CA2779052A1 - Pharmaceutical composition of entecavir and process of manufacturing - Google Patents

Pharmaceutical composition of entecavir and process of manufacturing Download PDF

Info

Publication number
CA2779052A1
CA2779052A1 CA 2779052 CA2779052A CA2779052A1 CA 2779052 A1 CA2779052 A1 CA 2779052A1 CA 2779052 CA2779052 CA 2779052 CA 2779052 A CA2779052 A CA 2779052A CA 2779052 A1 CA2779052 A1 CA 2779052A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
entecavir
composition according
adhesive
granules
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.)
Abandoned
Application number
CA 2779052
Other languages
English (en)
French (fr)
Inventor
Mathew Philip
Naresh Talwar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pharmascience Inc
Original Assignee
Pharmascience Inc
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 Pharmascience Inc filed Critical Pharmascience Inc
Priority to CA 2779052 priority Critical patent/CA2779052A1/en
Priority to KR20147034899A priority patent/KR20150015500A/ko
Priority to CA2874779A priority patent/CA2874779C/en
Priority to CN201380030696.6A priority patent/CN104363896A/zh
Priority to PCT/CA2013/000517 priority patent/WO2013177672A1/en
Priority to HK15109146.7A priority patent/HK1208620A1/xx
Priority to EP13797878.9A priority patent/EP2854773B1/en
Priority to IN2487MUN2014 priority patent/IN2014MN02487A/en
Priority to JP2015514297A priority patent/JP6320371B2/ja
Priority to US14/404,176 priority patent/US20150110869A1/en
Publication of CA2779052A1 publication Critical patent/CA2779052A1/en
Priority to US15/944,452 priority patent/US20190076366A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/662Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals 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)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Virology (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)
CA 2779052 2012-05-31 2012-05-31 Pharmaceutical composition of entecavir and process of manufacturing Abandoned CA2779052A1 (en)

Priority Applications (11)

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
HK15109146.7A HK1208620A1 (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing
CA2874779A CA2874779C (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing
CN201380030696.6A CN104363896A (zh) 2012-05-31 2013-05-28 恩替卡韦的药物组合物及制造方法
PCT/CA2013/000517 WO2013177672A1 (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing
KR20147034899A KR20150015500A (ko) 2012-05-31 2013-05-28 엔테카비어의 약제학적 조성물 및 제조 방법
EP13797878.9A EP2854773B1 (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing
IN2487MUN2014 IN2014MN02487A (enExample) 2012-05-31 2013-05-28
JP2015514297A JP6320371B2 (ja) 2012-05-31 2013-05-28 エンテカビルの医薬組成物および製造方法
US14/404,176 US20150110869A1 (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing
US15/944,452 US20190076366A1 (en) 2012-05-31 2018-04-03 Pharmaceutical composition of entecavir and process of manufacturing

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
CA2779052A1 true CA2779052A1 (en) 2013-11-30

Family

ID=49672225

Family Applications (2)

Application Number Title Priority Date Filing Date
CA 2779052 Abandoned CA2779052A1 (en) 2012-05-31 2012-05-31 Pharmaceutical composition of entecavir and process of manufacturing
CA2874779A Active CA2874779C (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2874779A Active CA2874779C (en) 2012-05-31 2013-05-28 Pharmaceutical composition of entecavir and process of manufacturing

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 (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201610636VA (en) 2014-06-20 2017-01-27 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
EP3478286B1 (en) 2016-06-29 2024-01-03 Tesaro, Inc. Methods of treating ovarian cancer
MX2019011496A (es) 2017-03-27 2020-01-23 Tesaro Inc Composiciones de niraparib.
EP3606523A1 (en) * 2017-03-27 2020-02-12 Tesaro, Inc. Niraparib formulations
BR112020006039A2 (pt) 2017-09-26 2020-10-06 Tesaro, Inc. formulações de niraparibe
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

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2401569C (en) * 2000-02-29 2009-08-18 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
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
WO2011009961A1 (en) * 2009-07-24 2011-01-27 Virologik Gmbh Combination of proteasome inhibitors and anti-hepatitis medication for treating hepatitis
EA201290556A1 (ru) * 2009-12-23 2013-01-30 Рациофарм Гмбх Оральная лекарственная форма, включающая энтекавир
ES2524408T5 (es) * 2010-11-19 2022-04-25 Gilead Sciences Inc Composiciones terapéuticas que comprenden rilpivirina HCl y tenofovir disoproxil fumarato
EP2508172A1 (en) * 2011-04-06 2012-10-10 Zentiva, a.s. Stable and uniform formulations of entecavir and preparation method thereof
US20140315930A1 (en) * 2011-11-14 2014-10-23 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

Also Published As

Publication number Publication date
CA2874779C (en) 2019-03-05
IN2014MN02487A (enExample) 2015-07-17
JP6320371B2 (ja) 2018-05-09
JP2015521191A (ja) 2015-07-27
CA2874779A1 (en) 2013-12-05
US20190076366A1 (en) 2019-03-14
KR20150015500A (ko) 2015-02-10
HK1208620A1 (en) 2016-03-11
CN104363896A (zh) 2015-02-18
WO2013177672A1 (en) 2013-12-05
US20150110869A1 (en) 2015-04-23
EP2854773A4 (en) 2016-01-27
EP2854773B1 (en) 2020-05-06
EP2854773A1 (en) 2015-04-08

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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20150602

FZDE Discontinued

Effective date: 20150602