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

Info

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
Authority
CN
China
Prior art keywords
dosage form
opioid
weight
oxycodone
sulfate
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
CN201680019821.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN107820424A (zh
Inventor
李少玲
梁文瑞
张�浩
文卡特·R·萨兰迪
莫韫
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 CN107820424A publication Critical patent/CN107820424A/zh
Application granted granted Critical
Publication of CN107820424B publication Critical patent/CN107820424B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
  • 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)
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

Family

ID=55806767

Family Applications (1)

Application Number Title Priority Date Filing Date
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
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

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

Family Cites Families (19)

* 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
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
KR101783945B1 (ko) * 2009-05-12 2017-10-10 비피에스아이 홀딩스, 엘엘씨. 향상된 수분차단 속방출형 필름의 코팅 시스템 및 이에 의하여 코팅된 기재
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

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

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
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
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

Similar Documents

Publication Publication Date Title
EP0888111B1 (en) Modified release multiple-units dosage composition
SK285129B6 (sk) Preparát na orálnu aplikáciu s kontrolovaným uvoľňovaním opioidného analgetika
MXPA02011610A (es) Combinacion de sustancia activa que contiene un opioide que tiene una estructura tipo fentanilo y cetamina.
TW200942273A (en) Drug delivery systems comprising weakly basic drugs and organic acids
WO2013092589A1 (en) Multiple unit pellet tablet formulation comprising an opioid
WO2006046256A1 (en) Extended release formulation of pramipexole dihydrochloride
US11452723B2 (en) Combination dosage form of a mu opioid receptor antagonist and an opioid agent
WO2008005287A1 (en) Pharmaceutical compositions comprising a combination of piperidinoalkanol and decongestant
AU2020233614B2 (en) Dosage form providing prolonged release of tapentadol phosphoric acid salt
AU2020100441A4 (en) Dosage form providing prolonged release of tapentadol phosphoric acid salt
EP2531180B1 (en) Oral complex composition comprising pseudoephedrine and levocetirizine
AU2017244269A1 (en) Composite capsule preparation containing tadalafil and tamsulosin and having improved stability and elution rate
WO2026084757A1 (en) Pharmaceutical formulations comprising naltrexone and bupropion
AU2021201351B1 (en) Dosage form providing prolonged release of a salt of Tapentadol with L-(+)-tartaric acid
EP4142694A1 (en) Novel multiparticulate pharmaceutical composition of tamsulosin and solifenacin
JP2006509789A (ja) 不安症治療法及び治療薬

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant