PE20020770A1 - Formulaciones de entecavir de dosis bajas y uso - Google Patents

Formulaciones de entecavir de dosis bajas y uso

Info

Publication number
PE20020770A1
PE20020770A1 PE2001000552A PE2001000552A PE20020770A1 PE 20020770 A1 PE20020770 A1 PE 20020770A1 PE 2001000552 A PE2001000552 A PE 2001000552A PE 2001000552 A PE2001000552 A PE 2001000552A PE 20020770 A1 PE20020770 A1 PE 20020770A1
Authority
PE
Peru
Prior art keywords
entecavir
low dose
dextrosphate
use formulations
calcium
Prior art date
Application number
PE2001000552A
Other languages
English (en)
Inventor
Richard J Colonno
Divyakant Desai
Omar L Sprockel
Abizer Harianawala
Michael G Fakes
Original Assignee
Bristol Myers Squibb Co
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26881354&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20020770(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of PE20020770A1 publication Critical patent/PE20020770A1/es

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
    • A61K9/2004Excipients; 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • 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
    • 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
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

SE REFIERE A UNA COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL VIRUS DE LA HEPATITIS B QUE COMPRENDE: a) DE 0.001 mg A 25 mg DE ENTECAVIR Y b) UN PORTADOR FARMACEUTICAMENTE ACEPTABLE SELECCIONADO DE LACTOSA, CELULOSA MICROCRISTALINA, FOSFATO DE CALCIO, DEXTRINA, DEXTROSA, ENTRE OTROS. EL ENTECAVIR [1S-(1O,3O,4ß)]-2-AMINO-1,9-DIHIDRO-9-[4-HIDROXI-3-(HIDROXIMETIL)-2-METILENCICLOPENTIL]-6H-PURIN-6-ONA SE ADHIERE A DICHO SUBSTRATO POR UNA SUBSTANCIA ADHESIVA LA CUAL ES UN MATERIAL POLIMERICO QUE POSEE SUFICIENTE VISCOSIDAD Y ES SELECCIONADA DE POVIDONA, METILCELULOSA, HIDROXIMETILCELULOSA, ENTRE OTROS. LA COMPOSICION INCLUYE ADEMAS UN LUBRICANTE Y UN DESINTEGRANTE. SE REFIERE TAMBIEN A UN PROCEDIMIENTO PARA LA PREPARACION
PE2001000552A 2000-02-29 2001-06-12 Formulaciones de entecavir de dosis bajas y uso PE20020770A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18567200P 2000-02-29 2000-02-29
US22131300P 2000-07-28 2000-07-28

Publications (1)

Publication Number Publication Date
PE20020770A1 true PE20020770A1 (es) 2002-09-06

Family

ID=26881354

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2001000552A PE20020770A1 (es) 2000-02-29 2001-06-12 Formulaciones de entecavir de dosis bajas y uso

Country Status (35)

Country Link
US (1) US6627224B2 (es)
EP (2) EP1642582A1 (es)
JP (3) JP5140222B2 (es)
KR (1) KR100757155B1 (es)
AR (1) AR027965A1 (es)
AT (1) ATE312613T1 (es)
AU (1) AU2001229775A1 (es)
BG (1) BG65815B1 (es)
BR (1) BRPI0108435B8 (es)
CA (1) CA2401569C (es)
CO (1) CO5261593A1 (es)
CZ (1) CZ303395B6 (es)
DE (1) DE60115870T3 (es)
DK (1) DK1267880T4 (es)
EA (1) EA006181B1 (es)
EE (1) EE05442B1 (es)
EG (1) EG24408A (es)
ES (1) ES2253403T5 (es)
GE (1) GEP20053504B (es)
HK (1) HK1048771A1 (es)
HR (1) HRP20020649A2 (es)
HU (1) HU230698B1 (es)
IL (1) IL150447A0 (es)
MX (1) MXPA02008359A (es)
MY (1) MY127422A (es)
NO (1) NO324014B1 (es)
NZ (1) NZ520024A (es)
PE (1) PE20020770A1 (es)
PL (1) PL201411B1 (es)
RS (1) RS51561B (es)
SI (1) SI1267880T2 (es)
SK (1) SK288008B6 (es)
TW (1) TWI287988B (es)
UA (1) UA84534C2 (es)
WO (1) WO2001064221A1 (es)

Families Citing this family (33)

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EP1642582A1 (en) * 2000-02-29 2006-04-05 Bristol-Myers Squibb Company Low dose entecavir formulation and use
TWI275392B (en) * 2002-04-08 2007-03-11 Bristol Myers Squibb Co Low dose liquid entecavir formulations and use
AR040588A1 (es) 2002-07-26 2005-04-13 Schering Corp Formulacion farmaceutica que comprende un inhibidor de la absorcion del colesterol y un inhibidor de una hmg- co a reductasa
CN101130552B (zh) * 2002-12-11 2010-07-28 布里斯托尔-迈尔斯斯奎布公司 制备抗病毒药[1S-(1α,3α,4β)]-2-氨基-1,9-二氢-9-[4-羟基-3-(羟甲基)-2-亚甲环戊基]-6H-嘌呤-6-酮的方法
ATE398455T1 (de) * 2003-01-14 2008-07-15 Gilead Sciences Inc Zusammensetzungen und verfahren zur antiviralen kombinationstherapie
HUE058126T2 (hu) 2003-11-17 2022-07-28 Biomarin Pharm Inc Módszerek és készítmények metabolikus rendellenességek kezelésére
BRPI0416691A (pt) * 2003-11-18 2007-01-30 Boehringer Ingelheim Int forma de preparação farmacêutica sólida
US7511139B2 (en) * 2004-06-04 2009-03-31 Bristol-Myers Squibb Company Process for the preparation of entecavir and novel intermediates thereof via carbon-silicon oxidation
JP4756153B2 (ja) * 2004-08-27 2011-08-24 富士製薬工業株式会社 低成分含量の錠剤の製造方法
CA2580117A1 (en) * 2004-09-23 2006-03-30 Fmc Corporation Coating composition
TWI375560B (en) 2005-06-13 2012-11-01 Gilead Sciences Inc Composition comprising dry granulated emtricitabine and tenofovir df and method for making the same
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
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
TW200904405A (en) 2007-03-22 2009-02-01 Bristol Myers Squibb Co Pharmaceutical formulations containing an SGLT2 inhibitor
WO2011056702A2 (en) 2009-10-28 2011-05-12 Mcneil-Ppc, Inc. Fast dissolving/disintegrating coating compositions
EP2515872A1 (de) 2009-12-23 2012-10-31 Ratiopharm GmbH Orale darreichungsform umfassend entecavir
DE102009060194A1 (de) 2009-12-23 2011-06-30 ratiopharm GmbH, 89079 Orale Darreichungsform umfassend Entecavir
WO2011103516A2 (en) * 2010-02-18 2011-08-25 The Trustees Of Princeton University Inhibitors of long and very long chain fatty acid metabolism as broad spectrum anti-virals
UA110612C2 (uk) 2010-03-31 2016-01-25 Мілленніум Фармасьютікалз, Інк. Похідні 1-аміно-2-циклопропілетилборонової кислоти
WO2012048455A1 (zh) * 2010-10-12 2012-04-19 武汉大学 一种抗病毒透皮吸收贴片及其制备方法
EP2508172A1 (en) 2011-04-06 2012-10-10 Zentiva, a.s. Stable and uniform formulations of entecavir and preparation method thereof
KR101594820B1 (ko) * 2011-06-16 2016-02-17 건일제약 주식회사 엔테카비르를 함유하는 미립구 및 이의 제조방법
WO2013066028A1 (ko) 2011-11-01 2013-05-10 대원제약주식회사 안정성이 향상된 엔테카비어를 함유하는 약학적 조성물 및 그 제조방법
CA2881119A1 (en) * 2011-11-14 2013-05-23 Hetero Research Foundation Fast release solid oral compositions of entecavir
EP2644196B1 (en) * 2012-03-26 2019-09-18 Arven Ilac Sanayi ve Ticaret A.S. Pharmaceutical compositions of Entecavir
EP2644197A1 (en) * 2012-03-26 2013-10-02 Sanovel Ilac Sanayi ve Ticaret A.S. Novel Pharmaceutical Compositions of Entecavir
KR101285008B1 (ko) * 2012-04-18 2013-07-10 제일약품주식회사 저용량 엔테카비어의 경구투여 제제의 제조방법
CA2779052A1 (en) * 2012-05-31 2013-11-30 Pharmascience Inc. Pharmaceutical composition of entecavir and process of manufacturing
CN103908436B (zh) * 2012-12-29 2016-02-10 安徽贝克生物制药有限公司 一种速释型恩替卡韦组合物
KR101512895B1 (ko) 2013-08-09 2015-04-16 대화제약 주식회사 엔테카비어를 포함하는 약학적 조성물의 제조방법
EP3158998A4 (en) * 2014-06-20 2018-02-14 CTC Bio, Inc. Pharmaceutical preparation containing entecavir as active ingredient, and preparation method therefor
CN108348616B (zh) * 2015-09-30 2022-12-23 株式会社大赛璐 易服用性固体制剂用颗粒组合物和包含该颗粒组合物的易服用性固体制剂
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Also Published As

Publication number Publication date
SI1267880T1 (sl) 2006-06-30
JP2012255017A (ja) 2012-12-27
PL201411B1 (pl) 2009-04-30
MXPA02008359A (es) 2003-02-12
SI1267880T2 (sl) 2010-04-30
EG24408A (en) 2009-05-20
BRPI0108435B1 (pt) 2019-02-05
NO20024099L (no) 2002-08-28
EA200200812A1 (ru) 2003-12-25
DK1267880T4 (da) 2010-05-17
JP2004503467A (ja) 2004-02-05
MY127422A (en) 2006-11-30
PL366102A1 (en) 2005-01-24
EE200200484A (et) 2004-04-15
BG106905A (bg) 2003-04-30
EP1267880A1 (en) 2003-01-02
NO20024099D0 (no) 2002-08-28
TWI287988B (en) 2007-10-11
HUP0500558A3 (en) 2012-08-28
WO2001064221A1 (en) 2001-09-07
US6627224B2 (en) 2003-09-30
ES2253403T5 (es) 2010-04-22
RS51561B (sr) 2011-08-31
AU2001229775A1 (en) 2001-09-12
HRP20020649A2 (en) 2004-12-31
ATE312613T1 (de) 2005-12-15
SK288008B6 (sk) 2012-10-02
EA006181B1 (ru) 2005-10-27
US20010033864A1 (en) 2001-10-25
JP5921746B2 (ja) 2016-05-24
DE60115870D1 (de) 2006-01-19
HUP0500558A2 (hu) 2005-09-28
JP2015178523A (ja) 2015-10-08
DE60115870T2 (de) 2006-08-17
CO5261593A1 (es) 2003-03-31
ES2253403T3 (es) 2006-06-01
EP1267880B2 (en) 2010-01-20
BR0108435A (pt) 2004-06-15
CA2401569C (en) 2009-08-18
BRPI0108435B8 (pt) 2021-05-25
EP1267880B1 (en) 2005-12-14
EE05442B1 (et) 2011-08-15
NZ520024A (en) 2005-03-24
BG65815B1 (bg) 2010-01-29
UA84534C2 (uk) 2008-11-10
HK1048771A1 (zh) 2003-04-17
NO324014B1 (no) 2007-07-30
JP5140222B2 (ja) 2013-02-06
CA2401569A1 (en) 2001-09-07
AR027965A1 (es) 2003-04-16
KR100757155B1 (ko) 2007-09-07
HU230698B1 (hu) 2017-09-28
DK1267880T3 (da) 2006-03-06
KR20020082230A (ko) 2002-10-30
EP1642582A1 (en) 2006-04-05
SK11652002A3 (sk) 2003-09-11
IL150447A0 (en) 2002-12-01
YU63002A (sh) 2005-03-15
CZ303395B6 (cs) 2012-08-29
DE60115870T3 (de) 2010-07-29
GEP20053504B (en) 2005-05-10

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