ES2774473T3 - Forma de dosificación combinada de un antagonista del receptor opioide mu y un agente opioide - Google Patents

Forma de dosificación combinada de un antagonista del receptor opioide mu y un agente opioide Download PDF

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Publication number
ES2774473T3
ES2774473T3 ES16718062T ES16718062T ES2774473T3 ES 2774473 T3 ES2774473 T3 ES 2774473T3 ES 16718062 T ES16718062 T ES 16718062T ES 16718062 T ES16718062 T ES 16718062T ES 2774473 T3 ES2774473 T3 ES 2774473T3
Authority
ES
Spain
Prior art keywords
dosage form
axelopran
weight
opioid
solid
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.)
Active
Application number
ES16718062T
Other languages
English (en)
Spanish (es)
Inventor
Shaoling Li
Manshiu Leung
Hao Zhang
Venkat R Thalladi
Yun Mo
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.)
Theravance Biopharma R&D IP LLC
Original Assignee
Theravance Biopharma R&D IP LLC
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 Theravance Biopharma R&D IP LLC filed Critical Theravance Biopharma R&D IP LLC
Application granted granted Critical
Publication of ES2774473T3 publication Critical patent/ES2774473T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/2086Layered 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
    • 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
    • A61K9/28Dragees; 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

Landscapes

  • 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)
ES16718062T 2015-04-02 2016-03-31 Forma de dosificación combinada de un antagonista del receptor opioide mu y un agente opioide Active ES2774473T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562141981P 2015-04-02 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
ES2774473T3 true ES2774473T3 (es) 2020-07-21

Family

ID=55806767

Family Applications (1)

Application Number Title Priority Date Filing Date
ES16718062T Active ES2774473T3 (es) 2015-04-02 2016-03-31 Forma de dosificación combinada de un antagonista del receptor opioide mu y un agente opioide

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
KR20170132325A (ko) 2017-12-01
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
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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