JP7774958B2 - 二層医薬錠剤製剤 - Google Patents

二層医薬錠剤製剤

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Publication number
JP7774958B2
JP7774958B2 JP2020520646A JP2020520646A JP7774958B2 JP 7774958 B2 JP7774958 B2 JP 7774958B2 JP 2020520646 A JP2020520646 A JP 2020520646A JP 2020520646 A JP2020520646 A JP 2020520646A JP 7774958 B2 JP7774958 B2 JP 7774958B2
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JP
Japan
Prior art keywords
dolutegravir
tablet
lamivudine
layer
hiv
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
JP2020520646A
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English (en)
Japanese (ja)
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JP2020536931A5 (https=
JPWO2019074826A5 (https=
JP2020536931A (ja
Inventor
ケイ，ジョナサン，ルイス
Original Assignee
ヴィーブ ヘルスケア カンパニー
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Publication of JP2020536931A publication Critical patent/JP2020536931A/ja
Priority to JP2025120922A priority Critical patent/JP2025165977A/ja
Publication of JP2020536931A5 publication Critical patent/JP2020536931A5/ja
Publication of JPWO2019074826A5 publication Critical patent/JPWO2019074826A5/ja
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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
    • A61K31/513—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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/20—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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • AIDS & HIV (AREA)
  • Oncology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2020520646A 2017-10-13 2018-10-08 二層医薬錠剤製剤 Active JP7774958B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025120922A JP2025165977A (ja) 2017-10-13 2025-07-18 二層医薬錠剤製剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762571863P 2017-10-13 2017-10-13
US62/571,863 2017-10-13
US201862634317P 2018-02-23 2018-02-23
US62/634,317 2018-02-23
PCT/US2018/054825 WO2019074826A2 (en) 2017-10-13 2018-10-08 FORMULATION OF BICOLET PHARMACEUTICAL TABLET

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025120922A Division JP2025165977A (ja) 2017-10-13 2025-07-18 二層医薬錠剤製剤

Publications (4)

Publication Number Publication Date
JP2020536931A JP2020536931A (ja) 2020-12-17
JP2020536931A5 JP2020536931A5 (https=) 2025-09-11
JPWO2019074826A5 JPWO2019074826A5 (https=) 2025-09-11
JP7774958B2 true JP7774958B2 (ja) 2025-11-25

Family

ID=66101717

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020520646A Active JP7774958B2 (ja) 2017-10-13 2018-10-08 二層医薬錠剤製剤
JP2025120922A Pending JP2025165977A (ja) 2017-10-13 2025-07-18 二層医薬錠剤製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025120922A Pending JP2025165977A (ja) 2017-10-13 2025-07-18 二層医薬錠剤製剤

Country Status (18)

Country Link
US (1) US20200230141A1 (https=)
EP (2) EP4667003A3 (https=)
JP (2) JP7774958B2 (https=)
KR (2) KR20200070246A (https=)
CN (2) CN117281788A (https=)
AU (1) AU2018347990B2 (https=)
BR (1) BR112020006783A2 (https=)
CA (1) CA3078624A1 (https=)
CL (1) CL2020000959A1 (https=)
ES (1) ES3056013T3 (https=)
FI (1) FI3694522T3 (https=)
IL (1) IL273704B2 (https=)
MX (1) MX2020003377A (https=)
PL (1) PL3694522T3 (https=)
PT (1) PT3694522T (https=)
TW (1) TWI841539B (https=)
WO (1) WO2019074826A2 (https=)
ZA (1) ZA202002263B (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3920927A1 (en) * 2019-02-05 2021-12-15 VIIV Healthcare Company Method for treating hiv with dolutegravir and lamivudine
WO2021116244A1 (en) * 2019-12-12 2021-06-17 Sandoz Ag Modulation of drug release and bioavailability of compositions containing dolutegravir sodium and other anti hiv drugs
CN111991558B (zh) * 2020-08-28 2022-08-09 安徽贝克生物制药有限公司 一种抗逆转录病毒药物组合物及其制备方法
CN114191404B (zh) * 2022-01-10 2023-06-27 安徽贝克生物制药有限公司 一种多替拉韦片剂及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014184553A1 (en) 2013-05-15 2014-11-20 Cipla Limited Pharmaceutical antiretroviral compositions
JP2015534973A (ja) 2012-10-23 2015-12-07 シプラ・リミテッド 抗レトロウイルス医薬組成物

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2744019C (en) 2008-12-11 2017-03-14 Shionogi & Co., Ltd. Synthesis of carbamoylpyridone hiv integrase inhibitors and intermediates
US9713622B2 (en) * 2009-11-20 2017-07-25 Université Versailles Saint-Quentin-En-Yvelines Schedules for administering combination therapies useful for treating persons afflicted with the human immunodeficiency virus (HIV)
PE20121524A1 (es) * 2010-01-27 2012-12-03 Viiv Healthcare Co Combinaciones de compuestos que comprenden inhibidores de la integrasa de vih y otros agentes terapeuticos
US20170189402A1 (en) * 2012-03-28 2017-07-06 Abbvie Inc. Solid dosage forms
US10189860B2 (en) * 2014-07-29 2019-01-29 Lek Pharmaceuticals D.D. Hydrates of dolutegravir sodium
CN106860464A (zh) * 2017-02-16 2017-06-20 江苏艾迪药业有限公司 用于联合抗病毒治疗的药物组合物及应用

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015534973A (ja) 2012-10-23 2015-12-07 シプラ・リミテッド 抗レトロウイルス医薬組成物
WO2014184553A1 (en) 2013-05-15 2014-11-20 Cipla Limited Pharmaceutical antiretroviral compositions

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Journal of the International AIDS Society, 201705, 発行日, Vol.20, Articla No.21678
エピビル錠１５０エピビル錠３００添付文書, 日本, 2023, 発行日
テビケイ錠５０ｍｇ添付文書, 日本, 2023, 発行日

Also Published As

Publication number Publication date
EP4667003A3 (en) 2026-02-25
KR20250004136A (ko) 2025-01-07
PL3694522T3 (pl) 2026-03-02
ZA202002263B (en) 2024-10-30
CN117281788A (zh) 2023-12-26
WO2019074826A2 (en) 2019-04-18
IL273704B1 (en) 2024-02-01
CN111246851A (zh) 2020-06-05
MX2020003377A (es) 2020-09-28
EP3694522A4 (en) 2021-08-04
TW201927290A (zh) 2019-07-16
BR112020006783A2 (pt) 2020-10-06
IL273704B2 (en) 2024-06-01
EP3694522A2 (en) 2020-08-19
CL2020000959A1 (es) 2021-02-26
TWI841539B (zh) 2024-05-11
AU2018347990A1 (en) 2020-04-23
KR20200070246A (ko) 2020-06-17
EP3694522B1 (en) 2025-11-26
PT3694522T (pt) 2025-12-15
WO2019074826A3 (en) 2020-04-02
JP2025165977A (ja) 2025-11-05
RU2020118376A3 (https=) 2022-02-01
FI3694522T3 (fi) 2026-02-05
CA3078624A1 (en) 2019-04-18
IL273704A (en) 2020-05-31
US20200230141A1 (en) 2020-07-23
EP4667003A2 (en) 2025-12-24
RU2020118376A (ru) 2021-11-15
AU2018347990B2 (en) 2021-09-09
JP2020536931A (ja) 2020-12-17
ES3056013T3 (en) 2026-02-17

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