases 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 238000009505 enteric coating Methods 0.000 claims 3
- 239000002702 enteric coating Substances 0.000 claims 3
- 238000000227 grinding Methods 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- 239000007916 tablet composition Substances 0.000 claims 3
- 206010046851 Uveitis Diseases 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 239000012752 auxiliary agent Substances 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 201000006417 multiple sclerosis Diseases 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
- 238000007873 sieving Methods 0.000 claims 2
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- 208000023328 Basedow disease Diseases 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 206010010744 Conjunctivitis allergic Diseases 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 201000005708 Granuloma Annulare Diseases 0.000 claims 1
- 208000015023 Graves' disease Diseases 0.000 claims 1
- 208000030836 Hashimoto thyroiditis Diseases 0.000 claims 1
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 1
- 208000005777 Lupus Nephritis Diseases 0.000 claims 1
- 206010059605 Necrobiosis Diseases 0.000 claims 1
- 208000015906 Necrobiotic disease Diseases 0.000 claims 1
- 201000009053 Neurodermatitis Diseases 0.000 claims 1
- 208000003435 Optic Neuritis Diseases 0.000 claims 1
- 201000011152 Pemphigus Diseases 0.000 claims 1
- 208000031845 Pernicious anaemia Diseases 0.000 claims 1
- 206010036030 Polyarthritis Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- 206010059604 Radicular pain Diseases 0.000 claims 1
- 206010037779 Radiculopathy Diseases 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 208000021386 Sjogren Syndrome Diseases 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- 208000002205 allergic conjunctivitis Diseases 0.000 claims 1
- 206010003246 arthritis Diseases 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 238000005056 compaction Methods 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 239000003995 emulsifying agent Substances 0.000 claims 1
- 208000006454 hepatitis Diseases 0.000 claims 1
- 231100000283 hepatitis Toxicity 0.000 claims 1
- 230000000366 juvenile effect Effects 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 239000013563 matrix tablet Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 206010028417 myasthenia gravis Diseases 0.000 claims 1
- 208000004296 neuralgia Diseases 0.000 claims 1
- 208000021722 neuropathic pain Diseases 0.000 claims 1
- 210000000056 organ Anatomy 0.000 claims 1
- 201000001976 pemphigus vulgaris Diseases 0.000 claims 1
- 208000030428 polyarticular arthritis Diseases 0.000 claims 1
- 201000000306 sarcoidosis Diseases 0.000 claims 1
- 238000012216 screening Methods 0.000 claims 1
- 229910052814 silicon oxide Inorganic materials 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 238000002054 transplantation Methods 0.000 claims 1
- 201000005539 vernal conjunctivitis Diseases 0.000 claims 1
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- 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
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- 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
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Claims (11)
1. Farmaceutska formulacija u obliku tablete erozijskog matriksa, naznačena time, da obuhvaća:
i) dimetilfumarat od 35 do 55 % po masi;
ii) hidroksipropilcelulozu od 3 do 6% po masi; i
iii) laktozu od 40 do 60 % po masi.
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time, da obuhvaća:
i) dimetilfumarat od 40 do 50 % po masi;
ii) hidroksipropilcelulozu od 3 do 6% po masi; i
iii) laktozu od 45 do 55 % po masi.
3. Farmaceutska formulacija prema zahtjevu 1, naznačena time, da obuhvaća:
i) dimetilfumarat od 42 do 48 % po masi;
ii) hidroksipropilcelulozu od 3 do 5,5% po masi; i
iii) laktozu od 45 do 52 % po masi.
4. Formulacija prema zahtjevu 1, naznačena time, da dodatno obuhvaća magnezijev stearat od 0,15 do 0,7 % po masi, i po želji silicijev oksid od 0,05 do 0,25 % po masi.
5. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da formulacija nadalje obuhvaća enteričku oblogu.
6. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da dodatno obuhvaća jedno ili više farmaceutski prihvatljivih pomoćnih sredstava i aditiva odabranih iz skupine koju čine lubrikanti, klizna sredstva, dezintegratori, sredstva za kontrolu protoka, otapala, sredstva za kontrolu pH-vrijednosti, tenzidi i emulgatori.
7. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da se primjenjuje jednom, dvaput i tri puta dnevno.
8. Postupak za pripravljanje formulacije prema bilo kojem zahtjevu od 1 do 7,naznačen time, da obuhvaća sljedeće korake:
a) opcijski prosijavanje ili mljevenje kristala dimetilfumarata;
b) sastavljanje navedenih kristala dimetilfumarata, hidroksipropilceluloze u obliku materijala polimernog matriksa, i bilo kojeg farmaceutski prihvatljivog pomoćnog sredstva i aditiva pomoću izravnog stlačivanja za dobivanje formulacije tablete;
c) opcijski oblaganje filmom i/ili enteričko oblaganje dobivene formulacije tablete na otprije poznat način; pri čemu se gornji koraci provode na temperaturi koja ne dopušta da se temperatura proizvoda podigne iznad 45°C.
9. Postupak prema zahtjevu 8, naznačen time, da se kristali dimetilfumarata prosijavaju ili melju tako, da 90 % od čestica imaju veličinu jedne čestice u rasponu od 5 do 1000 μm.
10. Postupak za pripravljanje formulacije prema bilo kojem zahtjevu od 1 do 7, naznačen time, da obuhvaća sljedeće korake:
a) opcijski prosijavanje ili mljevenje kristala dimetilfumarata;
b) sastavljanje spomenutih kristala dimetilfumarata s bilo kojim farmaceutski prihvatljivim pomoćnim sredstvom i hidroksipropilcelulozom u obliku materijala polimernog matriksa za dobivanje formulacije tablete;
c) sabijanje ove smjese valjcima i njezino prosijavanje/mljevenje u svrhu dobivanja granulata;
d) miješanje bilo kojeg dodatnog farmaceutski prihvatljivog pomoćnog sredstva s granulatom za dobivanje konačne smjese spremne za tabletiranje;
e) stlačivanje u tablete;
f) opcijski oblaganje filmom i/ili enteričko oblaganje navedenih tableta.
11. Farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 7, naznačena time, da se upotrebljava za liječenje psorijaze, psorijatičkog artritisa,neurodermatitisa, upalne bolesti crijeva kao što su Chronova bolest i ulcerativni kolitis, poliartritisa, multiple skleroze (MS), mladenačkog melitus dijabetesa, Hashimotovog tiroiditisa, Gravesove bolesti, SLE (sistemske lupus eritematoze), Sjögrenovog sindroma, perniciozne anemije, kroničnog aktivnog (lupoidnog) hepatitisa, reumatoidnog artritisa (RA), lupus nefritisa, mijastenije gravis, uveitisa, refraktornog uveitisa, vernalnog konjunktivitisa, pemfigusa vulgaris, skleroderme, optičkog neuritisa, bolova kao što su radikularni bolovi, bolovi povezani s radikulopatijom, neuropatski bolovi ili sciatički bolovi, nakon transplantacije organa (za prevenciju odbijanja), sarkoidoze, lipoidne nekrobioze ili anularnog granuloma.
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US14361309P | 2009-01-09 | 2009-01-09 | |
DKPA200900034 | 2009-01-09 | ||
EP12193798.1A EP2564839B1 (en) | 2009-01-09 | 2010-01-08 | Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix |
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HRP20130480TT HRP20130480T4 (hr) | 2009-01-09 | 2010-01-08 | Farmaceutska formulacija koja sadrži jedan ili više estera fumarne kiseline na erozijskom matriksu |
HRP20160982TT HRP20160982T1 (hr) | 2009-01-09 | 2016-08-01 | Farmaceutska formulacija koja sadrži jedan ili više estera fumarne kiseline na erozijskom matriksu |
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