JP2018193401A5 - - Google Patents
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- Publication number
- JP2018193401A5 JP2018193401A5 JP2018168220A JP2018168220A JP2018193401A5 JP 2018193401 A5 JP2018193401 A5 JP 2018193401A5 JP 2018168220 A JP2018168220 A JP 2018168220A JP 2018168220 A JP2018168220 A JP 2018168220A JP 2018193401 A5 JP2018193401 A5 JP 2018193401A5
- Authority
- JP
- Japan
- Prior art keywords
- solid pharmaceutical
- pharmaceutical formulation
- minutes
- formulation according
- hcmv
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000007787 solid Substances 0.000 claims 15
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims 9
- 206010011831 Cytomegalovirus infection Diseases 0.000 claims 7
- 201000010099 disease Diseases 0.000 claims 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 241000701022 Cytomegalovirus Species 0.000 claims 4
- 241000701024 Human betaherpesvirus 5 Species 0.000 claims 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 238000000034 method Methods 0.000 claims 3
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 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 2
- 239000007853 buffer solution Substances 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 229960001681 croscarmellose sodium Drugs 0.000 claims 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 2
- 238000001514 detection method Methods 0.000 claims 2
- 238000004128 high performance liquid chromatography Methods 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- FWYSMLBETOMXAG-QHCPKHFHSA-N letermovir Chemical compound COC1=CC=CC(N2CCN(CC2)C=2N([C@@H](CC(O)=O)C3=CC=CC(F)=C3N=2)C=2C(=CC=C(C=2)C(F)(F)F)OC)=C1 FWYSMLBETOMXAG-QHCPKHFHSA-N 0.000 claims 2
- 229950010668 letermovir Drugs 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 229940069328 povidone Drugs 0.000 claims 2
- 238000004007 reversed phase HPLC Methods 0.000 claims 2
- 239000000377 silicon dioxide Substances 0.000 claims 2
- 238000011282 treatment Methods 0.000 claims 2
- 241001529453 unidentified herpesvirus Species 0.000 claims 2
- 208000030507 AIDS Diseases 0.000 claims 1
- 206010061309 Neoplasm progression Diseases 0.000 claims 1
- 206010035664 Pneumonia Diseases 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 230000002378 acidificating effect Effects 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003480 eluent Substances 0.000 claims 1
- 206010014599 encephalitis Diseases 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 1
- 230000000968 intestinal effect Effects 0.000 claims 1
- 230000014759 maintenance of location Effects 0.000 claims 1
- 230000001404 mediated effect Effects 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000007415 particle size distribution analysis Methods 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 238000011321 prophylaxis Methods 0.000 claims 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 210000002784 stomach Anatomy 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 230000009885 systemic effect Effects 0.000 claims 1
- 230000005751 tumor progression Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000003643 water by type Substances 0.000 claims 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13003120.6 | 2013-06-19 | ||
| EP13003120 | 2013-06-19 | ||
| EP14165027.5 | 2014-04-16 | ||
| EP14165027 | 2014-04-16 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016520499A Division JP6445546B2 (ja) | 2013-06-19 | 2014-06-19 | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018193401A JP2018193401A (ja) | 2018-12-06 |
| JP2018193401A5 true JP2018193401A5 (https=) | 2019-06-20 |
| JP6770035B2 JP6770035B2 (ja) | 2020-10-14 |
Family
ID=50982905
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016520499A Active JP6445546B2 (ja) | 2013-06-19 | 2014-06-19 | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
| JP2018168220A Active JP6770035B2 (ja) | 2013-06-19 | 2018-09-07 | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016520499A Active JP6445546B2 (ja) | 2013-06-19 | 2014-06-19 | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
Country Status (34)
| Country | Link |
|---|---|
| US (1) | US10442773B2 (https=) |
| EP (1) | EP3010891B1 (https=) |
| JP (2) | JP6445546B2 (https=) |
| KR (1) | KR101953270B1 (https=) |
| CN (2) | CN120097924A (https=) |
| AU (1) | AU2014283231B2 (https=) |
| BR (1) | BR112015031979B1 (https=) |
| CA (1) | CA2916143C (https=) |
| CU (1) | CU24619B1 (https=) |
| CY (1) | CY1121732T1 (https=) |
| DK (1) | DK3010891T3 (https=) |
| DO (1) | DOP2015000303A (https=) |
| EA (1) | EA036131B1 (https=) |
| ES (1) | ES2730958T3 (https=) |
| HR (1) | HRP20190936T1 (https=) |
| HU (1) | HUE043721T2 (https=) |
| IL (2) | IL243228B (https=) |
| LT (1) | LT3010891T (https=) |
| MD (1) | MD4673C1 (https=) |
| ME (1) | ME03483B (https=) |
| MX (1) | MX373764B (https=) |
| MY (1) | MY179502A (https=) |
| NZ (1) | NZ715387A (https=) |
| PE (1) | PE20160659A1 (https=) |
| PH (1) | PH12015502821B1 (https=) |
| PL (1) | PL3010891T3 (https=) |
| PT (1) | PT3010891T (https=) |
| RS (1) | RS58882B1 (https=) |
| SG (1) | SG11201510426PA (https=) |
| SI (1) | SI3010891T1 (https=) |
| SM (1) | SMT201900327T1 (https=) |
| UA (1) | UA117755C2 (https=) |
| WO (1) | WO2014202737A1 (https=) |
| ZA (1) | ZA201509239B (https=) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10319612A1 (de) * | 2003-05-02 | 2004-11-18 | Bayer Healthcare Ag | Substituierte Dihydrochinazoline |
| DE102012101673A1 (de) | 2012-02-29 | 2013-08-29 | Aicuris Gmbh & Co. Kg | Salze eines Dihydrochinazolinderivats |
| JP6445546B2 (ja) * | 2013-06-19 | 2018-12-26 | アイキュリス アンチ−インフェクティブ キュアズ ゲゼルシャフト ミット ベシュレンクテル ハフツング | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
| WO2017170858A1 (ja) | 2016-03-31 | 2017-10-05 | 大日本住友製薬株式会社 | 溶出性に優れた経口製剤 |
| WO2020186025A1 (en) * | 2019-03-12 | 2020-09-17 | Microbiotix, Inc. | Combination drug treatment for human cytomegalovirus |
| CN111024861A (zh) * | 2019-12-31 | 2020-04-17 | 山东省药学科学院 | 一种莱特莫韦及含莱特莫韦的制剂中有关物质的检测方法 |
| EP3906929A1 (en) | 2020-05-08 | 2021-11-10 | AiCuris GmbH & Co. KG | Letermovir for use in the prevention and the treatment of coronavirus infections |
| US20230312485A1 (en) | 2020-08-17 | 2023-10-05 | Lupin Limited | A precipitation process for amorphous letermovir |
| EP4262805A4 (en) * | 2020-12-16 | 2024-11-27 | Merck Sharp & Dohme LLC | MINI-TABLET DOSAGE FORM OF A VIRAL TERMINASE INHIBITOR AND USES THEREOF |
| CN115403528B (zh) * | 2021-05-27 | 2025-01-07 | 南京正大天晴制药有限公司 | 无定形3,4-二氢喹唑啉衍生物的制备方法 |
| AR128035A1 (es) * | 2021-12-21 | 2024-03-20 | Aic246 Ag & Co Kg | Composiciones farmacéuticas que comprenden acetato de 2-[(4s)-8-fluoro-2-[4-(3-metoxifenil)piperazin-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-4h-quinazolin-4-il] e iones de potasio |
| CN114942278B (zh) * | 2022-04-12 | 2023-09-08 | 山东诚创蓝海医药科技有限公司 | 来特莫韦中间体二d-(+)-二对甲基苯甲酰酒石酸乙酸乙酯络合物有关物质的分析方法 |
| WO2024037485A1 (zh) * | 2022-08-15 | 2024-02-22 | 上海迪赛诺化学制药有限公司 | 一种来特莫韦无定形的制备方法 |
| CN116338119B (zh) * | 2023-02-24 | 2026-03-13 | 重庆希韦医药科技有限公司 | 一种来特莫韦包合物溶液体外释放度的测定方法 |
| WO2025133248A1 (en) | 2023-12-21 | 2025-06-26 | Aic246 Ag & Co. Kg | Diastereomeric aminoalcohol and aminoether salts of 2-[(4r,s)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl]acetic acid and their use for enantiomeric separation |
| WO2025216283A1 (ja) * | 2024-04-12 | 2025-10-16 | 東和薬品株式会社 | レテルモビル含有医薬組成物ならびにその製造方法および用途 |
| CN119745803A (zh) * | 2024-12-30 | 2025-04-04 | 上海奥科达医药科技股份有限公司 | 一种来特莫韦制剂组合物及其制备方法 |
| CN120927867B (zh) * | 2025-10-11 | 2026-01-06 | 成都诺和晟欣生物医药有限公司 | 一种来特莫韦注射液中对映异构体的hplc检测方法 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10207026A1 (de) * | 2002-02-20 | 2003-08-28 | Boehringer Ingelheim Kg | Pulverinhalativum, enthaltend den CGRP-Antagonisten BIBN4096 und Verfahren zu dessen Herstellung |
| DE10319612A1 (de) * | 2003-05-02 | 2004-11-18 | Bayer Healthcare Ag | Substituierte Dihydrochinazoline |
| DE10305785A1 (de) * | 2003-02-12 | 2004-08-26 | Bayer Healthcare Ag | Dihydrochinazoline |
| DE10338402A1 (de) * | 2003-08-18 | 2005-03-17 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknetes, amorphes BIBN 4096, Verfahren zu dessen Herstellung sowie dessen Verwendung als Inhalativum |
| EP1871345B1 (en) * | 2005-04-12 | 2012-08-01 | Elan Pharma International Limited | Nanoparticulate erlotinib formulations |
| DE102005027517A1 (de) * | 2005-06-15 | 2006-12-21 | Bayer Healthcare Ag | Verfahren zur Herstellung von Dihydrochinazolinen |
| CN103501608A (zh) * | 2011-05-04 | 2014-01-08 | 默沙东公司 | 药用物质、药物组合物和制备它们的方法 |
| DE102012101673A1 (de) * | 2012-02-29 | 2013-08-29 | Aicuris Gmbh & Co. Kg | Salze eines Dihydrochinazolinderivats |
| DE102012101659A1 (de) * | 2012-02-29 | 2013-08-29 | Aicuris Gmbh & Co. Kg | Salze eines Dihydrochinazolinderivats |
| DE102012101680A1 (de) * | 2012-02-29 | 2013-08-29 | Aicuris Gmbh & Co. Kg | Pharmazeutische Zubereitung enthaltend ein antiviral wirksames Dihydrochinazolinderivat |
| WO2014047562A2 (en) * | 2012-09-21 | 2014-03-27 | Epiphany Biosciences | Method of treating and/or preventing shingles and method of treating and/or preventing zoster associated pain |
| JP6445546B2 (ja) * | 2013-06-19 | 2018-12-26 | アイキュリス アンチ−インフェクティブ キュアズ ゲゼルシャフト ミット ベシュレンクテル ハフツング | 非晶質レテルモビル及び経口投与のためのその固形医薬製剤 |
-
2014
- 2014-06-19 JP JP2016520499A patent/JP6445546B2/ja active Active
- 2014-06-19 US US14/899,178 patent/US10442773B2/en active Active
- 2014-06-19 PE PE2015002639A patent/PE20160659A1/es unknown
- 2014-06-19 CU CU2015000179A patent/CU24619B1/es unknown
- 2014-06-19 MY MYPI2015002983A patent/MY179502A/en unknown
- 2014-06-19 CN CN202510264255.7A patent/CN120097924A/zh active Pending
- 2014-06-19 EA EA201600024A patent/EA036131B1/ru unknown
- 2014-06-19 ME MEP-2019-149A patent/ME03483B/me unknown
- 2014-06-19 SI SI201431243T patent/SI3010891T1/sl unknown
- 2014-06-19 MX MX2015017758A patent/MX373764B/es active IP Right Grant
- 2014-06-19 AU AU2014283231A patent/AU2014283231B2/en active Active
- 2014-06-19 HU HUE14732545A patent/HUE043721T2/hu unknown
- 2014-06-19 UA UAA201600339A patent/UA117755C2/uk unknown
- 2014-06-19 BR BR112015031979-3A patent/BR112015031979B1/pt active IP Right Grant
- 2014-06-19 DK DK14732545.0T patent/DK3010891T3/da active
- 2014-06-19 SG SG11201510426PA patent/SG11201510426PA/en unknown
- 2014-06-19 EP EP14732545.0A patent/EP3010891B1/en active Active
- 2014-06-19 MD MDA20150126A patent/MD4673C1/ro active IP Right Grant
- 2014-06-19 ES ES14732545T patent/ES2730958T3/es active Active
- 2014-06-19 PL PL14732545T patent/PL3010891T3/pl unknown
- 2014-06-19 CN CN201480040969.XA patent/CN105555771B/zh active Active
- 2014-06-19 LT LTEP14732545.0T patent/LT3010891T/lt unknown
- 2014-06-19 WO PCT/EP2014/062974 patent/WO2014202737A1/en not_active Ceased
- 2014-06-19 SM SM20190327T patent/SMT201900327T1/it unknown
- 2014-06-19 NZ NZ715387A patent/NZ715387A/en unknown
- 2014-06-19 RS RS20190686A patent/RS58882B1/sr unknown
- 2014-06-19 PT PT14732545T patent/PT3010891T/pt unknown
- 2014-06-19 CA CA2916143A patent/CA2916143C/en active Active
- 2014-06-19 HR HRP20190936TT patent/HRP20190936T1/hr unknown
- 2014-06-19 KR KR1020167001010A patent/KR101953270B1/ko active Active
-
2015
- 2015-12-18 ZA ZA2015/09239A patent/ZA201509239B/en unknown
- 2015-12-18 PH PH12015502821A patent/PH12015502821B1/en unknown
- 2015-12-18 DO DO2015000303A patent/DOP2015000303A/es unknown
- 2015-12-20 IL IL243228A patent/IL243228B/en active IP Right Grant
-
2018
- 2018-09-07 JP JP2018168220A patent/JP6770035B2/ja active Active
- 2018-12-26 IL IL263978A patent/IL263978B/en active IP Right Grant
-
2019
- 2019-06-11 CY CY20191100607T patent/CY1121732T1/el unknown
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