KR20150015500A - 엔테카비어의 약제학적 조성물 및 제조 방법 - Google Patents

엔테카비어의 약제학적 조성물 및 제조 방법 Download PDF

Info

Publication number
KR20150015500A
KR20150015500A KR20147034899A KR20147034899A KR20150015500A KR 20150015500 A KR20150015500 A KR 20150015500A KR 20147034899 A KR20147034899 A KR 20147034899A KR 20147034899 A KR20147034899 A KR 20147034899A KR 20150015500 A KR20150015500 A KR 20150015500A
Authority
KR
South Korea
Prior art keywords
pharmaceutical composition
entecavir
pharmaceutical
filler
composition according
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.)
Ceased
Application number
KR20147034899A
Other languages
English (en)
Korean (ko)
Inventor
매튜 필립
나레쉬 탈바르
Original Assignee
파마사이언스 인크.
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 파마사이언스 인크. filed Critical 파마사이언스 인크.
Publication of KR20150015500A publication Critical patent/KR20150015500A/ko
Ceased legal-status Critical Current

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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • 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
    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Biotechnology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR20147034899A 2012-05-31 2013-05-28 엔테카비어의 약제학적 조성물 및 제조 방법 Ceased KR20150015500A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA 2779052 CA2779052A1 (en) 2012-05-31 2012-05-31 Pharmaceutical composition of entecavir and process of manufacturing
CA2,779,052 2012-05-31
PCT/CA2013/000517 WO2013177672A1 (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing

Publications (1)

Publication Number Publication Date
KR20150015500A true KR20150015500A (ko) 2015-02-10

Family

ID=49672225

Family Applications (1)

Application Number Title Priority Date Filing Date
KR20147034899A Ceased KR20150015500A (ko) 2012-05-31 2013-05-28 엔테카비어의 약제학적 조성물 및 제조 방법

Country Status (9)

Country Link
US (2) US20150110869A1 (enExample)
EP (1) EP2854773B1 (enExample)
JP (1) JP6320371B2 (enExample)
KR (1) KR20150015500A (enExample)
CN (1) CN104363896A (enExample)
CA (2) CA2779052A1 (enExample)
HK (1) HK1208620A1 (enExample)
IN (1) IN2014MN02487A (enExample)
WO (1) WO2013177672A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3158998A4 (en) 2014-06-20 2018-02-14 CTC Bio, Inc. Pharmaceutical preparation containing entecavir as active ingredient, and preparation method therefor
CN104473896B (zh) * 2014-12-01 2017-04-19 东莞市金美济药业有限公司 一种快速崩解的拉米夫定片及其制备工艺
HRP20240136T1 (hr) 2016-06-29 2024-04-12 Tesaro, Inc. Metode liječenja raka jajnika
EP3606523A1 (en) * 2017-03-27 2020-02-12 Tesaro, Inc. Niraparib formulations
AU2018246214B2 (en) 2017-03-27 2021-07-08 Merck Sharp & Dohme Llc Niraparib compositions
CN111278433A (zh) 2017-09-26 2020-06-12 特沙诺有限公司 尼拉帕尼制剂
CN109550020A (zh) * 2019-02-14 2019-04-02 任连智 一种治疗乙肝大小三阳的药物制剂及制备方法
CN110354129A (zh) * 2019-08-19 2019-10-22 苏州扬厉医药科技有限公司 一种治疗乙肝病毒的新药药物组合及制备方法
AU2022289906A1 (en) * 2021-06-07 2023-11-09 R.P. Scherer Technologies, Llc Protective coating for moisture sensitive pharmaceutical compositions

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2001229775A1 (en) * 2000-02-29 2001-09-12 Bristol-Myers Squibb Company Low dose entecavir formulation and use
CA2311734C (en) * 2000-04-12 2011-03-08 Bristol-Myers Squibb Company Flash-melt oral dosage formulation
EP1517678A2 (en) * 2002-06-24 2005-03-30 Ranbaxy Laboratories Limited Process for the preparation of robust formulations of valacyclovir hydrochloride tablets
US7905852B2 (en) * 2006-05-16 2011-03-15 Barbara Jennings-Spring Skin-contacting-adhesive free dressing
US20070281000A1 (en) * 2006-06-02 2007-12-06 Michael Fox Stable formulation comprising moisture sensitive drug/s and manufacturing procedure thereof
CN101245068A (zh) * 2007-02-14 2008-08-20 浙江医药股份有限公司新昌制药厂 结晶型态的恩替卡韦及其制备方法和其药物组合物及用途
WO2009106954A1 (en) * 2008-02-27 2009-09-03 Aurobindo Pharma Limited Stable dosage forms of lamivudine and tenofovir
WO2009106960A2 (en) * 2008-02-27 2009-09-03 Aurobindo Pharma Limited Stable compositions of lamivudine, tenofovir and efavirenz
EP2467144A1 (en) * 2009-07-24 2012-06-27 ViroLogik GmbH Combination of proteasome inhibitors and anti-hepatitis medication for treating hepatitis
WO2011076412A1 (de) * 2009-12-23 2011-06-30 Ratiopharm Gmbh Orale darreichungsform umfassend entecavir
NZ610729A (en) * 2010-11-19 2015-10-30 Gilead Sciences Inc Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
EP2508172A1 (en) * 2011-04-06 2012-10-10 Zentiva, a.s. Stable and uniform formulations of entecavir and preparation method thereof
EP2780001A4 (en) * 2011-11-14 2015-10-28 Hetero Research Foundation SOLID ORAL ENTECAVIR COMPOSITIONS WITH FAST RELEASE
WO2013114389A1 (en) * 2011-12-21 2013-08-08 Mylan Laboratories Limited. Process for preparing solid oral formulations comprising low dose of entecavir

Also Published As

Publication number Publication date
JP6320371B2 (ja) 2018-05-09
EP2854773B1 (en) 2020-05-06
IN2014MN02487A (enExample) 2015-07-17
US20190076366A1 (en) 2019-03-14
EP2854773A1 (en) 2015-04-08
CA2874779C (en) 2019-03-05
US20150110869A1 (en) 2015-04-23
WO2013177672A1 (en) 2013-12-05
CA2779052A1 (en) 2013-11-30
CA2874779A1 (en) 2013-12-05
JP2015521191A (ja) 2015-07-27
HK1208620A1 (en) 2016-03-11
EP2854773A4 (en) 2016-01-27
CN104363896A (zh) 2015-02-18

Similar Documents

Publication Publication Date Title
EP2854773B1 (en) Pharmaceutical composition of entecavir and process of manufacturing
KR100757155B1 (ko) 저용량의 엔테카비르 제제 및 그의 용도
CN101983054B (zh) 含有咪达那新的口腔内迅速崩解性片剂
JP6101260B2 (ja) ダルナビル製剤
ES2437072T5 (es) Preparación sólida
JP6001763B2 (ja) 低用量エンテカビルの経口投与製剤の製造方法
JP2023513249A (ja) オメカムチブメカルビル製剤
JP2014520787A (ja) ダルナビル複合製剤
JP7377943B2 (ja) 固形製剤の製造方法
EP1738754B1 (en) Solid pharmaceutical preparation
WO2013114389A1 (en) Process for preparing solid oral formulations comprising low dose of entecavir
EP2612657B1 (en) Orodispersible tablet
WO2014193528A1 (en) Amorphous dosage forms and methods
WO2006044968A2 (en) Combination therapy for treating viral infections
TW201542212A (zh) 包括恩曲他濱、泰諾福韋、地瑞那韋與利托那韋的單位劑量形式以及包括地瑞那韋與利托那韋的單體錠劑
JP6538321B2 (ja) 経口組成物
JP4572296B2 (ja) ピモベンダン経口投与製剤
WO2017029225A1 (en) Solid pharmaceutical composition of abacavir, lamivudine, and efavirenz
WO2020122244A1 (ja) 錠剤及びその製造方法
CN108785273B (zh) 一种恩替卡韦胶囊药物组合物及其制备方法
WO2018130943A1 (en) Oral pharmaceutical composition of lurasidone and preparation thereof
JP2004238348A (ja) 経口投与用イトラコナゾール製剤
US20250195417A1 (en) Additive composition for orally disintegrating tablet
RU2589502C1 (ru) Лекарственное средство и способы его получения (варианты)
CN111759850A (zh) 草酸替诺福韦的药物组合物

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20141211

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20180528

Comment text: Request for Examination of Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20190909

Patent event code: PE09021S01D

E601 Decision to refuse application
PE0601 Decision on rejection of patent

Patent event date: 20191126

Comment text: Decision to Refuse Application

Patent event code: PE06012S01D

Patent event date: 20190909

Comment text: Notification of reason for refusal

Patent event code: PE06011S01I