JP5964940B2 - 制御放出性医薬剤形 - Google Patents

制御放出性医薬剤形 Download PDF

Info

Publication number
JP5964940B2
JP5964940B2 JP2014500486A JP2014500486A JP5964940B2 JP 5964940 B2 JP5964940 B2 JP 5964940B2 JP 2014500486 A JP2014500486 A JP 2014500486A JP 2014500486 A JP2014500486 A JP 2014500486A JP 5964940 B2 JP5964940 B2 JP 5964940B2
Authority
JP
Japan
Prior art keywords
sustained release
dosage form
pharmaceutical dosage
solid oral
active agent
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
JP2014500486A
Other languages
English (en)
Japanese (ja)
Other versions
JP2014510094A (ja
JP2014510094A5 (enExample
Inventor
ヒュー ヒュアン,ハイヨン
ヒュー ヒュアン,ハイヨン
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.)
Purdue Pharma LP
Original Assignee
Purdue Pharma LP
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 Purdue Pharma LP filed Critical Purdue Pharma LP
Publication of JP2014510094A publication Critical patent/JP2014510094A/ja
Publication of JP2014510094A5 publication Critical patent/JP2014510094A5/ja
Application granted granted Critical
Publication of JP5964940B2 publication Critical patent/JP5964940B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2014500486A 2011-03-25 2012-03-22 制御放出性医薬剤形 Active JP5964940B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161467824P 2011-03-25 2011-03-25
US61/467,824 2011-03-25
PCT/IB2012/000595 WO2012131463A2 (en) 2011-03-25 2012-03-22 Controlled release pharmaceutical dosage forms

Publications (3)

Publication Number Publication Date
JP2014510094A JP2014510094A (ja) 2014-04-24
JP2014510094A5 JP2014510094A5 (enExample) 2014-12-04
JP5964940B2 true JP5964940B2 (ja) 2016-08-03

Family

ID=46018006

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014500486A Active JP5964940B2 (ja) 2011-03-25 2012-03-22 制御放出性医薬剤形

Country Status (24)

Country Link
US (1) US20140056979A1 (enExample)
EP (1) EP2688556B1 (enExample)
JP (1) JP5964940B2 (enExample)
KR (1) KR101619579B1 (enExample)
CN (1) CN103547259A (enExample)
AU (1) AU2012235878B2 (enExample)
BR (1) BR112013024585A8 (enExample)
CA (1) CA2831218C (enExample)
CY (1) CY1116579T1 (enExample)
DK (1) DK2688556T3 (enExample)
ES (1) ES2544735T3 (enExample)
HR (1) HRP20150835T1 (enExample)
HU (1) HUE026981T2 (enExample)
IL (1) IL228441B (enExample)
ME (1) ME02189B (enExample)
MX (1) MX350875B (enExample)
PH (1) PH12013501994A1 (enExample)
PL (1) PL2688556T3 (enExample)
PT (1) PT2688556E (enExample)
RS (1) RS54152B1 (enExample)
SI (1) SI2688556T1 (enExample)
SM (1) SMT201500209B (enExample)
WO (1) WO2012131463A2 (enExample)
ZA (1) ZA201307862B (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1407884B (zh) 1999-10-29 2012-06-20 欧罗赛铁克股份有限公司 控释氢可酮制剂
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
WO2002036099A1 (en) 2000-10-30 2002-05-10 Euro-Celtique S.A. Controlled release hydrocodone formulations
EP2957281A1 (en) 2001-09-21 2015-12-23 Egalet Ltd. Polymer release system
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
ES2360102T3 (es) 2003-03-26 2011-05-31 Egalet A/S Sistema para la liberación controlada de morfina.
EP2155167A2 (en) 2007-06-04 2010-02-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
AU2010211220B2 (en) 2009-02-06 2013-08-01 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
NZ603579A (en) 2009-06-24 2014-02-28 Egalet Ltd Controlled release formulations
AP3815A (en) 2010-12-22 2016-09-30 Purdue Pharma Lp Encased tamper resistant controlled release dosage forms
PH12013501345A1 (en) 2010-12-23 2022-10-24 Purdue Pharma Lp Tamper resistant solid oral dosage forms
EP2844236B1 (en) 2012-04-17 2018-12-19 Purdue Pharma LP Systems and methods for treating an opioid-induced adverse pharmacodynamic response
NZ704011A (en) 2012-07-06 2016-04-29 Egalet Ltd Abuse deterrent pharmaceutical compositions for controlled release
SG11201506064UA (en) 2013-02-05 2015-08-28 Purdue Pharma Lp Tamper resistant pharmaceutical formulations
US10751287B2 (en) 2013-03-15 2020-08-25 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
JP6539274B2 (ja) 2013-08-12 2019-07-03 ファーマシューティカル マニュファクチュアリング リサーチ サービシズ,インコーポレーテッド 押出成形された即放性乱用抑止性丸剤
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP3169315B1 (en) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
US9849124B2 (en) 2014-10-17 2017-12-26 Purdue Pharma L.P. Systems and methods for treating an opioid-induced adverse pharmacodynamic response
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form
US9839212B2 (en) 2015-04-16 2017-12-12 Bio-Lab, Inc. Multicomponent and multilayer compacted tablets
KR20200022026A (ko) 2017-06-30 2020-03-02 퍼듀 퍼머 엘피 치료 방법 및 이의 약형
JP7335870B2 (ja) * 2017-08-31 2023-08-30 パーデュー、ファーマ、リミテッド、パートナーシップ 医薬剤形
IL273627B2 (en) 2017-12-20 2025-03-01 Purdue Pharma Lp Morphine sulfate dosage forms for abuse deterrence

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR950007907B1 (ko) * 1992-09-01 1995-07-21 동국제약 주식회사 치주질환 치료용 막형 국소약물송달제제
US5567439A (en) * 1994-06-14 1996-10-22 Fuisz Technologies Ltd. Delivery of controlled-release systems(s)
US5634702A (en) 1995-09-27 1997-06-03 Fistonich; Juraj Hands free waste container having a closed cover that automatically opens when the container is moved outside its cabinet enclosure
PT1251832E (pt) * 2000-02-04 2007-01-31 Depomed Inc Forma de dosagem constituída por invólucro-e-núcleo que conduz a uma libertação do fármaco de ordem zero
WO2002036099A1 (en) * 2000-10-30 2002-05-10 Euro-Celtique S.A. Controlled release hydrocodone formulations
AU2005259476B2 (en) * 2004-07-01 2010-07-29 Gruenenthal Gmbh Oral dosage form safeguarded against abuse
US7434308B2 (en) * 2004-09-02 2008-10-14 International Business Machines Corporation Cooling of substrate using interposer channels
EP1874269A2 (en) * 2005-04-19 2008-01-09 Alza Corporation Combination of tramadol and substances that comprise gabapentin
EP2019904A1 (en) * 2006-05-17 2009-02-04 Sandvik Intellectual Property AB A rock-drilling tool, a drill rod and coupling sleeve
SA07280459B1 (ar) * 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
WO2009012122A1 (en) * 2007-07-13 2009-01-22 Marvell World Trade Ltd. Method for shallow trench isolation
AU2009223061B2 (en) * 2008-03-11 2014-10-09 Depomed Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
CN101933907A (zh) * 2009-06-30 2011-01-05 北京天衡药物研究院 新型骨架缓释片及其制备方法

Also Published As

Publication number Publication date
MX2013010987A (es) 2014-10-13
CY1116579T1 (el) 2017-03-15
PH12013501994A1 (en) 2013-12-02
KR20130135973A (ko) 2013-12-11
SI2688556T1 (sl) 2015-09-30
NZ616600A (en) 2015-07-31
US20140056979A1 (en) 2014-02-27
PL2688556T3 (pl) 2015-10-30
ME02189B (me) 2016-02-20
RS54152B1 (sr) 2015-12-31
BR112013024585A8 (pt) 2018-01-09
JP2014510094A (ja) 2014-04-24
ES2544735T3 (es) 2015-09-03
CA2831218C (en) 2017-01-17
EP2688556B1 (en) 2015-05-06
HUE026981T2 (en) 2016-08-29
IL228441A0 (en) 2013-12-31
CN103547259A (zh) 2014-01-29
AU2012235878B2 (en) 2015-10-15
ZA201307862B (en) 2014-06-25
WO2012131463A3 (en) 2012-11-29
EP2688556A2 (en) 2014-01-29
DK2688556T3 (en) 2015-08-03
MX350875B (es) 2017-09-19
SMT201500209B (it) 2015-10-30
HRP20150835T1 (hr) 2015-09-11
IL228441B (en) 2019-05-30
AU2012235878A1 (en) 2013-05-02
WO2012131463A2 (en) 2012-10-04
CA2831218A1 (en) 2012-10-04
KR101619579B1 (ko) 2016-05-10
PT2688556E (pt) 2015-09-11

Similar Documents

Publication Publication Date Title
JP5964940B2 (ja) 制御放出性医薬剤形
JP6286491B2 (ja) オピオイド鎮痛薬を含む不正改変抵抗性経口医薬剤形
KR20130097807A (ko) 케이싱된 탬퍼 저항성 제어 방출 투여 형태
AU2017208264B2 (en) Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
HK1246175B (zh) 含有阿片类镇痛剂的抗篡改口服药物剂型
NZ616600B2 (en) Tamper-resistant controlled release pharmaceutical dosage forms

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20141010

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20141010

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20150619

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20150623

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150924

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160223

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160511

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20160607

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20160630

R150 Certificate of patent or registration of utility model

Ref document number: 5964940

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250