MD20150126A2 - Letermovir amorf şi forme preparative farmaceutice solide ale acestuia pentru administrare orală - Google Patents
Letermovir amorf şi forme preparative farmaceutice solide ale acestuia pentru administrare oralăInfo
- Publication number
- MD20150126A2 MD20150126A2 MDA20150126A MD20150126A MD20150126A2 MD 20150126 A2 MD20150126 A2 MD 20150126A2 MD A20150126 A MDA20150126 A MD A20150126A MD 20150126 A MD20150126 A MD 20150126A MD 20150126 A2 MD20150126 A2 MD 20150126A2
- Authority
- MD
- Moldova
- Prior art keywords
- amorphous letermovir
- amorphous
- solid pharmaceutical
- pharmaceutical formulations
- immediate release
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
- C07D239/70—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings condensed with carbocyclic rings or ring systems
- C07D239/72—Quinazolines; Hydrogenated quinazolines
- C07D239/78—Quinazolines; Hydrogenated quinazolines with hetero atoms directly attached in position 2
- C07D239/84—Nitrogen atoms
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Virology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- AIDS & HIV (AREA)
- Biotechnology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Invenţia se referă la Letermovir amorf şi formele sale preparative farmaceutice solide, administrabile oral (formă preparativă cu eliberare imediată). Letermovirul amorf menţionat este obţinut prin izolarea dintr-o soluţie organică fie prin metoda uscării cu role a soluţiei organice respective într-un solvent organic volatil, în special acetonă, la o temperatură de 30...60°C, cu uscarea ulterioară a Letermovirului amorf obţinut, fie prin metoda izolării Letermovirului amorf menţionat prin precipitare din solvenţi miscibili cu apa, selectaţi din acetonă sau acetonitril, în exces de apă în calitate de antisolvent, cu filtrarea sau centrifugarea ulterioară a Letermovirului amorfobţinut.Formele preparative de Letermovir amorf cu eliberare imediată sunt destinate utilizării în metodele de profilaxie sau de tratament al bolilor asociate cu grupa Herpesviridae, preferabil asociate cu citomegalovirusul, mai preferabil asociate cu citomegalovirusul uman.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13003120 | 2013-06-19 | ||
| EP14165027 | 2014-04-16 | ||
| PCT/EP2014/062974 WO2014202737A1 (en) | 2013-06-19 | 2014-06-19 | Amorphous letermovir and solid pharmaceutical formulations thereof for oral administration |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| MD20150126A2 true MD20150126A2 (ro) | 2016-06-30 |
| MD4673B1 MD4673B1 (ro) | 2020-02-29 |
| MD4673C1 MD4673C1 (ro) | 2020-11-30 |
Family
ID=50982905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MDA20150126A MD4673C1 (ro) | 2013-06-19 | 2014-06-19 | Letermovir amorf şi forme preparative farmaceutice solide ale acestuia pentru administrare orală |
Country Status (34)
| Country | Link |
|---|---|
| US (1) | US10442773B2 (ro) |
| EP (1) | EP3010891B1 (ro) |
| JP (2) | JP6445546B2 (ro) |
| KR (1) | KR101953270B1 (ro) |
| CN (1) | CN105555771A (ro) |
| AU (1) | AU2014283231B2 (ro) |
| BR (1) | BR112015031979B1 (ro) |
| CA (1) | CA2916143C (ro) |
| CU (1) | CU24619B1 (ro) |
| CY (1) | CY1121732T1 (ro) |
| DK (1) | DK3010891T3 (ro) |
| DO (1) | DOP2015000303A (ro) |
| EA (1) | EA036131B1 (ro) |
| ES (1) | ES2730958T3 (ro) |
| HK (1) | HK1223935A1 (ro) |
| HR (1) | HRP20190936T1 (ro) |
| HU (1) | HUE043721T2 (ro) |
| IL (2) | IL243228B (ro) |
| LT (1) | LT3010891T (ro) |
| MD (1) | MD4673C1 (ro) |
| ME (1) | ME03483B (ro) |
| MX (1) | MX2015017758A (ro) |
| MY (1) | MY179502A (ro) |
| NZ (1) | NZ715387A (ro) |
| PE (1) | PE20160659A1 (ro) |
| PH (1) | PH12015502821A1 (ro) |
| PL (1) | PL3010891T3 (ro) |
| PT (1) | PT3010891T (ro) |
| RS (1) | RS58882B1 (ro) |
| SG (1) | SG11201510426PA (ro) |
| SI (1) | SI3010891T1 (ro) |
| UA (1) | UA117755C2 (ro) |
| WO (1) | WO2014202737A1 (ro) |
| ZA (1) | ZA201509239B (ro) |
Families Citing this family (12)
| 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 |
| DK3010891T3 (da) * | 2013-06-19 | 2019-06-24 | Aicuris Anti Infective Cures Gmbh | Amorf letermovir og faste farmaceutiske formuleringer deraf til oral indgivelse |
| CN109152787A (zh) | 2016-03-31 | 2019-01-04 | 英特塞普特医药品公司 | 具有优越的溶出性的口服制剂 |
| 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 |
| EP4262805A1 (en) * | 2020-12-16 | 2023-10-25 | Merck Sharp & Dohme LLC | Mini-tablet dosage form of a viral terminase inhibitor and uses thereof |
| CN115403528A (zh) * | 2021-05-27 | 2022-11-29 | 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 |
| 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 |
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 |
| KR20080002939A (ko) * | 2005-04-12 | 2008-01-04 | 엘란 파마 인터내셔널 리미티드 | 나노입자형 퀴나졸린 유도체 제제 |
| DE102005027517A1 (de) | 2005-06-15 | 2006-12-21 | Bayer Healthcare Ag | Verfahren zur Herstellung von Dihydrochinazolinen |
| KR20140030169A (ko) * | 2011-05-04 | 2014-03-11 | 머크 샤프 앤드 돔 코포레이션 | 약물 물질, 제약 조성물 및 그의 제조 방법 |
| DE102012101680A1 (de) * | 2012-02-29 | 2013-08-29 | Aicuris Gmbh & Co. Kg | Pharmazeutische Zubereitung enthaltend ein antiviral wirksames Dihydrochinazolinderivat |
| 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 |
| 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 |
| DK3010891T3 (da) * | 2013-06-19 | 2019-06-24 | Aicuris Anti Infective Cures Gmbh | Amorf letermovir og faste farmaceutiske formuleringer deraf til oral indgivelse |
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2014
- 2014-06-19 DK DK14732545.0T patent/DK3010891T3/da active
- 2014-06-19 MX MX2015017758A patent/MX2015017758A/es active IP Right Grant
- 2014-06-19 US US14/899,178 patent/US10442773B2/en active Active
- 2014-06-19 NZ NZ715387A patent/NZ715387A/en unknown
- 2014-06-19 PT PT14732545T patent/PT3010891T/pt unknown
- 2014-06-19 RS RS20190686A patent/RS58882B1/sr unknown
- 2014-06-19 JP JP2016520499A patent/JP6445546B2/ja active Active
- 2014-06-19 CN CN201480040969.XA patent/CN105555771A/zh active Pending
- 2014-06-19 EA EA201600024A patent/EA036131B1/ru unknown
- 2014-06-19 SG SG11201510426PA patent/SG11201510426PA/en unknown
- 2014-06-19 ES ES14732545T patent/ES2730958T3/es active Active
- 2014-06-19 MY MYPI2015002983A patent/MY179502A/en unknown
- 2014-06-19 UA UAA201600339A patent/UA117755C2/uk unknown
- 2014-06-19 CU CU2015000179A patent/CU24619B1/es unknown
- 2014-06-19 BR BR112015031979-3A patent/BR112015031979B1/pt active IP Right Grant
- 2014-06-19 EP EP14732545.0A patent/EP3010891B1/en active Active
- 2014-06-19 SI SI201431243T patent/SI3010891T1/sl unknown
- 2014-06-19 CA CA2916143A patent/CA2916143C/en active Active
- 2014-06-19 MD MDA20150126A patent/MD4673C1/ro active IP Right Grant
- 2014-06-19 HU HUE14732545A patent/HUE043721T2/hu unknown
- 2014-06-19 WO PCT/EP2014/062974 patent/WO2014202737A1/en active Application Filing
- 2014-06-19 PL PL14732545T patent/PL3010891T3/pl unknown
- 2014-06-19 KR KR1020167001010A patent/KR101953270B1/ko active IP Right Grant
- 2014-06-19 PE PE2015002639A patent/PE20160659A1/es unknown
- 2014-06-19 AU AU2014283231A patent/AU2014283231B2/en active Active
- 2014-06-19 ME MEP-2019-149A patent/ME03483B/me unknown
- 2014-06-19 LT LTEP14732545.0T patent/LT3010891T/lt unknown
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2015
- 2015-12-18 ZA ZA2015/09239A patent/ZA201509239B/en unknown
- 2015-12-18 DO DO2015000303A patent/DOP2015000303A/es unknown
- 2015-12-18 PH PH12015502821A patent/PH12015502821A1/en unknown
- 2015-12-20 IL IL243228A patent/IL243228B/en active IP Right Grant
-
2016
- 2016-10-25 HK HK16112264.6A patent/HK1223935A1/zh unknown
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2018
- 2018-09-07 JP JP2018168220A patent/JP6770035B2/ja active Active
- 2018-12-26 IL IL263978A patent/IL263978B/en active IP Right Grant
-
2019
- 2019-05-21 HR HRP20190936TT patent/HRP20190936T1/hr unknown
- 2019-06-11 CY CY20191100607T patent/CY1121732T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG4A | Patent for invention issued | ||
| PD4A | Change of proprietorship (patent for invention) |
Owner name: AIC246 GMBH & CO. KG, DE FRIEDRICH-EBERT-STR. 475, 42117 WUPPERTAL, GERMANIA Free format text: PREVIOUS PROPRIETOR: AICURIS ANTI-INFECTIVE CURES GMBH, DE FRIEDRICH-EBERT-STR. 475, 42117 WUPPERTAL, GERMANIA |
|
| TC4A | Change of name of proprietor (patent for invention) |
Owner name: AIC246 AG & CO. KG, DE FRIEDRICH-EBERT-STR. 475, 42117 WUPPERTAL, GERMANIA Free format text: PREVIOUS NAME OF PROPRIETOR: AIC246 GMBH & CO. KG, DE FRIEDRICH-EBERT-STR. 475, 42117 WUPPERTAL, GERMANIA |