CN104363896A - 恩替卡韦的药物组合物及制造方法 - Google Patents

恩替卡韦的药物组合物及制造方法 Download PDF

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Publication number
CN104363896A
CN104363896A CN201380030696.6A CN201380030696A CN104363896A CN 104363896 A CN104363896 A CN 104363896A CN 201380030696 A CN201380030696 A CN 201380030696A CN 104363896 A CN104363896 A CN 104363896A
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CN
China
Prior art keywords
pharmaceutical composition
composition according
entecavir
granules
pharmaceutical
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.)
Pending
Application number
CN201380030696.6A
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English (en)
Chinese (zh)
Inventor
M·菲利普
N·泰尔沃
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Pharmascience Inc
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Pharmascience Inc
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Filing date
Publication date
Application filed by Pharmascience Inc filed Critical Pharmascience Inc
Publication of CN104363896A publication Critical patent/CN104363896A/zh
Pending legal-status Critical Current

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    • 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
    • A61K31/33—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
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Biotechnology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201380030696.6A 2012-05-31 2013-05-28 恩替卡韦的药物组合物及制造方法 Pending CN104363896A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA2,779,052 2012-05-31
CA 2779052 CA2779052A1 (en) 2012-05-31 2012-05-31 Pharmaceutical composition of entecavir and process of manufacturing
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
CN104363896A true CN104363896A (zh) 2015-02-18

Family

ID=49672225

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380030696.6A Pending CN104363896A (zh) 2012-05-31 2013-05-28 恩替卡韦的药物组合物及制造方法

Country Status (9)

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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110709083A (zh) * 2017-03-27 2020-01-17 特沙诺有限公司 尼拉帕尼制剂
US11730725B2 (en) 2017-09-26 2023-08-22 Tesaro, Inc. Niraparib formulations

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY185605A (en) * 2014-06-20 2021-05-25 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
KR20230042136A (ko) 2016-06-29 2023-03-27 테사로, 인코포레이티드 난소암의 치료 방법
BR112019020211A2 (pt) 2017-03-27 2020-04-22 Tesaro, Inc. composições de niraparib
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
KR20240019293A (ko) * 2021-06-07 2024-02-14 알.피.쉐러 테크놀러지즈 엘엘씨 습기 감응성 약학 조성물용 보호 코팅

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GEP20053504B (en) * 2000-02-29 2005-05-10 Bristol Myers Squibb Co Low Dose Entecavir Pharmaceutical Composition and Use Thereof for Treatment of Hepatitis B
CA2311734C (en) * 2000-04-12 2011-03-08 Bristol-Myers Squibb Company Flash-melt oral dosage formulation
WO2004000265A2 (en) * 2002-06-24 2003-12-31 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
US20110020272A1 (en) * 2009-07-24 2011-01-27 Ulrich Schubert Combination therapy for treating hepatitis viral infection
WO2011076412A1 (de) * 2009-12-23 2011-06-30 Ratiopharm Gmbh Orale darreichungsform umfassend entecavir
SG10201509521WA (en) * 2010-11-19 2015-12-30 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
WO2013072937A2 (en) * 2011-11-14 2013-05-23 Hetero Research Foundation Fast release solid oral compositions of entecavir
WO2013114389A1 (en) * 2011-12-21 2013-08-08 Mylan Laboratories Limited. Process for preparing solid oral formulations comprising low dose of entecavir

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110709083A (zh) * 2017-03-27 2020-01-17 特沙诺有限公司 尼拉帕尼制剂
US11730725B2 (en) 2017-09-26 2023-08-22 Tesaro, Inc. Niraparib formulations

Also Published As

Publication number Publication date
CA2874779C (en) 2019-03-05
JP2015521191A (ja) 2015-07-27
KR20150015500A (ko) 2015-02-10
US20190076366A1 (en) 2019-03-14
US20150110869A1 (en) 2015-04-23
CA2874779A1 (en) 2013-12-05
EP2854773B1 (en) 2020-05-06
IN2014MN02487A (https=) 2015-07-17
EP2854773A4 (en) 2016-01-27
JP6320371B2 (ja) 2018-05-09
EP2854773A1 (en) 2015-04-08
WO2013177672A1 (en) 2013-12-05
HK1208620A1 (en) 2016-03-11
CA2779052A1 (en) 2013-11-30

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Application publication date: 20150218

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