CA2980328A1 - Combination dosage form of a mu opioid receptor antagonist and an opioid agent - Google Patents

Combination dosage form of a mu opioid receptor antagonist and an opioid agent Download PDF

Info

Publication number
CA2980328A1
CA2980328A1 CA2980328A CA2980328A CA2980328A1 CA 2980328 A1 CA2980328 A1 CA 2980328A1 CA 2980328 A CA2980328 A CA 2980328A CA 2980328 A CA2980328 A CA 2980328A CA 2980328 A1 CA2980328 A1 CA 2980328A1
Authority
CA
Canada
Prior art keywords
dosage form
axelopran
weight
polyvinyl alcohol
combination dosage
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.)
Abandoned
Application number
CA2980328A
Other languages
English (en)
French (fr)
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
Publication of CA2980328A1 publication Critical patent/CA2980328A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/439Heterocyclic 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
    • A61K31/47Quinolines; 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

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)
  • 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)
CA2980328A 2015-04-02 2016-03-31 Combination dosage form of a mu opioid receptor antagonist and an opioid agent Abandoned CA2980328A1 (en)

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
CA2980328A1 true CA2980328A1 (en) 2016-10-06

Family

ID=55806767

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2980328A Abandoned CA2980328A1 (en) 2015-04-02 2016-03-31 Combination dosage form of a mu opioid receptor antagonist and an opioid agent

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

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
NZ560828A (en) * 2005-03-02 2011-01-28 Theravance Inc Quinolinone compounds as 5-HT4 receptor agonists
ES2366058T3 (es) * 2006-03-01 2011-10-14 Theravance, Inc. Compuestos de 8-azabiciclo[3.2.1]octano como antagonistas de los receptores opioides mu.
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
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
IT1398930B1 (it) * 2010-03-24 2013-03-28 Molteni & C Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi.
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

Also Published As

Publication number Publication date
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
CN107820424B (zh) 2020-07-28
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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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20200831