HRP20231670T1 - Farmaceutski pripravak za oralnu primjenu koji sadrži derivat aminopirimidina ili njegovu sol - Google Patents
Farmaceutski pripravak za oralnu primjenu koji sadrži derivat aminopirimidina ili njegovu sol Download PDFInfo
- Publication number
- HRP20231670T1 HRP20231670T1 HRP20231670TT HRP20231670T HRP20231670T1 HR P20231670 T1 HRP20231670 T1 HR P20231670T1 HR P20231670T T HRP20231670T T HR P20231670TT HR P20231670 T HRP20231670 T HR P20231670T HR P20231670 T1 HRP20231670 T1 HR P20231670T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- preparation according
- morpholinophenyl
- ylamino
- pyrimidin
- Prior art date
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- 150000003839 salts Chemical class 0.000 title claims 3
- 150000005005 aminopyrimidines Chemical class 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 8
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 5
- BXBUSQVSAAMGMR-UHFFFAOYSA-N S(C)(=O)(=O)O.C(C=C)(=O)NC1=C(C=C(C(=C1)NC1=NC=CC(=N1)N1N=C(C(=C1)CN(C)C)C1=CC=CC=C1)OC)N1CCOCC1 Chemical compound S(C)(=O)(=O)O.C(C=C)(=O)NC1=C(C=C(C(=C1)NC1=NC=CC(=N1)N1N=C(C(=C1)CN(C)C)C1=CC=CC=C1)OC)N1CCOCC1 BXBUSQVSAAMGMR-UHFFFAOYSA-N 0.000 claims 5
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 5
- 229960001681 croscarmellose sodium Drugs 0.000 claims 5
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 5
- 239000005434 MCC/mannitol excipient Substances 0.000 claims 4
- 235000019359 magnesium stearate Nutrition 0.000 claims 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 239000004480 active ingredient Substances 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- RRMJMHOQSALEJJ-UHFFFAOYSA-N N-[5-[[4-[4-[(dimethylamino)methyl]-3-phenylpyrazol-1-yl]pyrimidin-2-yl]amino]-4-methoxy-2-morpholin-4-ylphenyl]prop-2-enamide Chemical compound CN(C)CC=1C(=NN(C=1)C1=NC(=NC=C1)NC=1C(=CC(=C(C=1)NC(C=C)=O)N1CCOCC1)OC)C1=CC=CC=C1 RRMJMHOQSALEJJ-UHFFFAOYSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 238000000113 differential scanning calorimetry Methods 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 238000001757 thermogravimetry curve Methods 0.000 claims 2
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 claims 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 1
- 238000001144 powder X-ray diffraction data Methods 0.000 claims 1
Classifications
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- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/2022—Organic macromolecular compounds
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Claims (14)
1. Farmaceutski pripravak za oralnu primjenu, naznačen time, da sadrži: N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid (lazertinib) ili njegovu farmaceutski prihvatljivu sol kao aktivni sastojak; i kombinaciju mikrokristalne celuloze i manitola kao razrjeđivač.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je maseni omjer mikrokristalne celuloze prema manitolu u rasponu od 1:0,5 do 1:3.
3. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je maseni omjer mikrokristalne celuloze prema manitolu u rasponu od 1:0,9 do 1:3.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da je maseni omjer mikrokristalne celuloze prema manitolu u rasponu od 1:0,9 do 1:1,5.
5. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da nadalje sadrži kroskarmelozu natrij kao sredstvo za dezintegraciju.
6. Farmaceutski pripravak prema patentnom zahtjevu 5, naznačen time, da se kroskarmeloza natrij nalazi u rasponu od 2 do 5 % po masi, u odnosu na ukupnu masu pripravka.
7. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da nadalje sadrži magnezijev stearat kao lubrikant.
8. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da sadrži: N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid ili njegovu farmaceutski prihvatljivu sol kao aktivni sastojak; kombinaciju mikrokristalne celuloze i manitola kao razrjeđivač; kroskarmelozu natrij kao sredstvo za dezintegraciju; i magnezijev stearat kao lubrikant.
9. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da aktivni sastojak je N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilat.
10. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se farmaceutski pripravak sastoji od 5 do 54 % po masi N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilata; 45 do 87 % po masi kombinacije mikrokristalne celuloze i manitola; 0,5 do 10 % po masi kroskarmeloze natrij; i 0,4 do 2 % po masi magnezijevog stearata.
11. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se farmaceutski pripravak sastoji od 7 do 46 % po masi N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilata; 50 do 87 % po masi kombinacije mikrokristalne celuloze i manitola; 2 do 5 % po masi kroskarmeloze natrij; i 0,5 do 1,5 % po masi magnezijevog stearata.
12. Farmaceutski pripravak prema patentnom zahtjevu 9, naznačen time, da N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilat je kristalni oblik koji ima uzorak rendgenske difrakcije na prahu (PXRD) s maksimumima na 5,614, 12,394, 14,086, 17,143, 18,020, 19,104, 21,585, 22,131, i 22,487° 2θ ± 0,2° 2θ.
13. Farmaceutski pripravak prema patentnom zahtjevu 9, naznačen time, da N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilat je kristalni oblik koji ima termogram diferencijalne pretražne kalorimetrije (DSC) s endotermičkim maksimumom na 210 do 230 °C.
14. Farmaceutski pripravak prema patentnom zahtjevu 13, naznačen time, da N-(5-(4-(4-((dimetilamino)metil)-3-fenil-1H-pirazol-1-il)pirimidin-2-ilamino)-4-metoksi-2-morfolinofenil)akrilamid mesilat je kristalni oblik koji ima termogram diferencijalne pretražne kalorimetrije (DSC) s endotermičkim maksimumom na 217 ± 2 °C.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020180124171A KR20200043618A (ko) | 2018-10-18 | 2018-10-18 | 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물 |
| PCT/IB2019/058862 WO2020079637A1 (en) | 2018-10-18 | 2019-10-17 | Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt |
| EP19872427.0A EP3866767B1 (en) | 2018-10-18 | 2019-10-17 | Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231670T1 true HRP20231670T1 (hr) | 2024-03-15 |
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| US11850248B2 (en) | 2019-05-14 | 2023-12-26 | Yuhan Corporation | Therapies with 3rd generation EGFR tyrosine kinase inhibitors |
| JOP20210304A1 (ar) * | 2019-05-14 | 2023-01-30 | Janssen Biotech Inc | علاجات مركبة باستخدام الأجسام المضادة ثنائية النوعية المضادة لمستقبل عامل نمو البشرة (EGFR)/ مستقبل عامل نمو خلايا الكبد (c-Met) ومثبطات كيناز التيروسين الخاصة بمستقبل عامل نمو البشرة (EGFR) من الجيل الثالث |
| JOP20220184A1 (ar) | 2020-02-12 | 2023-01-30 | Janssen Biotech Inc | علاج مصابي السرطان ممن لديهم طفرات تخطي c-Met إكسون14 |
| TW202207940A (zh) * | 2020-04-14 | 2022-03-01 | 美商健生生物科技公司 | 包含胺基嘧啶衍生物或其醫藥上可接受之鹽、水合物、或溶劑化物之用於經口投予之醫藥組成物 |
| CN117425651A (zh) * | 2021-06-01 | 2024-01-19 | 杭州领业医药科技有限公司 | Lazertinib甲磺酸盐的水合物晶型及其制备方法和用途 |
| WO2024241273A1 (en) | 2023-05-23 | 2024-11-28 | Janssen Biotech, Inc. | Methods for treatment of non-small cell lung cancer (nsclc) |
| WO2025052273A1 (en) | 2023-09-05 | 2025-03-13 | Janssen Biotech, Inc. | Methods of treating non-small cell lung cancer |
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| CA2338256C (en) * | 1998-07-20 | 2008-09-23 | Smithkline Beecham Corporation | Bioenhanced formulations comprising eprosartan in oral solid dosage form |
| DE10319450A1 (de) | 2003-04-30 | 2004-11-18 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Pharmazeutische Formulierung des Telmisartan Natriumsalzes |
| EP2076249A2 (en) * | 2006-10-27 | 2009-07-08 | FMC Corporation | Dry granulation binders, products, and use thereof |
| CN101528201B (zh) * | 2006-10-27 | 2016-03-23 | Fmc有限公司 | 作为片剂配料赋形剂的共处理的微晶纤维素和糖醇 |
| US11453646B2 (en) * | 2011-07-27 | 2022-09-27 | Cornell University | Methods for RNA detection and quantification |
| RU2627471C2 (ru) | 2011-09-14 | 2017-08-08 | Селджин Корпорейшн | Препараты { 2-[(1s)-1-(3-этокси-4-метоксифенил)-2-метансульфонилэтил]-3-оксо-2,3-дигидро-1h-изоиндол-4-ил} амида циклопропанкарбоновой кислоты |
| CA2856529C (en) | 2011-11-29 | 2018-03-06 | Gilead Pharmasset Llc | Compositions and methods for treating hepatitis c virus |
| US9539098B2 (en) * | 2013-04-23 | 2017-01-10 | Rev Ortho Llc | System for modular hip resurfacing |
| GB201400034D0 (en) | 2014-01-02 | 2014-02-19 | Astrazeneca Ab | Pharmaceutical Compositions comprising AZD9291 |
| RS66529B1 (sr) | 2014-10-13 | 2025-03-31 | Yuhan Corp | Jedinjenja i kompozicije za modulaciju aktivnosti egfr mutant kinaze |
| EP3712134B1 (en) | 2014-12-16 | 2023-11-29 | Signal Pharmaceuticals, LLC | Salts of 2-(tert-butylamino)-4-((1r,3r,4r)-3-hydroxy-4-methycyclohexylamino)-pyrimidine-5-carboxamide |
| CN104788427B (zh) * | 2015-02-05 | 2017-05-31 | 上海泓博智源医药股份有限公司 | 3‑(2‑嘧啶氨基)苯基丙烯酰胺类化合物及其应用 |
| KR20180008511A (ko) | 2015-05-22 | 2018-01-24 | 노파르티스 아게 | 제약 조성물 |
| WO2017061621A1 (ja) | 2015-10-07 | 2017-04-13 | 協和発酵キリン株式会社 | アリールアルキルアミン化合物含有医薬組成物 |
| CA3019391A1 (en) | 2016-04-07 | 2017-10-12 | Chemocentryx, Inc. | Reducing tumor burden by administering ccr1 antagonists in combination with pd-1 inhibitors or pd-l1 inhibitors |
| AR111469A1 (es) * | 2017-04-21 | 2019-07-17 | Yuhan Corp | Sal de un compuesto del derivado de aminopiridina, una forma cristalina de la misma, y un proceso para preparar la misma |
| TW202207940A (zh) * | 2020-04-14 | 2022-03-01 | 美商健生生物科技公司 | 包含胺基嘧啶衍生物或其醫藥上可接受之鹽、水合物、或溶劑化物之用於經口投予之醫藥組成物 |
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