CN104379147A - 制备用于口服给药的低剂量恩替卡韦制剂的方法 - Google Patents

制备用于口服给药的低剂量恩替卡韦制剂的方法 Download PDF

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Publication number
CN104379147A
CN104379147A CN201380030483.3A CN201380030483A CN104379147A CN 104379147 A CN104379147 A CN 104379147A CN 201380030483 A CN201380030483 A CN 201380030483A CN 104379147 A CN104379147 A CN 104379147A
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CN
China
Prior art keywords
entecavir
preparation
oral administration
micronized
mixture
Prior art date
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Pending
Application number
CN201380030483.3A
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English (en)
Chinese (zh)
Inventor
崔旻寿
金升柱
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.)
Jeil Pharmaceutical Co Ltd
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Jeil Pharmaceutical Co Ltd
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Publication date
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Publication of CN104379147A publication Critical patent/CN104379147A/zh
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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
    • A61K31/495—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
    • A61K31/33—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
    • 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
    • A61K9/14—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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201380030483.3A 2012-04-18 2013-03-28 制备用于口服给药的低剂量恩替卡韦制剂的方法 Pending CN104379147A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020120040433A KR101285008B1 (ko) 2012-04-18 2012-04-18 저용량 엔테카비어의 경구투여 제제의 제조방법
KR10-2012-0040433 2012-04-18
PCT/KR2013/002571 WO2013157754A1 (ko) 2012-04-18 2013-03-28 저용량 엔테카비어의 경구투여 제제의 제조방법

Publications (1)

Publication Number Publication Date
CN104379147A true CN104379147A (zh) 2015-02-25

Family

ID=48997118

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380030483.3A Pending CN104379147A (zh) 2012-04-18 2013-03-28 制备用于口服给药的低剂量恩替卡韦制剂的方法

Country Status (4)

Country Link
JP (1) JP6001763B2 (ko)
KR (1) KR101285008B1 (ko)
CN (1) CN104379147A (ko)
WO (1) WO2013157754A1 (ko)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106667926A (zh) * 2015-11-09 2017-05-17 石药集团中奇制药技术（石家庄）有限公司 一种法匹拉韦片剂及其制备方法
CN107213130A (zh) * 2017-05-12 2017-09-29 上海奥科达生物医药科技有限公司 一种恩替卡韦药用组合物、制备方法及其应用
CN110585148A (zh) * 2019-09-19 2019-12-20 苏州扬厉医药科技有限公司 一种恩替卡韦片及其制备方法
CN112370434A (zh) * 2020-10-26 2021-02-19 石药集团欧意药业有限公司 一种恩替卡韦片剂组合物及其制备方法

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160175313A1 (en) * 2013-08-06 2016-06-23 Dongkook Pharmaceutical Co., Ltd., Entecavir microspheres and pharmaceutical composition for parenteral administration containing same
KR101512895B1 (ko) 2013-08-09 2015-04-16 대화제약 주식회사 엔테카비어를 포함하는 약학적 조성물의 제조방법
CN106573003B (zh) * 2014-06-20 2022-04-01 西梯茜生命工学股份有限公司 含有恩替卡韦作为活性成分的药物制剂及其制备方法
CA3048360C (en) 2016-12-26 2021-06-29 Shionogi & Co., Ltd. Production method for formulation having improved content uniformity
CN110856719B (zh) * 2018-08-23 2021-08-10 江苏奥赛康药业有限公司 一种2-氨基嘧啶类化合物的药用组合物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1310999A (zh) * 2000-02-29 2001-09-05 布里斯托尔-迈尔斯斯奎布公司 低剂量艾替开韦制剂及其应用
CN102100677A (zh) * 2010-06-28 2011-06-22 江苏正大天晴药业股份有限公司 恩替卡韦分散片及其制备方法
WO2011076412A1 (de) * 2009-12-23 2011-06-30 Ratiopharm Gmbh Orale darreichungsform umfassend entecavir

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU230698B1 (hu) * 2000-02-29 2017-09-28 Bristol-Myers Squibb Holdings Ireland Alacsony dózisú entecavir formuláció és alkalmazása
KR20040045499A (ko) * 2001-10-09 2004-06-01 브리스톨-마이어스스퀴브컴파니 급속 용융 경구 투여 제제
JP4887635B2 (ja) * 2005-02-28 2012-02-29 ゼリア新薬工業株式会社 経口固形製剤
CA2668267A1 (en) * 2006-10-31 2008-05-08 Achillion Pharmaceuticals, Inc. Elvucitabine pharmaceutical compositions
BRPI0821761A2 (pt) * 2007-12-21 2015-06-16 Eurand Inc Composições de comprimidos de desintegração oral de temazepam

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1310999A (zh) * 2000-02-29 2001-09-05 布里斯托尔-迈尔斯斯奎布公司 低剂量艾替开韦制剂及其应用
WO2011076412A1 (de) * 2009-12-23 2011-06-30 Ratiopharm Gmbh Orale darreichungsform umfassend entecavir
CN102100677A (zh) * 2010-06-28 2011-06-22 江苏正大天晴药业股份有限公司 恩替卡韦分散片及其制备方法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106667926A (zh) * 2015-11-09 2017-05-17 石药集团中奇制药技术（石家庄）有限公司 一种法匹拉韦片剂及其制备方法
CN106667926B (zh) * 2015-11-09 2020-01-17 石药集团中奇制药技术（石家庄）有限公司 一种法匹拉韦片剂及其制备方法
CN107213130A (zh) * 2017-05-12 2017-09-29 上海奥科达生物医药科技有限公司 一种恩替卡韦药用组合物、制备方法及其应用
CN110585148A (zh) * 2019-09-19 2019-12-20 苏州扬厉医药科技有限公司 一种恩替卡韦片及其制备方法
CN112370434A (zh) * 2020-10-26 2021-02-19 石药集团欧意药业有限公司 一种恩替卡韦片剂组合物及其制备方法

Also Published As

Publication number Publication date
WO2013157754A1 (ko) 2013-10-24
JP2015530355A (ja) 2015-10-15
KR101285008B1 (ko) 2013-07-10
JP6001763B2 (ja) 2016-10-05

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Application publication date: 20150225