KR20170132325A - 뮤 오피오이드 수용체 길항제 및 오피오이드 제제의 조합 제형 - Google Patents

뮤 오피오이드 수용체 길항제 및 오피오이드 제제의 조합 제형 Download PDF

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Publication number
KR20170132325A
KR20170132325A KR1020177031800A KR20177031800A KR20170132325A KR 20170132325 A KR20170132325 A KR 20170132325A KR 1020177031800 A KR1020177031800 A KR 1020177031800A KR 20177031800 A KR20177031800 A KR 20177031800A KR 20170132325 A KR20170132325 A KR 20170132325A
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KR
South Korea
Prior art keywords
formulation
weight
polyvinyl alcohol
polyethylene glycol
sulfate
Prior art date
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Withdrawn
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KR1020177031800A
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English (en)
Korean (ko)
Inventor
샤오링 리
만쉬 렁
하오 장
벤캇 알. 탈라디
윤 모
Original Assignee
세라밴스 바이오파마 알앤디 아이피, 엘엘씨
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Publication of KR20170132325A publication Critical patent/KR20170132325A/ko
Withdrawn legal-status Critical Current

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    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/439Heterocyclic 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
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • 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
    • A61K9/282Organic compounds, e.g. fats
    • 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
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/2853Organic 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)
    • 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
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs 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)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (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)
KR1020177031800A 2015-04-02 2016-03-31 뮤 오피오이드 수용체 길항제 및 오피오이드 제제의 조합 제형 Withdrawn KR20170132325A (ko)

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 (1)

Publication Number Publication Date
KR20170132325A true KR20170132325A (ko) 2017-12-01

Family

ID=55806767

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020177031800A Withdrawn KR20170132325A (ko) 2015-04-02 2016-03-31 뮤 오피오이드 수용체 길항제 및 오피오이드 제제의 조합 제형

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
DK3277278T3 (da) 2015-04-02 2020-04-06 Theravance Biopharma R&D Ip Llc Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid
EP3666261B1 (en) 2017-08-08 2025-01-15 Mitsubishi Chemical Corporation Pharmaceutical tablet and method for producing same

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1041987B1 (en) 1997-12-22 2006-04-19 Euro-Celtique S.A. Pharmaceutical oral dosage form comprising a combination of an opioid agonist and naltrexone
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
IL160222A0 (en) * 2001-08-06 2004-07-25 Euro Celtique Sa Opioid agonist formulations with releasable and sequestered antagonist
EP1572164A2 (en) * 2002-12-18 2005-09-14 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
KR20060092255A (ko) 2003-09-26 2006-08-22 알자 코포레이션 고도의 약물적재를 제공하는 약물코팅제 및 그의 제조방법
TWI354569B (en) 2004-05-28 2011-12-21 Bristol Myers Squibb Co Coated tablet formulation and method
CN101163701A (zh) * 2005-03-02 2008-04-16 施万制药 作为5-ht4受体激动剂的喹啉酮化合物
CN101395154B (zh) * 2006-03-01 2011-01-19 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
MY145633A (en) 2006-03-01 2012-03-15 Theravance Inc 8-azabicyclo[3.2.1]octane compounds as mu opioid receptor antagonists
CN101500542A (zh) * 2006-07-11 2009-08-05 共有药物有限公司 控释制剂
TWI409067B (zh) 2007-02-28 2013-09-21 Theravance Inc 8-氮雜雙環〔3.2.1〕辛烷化合物之結晶型
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
KR101783945B1 (ko) * 2009-05-12 2017-10-10 비피에스아이 홀딩스, 엘엘씨. 향상된 수분차단 속방출형 필름의 코팅 시스템 및 이에 의하여 코팅된 기재
IT1398930B1 (it) * 2010-03-24 2013-03-28 Molteni & C Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi.
CN103370064A (zh) * 2010-09-03 2013-10-23 百时美施贵宝公司 使用水溶性抗氧化剂的药物制剂
CA2826391C (en) 2011-02-01 2017-01-24 Bristol-Myers Squibb Company Pharmaceutical formulations including an amine compound
US9339489B2 (en) * 2013-03-15 2016-05-17 Aprecia Pharmaceuticals Company Rapid disperse dosage form containing levetiracetam
DK3277278T3 (da) 2015-04-02 2020-04-06 Theravance Biopharma R&D Ip Llc Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid

Also Published As

Publication number Publication date
PH12017501767A1 (en) 2018-06-11
JP6713483B2 (ja) 2020-06-24
TW201642856A (zh) 2016-12-16
JP2018513138A (ja) 2018-05-24
SI3277278T1 (sl) 2020-04-30
CN107820424A (zh) 2018-03-20
US20210161884A1 (en) 2021-06-03
HRP20200432T1 (hr) 2020-06-12
US10369142B2 (en) 2019-08-06
BR112017021120A2 (pt) 2018-07-03
ME03671B (me) 2020-10-20
CN107820424B (zh) 2020-07-28
US20180050028A1 (en) 2018-02-22
WO2016161069A1 (en) 2016-10-06
CA2980328A1 (en) 2016-10-06
EP3277278B1 (en) 2020-01-08
CY1122828T1 (el) 2021-05-05
US11452723B2 (en) 2022-09-27
HUE048785T2 (hu) 2020-08-28
ES2774473T3 (es) 2020-07-21
EP3277278A1 (en) 2018-02-07
DK3277278T3 (da) 2020-04-06
JP2020073583A (ja) 2020-05-14
LT3277278T (lt) 2020-03-25
MX2017012474A (es) 2018-01-11
PT3277278T (pt) 2020-04-16
HK1247105A1 (zh) 2018-09-21
RU2017134794A (ru) 2019-04-04
PL3277278T3 (pl) 2020-07-27
US10946009B2 (en) 2021-03-16
RS60074B1 (sr) 2020-05-29
SMT202000157T1 (it) 2020-05-08
US20190321350A1 (en) 2019-10-24
IL254593A0 (en) 2017-11-30
US20160287573A1 (en) 2016-10-06
AU2016243691A1 (en) 2017-10-12

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PA0105 International application

Patent event date: 20171101

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PC1203 Withdrawal of no request for examination