HRP20170620T1 - Obloženi farmaceutski pripravak koji sadrži regorafenib - Google Patents
Obloženi farmaceutski pripravak koji sadrži regorafenib Download PDFInfo
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- HRP20170620T1 HRP20170620T1 HRP20170620TT HRP20170620T HRP20170620T1 HR P20170620 T1 HRP20170620 T1 HR P20170620T1 HR P20170620T T HRP20170620T T HR P20170620TT HR P20170620 T HRP20170620 T HR P20170620T HR P20170620 T1 HRP20170620 T1 HR P20170620T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation according
- regorafenib
- polyvinyl alcohol
- polymer
- fluorophenoxy
- Prior art date
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- 239000002138 L01XE21 - Regorafenib Substances 0.000 title claims 9
- FNHKPVJBJVTLMP-UHFFFAOYSA-N regorafenib Chemical compound C1=NC(C(=O)NC)=CC(OC=2C=C(F)C(NC(=O)NC=3C=C(C(Cl)=CC=3)C(F)(F)F)=CC=2)=C1 FNHKPVJBJVTLMP-UHFFFAOYSA-N 0.000 title claims 9
- 229960004836 regorafenib Drugs 0.000 title claims 9
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 14
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 9
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- 235000013769 triethyl citrate Nutrition 0.000 claims 1
- PHYFQTYBJUILEZ-IUPFWZBJSA-N triolein Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC PHYFQTYBJUILEZ-IUPFWZBJSA-N 0.000 claims 1
- 229940117958 vinyl acetate Drugs 0.000 claims 1
- 239000000230 xanthan gum Substances 0.000 claims 1
- 229920001285 xanthan gum Polymers 0.000 claims 1
- 235000010493 xanthan gum Nutrition 0.000 claims 1
- 229940082509 xanthan gum Drugs 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims 1
Classifications
-
- 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
- A61K31/33—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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Claims (15)
1. Farmaceutski pripravak koji sadrži regorafenib, hidrat, solvat, metabolit ili farmaceutski prihvatljivu sol regorafeniba, ili njegov polimorf i barem jedan farmaceutski prihvatljiv ekscipijent naznačen time da je farmaceutski pripravak obložen s premazom koji sadrži polimer koji se temelji na polivinil alkoholu i proizvoljno jedan ili više dodatnih farmaceutski prihvatljivih ekscipijenata pri čemu je navedeni metabolit odabran iz skupine koju čine 4-[4-({[4-klor-3-(trifluormetil)fenil]karbamoil}amino)-3-fluorfenoksi]-N-metilpiridin-2-karboksamid 1-oksid, 4-[4-({[4-klor-3-(trifluormetil)fenil]karbamoil}amino)-3-fluorfenoksi]-N-(hidroksimetil)piridin-2-karboksamid, 4-[4-({[4-klor-3-(trifluormetil)fenil]karbamoil}amino)-3-fluorfenoksi]piridin-2-karboksamid i 4-[4-({[4-klor-3-(trifluormetil)fenil]karbamoil}amino)-3-fluorfenoksi]piridin-2-karboksamid 1-oksid.
2. Pripravak prema zahtjevu 1 naznačen time da kao aktivni sastojak sadrži regorafenib.
3. Pripravak prema bilo kojem od zahtjeva 1 ili 2 naznačen time da je tableta.
4. Pripravak prema bilo kojem od zahtjeva 1 do 3 naznačen time da je tableta s trenutnim otpuštanjem.
5. Pripravak prema bilo kojem od zahtjeva 1 do 4 naznačen time da polimer koji se temelji na polivinil alkoholu je hidrolizirani polimer polivinil alkohola, djelomično hidrolizirani polimer polivinil alkohola, esterificiran polimer polivinil alkohola, njegov kopolimer s polietilen glikolom ili njihova smjesa.
6. Pripravak prema zahtjevu 5 naznačen time da polimer koji se temelji na polivinil alkoholu je djelomično hidrolizirani polimer polivinil alkohola.
7. Pripravak prema bilo kojem od zahtjeva 1 do 6 naznačen time da je polimer koji se temelji na polivinil alkoholu prisutan u količini od 30 do 70% težinski premaza tablete.
8. Pripravak prema bilo kojem od zahtjeva 1 do 7 naznačen time da premaz kao plastifikator sadrži polietilen glikol, propilen glikol, sorbitol, glicerol, maltitol, ksilitol, manitol, eritritol, glicerol trioleat, tributil citrat, trietil citrat, acetil trietil citrat, gliceril triacetat, stearinsku kiselinu, trigliceride srednjeg lanca ili njihovu smjesu.
9. Pripravak prema zahtjevu 8 naznačen time da plastifikator je polietilen glikol.
10. Pripravak prema bilo kojem od zahtjeva 8 ili 9 naznačen time da plastifikator je u količini od 5 do 30% težinski od ukupnog premaza.
11. Pripravak prema bilo kojem od zahtjeva 1 do 10 naznačen time da sadrži krutu disperziju koja sadrži regorafenib.
12. Pripravak prema zahtjevu 11 koji sadrži regorafenib u amorfnom stanju i farmaceutski prihvatljivu matricu naznačen time da matrica sadrži polivinilpirolidon, kopolimer vinilpirolidon/vinilacetat, polialkilen glikol, hidroksialkil, hidroksialkil metil celulozu, karboksimetil celulozu, natrijevu karboksimetil celulozu, etil celulozu, polimetakrilate, polivinil alkohol, polivinil acetat, kopolimer vinil alkohol/vinil acetat, poliglikolizirane gliceride, ksantan gumu, karagenan, kitosan, kitin, polidekstrin, dekstrin, škrob, proteine, sukrozu, laktozu, fruktozu, maltozu, rafinozu, sorbitol, laktitol, manitol, maltitol, eritritol, inositol, trehalozu, izomalt, inulin, maltodekstrin, ß-ciklodekstrin, hidroksipropil-ß-ciklodekstrin ili sulfobutil eter ciklodekstrin ili njihovu smjesu.
13. Pripravak prema bilo kojem od zahtjeva 11 do 12 naznačen time da sadrži regorafenib i sredstvo matrice u težinskom omjeru od 1:0.5 do 1:20.
14. Pripravak prema bilo kojem od zahtjeva 11 do 13 naznačen time da sadrži regorafenib i polivinilpirolidon, kroskarmeloza natrij i/ili mikrokristalnu celulozu.
15. Pripravak prema zahtjevu 14 naznačen time da sadrži regorafenib i zbroj kroskarmeloza natrija i/ili mikrokristalne celuloze u težinskom omjeru od 1:0.5 do 1:20.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12183331 | 2012-09-06 | ||
| PCT/US2013/058257 WO2014039677A1 (en) | 2012-09-06 | 2013-09-05 | Coated pharmaceutical composition containing regorafenib |
| EP13762967.1A EP2892507B1 (en) | 2012-09-06 | 2013-09-05 | Coated pharmaceutical composition containing regorafenib |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20170620T1 true HRP20170620T1 (hr) | 2017-06-30 |
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| HRP20170620TT HRP20170620T1 (hr) | 2012-09-06 | 2017-04-19 | Obloženi farmaceutski pripravak koji sadrži regorafenib |
Country Status (43)
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR081060A1 (es) | 2010-04-15 | 2012-06-06 | Bayer Schering Pharma Ag | Procedimiento para preparar 4-{4-[({[4-cloro-3-(trifluorometil)fenil]amino}carbonil)amino]-3-fluorofenoxi}-n-metilpiridin-2-carboxamida |
| JP2016531151A (ja) * | 2013-09-13 | 2016-10-06 | バイエル ファーマ アクチエンゲゼルシャフト | レファメチニブを含有する医薬組成物 |
| CN104586808B (zh) * | 2014-12-27 | 2017-08-18 | 北京元延医药科技股份有限公司 | 抗肿瘤药物组合物 |
| CN105136956A (zh) * | 2015-09-11 | 2015-12-09 | 江苏嘉逸医药有限公司 | 一种快速测定瑞戈非尼含量的方法 |
| CN105267167A (zh) * | 2015-09-11 | 2016-01-27 | 江苏嘉逸医药有限公司 | 一种瑞戈非尼口服固体药物组合物的制备方法 |
| CN106880615A (zh) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | 一种瑞戈非尼的口服固体制剂及其制备方法 |
| CN106880607A (zh) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | 一种含有瑞戈非尼的口腔崩解片及其制备方法 |
| CN105496975B (zh) * | 2015-12-17 | 2019-01-04 | 河南润弘制药股份有限公司 | 一种瑞戈非尼片剂及其制备方法 |
| CN106913527A (zh) * | 2015-12-28 | 2017-07-04 | 江苏先声药业有限公司 | 一种瑞戈非尼速释微丸及其制备方法 |
| CN105879049B (zh) * | 2016-05-13 | 2019-03-26 | 浙江大学 | 一种瑞戈非尼与β-环糊精的包合物及其制备方法 |
| CN107661296A (zh) * | 2016-07-27 | 2018-02-06 | 江苏先声药业有限公司 | 一种瑞戈非尼固体分散体及其制备方法 |
| BR112019025478A8 (pt) * | 2017-06-02 | 2022-12-06 | Bayer Ag | Combinação de regorafenib e inibidores de pd-1/pd-l1(2) para tratamento de câncer |
| MX2021000068A (es) * | 2018-07-06 | 2021-03-25 | Agios Pharmaceuticals Inc | Formas y composiciones farmaceuticas de ivosidenib. |
| CN111053751A (zh) * | 2018-10-16 | 2020-04-24 | 正大天晴药业集团股份有限公司 | 瑞戈非尼的缓释片剂及其制备方法 |
| TWI799599B (zh) * | 2019-06-06 | 2023-04-21 | 華納國際生物科技股份有限公司 | 醫藥或保健品自乳化固體分散組成物 |
| EP3861989A1 (en) | 2020-02-07 | 2021-08-11 | Bayer Aktiengesellschaft | Pharmaceutical composition containing regorafenib and a stabilizing agent |
| CN112587485A (zh) * | 2021-01-08 | 2021-04-02 | 湖南南新制药股份有限公司 | 一种药物固体分散体及其制备方法 |
| CN113018274A (zh) * | 2021-03-10 | 2021-06-25 | 药源生物科技（启东）有限公司 | 一种含羟丙甲纤维素的药物组合物及其制备方法 |
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| KR101363679B1 (ko) * | 2002-09-20 | 2014-02-14 | 안드렉스 랩스 엘엘씨 | 약제학적 정제 |
| CN1265793C (zh) * | 2002-11-18 | 2006-07-26 | 杭州容立医药科技有限公司 | 左西替利嗪伪麻黄碱复方口服制剂及制备方法 |
| NZ580384A (en) | 2003-07-23 | 2011-03-31 | Bayer Pharmaceuticals Corp | 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide and metabolites for the treatment and prevention of diseases and conditions |
| MY191349A (en) * | 2004-08-27 | 2022-06-17 | Bayer Pharmaceuticals Corp | New pharmaceutical compositions for the treatment of hyper-proliferative disorders |
| CA2633411A1 (en) * | 2005-12-15 | 2007-06-21 | Bayer Healthcare Ag | Diaryl ureas for treating inflammatory skin, eye and/or ear diseases |
| AR062927A1 (es) * | 2006-10-11 | 2008-12-17 | Bayer Healthcare Ag | 4- [4-( [ [ 4- cloro-3-( trifluorometil) fenil) carbamoil] amino] -3- fluorofenoxi) -n- metilpiridin-2- carboxamida monohidratada |
| WO2008044111A1 (en) * | 2006-10-13 | 2008-04-17 | Pfizer Products Inc. | Pharmaceutical formulation tablet |
| AU2007333302A1 (en) * | 2006-12-07 | 2008-06-19 | Eli Lilly And Company | An article comprising prasugrel |
| US20100316711A1 (en) * | 2007-10-25 | 2010-12-16 | Bayer Yakuhin ,Ltd. | Nifedipine containing opress coated tablet and method of preparing same |
| AR081060A1 (es) * | 2010-04-15 | 2012-06-06 | Bayer Schering Pharma Ag | Procedimiento para preparar 4-{4-[({[4-cloro-3-(trifluorometil)fenil]amino}carbonil)amino]-3-fluorofenoxi}-n-metilpiridin-2-carboxamida |
| AU2012260605B2 (en) * | 2011-05-20 | 2015-02-19 | Astrazeneca Uk Limited | Pharmaceutical composition of rosuvastatin calcium |
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