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 (OSRAM
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

    • 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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • 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

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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (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 (OSRAM) 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 (OSRAM)
EP (1) EP2688556B1 (OSRAM)
JP (1) JP5964940B2 (OSRAM)
KR (1) KR101619579B1 (OSRAM)
CN (1) CN103547259A (OSRAM)
AU (1) AU2012235878B2 (OSRAM)
BR (1) BR112013024585A8 (OSRAM)
CA (1) CA2831218C (OSRAM)
CY (1) CY1116579T1 (OSRAM)
DK (1) DK2688556T3 (OSRAM)
ES (1) ES2544735T3 (OSRAM)
HR (1) HRP20150835T1 (OSRAM)
HU (1) HUE026981T2 (OSRAM)
IL (1) IL228441B (OSRAM)
ME (1) ME02189B (OSRAM)
MX (1) MX350875B (OSRAM)
PH (1) PH12013501994A1 (OSRAM)
PL (1) PL2688556T3 (OSRAM)
PT (1) PT2688556E (OSRAM)
RS (1) RS54152B1 (OSRAM)
SI (1) SI2688556T1 (OSRAM)
SM (1) SMT201500209B (OSRAM)
WO (1) WO2012131463A2 (OSRAM)
ZA (1) ZA201307862B (OSRAM)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20020059653A (ko) 1999-10-29 2002-07-13 그린 마틴, 브라이언 쥐 테슬리 서방성 하이드로코돈 제형
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
US6733783B2 (en) 2000-10-30 2004-05-11 Euro-Celtique S.A. Controlled release hydrocodone formulations
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
WO2003024429A1 (en) 2001-09-21 2003-03-27 Egalet A/S Polymer release system
EP1610767B1 (en) 2003-03-26 2011-01-19 Egalet A/S Morphine controlled release system
WO2008148798A2 (en) 2007-06-04 2008-12-11 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
CA2751667C (en) 2009-02-06 2016-12-13 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
EP2445487A2 (en) 2009-06-24 2012-05-02 Egalet Ltd. Controlled release formulations
US8808740B2 (en) 2010-12-22 2014-08-19 Purdue Pharma L.P. Encased tamper resistant controlled release dosage forms
PH12013501345A1 (en) 2010-12-23 2022-10-24 Purdue Pharma Lp Tamper resistant solid oral dosage forms
JP6279547B2 (ja) 2012-04-17 2018-02-14 パーデュー、ファーマ、リミテッド、パートナーシップ オピオイド誘発性有害薬力学的応答を治療するためのシステムおよび方法
MX2014015880A (es) 2012-07-06 2015-08-05 Egalet Ltd Composiciones farmaceuticas disuasivas de abuso para liberacion controlada.
PE20151301A1 (es) 2013-02-05 2015-09-16 Purdue Pharma Lp Formulaciones farmaceuticas resistentes a la manipulacion indebida
US10751287B2 (en) 2013-03-15 2020-08-25 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
WO2015023675A2 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
AU2015290098B2 (en) 2014-07-17 2018-11-01 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
AU2015336065A1 (en) 2014-10-20 2017-05-04 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
WO2019006404A1 (en) 2017-06-30 2019-01-03 Purdue Pharma L.P. METHOD OF TREATMENT AND DOSAGE FORMS
US11911510B2 (en) 2017-08-31 2024-02-27 Purdue Pharma L.P Pharmaceutical dosage forms
EP3727384A4 (en) 2017-12-20 2021-11-03 Purdue Pharma L.P. ABUSE-DISSUASIVE MORPHINE SULPHATE FORMES

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
ATE340563T1 (de) * 2000-02-04 2006-10-15 Depomed Inc DOSIERUNGSFORM DES TYPS ßHÜLLE UND KERNß MIT EINER WIRKSTOFFFREISETZUNG, DIE SICH DER NULLTEN ORDNUNG ANNÄHERT
US6733783B2 (en) * 2000-10-30 2004-05-11 Euro-Celtique S.A. Controlled release hydrocodone formulations
WO2006002884A1 (de) * 2004-07-01 2006-01-12 Grünenthal GmbH Gegen missbrauch gesicherte, orale darreichtungsform
US7434308B2 (en) * 2004-09-02 2008-10-14 International Business Machines Corporation Cooling of substrate using interposer channels
WO2006113568A2 (en) * 2005-04-19 2006-10-26 Alza Corporation Controlled delivery dosage form of tramadol and gabapentin
RU2008149702A (ru) * 2006-05-17 2010-06-27 Сандвик Интеллекчуал Проперти Аб (Se) Верхнеударный инструмент для сверления камня, стержень сверла и соединительный рукав
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
US8241993B2 (en) * 2007-07-13 2012-08-14 Marvell World Trade Ltd. Method for shallow trench isolation
CN102105136B (zh) * 2008-03-11 2014-11-26 蒂宝制药公司 包含非-阿片类止痛剂和阿片类止痛剂的组合的胃滞留型缓释剂型
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
RS54152B1 (sr) 2015-12-31
KR20130135973A (ko) 2013-12-11
BR112013024585A8 (pt) 2018-01-09
WO2012131463A2 (en) 2012-10-04
JP2014510094A (ja) 2014-04-24
DK2688556T3 (en) 2015-08-03
HRP20150835T1 (hr) 2015-09-11
EP2688556B1 (en) 2015-05-06
MX350875B (es) 2017-09-19
PT2688556E (pt) 2015-09-11
EP2688556A2 (en) 2014-01-29
IL228441B (en) 2019-05-30
KR101619579B1 (ko) 2016-05-10
US20140056979A1 (en) 2014-02-27
AU2012235878A1 (en) 2013-05-02
CA2831218C (en) 2017-01-17
AU2012235878B2 (en) 2015-10-15
ZA201307862B (en) 2014-06-25
CN103547259A (zh) 2014-01-29
NZ616600A (en) 2015-07-31
ME02189B (me) 2016-02-20
WO2012131463A3 (en) 2012-11-29
IL228441A0 (en) 2013-12-31
CA2831218A1 (en) 2012-10-04
SMT201500209B (it) 2015-10-30
PL2688556T3 (pl) 2015-10-30
CY1116579T1 (el) 2017-03-15
PH12013501994A1 (en) 2013-12-02
SI2688556T1 (sl) 2015-09-30
MX2013010987A (es) 2014-10-13
HUE026981T2 (en) 2016-08-29
ES2544735T3 (es) 2015-09-03

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