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

    • 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

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160287573A1 (en) 2015-04-02 2016-10-06 Theravance Biopharma R&D Ip, Llc Combination dosage form of a mu opioid receptor antagonist and an opioid agent
WO2019031560A1 (ja) * 2017-08-08 2019-02-14 日本合成化学工業株式会社 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
TR200001942T2 (tr) 1997-12-22 2000-11-21 Euro-Celtique, S.A. Opioid agonist/antagonist kombinasyonlar
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
ES2326794T3 (es) * 2001-08-06 2009-10-20 Euro-Celtique S.A. Formulaciones de agonistas opioides con antagonista liberable y secuestrado.
US7842307B2 (en) 2001-08-06 2010-11-30 Purdue Pharma L.P. Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent
US20040224020A1 (en) * 2002-12-18 2004-11-11 Schoenhard Grant L. 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
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
BRPI0608392A2 (pt) 2005-03-02 2009-12-29 Theravance Inc compostos de quinolinona como agonistas do receptor 5-ht4
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
HRP20140939T1 (hr) * 2008-05-07 2014-11-21 Salix Pharmaceuticals, Ltd. Davanje preparata za äśišä†enje crijeva i antibiotika za lijeäśenje bolesti crijeva
EP2210595A1 (en) 2009-01-14 2010-07-28 LEK Pharmaceuticals d.d. Active coating of pharmaceutical dosage forms
WO2010132204A1 (en) * 2009-05-12 2010-11-18 Bpsi Holdings, Llc. Enhanced moisture barrier immediate release film coating systems and substrates coated therewith
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
AU2012212448B9 (en) 2011-02-01 2015-06-25 Astrazeneca Uk Limited Pharmaceutical formulations including an amine compound
WO2014144512A1 (en) * 2013-03-15 2014-09-18 Aprecia Pharmaceuticals Company Rapid disperse dosage form containing levetiracetam
US20160287573A1 (en) 2015-04-02 2016-10-06 Theravance Biopharma R&D Ip, Llc Combination dosage form of a mu opioid receptor antagonist and an opioid agent

Also Published As

Publication number Publication date
CN107820424A (zh) 2018-03-20
KR20170132325A (ko) 2017-12-01
WO2016161069A1 (en) 2016-10-06
EP3277278A1 (en) 2018-02-07
US20210161884A1 (en) 2021-06-03
JP2018513138A (ja) 2018-05-24
CY1122828T1 (el) 2021-05-05
HK1247105A1 (zh) 2018-09-21
US20190321350A1 (en) 2019-10-24
CA2980328A1 (en) 2016-10-06
IL254593A0 (en) 2017-11-30
US20180050028A1 (en) 2018-02-22
MX2017012474A (es) 2018-01-11
TW201642856A (zh) 2016-12-16
JP6713483B2 (ja) 2020-06-24
AU2016243691A1 (en) 2017-10-12
US10946009B2 (en) 2021-03-16
US11452723B2 (en) 2022-09-27
SMT202000157T1 (it) 2020-05-08
PT3277278T (pt) 2020-04-16
US20160287573A1 (en) 2016-10-06
RS60074B1 (sr) 2020-05-29
US10369142B2 (en) 2019-08-06
DK3277278T3 (da) 2020-04-06
CN107820424B (zh) 2020-07-28
HUE048785T2 (hu) 2020-08-28
PH12017501767A1 (en) 2018-06-11
RU2017134794A (ru) 2019-04-04
EP3277278B1 (en) 2020-01-08
SI3277278T1 (sl) 2020-04-30
PL3277278T3 (pl) 2020-07-27
ME03671B (me) 2020-10-20
BR112017021120A2 (pt) 2018-07-03
JP2020073583A (ja) 2020-05-14
HRP20200432T1 (hr) 2020-06-12
LT3277278T (lt) 2020-03-25

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