JP6122639B2 - インテグラーゼ阻害剤を含有する固形医薬組成物 - Google Patents

インテグラーゼ阻害剤を含有する固形医薬組成物 Download PDF

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Publication number
JP6122639B2
JP6122639B2 JP2012535360A JP2012535360A JP6122639B2 JP 6122639 B2 JP6122639 B2 JP 6122639B2 JP 2012535360 A JP2012535360 A JP 2012535360A JP 2012535360 A JP2012535360 A JP 2012535360A JP 6122639 B2 JP6122639 B2 JP 6122639B2
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amounts ranging
compressed tablet
raltegravir
iii
superdisintegrant
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JP2013508395A (ja
Inventor
マージヨール，マジード
リー，フオン
マー，ドウチユヨン
ソツテイビラツト，スツテイルグ
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Merck and Co Inc
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Merck and Co Inc
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    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4245—Oxadiazoles
    • 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
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • 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)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2012535360A 2009-10-26 2010-10-21 インテグラーゼ阻害剤を含有する固形医薬組成物 Active JP6122639B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25486909P 2009-10-26 2009-10-26
US61/254,869 2009-10-26
PCT/US2010/053507 WO2011053504A1 (en) 2009-10-26 2010-10-21 Solid pharmaceutical compositions containing an integrase inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015188605A Division JP2016034962A (ja) 2009-10-26 2015-09-25 インテグラーゼ阻害剤を含有する固形医薬組成物

Publications (2)

Publication Number Publication Date
JP2013508395A JP2013508395A (ja) 2013-03-07
JP6122639B2 true JP6122639B2 (ja) 2017-04-26

Family

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Family Applications (2)

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JP2012535360A Active JP6122639B2 (ja) 2009-10-26 2010-10-21 インテグラーゼ阻害剤を含有する固形医薬組成物
JP2015188605A Pending JP2016034962A (ja) 2009-10-26 2015-09-25 インテグラーゼ阻害剤を含有する固形医薬組成物

Family Applications After (1)

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JP2015188605A Pending JP2016034962A (ja) 2009-10-26 2015-09-25 インテグラーゼ阻害剤を含有する固形医薬組成物

Country Status (26)

Country Link
US (2) US9649311B2 (enExample)
EP (2) EP3970702A1 (enExample)
JP (2) JP6122639B2 (enExample)
KR (1) KR101835893B1 (enExample)
CN (2) CN106074411A (enExample)
AU (1) AU2010313571B2 (enExample)
BR (1) BR112012009857A8 (enExample)
CA (1) CA2777937C (enExample)
CO (1) CO6531485A2 (enExample)
CY (1) CY1124914T1 (enExample)
DK (1) DK2493312T3 (enExample)
ES (1) ES2898348T3 (enExample)
HR (1) HRP20211826T1 (enExample)
HU (1) HUE057248T2 (enExample)
IL (1) IL219369A (enExample)
IN (1) IN2012DN03377A (enExample)
LT (1) LT2493312T (enExample)
MX (1) MX345227B (enExample)
MY (1) MY162494A (enExample)
PL (1) PL2493312T3 (enExample)
PT (1) PT2493312T (enExample)
RS (1) RS62600B1 (enExample)
RU (1) RU2602865C2 (enExample)
SI (1) SI2493312T1 (enExample)
WO (1) WO2011053504A1 (enExample)
ZA (1) ZA201203012B (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106074411A (zh) 2009-10-26 2016-11-09 默沙东公司 包含整合酶抑制剂的固体药物组合物
WO2012145446A1 (en) * 2011-04-22 2012-10-26 Merck Sharp & Dohme Corp. Taste-masked formulations of raltegravir
US20150166520A1 (en) * 2012-07-20 2015-06-18 Merck Sharp & Dohme Corp. Amido-substituted pyrimidinone derivatives useful for the treatment of hiv infection
WO2014064711A2 (en) * 2012-10-22 2014-05-01 Hetero Research Foundation Methods of administering raltegravir and raltegravir compositions
NZ706223A (en) 2012-10-23 2018-11-30 Cipla Ltd Pharmaceutical antiretroviral composition
EP3019468A4 (en) * 2013-07-11 2017-01-11 Merck Sharp & Dohme Corp. Formulations for cathepsin k inhibitors with vitamin d
CN105237526B (zh) * 2014-06-20 2018-01-23 朱靖华 一种抗艾滋病毒药物及其制备方法
JP7023054B2 (ja) * 2017-04-05 2022-02-21 東和薬品株式会社 レベチラセタム含有医薬組成物及びその製造方法
CN111615391B (zh) * 2018-01-19 2023-05-30 吉利德科学公司 比卡格韦的代谢物
US20210290548A1 (en) * 2018-06-06 2021-09-23 Merck Sharp & Dohme Corp. Formulations of raltegravir
RU2688235C1 (ru) * 2018-06-19 2019-05-21 Федеральное государственное бюджетное образовательное учреждение высшего образования "Пермский государственный национальный исследовательский университет" Фармацевтическая противодиабетическая композиция на основе замещенного тиофенкарбоксилата и способ её получения
DE202019005769U1 (de) 2018-08-31 2022-01-13 Eirgen Pharma Ltd. Pädiatrische Darreichungsformen von Vitamin D und Verwendung

Family Cites Families (22)

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GB9109862D0 (en) 1991-05-08 1991-07-03 Beecham Lab Sa Pharmaceutical formulations
US6087383A (en) 1998-01-20 2000-07-11 Bristol-Myers Squibb Company Bisulfate salt of HIV protease inhibitor
GB9922963D0 (en) 1999-09-28 1999-12-01 Pfizer Ltd Polymorphic salt
FR2795962B1 (fr) * 1999-07-08 2003-05-09 Prographarm Laboratoires Procede de fabrication de granules enrobes a gout masque et liberation immediate du principe actif
ES2295068T3 (es) 1999-11-24 2008-04-16 MERCK & CO., INC. Gamma-hidroxi-2-(fluoroalquilaminocarbonil)-1-piperazinpentanamidas como inhibidores de la proteasa del vih.
AU1152702A (en) 2000-10-12 2002-04-22 Merck & Co Inc Aza- and polyaza-naphthalenyl carboxamides useful as hiv integrase inhibitors
AU2002334205B2 (en) 2001-10-26 2007-07-05 Istituto Di Ricerche Di Biologia Molecolara P. Angeletti Spa Dihydroxypyrimidine carboxamide inhibitors of HIV integrase
US7169780B2 (en) 2001-10-26 2007-01-30 Istitute Di Ricerche Di Biologia Molecolare P. Angeletti S.P.A. N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
AU2003220186A1 (en) 2002-04-10 2003-10-27 Merck And Co., Inc. Pharmaceutical compositions containing an hiv integrase inhibitor and a nonionic surfactant
AU2003292436B2 (en) 2002-12-27 2009-07-30 Msd Italia S.R.L. Tetrahydro-4H-pyrido[1,2-A]pyrimidines and related compounds useful as HIV integrase inhibitors
ATE500819T1 (de) 2003-12-31 2011-03-15 Bend Res Inc Stabilisierte pharmazeutische feste zusammensetzungen von arzneimitteln mit geringer löslichkeit, poloxameren und stabilisierenden polymeren
US7829720B2 (en) 2004-05-04 2010-11-09 Bristol-Myers Squibb Company Process for preparing atazanavir bisulfate and novel forms
UA87884C2 (uk) * 2004-12-03 2009-08-25 Мерк Энд Ко., Инк. Безводна кристалічна калієва сіль інгібітора віл-інтегрази
US8771733B2 (en) * 2004-12-03 2014-07-08 Merck Sharp & Dohme Corp. Pharmaceutical composition containing an anti-nucleating agent
MX2007006637A (es) 2004-12-03 2007-06-19 Merck & Co Inc Uso de atazanavir para mejorar los parametros farmacocineticos de farmacos metabolizados por isoforma 1a1 de udp-glucuronosil- transferasa.
NZ555120A (en) * 2004-12-03 2009-11-27 Merck & Co Inc Pharmaceutical formulation of carboxamide HIV integrase inhibitors containing a release rate controlling composition
US20090136570A1 (en) * 2006-01-20 2009-05-28 Bhagwant Rege Taste-Masked Tablets and Granules
CA2563690C (en) * 2006-10-12 2014-10-07 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
US20100178339A1 (en) 2007-06-22 2010-07-15 Bristol-Myers Squibb Company Tableted compositions containing atazanavir
US7687509B2 (en) * 2007-07-09 2010-03-30 Concert Pharmaceuticals Inc. Pyrimidinecarboxamide derivatives
US8372431B2 (en) 2007-10-26 2013-02-12 Bial-Portela & C.A., S.A. Pharmaceutical composition comprising licarbazepine acetate
CN106074411A (zh) * 2009-10-26 2016-11-09 默沙东公司 包含整合酶抑制剂的固体药物组合物

Also Published As

Publication number Publication date
CA2777937A1 (en) 2011-05-05
BR112012009857A8 (pt) 2023-04-11
JP2013508395A (ja) 2013-03-07
EP3970702A1 (en) 2022-03-23
MX345227B (es) 2017-01-20
US20170231993A1 (en) 2017-08-17
HUE057248T2 (hu) 2022-04-28
RU2012121857A (ru) 2013-12-10
EP2493312B1 (en) 2021-10-20
MY162494A (en) 2017-06-15
KR20120102063A (ko) 2012-09-17
HRP20211826T1 (hr) 2022-03-04
BR112012009857A2 (pt) 2015-09-29
AU2010313571A1 (en) 2012-06-07
CA2777937C (en) 2017-08-29
CN102655752A (zh) 2012-09-05
US10772888B2 (en) 2020-09-15
CO6531485A2 (es) 2012-09-28
RS62600B1 (sr) 2021-12-31
KR101835893B1 (ko) 2018-04-19
EP2493312A4 (en) 2013-07-10
EP2493312A1 (en) 2012-09-05
WO2011053504A1 (en) 2011-05-05
ZA201203012B (en) 2012-12-27
PT2493312T (pt) 2021-11-25
LT2493312T (lt) 2022-01-10
IL219369A (en) 2017-06-29
AU2010313571B2 (en) 2014-07-31
JP2016034962A (ja) 2016-03-17
ES2898348T3 (es) 2022-03-07
CN106074411A (zh) 2016-11-09
IL219369A0 (en) 2012-06-28
PL2493312T3 (pl) 2022-01-03
US9649311B2 (en) 2017-05-16
RU2602865C2 (ru) 2016-11-20
MX2012004903A (es) 2012-06-14
IN2012DN03377A (enExample) 2015-10-23
CY1124914T1 (el) 2023-01-05
DK2493312T3 (da) 2021-12-13
US20120213851A1 (en) 2012-08-23
SI2493312T1 (sl) 2021-12-31

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