HRP20130480T4 - 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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- HRP20130480T4 HRP20130480T4 HRP20130480TT HRP20130480T HRP20130480T4 HR P20130480 T4 HRP20130480 T4 HR P20130480T4 HR P20130480T T HRP20130480T T HR P20130480TT HR P20130480 T HRP20130480 T HR P20130480T HR P20130480 T4 HRP20130480 T4 HR P20130480T4
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- Croatia
- Prior art keywords
- fumaric acid
- formulation according
- frequency control
- mass
- alkylesters
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- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 title claims 34
- 230000003628 erosive effect Effects 0.000 title claims 6
- 239000011159 matrix material Substances 0.000 title claims 6
- 239000008194 pharmaceutical composition Substances 0.000 title claims 6
- 239000001530 fumaric acid Substances 0.000 claims 20
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 20
- 239000000203 mixture Substances 0.000 claims 18
- 238000009472 formulation Methods 0.000 claims 16
- 239000003795 chemical substances by application Substances 0.000 claims 10
- -1 fumaric acid ester Chemical class 0.000 claims 7
- 208000002193 Pain Diseases 0.000 claims 6
- 239000013543 active substance Substances 0.000 claims 6
- 150000002148 esters Chemical class 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 4
- 206010046851 Uveitis Diseases 0.000 claims 4
- 239000011230 binding agent Substances 0.000 claims 4
- 239000002702 enteric coating Substances 0.000 claims 4
- 238000009505 enteric coating Methods 0.000 claims 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 4
- 201000006417 multiple sclerosis Diseases 0.000 claims 4
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 4
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 4
- 239000007916 tablet composition Substances 0.000 claims 4
- 239000013078 crystal Substances 0.000 claims 3
- LDCRTTXIJACKKU-ONEGZZNKSA-N dimethyl fumarate Chemical compound COC(=O)\C=C\C(=O)OC LDCRTTXIJACKKU-ONEGZZNKSA-N 0.000 claims 3
- 229960004419 dimethyl fumarate Drugs 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 208000023328 Basedow disease Diseases 0.000 claims 2
- 206010009900 Colitis ulcerative Diseases 0.000 claims 2
- 206010010744 Conjunctivitis allergic Diseases 0.000 claims 2
- 208000011231 Crohn disease Diseases 0.000 claims 2
- 201000005708 Granuloma Annulare Diseases 0.000 claims 2
- 208000015023 Graves' disease Diseases 0.000 claims 2
- 208000030836 Hashimoto thyroiditis Diseases 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 2
- 208000005777 Lupus Nephritis Diseases 0.000 claims 2
- 206010059605 Necrobiosis Diseases 0.000 claims 2
- 208000015906 Necrobiotic disease Diseases 0.000 claims 2
- 201000009053 Neurodermatitis Diseases 0.000 claims 2
- 208000003435 Optic Neuritis Diseases 0.000 claims 2
- 201000011152 Pemphigus Diseases 0.000 claims 2
- 208000031845 Pernicious anaemia Diseases 0.000 claims 2
- 206010036030 Polyarthritis Diseases 0.000 claims 2
- 201000004681 Psoriasis Diseases 0.000 claims 2
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 2
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 2
- 206010059604 Radicular pain Diseases 0.000 claims 2
- 206010037779 Radiculopathy Diseases 0.000 claims 2
- 206010039710 Scleroderma Diseases 0.000 claims 2
- 208000021386 Sjogren Syndrome Diseases 0.000 claims 2
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 2
- 208000002205 allergic conjunctivitis Diseases 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 206010003246 arthritis Diseases 0.000 claims 2
- 239000001913 cellulose Substances 0.000 claims 2
- 229920002678 cellulose Polymers 0.000 claims 2
- 230000001684 chronic effect Effects 0.000 claims 2
- 239000012738 dissolution medium Substances 0.000 claims 2
- 238000000227 grinding Methods 0.000 claims 2
- 208000006454 hepatitis Diseases 0.000 claims 2
- 231100000283 hepatitis Toxicity 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 206010028417 myasthenia gravis Diseases 0.000 claims 2
- 208000004296 neuralgia Diseases 0.000 claims 2
- 208000021722 neuropathic pain Diseases 0.000 claims 2
- 210000000056 organ Anatomy 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 201000001976 pemphigus vulgaris Diseases 0.000 claims 2
- 208000030428 polyarticular arthritis Diseases 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 239000000047 product Substances 0.000 claims 2
- 201000000306 sarcoidosis Diseases 0.000 claims 2
- 238000007873 sieving Methods 0.000 claims 2
- 238000002054 transplantation Methods 0.000 claims 2
- 201000005539 vernal conjunctivitis Diseases 0.000 claims 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 230000000366 juvenile effect Effects 0.000 claims 1
- 239000013563 matrix tablet Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 238000005507 spraying Methods 0.000 claims 1
- 239000013589 supplement Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 229920003169 water-soluble polymer Polymers 0.000 claims 1
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- 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 (20)
1. Farmaceutska formulacija u obliku tablete erozijskog matriksa, naznačena time, da obuhvaća:
i) kao aktivnu tvar jedan ili više estera fumarne kiseline odabranih od di-(C1-C5)alkilestera fumarne kiseline i mono-(C1-C5)alkilestera fumarne kiseline od 10% do 80% po masi, ili farmaceutski prihvatljivu sol od istih;
ii) jedan ili više sredstava za kontrolu učestalosti od 1 do 50% po masi; naznačeno time, da sredstvo za kontrolu učestalosti je polimer topiv u vodi; i
enteričku oblogu, pri čemu se ta enterička obloga nanosi na razini od 1,5 do 3,5% po masi jezgre, gdje erozija od spomenutog erozijskog matriksa dopušta kontrolirano ili potpomognuto oslobađanje spomenute aktivne tvari.
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time, da obuhvaća:
i) kao aktivnu tvar jedan ili više estera fumarne kiseline odabranih od di-(C1-C5)alkilestera fumarne kiseline i mono-(C1-C5)alkilestera fumarne kiseline od 30% do 60% po masi, ili farmaceutski prihvatljivu sol od istih;
ii) jedan ili više sredstava za kontrolu učestalosti od 3 do 40% po masi.
3. Farmaceutska formulacija prema zahtjevu 1 ili 2, naznačena time, da erozijski matriks je monolitni erozijski matriks.
4. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da sredstvo za kontrolu učestalosti je polimer celuloze ili derivat celuloze ili njihova mješavina.
5. Formulacija prema zahtjevu 4, naznačena time, da sredstvo za kontrolu učestalosti je odabrano iz skupine koju čine hidroksipropilna celuloza, hidroksipropilna metilna celuloza (HPMC), metilna celuloza, karboksimetilna celuloza i njihove mješavine.
6. Formulacija prema zahtjevu 5, naznačena time, da sredstvo za kontrolu učestalosti je hidroksipropilna celuloza.
7. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da nadalje sadrži vezivno sredstvo.
8. Formulacija prema zahtjevu 7, naznačena time, da vezivno sredstvo je laktoza.
9. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da obuhvaća:
i) kao aktivnu tvar jedan ili više estera fumarne kiseline odabranih od di-(C1-C5)alkilestera fumarne kiseline i mono-(C1-C5)alkilestera fumarne kiseline od 40% do 60% po masi, ili farmaceutski prihvatljivu sol od istih;
ii) sredstvo za kontrolu učestalosti od 4 do 6% po masi;
iii) vezivno sredstvo od 35 do 55% po masi.
10. Formulacija prema bilo kojem zahtjevu od 1 do 8, naznačena time, da obuhvaća:
i) kao aktivnu tvar jedan ili više estera fumarne kiseline odabranih od di-(C1-C5)alkilestera fumarne kiseline i mono-(C1-C5)alkilestera fumarne kiseline od 30% do 60% po masi, ili farmaceutski prihvatljivu sol od istih;
ii) sredstvo za kontrolu učestalosti od 3 do 6% po masi;
iii) vezivno sredstvo od 35 do 65% po masi.
11. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da kada je izložena in vitro testu rastvaranja koji angažira 0,1 N klorovodične kiseline kao medij za rastvaranje u vrijeme od prva dva sata testa, a zatim angažira 0,05 M fosfatnog pufera kao medij za rastvaranje s pH vrijednošću 6,8, tada je oslobađanje estera fumarne kiseline kako slijedi:
unutar prva dva sata nakon početka testa se oslobađa oko 0% do oko 50% (masa/masa) fumarnog estera sadržanog u formulaciji, i/ili unutar prva tri sata nakon početka testa se oslobađa oko 20% do oko 75% (masa/masa) od ukupne količine estera fumarne kiseline sadržanog u formulaciji.
12. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da ester fumarne kiseline je mono-(C1-C5)alkilester fumarne kiseline koji je prisutan u obliku farmaceutski prihvatljive soli.
13. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da kao aktivnu tvar sadrži dimetilfumarat.
14. Formulacija prema bilo kojem prethodnom zahtjevu, naznačena time, da obuhvaća:
i) dimetil fumarat od 40% do 55% po masi;
ii) hidroksipropil celulozu od 4 do 6% po masi;
iii) laktozu od 35 do 55% po masi.
15. Formulacija prema bilo kojem zahtjevu od 1 do 13, naznačena time, da obuhvaća:
i) dimetil fumarat od 30% do 60% po masi;
ii) hidroksipropil celulozu od 3 do 6% po masi;
iii) laktozu od 35 do 65% po masi.
16. Postupak za pripravljanje formulacije prema bilo kojem zahtjevu od 1 do 15, naznačen time, da obuhvaća sljedeće korake:
a) otapanje ili zaustavljanje sredstva za kontrolu učestalosti u obliku materijala polimernog matriksa u vodi za dobivanje njegove vodene otopine;
b) raspršivanje spomenute vodene otopine na granule estera fumarne kiseline u vremenskom razdoblju dovoljnom za dobivanje jednolične obloge na njima;
c) sušenje dobivenih granula;
d) opcijski prosijavanje ili mljevenje tih granula;
e) sastavljanje bilo kojeg farmaceutski prihvatljivog pomoćnog sredstva i dodatka na otprije poznat način za dobivanje formulacije tablete;
f) 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.
17. Postupak za pripravljanje formulacije prema bilo kojem zahtjevu od 1 do 15, naznačen time, da obuhvaća sljedeće korake:
a) opcijski prosijavanje ili mljevenje kristala estera fumarne kiseline;
b) sastavljanje spomenutih kristala estera fumarne kiseline, sredstva za kontrolu učestalosti
u obliku materijala polimernog matriksa i bilo kojeg farmaceutski prihvatljivog pomoćnog
sredstva i dodatka pomoću izravnog stlačivanja za dobivanje formulacije tablete;
c) 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.
18. Postupak prema zahtjevu 17, naznačen time, da se kristali estera fumarne kiseline prosijavaju ili melju tako da 90% čestica imaju veličinu čestice u rasponu od 5 do 1000μm.
19. Farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 15, naznačena time, da se upotrebljava za liječenje psorijaze, psorijatičkog artritisa, neurodermatitisa, upalne bolesti crijeva kao što su Crohnova 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.
20. Uporaba frmaceutske formulacije prema bilo kojem zahtjevu od 1 do 15, naznačena time, da je za proizvodnju lijeka za liječenje psorijaze, psorijatičkog artritisa, neurodermatitisa, upalne bolesti crijeva kao što su Crohnova 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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EP10700730.4A EP2379063B2 (en) | 2009-01-09 | 2010-01-08 | Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix |
PCT/EP2010/050172 WO2010079222A1 (en) | 2009-01-09 | 2010-01-08 | Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix |
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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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