DOP2015000303A - Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por vía oral - Google Patents

Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por vía oral

Info

Publication number
DOP2015000303A
DOP2015000303A DO2015000303A DO2015000303A DOP2015000303A DO P2015000303 A DOP2015000303 A DO P2015000303A DO 2015000303 A DO2015000303 A DO 2015000303A DO 2015000303 A DO2015000303 A DO 2015000303A DO P2015000303 A DOP2015000303 A DO P2015000303A
Authority
DO
Dominican Republic
Prior art keywords
amorfo
letermovir
same
pharmaceutical formulations
immediate release
Prior art date
Application number
DO2015000303A
Other languages
English (en)
Inventor
Wilfried Schwab
Dirk Jung
Christian Schickaneder
Welljanne Märtens
Michael Limmert
Clemens Bothe
Mathias Berwe
Nicole Rindermann
Original Assignee
Aicuris Anti Infective Cures Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Aicuris Anti Infective Cures Gmbh filed Critical Aicuris Anti Infective Cures Gmbh
Publication of DOP2015000303A publication Critical patent/DOP2015000303A/es

Links

Classifications

    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • AIDS & HIV (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

LA PRESENTE INVENCIÓN PROPORCIONA LETERMOVIR AMORFO Y FORMULACIONES FARMACÉUTICAS SÓLIDAS ADMINISTRABLES POR VÍA ORAL DEL MISMO (FORMULACIÓN DE LIBERACIÓN INMEDIATA). DICHO LETERMOVIR AMORFO ES ADECUADO PARA FORMULACIONES DE LIBERACIÓN INMEDIATA CUANDO SE AÍSLA DE UNA DISOLUCIÓN ORGÁNICA POR CUALQUIERA DE SECADO CON RODILLOS DE DICHA DISOLUCIÓN ORGÁNICA EN UN DISOLVENTE ORGÁNICO VOLÁTIL, EN PARTICULAR ACETONA, A UNA TEMPERATURA DE 30 ºC A 60 ºC, Y POSTERIORMENTE SECADO DEL LETERMOVIR AMORFO OBTENIDO, O AISLAMIENTO DE DICHO LETERMOVIR AMORFO MEDIANTE PRECIPITACIÓN EN DISOLVENTES MISCIBLES CON AGUA SELECCIONADOS DE ACETONA O ACETONITRILO EN EXCESO DE AGUA COMO ANTIDISOLVENTE, Y POSTERIORMENTE FILTRACIÓN O CENTRIFUGACIÓN DEL LETERMOVIR AMORFO OBTENIDO. LAS FORMULACIONES DE LIBERACIÓN INMEDIATA DE LETERMOVIR AMORFO ESTÁN PREVISTAS PARA SU USO EN MÉTODOS DE PROFILAXIS O MÉTODOS DE TRATAMIENTO DE ENFERMEDADES ASOCIADAS AL GRUPO DE HERPESVIRIDAE, PREFERENTEMENTE ASOCIADAS A CITOMEGALOVIRUS (CMV), INCLUSO MÁS PREFERENTEMENTE ASOCIADAS A CITOMEGALOVIRUS HUMANO (CMVH).
DO2015000303A 2013-06-19 2015-12-18 Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por vía oral DOP2015000303A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13003120 2013-06-19
EP14165027 2014-04-16

Publications (1)

Publication Number Publication Date
DOP2015000303A true DOP2015000303A (es) 2016-01-15

Family

ID=50982905

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2015000303A DOP2015000303A (es) 2013-06-19 2015-12-18 Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por vía oral

Country Status (34)

Country Link
US (1) US10442773B2 (es)
EP (1) EP3010891B1 (es)
JP (2) JP6445546B2 (es)
KR (1) KR101953270B1 (es)
CN (1) CN105555771A (es)
AU (1) AU2014283231B2 (es)
BR (1) BR112015031979B1 (es)
CA (1) CA2916143C (es)
CU (1) CU24619B1 (es)
CY (1) CY1121732T1 (es)
DK (1) DK3010891T3 (es)
DO (1) DOP2015000303A (es)
EA (1) EA036131B1 (es)
ES (1) ES2730958T3 (es)
HK (1) HK1223935A1 (es)
HR (1) HRP20190936T1 (es)
HU (1) HUE043721T2 (es)
IL (2) IL243228B (es)
LT (1) LT3010891T (es)
MD (1) MD4673C1 (es)
ME (1) ME03483B (es)
MX (1) MX2015017758A (es)
MY (1) MY179502A (es)
NZ (1) NZ715387A (es)
PE (1) PE20160659A1 (es)
PH (1) PH12015502821B1 (es)
PL (1) PL3010891T3 (es)
PT (1) PT3010891T (es)
RS (1) RS58882B1 (es)
SG (1) SG11201510426PA (es)
SI (1) SI3010891T1 (es)
UA (1) UA117755C2 (es)
WO (1) WO2014202737A1 (es)
ZA (1) ZA201509239B (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
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
BR112015031979B1 (pt) * 2013-06-19 2022-05-24 Aicuris Anti-Infective Cures Gmbh Letermovir, formulação farmacêutica oral sólida, uso de uma formulação farmacêutica oral sólida, e processo para preparar letermovir
TW201735928A (zh) 2016-03-31 2017-10-16 大日本住友製藥股份有限公司 溶出性優異之口服製劑
JP7264537B2 (ja) * 2019-03-12 2023-04-25 マイクロバイオティックス， インク． ヒトサイトメガロウイルス用の併用薬物治療
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
WO2022132676A1 (en) * 2020-12-16 2022-06-23 Merck Sharp & Dohme Corp. 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)

* Cited by examiner, † Cited by third party
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
CN101198314A (zh) * 2005-04-12 2008-06-11 伊兰制药国际有限公司 纳米微粒喹唑啉衍生物制剂
DE102005027517A1 (de) * 2005-06-15 2006-12-21 Bayer Healthcare Ag Verfahren zur Herstellung von Dihydrochinazolinen
CA2832869A1 (en) * 2011-05-04 2012-11-08 Merck Sharp & Dohme Corp. Processes for preparing inhibitors of the hepatitis c virus
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
DE102012101673A1 (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
BR112015031979B1 (pt) * 2013-06-19 2022-05-24 Aicuris Anti-Infective Cures Gmbh Letermovir, formulação farmacêutica oral sólida, uso de uma formulação farmacêutica oral sólida, e processo para preparar letermovir

Also Published As

Publication number Publication date
JP6445546B2 (ja) 2018-12-26
WO2014202737A1 (en) 2014-12-24
JP2018193401A (ja) 2018-12-06
HUE043721T2 (hu) 2019-09-30
CA2916143A1 (en) 2014-12-24
SI3010891T1 (sl) 2019-09-30
MD20150126A2 (ro) 2016-06-30
EP3010891A1 (en) 2016-04-27
JP2016522238A (ja) 2016-07-28
ME03483B (me) 2020-01-20
PH12015502821A1 (en) 2016-03-21
ZA201509239B (en) 2022-03-30
BR112015031979B1 (pt) 2022-05-24
UA117755C2 (uk) 2018-09-25
DK3010891T3 (da) 2019-06-24
NZ715387A (en) 2018-02-23
AU2014283231B2 (en) 2017-12-07
EA036131B1 (ru) 2020-10-01
EA201600024A1 (ru) 2016-12-30
IL263978B (en) 2020-07-30
PL3010891T3 (pl) 2019-11-29
SG11201510426PA (en) 2016-01-28
ES2730958T3 (es) 2019-11-13
PH12015502821B1 (en) 2016-03-21
PE20160659A1 (es) 2016-07-24
PT3010891T (pt) 2019-06-21
CA2916143C (en) 2019-01-29
MD4673C1 (ro) 2020-11-30
BR112015031979A8 (pt) 2018-01-23
KR20160029075A (ko) 2016-03-14
CY1121732T1 (el) 2020-07-31
MY179502A (en) 2020-11-09
RS58882B1 (sr) 2019-08-30
HK1223935A1 (zh) 2017-08-11
US20160145216A1 (en) 2016-05-26
IL243228A0 (en) 2016-02-29
CU24619B1 (es) 2022-08-09
HRP20190936T1 (hr) 2019-10-04
BR112015031979A2 (pt) 2017-07-25
US10442773B2 (en) 2019-10-15
AU2014283231A1 (en) 2016-01-21
EP3010891B1 (en) 2019-04-10
CU20150179A7 (es) 2016-07-29
CN105555771A (zh) 2016-05-04
IL263978A (en) 2019-01-31
LT3010891T (lt) 2019-08-26
JP6770035B2 (ja) 2020-10-14
MX2015017758A (es) 2016-06-21
IL243228B (en) 2020-04-30
MD4673B1 (ro) 2020-02-29
KR101953270B1 (ko) 2019-02-28

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