CN107820424B - Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型 - Google Patents

Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型 Download PDF

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Publication number
CN107820424B
CN107820424B CN201680019821.7A CN201680019821A CN107820424B CN 107820424 B CN107820424 B CN 107820424B CN 201680019821 A CN201680019821 A CN 201680019821A CN 107820424 B CN107820424 B CN 107820424B
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China
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dosage form
opioid
weight
oxycodone
sulfate
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CN201680019821.7A
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Chinese (zh)
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CN107820424A (zh
Inventor
李少玲
梁文瑞
张�浩
文卡特·R·萨兰迪
莫韫
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Theravance Biopharma R&D IP LLC
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Theravance Biopharma R&D IP LLC
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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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CN201680019821.7A 2015-04-02 2016-03-31 Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型 Active CN107820424B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562141981P 2015-04-02 2015-04-02
US62/141,981 2015-04-02
PCT/US2016/025176 WO2016161069A1 (en) 2015-04-02 2016-03-31 Combination dosage form of a mu opioid receptor antagonist and an opioid agent

Publications (2)

Publication Number Publication Date
CN107820424A CN107820424A (zh) 2018-03-20
CN107820424B true CN107820424B (zh) 2020-07-28

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CN201680019821.7A Active CN107820424B (zh) 2015-04-02 2016-03-31 Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型

Country Status (27)

Country Link
US (4) US20160287573A1 (https=)
EP (1) EP3277278B1 (https=)
JP (2) JP6713483B2 (https=)
KR (1) KR20170132325A (https=)
CN (1) CN107820424B (https=)
AU (1) AU2016243691A1 (https=)
BR (1) BR112017021120A2 (https=)
CA (1) CA2980328A1 (https=)
CY (1) CY1122828T1 (https=)
DK (1) DK3277278T3 (https=)
ES (1) ES2774473T3 (https=)
HK (1) HK1247105A1 (https=)
HR (1) HRP20200432T1 (https=)
HU (1) HUE048785T2 (https=)
IL (1) IL254593A0 (https=)
LT (1) LT3277278T (https=)
ME (1) ME03671B (https=)
MX (1) MX2017012474A (https=)
PH (1) PH12017501767A1 (https=)
PL (1) PL3277278T3 (https=)
PT (1) PT3277278T (https=)
RS (1) RS60074B1 (https=)
RU (1) RU2017134794A (https=)
SI (1) SI3277278T1 (https=)
SM (1) SMT202000157T1 (https=)
TW (1) TW201642856A (https=)
WO (1) WO2016161069A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HK1247105A1 (zh) 2015-04-02 2018-09-21 Theravance Biopharma R&D Ip, Llc Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型
JP7222244B2 (ja) * 2017-08-08 2023-02-15 三菱ケミカル株式会社 医薬錠剤、およびその製造方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006094063A1 (en) * 2005-03-02 2006-09-08 Theravance, Inc. Quinolinone compounds as 5-ht4 receptor agonists
US20080207676A1 (en) * 2007-02-28 2008-08-28 Sean Dalziel Crystalline forms of an 8-Azabicyclo(3.2.1)octane compound
CN101395154A (zh) * 2006-03-01 2009-03-25 施万制药 作为μ阿片受体拮抗剂的8-氮杂双环[3.2.1]辛烷化合物
CN101500542A (zh) * 2006-07-11 2009-08-05 共有药物有限公司 控释制剂
CN102858324A (zh) * 2010-03-24 2013-01-02 L.莫尔特尼及阿利蒂兄弟联合股份公司 包含阿片样激动剂和拮抗剂的双层药物制剂

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JP2001526228A (ja) 1997-12-22 2001-12-18 ユーロ−セルティーク，エス．エイ． オピオイド作動薬／拮抗薬の併用
US6419960B1 (en) 1998-12-17 2002-07-16 Euro-Celtique S.A. Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
US6451806B2 (en) 1999-09-29 2002-09-17 Adolor Corporation Methods and compositions involving opioids and antagonists thereof
AR029538A1 (es) * 2000-07-06 2003-07-02 Wyeth Corp Composiciones farmaceuticas de agentes estrogenicos
US7842307B2 (en) 2001-08-06 2010-11-30 Purdue Pharma L.P. Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent
ATE431738T1 (de) * 2001-08-06 2009-06-15 Euro Celtique Sa Opioid-agonist-formulierungen mit freisetzbarem und sequestriertem antagonist
AU2003301121A1 (en) * 2002-12-18 2004-07-14 Pain Therapeutics, Inc. Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats
US20050013863A1 (en) 2003-07-18 2005-01-20 Depomed, Inc., A Corporation Of The State Of California Dual drug dosage forms with improved separation of drugs
CA2540308C (en) 2003-09-26 2013-08-06 Alza Corporation Drug coating providing high drug loading and methods for providing the same
TWI415635B (zh) 2004-05-28 2013-11-21 必治妥施貴寶公司 加衣錠片調製物及製備彼之方法
MY145633A (en) 2006-03-01 2012-03-15 Theravance Inc 8-azabicyclo[3.2.1]octane compounds as mu opioid receptor antagonists
TWI415850B (zh) 2007-07-20 2013-11-21 Theravance Inc 製備ｍｕ類鴉片受體拮抗劑之中間物的方法
WO2009137672A1 (en) * 2008-05-07 2009-11-12 Salix Pharmaceuticals, Ltd. Methods of treating bowel disease by administering a bowel cleanser and an antibiotic
EP2210595A1 (en) 2009-01-14 2010-07-28 LEK Pharmaceuticals d.d. Active coating of pharmaceutical dosage forms
CN102421423B (zh) * 2009-05-12 2014-11-05 Bpsi控股有限责任公司 增强型防潮即释薄膜包衣系统和覆有该包衣的基体
EP2611442B1 (en) * 2010-09-03 2018-07-04 Bristol-Myers Squibb Company Drug formulations using water soluble antioxidants
BR112013019026A2 (pt) 2011-02-01 2016-10-04 Astrazeneca Uk Ltd formulações farmacêuticas incluindo um composto amina
US9339489B2 (en) * 2013-03-15 2016-05-17 Aprecia Pharmaceuticals Company Rapid disperse dosage form containing levetiracetam
HK1247105A1 (zh) 2015-04-02 2018-09-21 Theravance Biopharma R&D Ip, Llc Mu类鸦片受体拮抗剂与类鸦片药剂的组合剂型

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006094063A1 (en) * 2005-03-02 2006-09-08 Theravance, Inc. Quinolinone compounds as 5-ht4 receptor agonists
CN101395154A (zh) * 2006-03-01 2009-03-25 施万制药 作为μ阿片受体拮抗剂的8-氮杂双环[3.2.1]辛烷化合物
CN101500542A (zh) * 2006-07-11 2009-08-05 共有药物有限公司 控释制剂
US20080207676A1 (en) * 2007-02-28 2008-08-28 Sean Dalziel Crystalline forms of an 8-Azabicyclo(3.2.1)octane compound
CN101616916A (zh) * 2007-02-28 2009-12-30 施万制药 8-氮杂双环[3.2.1]辛烷化合物的晶型
CN102858324A (zh) * 2010-03-24 2013-01-02 L.莫尔特尼及阿利蒂兄弟联合股份公司 包含阿片样激动剂和拮抗剂的双层药物制剂

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Publication number Publication date
CA2980328A1 (en) 2016-10-06
US10369142B2 (en) 2019-08-06
MX2017012474A (es) 2018-01-11
TW201642856A (zh) 2016-12-16
US20180050028A1 (en) 2018-02-22
EP3277278B1 (en) 2020-01-08
IL254593A0 (en) 2017-11-30
JP2020073583A (ja) 2020-05-14
LT3277278T (lt) 2020-03-25
WO2016161069A1 (en) 2016-10-06
AU2016243691A1 (en) 2017-10-12
US11452723B2 (en) 2022-09-27
BR112017021120A2 (pt) 2018-07-03
DK3277278T3 (da) 2020-04-06
RS60074B1 (sr) 2020-05-29
JP6713483B2 (ja) 2020-06-24
ME03671B (me) 2020-10-20
HUE048785T2 (hu) 2020-08-28
PH12017501767A1 (en) 2018-06-11
KR20170132325A (ko) 2017-12-01
CN107820424A (zh) 2018-03-20
HRP20200432T1 (hr) 2020-06-12
ES2774473T3 (es) 2020-07-21
PL3277278T3 (pl) 2020-07-27
SMT202000157T1 (it) 2020-05-08
US20160287573A1 (en) 2016-10-06
SI3277278T1 (sl) 2020-04-30
HK1247105A1 (zh) 2018-09-21
US20210161884A1 (en) 2021-06-03
EP3277278A1 (en) 2018-02-07
PT3277278T (pt) 2020-04-16
CY1122828T1 (el) 2021-05-05
JP2018513138A (ja) 2018-05-24
RU2017134794A (ru) 2019-04-04
US10946009B2 (en) 2021-03-16
US20190321350A1 (en) 2019-10-24

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