PE20160659A1 - Letermovir amorfo y formulaciones farmaceuticas solidas del mismo para administracion por via oral - Google Patents

Letermovir amorfo y formulaciones farmaceuticas solidas del mismo para administracion por via oral

Info

Publication number
PE20160659A1
PE20160659A1 PE2015002639A PE2015002639A PE20160659A1 PE 20160659 A1 PE20160659 A1 PE 20160659A1 PE 2015002639 A PE2015002639 A PE 2015002639A PE 2015002639 A PE2015002639 A PE 2015002639A PE 20160659 A1 PE20160659 A1 PE 20160659A1
Authority
PE
Peru
Prior art keywords
letermovir
amorphous letermovir
solid pharmaceutical
pharmaceutical formulations
immediate release
Prior art date
Application number
PE2015002639A
Other languages
English (en)
Inventor
Nicole Rindermann
Mathias Berwe
Clemens Bothe
Wilfried Schwab
Welljane Martens
Christian Schickaneder
Dirk Jung
Michael Limmert
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 PE20160659A1 publication Critical patent/PE20160659A1/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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Biotechnology (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 invencion proporciona letermovir amorfo y formulaciones farmaceuticas solidas administrables por via oral del mismo (formulacion de liberacion inmediata). Dicho letermovir amorfo es adecuado para formulaciones de liberacion inmediata cuando se aisla de una disolucion organica por cualquiera de secado con rodillos de dicha disolucion organica en un disolvente organico volatil, en particular acetona, a una temperatura de 30 °C a 60 °C, y posteriormente secado del letermovir amorfo obtenido, o aislamiento de dicho letermovir amorfo mediante precipitacion en disolventes miscibles con agua seleccionados de acetona o acetonitrilo en exceso de agua como antidisolvente, y posteriormente filtracion o centrifugacion del letermovir amorfo obtenido. Las formulaciones de liberacion inmediata de letermovir amorfo estan previstas para su uso en metodos de profilaxis o metodos de tratamiento de enfermedades asociadas al grupo de Herpesviridae, preferentemente asociadas a citomegalovirus (CMV), incluso mas preferentemente asociadas a citomegalovirus humano (CMVH)
PE2015002639A 2013-06-19 2014-06-19 Letermovir amorfo y formulaciones farmaceuticas solidas del mismo para administracion por via oral PE20160659A1 (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
PE20160659A1 true PE20160659A1 (es) 2016-07-24

Family

ID=50982905

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2015002639A PE20160659A1 (es) 2013-06-19 2014-06-19 Letermovir amorfo y formulaciones farmaceuticas solidas del mismo para administracion por via 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
DK3010891T3 (da) * 2013-06-19 2019-06-24 Aicuris Anti Infective Cures Gmbh Amorf letermovir og faste farmaceutiske formuleringer deraf til oral indgivelse
JPWO2017170858A1 (ja) 2016-03-31 2019-02-14 インターセプト ファーマシューティカルズ， インコーポレイテッド 溶出性に優れた経口製剤
CA3132741A1 (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
US20240041882A1 (en) * 2020-12-16 2024-02-08 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)

* 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
CA2604735A1 (en) * 2005-04-12 2006-10-19 Elan Pharma International Limited Nanoparticulate quinazoline derivative formulations
DE102005027517A1 (de) * 2005-06-15 2006-12-21 Bayer Healthcare Ag Verfahren zur Herstellung von Dihydrochinazolinen
MX2013012771A (es) * 2011-05-04 2013-11-21 Merck Sharp & Dohme Proceso para la preparacion de inhibidores del virus de la hepatitis c.
DE102012101659A1 (de) * 2012-02-29 2013-08-29 Aicuris Gmbh & Co. Kg Salze eines Dihydrochinazolinderivats
DE102012101673A1 (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
DK3010891T3 (da) * 2013-06-19 2019-06-24 Aicuris Anti Infective Cures Gmbh Amorf letermovir og faste farmaceutiske formuleringer deraf til oral indgivelse

Also Published As

Publication number Publication date
ZA201509239B (en) 2022-03-30
WO2014202737A1 (en) 2014-12-24
MY179502A (en) 2020-11-09
AU2014283231B2 (en) 2017-12-07
IL243228B (en) 2020-04-30
BR112015031979A2 (pt) 2017-07-25
ME03483B (me) 2020-01-20
PH12015502821A1 (en) 2016-03-21
MD4673C1 (ro) 2020-11-30
HRP20190936T1 (hr) 2019-10-04
AU2014283231A1 (en) 2016-01-21
JP6770035B2 (ja) 2020-10-14
PL3010891T3 (pl) 2019-11-29
ES2730958T3 (es) 2019-11-13
CN105555771A (zh) 2016-05-04
MD20150126A2 (ro) 2016-06-30
PH12015502821B1 (en) 2016-03-21
UA117755C2 (uk) 2018-09-25
RS58882B1 (sr) 2019-08-30
BR112015031979A8 (pt) 2018-01-23
EA036131B1 (ru) 2020-10-01
CA2916143C (en) 2019-01-29
JP6445546B2 (ja) 2018-12-26
DOP2015000303A (es) 2016-01-15
EA201600024A1 (ru) 2016-12-30
IL263978B (en) 2020-07-30
KR101953270B1 (ko) 2019-02-28
HK1223935A1 (zh) 2017-08-11
CA2916143A1 (en) 2014-12-24
US20160145216A1 (en) 2016-05-26
NZ715387A (en) 2018-02-23
BR112015031979B1 (pt) 2022-05-24
JP2016522238A (ja) 2016-07-28
HUE043721T2 (hu) 2019-09-30
CU20150179A7 (es) 2016-07-29
SI3010891T1 (sl) 2019-09-30
US10442773B2 (en) 2019-10-15
CY1121732T1 (el) 2020-07-31
DK3010891T3 (da) 2019-06-24
IL243228A0 (en) 2016-02-29
EP3010891B1 (en) 2019-04-10
IL263978A (en) 2019-01-31
EP3010891A1 (en) 2016-04-27
MD4673B1 (ro) 2020-02-29
KR20160029075A (ko) 2016-03-14
MX2015017758A (es) 2016-06-21
PT3010891T (pt) 2019-06-21
CU24619B1 (es) 2022-08-09
JP2018193401A (ja) 2018-12-06
SG11201510426PA (en) 2016-01-28
LT3010891T (lt) 2019-08-26

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