JP2016540798A - 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形 - Google Patents

共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形 Download PDF

Info

Publication number
JP2016540798A
JP2016540798A JP2016540038A JP2016540038A JP2016540798A JP 2016540798 A JP2016540798 A JP 2016540798A JP 2016540038 A JP2016540038 A JP 2016540038A JP 2016540038 A JP2016540038 A JP 2016540038A JP 2016540798 A JP2016540798 A JP 2016540798A
Authority
JP
Japan
Prior art keywords
segment
pharmacologically active
active ingredient
dosage form
pharmaceutical 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.)
Pending
Application number
JP2016540038A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016540798A5 (OSRAM
Inventor
ガイスラー・アンヤ
デンカー・ヤーナ
ヴェニング・クラウス
バルンシャイト・ルッツ
Original Assignee
グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング
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 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング filed Critical グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング
Publication of JP2016540798A publication Critical patent/JP2016540798A/ja
Publication of JP2016540798A5 publication Critical patent/JP2016540798A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2016540038A 2013-12-16 2014-12-15 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形 Pending JP2016540798A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13197503 2013-12-16
EP13197503.9 2013-12-16
PCT/EP2014/077748 WO2015091352A1 (en) 2013-12-16 2014-12-15 Tamper resistant dosage form with bimodal release profile manufactured by co-extrusion

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019107622A Division JP2019172688A (ja) 2013-12-16 2019-06-10 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形

Publications (2)

Publication Number Publication Date
JP2016540798A true JP2016540798A (ja) 2016-12-28
JP2016540798A5 JP2016540798A5 (OSRAM) 2018-12-06

Family

ID=49882823

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2016540038A Pending JP2016540798A (ja) 2013-12-16 2014-12-15 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形
JP2019107622A Withdrawn JP2019172688A (ja) 2013-12-16 2019-06-10 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2019107622A Withdrawn JP2019172688A (ja) 2013-12-16 2019-06-10 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形

Country Status (7)

Country Link
US (3) US20150164807A1 (OSRAM)
EP (1) EP3082781A1 (OSRAM)
JP (2) JP2016540798A (OSRAM)
AU (1) AU2014365038B2 (OSRAM)
CA (1) CA2933983A1 (OSRAM)
MX (1) MX2016007848A (OSRAM)
WO (1) WO2015091352A1 (OSRAM)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201502077D0 (en) * 2015-02-09 2015-03-25 Cubic Pharmaceuticals Ltd And Delta Pharmaceuticals Ltd Improved hme technology

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10251149A (ja) * 1997-03-12 1998-09-22 Basf Ag 固体の、少なくとも2相のオピオイド鎮痛薬製剤およびその製造方法
JP2007501201A (ja) * 2003-08-06 2007-01-25 グリューネンタ−ル・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 乱用防止剤形
JP2009523833A (ja) * 2006-01-21 2009-06-25 アボット ゲーエムベーハー ウント カンパニー カーゲー 乱用薬剤送達のための製剤および方法
JP2010527285A (ja) * 2007-04-26 2010-08-12 シグモイド・ファーマ・リミテッド 複数のミニカプセルの製造
JP2012515735A (ja) * 2009-01-26 2012-07-12 アボット ゲーエムベーハー ウント カンパニー カーゲー アルコール相互作用が低減した乱用抵抗性溶融押出製剤
WO2013156453A1 (en) * 2012-04-18 2013-10-24 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3612211A1 (de) 1986-04-11 1987-10-15 Basf Ag Kontinuierliches verfahren zum tablettieren
AU3024399A (en) 1998-04-03 1999-10-25 Bm Research A/S Controlled release composition
US7141250B2 (en) 2001-08-06 2006-11-28 Euro-Celtique S.A. Pharmaceutical formulation containing bittering agent
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
DE10252667A1 (de) 2002-11-11 2004-05-27 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
EP1610768B1 (en) 2003-03-26 2008-07-02 Egalet A/S Matrix compositions for controlled delivery of drug substances
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10360792A1 (de) 2003-12-23 2005-07-28 Grünenthal GmbH Spirocyclische Cyclohexan-Derivate
JP5064209B2 (ja) 2004-04-22 2012-10-31 グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 乱用防止固体剤形を製造する方法
WO2006002883A1 (de) 2004-07-01 2006-01-12 Grünenthal GmbH Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreichungsform unter verwendung eines planetwalzenextruders
JP5259183B2 (ja) 2004-07-01 2013-08-07 グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 乱用に対して保護された経口剤形
AR053304A1 (es) 2004-07-01 2007-05-02 Gruenenthal Gmbh Formas farmaceuticas orales protegidas frente al abuso con liberacion controlada de (1r,2r)-3-(3 dimetilamino-1-etil-2metil-propil)fenol y procedimiento para su produccion.
JP4563787B2 (ja) * 2004-12-10 2010-10-13 日立プラズマディスプレイ株式会社 プラズマディスプレイ装置及びその制御方法
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
CA2611081C (en) 2005-06-03 2016-05-31 Egalet A/S A drug delivery system for delivering active substances dispersed in a dispersion medium
US20090022798A1 (en) 2007-07-20 2009-01-22 Abbott Gmbh & Co. Kg Formulations of nonopioid and confined opioid analgesics
US20100172989A1 (en) 2006-01-21 2010-07-08 Abbott Laboratories Abuse resistant melt extruded formulation having reduced alcohol interaction
EP2104493A2 (en) 2007-01-16 2009-09-30 Egalet A/S Use of i) a polyglycol and n) an active drug substance for the preparation of a pharmaceutical composition for i) mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
AU2008258596B2 (en) 2007-06-04 2013-02-14 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
CA2713128C (en) * 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
CN107028908A (zh) * 2008-10-27 2017-08-11 阿尔扎公司 对乙酰氨基酚/曲马多口服延释剂型
AU2010206376B2 (en) 2009-01-26 2012-10-18 Egalet Ltd. Controlled release formulations with continuous efficacy
ES2607209T3 (es) 2009-02-06 2017-03-29 Egalet Ltd. Composiciones farmacéuticas resistentes al abuso
WO2010149169A2 (en) 2009-06-24 2010-12-29 Egalet A/S Controlled release formulations
CN102573805A (zh) * 2009-07-22 2012-07-11 格吕伦塔尔有限公司 热熔挤出的控制释放剂型
US10064945B2 (en) * 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10251149A (ja) * 1997-03-12 1998-09-22 Basf Ag 固体の、少なくとも2相のオピオイド鎮痛薬製剤およびその製造方法
JP2007501201A (ja) * 2003-08-06 2007-01-25 グリューネンタ−ル・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 乱用防止剤形
JP2009523833A (ja) * 2006-01-21 2009-06-25 アボット ゲーエムベーハー ウント カンパニー カーゲー 乱用薬剤送達のための製剤および方法
JP2010527285A (ja) * 2007-04-26 2010-08-12 シグモイド・ファーマ・リミテッド 複数のミニカプセルの製造
JP2012515735A (ja) * 2009-01-26 2012-07-12 アボット ゲーエムベーハー ウント カンパニー カーゲー アルコール相互作用が低減した乱用抵抗性溶融押出製剤
WO2013156453A1 (en) * 2012-04-18 2013-10-24 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
JP2015514733A (ja) * 2012-04-18 2015-05-21 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 不正使用防止および過量放出防止医薬剤形

Also Published As

Publication number Publication date
CA2933983A1 (en) 2015-06-25
US20180221307A1 (en) 2018-08-09
EP3082781A1 (en) 2016-10-26
AU2014365038B2 (en) 2019-09-12
MX2016007848A (es) 2016-09-07
AU2014365038A1 (en) 2016-06-30
JP2019172688A (ja) 2019-10-10
US20160338976A1 (en) 2016-11-24
WO2015091352A1 (en) 2015-06-25
US20150164807A1 (en) 2015-06-18

Similar Documents

Publication Publication Date Title
JP6445537B2 (ja) 1個または複数の粒子を含有する改変防止(tamper−resistant)剤形
JP6466417B2 (ja) 二峰性放出プロファイルを有する改変防止(tamper−resistant)剤形
JP6449871B2 (ja) エチレン−酢酸ビニルポリマーを含有する改変防止剤形
JP6316394B2 (ja) 即時薬剤放出を提供するタンパーレジスタント錠剤
JP6282261B2 (ja) 不正使用防止および過量放出防止医薬剤形
JP2014524925A (ja) 即時薬剤放出を提供するタンパーレジスタント錠剤
JP2018517676A (ja) 即時放出および溶媒抽出に対する耐性を有する改変防止製剤
EP2997965A1 (en) Tamper-resistant dosage form for oxidation-sensitive opioids
JP2018513872A (ja) 異なる粒子から2種の薬物の急速放出をもたらすタンパレジスタントな固定用量組合せ
JP2018515455A (ja) 粒子から2種の薬物の急速放出をもたらすタンパレジスタントな固定用量組合せ
JP2019172688A (ja) 共押出により製造される、二峰性放出プロファイルを有する改変防止(tamper resistant)剤形
JP2018503693A (ja) ポリエチレングリコールグラフトコポリマーを含む改変防止剤形

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20171214

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20180829

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20180905

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20181026

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20181026

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20190403