CU24619B1 - Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por via oral - Google Patents

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

Info

Publication number
CU24619B1
CU24619B1 CU2015000179A CU20150179A CU24619B1 CU 24619 B1 CU24619 B1 CU 24619B1 CU 2015000179 A CU2015000179 A CU 2015000179A CU 20150179 A CU20150179 A CU 20150179A CU 24619 B1 CU24619 B1 CU 24619B1
Authority
CU
Cuba
Prior art keywords
pharmaceutical formulations
solid pharmaceutical
oral administration
amorphous letermovir
letermovir
Prior art date
Application number
CU2015000179A
Other languages
English (en)
Other versions
CU20150179A7 (es
Inventor
Mathias Berwe
Clemens Bothe
Dirk Jung
Michael Limmert
Welljanne Märtens
Nicole Rindermann
Christian Schickaneder
Wilfried Schwab
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 CU20150179A7 publication Critical patent/CU20150179A7/es
Publication of CU24619B1 publication Critical patent/CU24619B1/es

Links

Classifications

    • 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
    • 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

Landscapes

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

<p>La presente invención está relacionada con la química farmacéutica/formulación galénica, y proporciona formulaciones farmacéuticas sólidas, que comprende una cantidad del 30,0% al 50% (peso/peso) de letermovir en el estado amorfo con una área superficial específica de al menos 1 m<sup>2</sup>/g, y 2,0% al 10,0% (peso/peso) de povidona, 2,0% al 10,0% (peso/peso) de croscarmelosa sódica, 20,0% al 70,0% (peso/peso) de celulosa microcristalina,0,5% al 5,0 % (peso/peso) de sílice anhidra coloidal y 0,1 % al 5,0% (peso/peso) de estearato de magnesio. Las formulaciones farmacéuticas sólidas son administrables por vía oral.</p> <p> </p> <p> </p>
CU2015000179A 2013-06-19 2014-06-19 Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración por via oral CU24619B1 (es)

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 (2)

Publication Number Publication Date
CU20150179A7 CU20150179A7 (es) 2016-07-29
CU24619B1 true CU24619B1 (es) 2022-08-09

Family

ID=50982905

Family Applications (1)

Application Number Title Priority Date Filing Date
CU2015000179A CU24619B1 (es) 2013-06-19 2014-06-19 Letermovir amorfo y formulaciones farmacéuticas sólidas del mismo para administración 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
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
DOP2015000303A (es) 2016-01-15
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
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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