JP2018515455A - 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 - Google Patents

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 Download PDF

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JP2018515455A
JP2018515455A JP2017555513A JP2017555513A JP2018515455A JP 2018515455 A JP2018515455 A JP 2018515455A JP 2017555513 A JP2017555513 A JP 2017555513A JP 2017555513 A JP2017555513 A JP 2017555513A JP 2018515455 A JP2018515455 A JP 2018515455A
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dosage form
weight
particle
active ingredient
pharmacologically active
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JP2018515455A5 (enExample
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ヴェニング・クラウス
バルンシャイト・ルッツ
ガイスラー・アンヤ
デンカー・ヤーナ
レートマー・ジェシカ
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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
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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2017555513A 2015-04-24 2016-04-22 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 Withdrawn JP2018515455A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15165069.4 2015-04-24
EP15165069 2015-04-24
PCT/EP2016/058978 WO2016170094A1 (en) 2015-04-24 2016-04-22 Tamper-resistant fixed dose combination providing fast release of two drugs from particles

Publications (2)

Publication Number Publication Date
JP2018515455A true JP2018515455A (ja) 2018-06-14
JP2018515455A5 JP2018515455A5 (enExample) 2019-05-30

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JP2017555513A Withdrawn JP2018515455A (ja) 2015-04-24 2016-04-22 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

Country Status (8)

Country Link
US (1) US20160310437A1 (enExample)
EP (1) EP3285747A1 (enExample)
JP (1) JP2018515455A (enExample)
AU (1) AU2016251851A1 (enExample)
BR (1) BR112017022856A2 (enExample)
CA (1) CA2983634A1 (enExample)
MX (1) MX2017013633A (enExample)
WO (1) WO2016170094A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3311667A1 (en) 2009-07-08 2018-04-25 Charleston Laboratories, Inc. Pharmaceutical compositions
JP2019507181A (ja) 2016-03-04 2019-03-14 チャールストン ラボラトリーズ，インコーポレイテッド 医薬組成物
EP3473246A1 (en) 2017-10-19 2019-04-24 Capsugel Belgium NV Immediate release abuse deterrent formulations

Family Cites Families (45)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7141250B2 (en) 2001-08-06 2006-11-28 Euro-Celtique S.A. Pharmaceutical formulation containing bittering agent
US20030092724A1 (en) 2001-09-18 2003-05-15 Huaihung Kao Combination sustained release-immediate release oral dosage forms with an opioid analgesic and a non-opioid analgesic
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DK1658054T3 (da) 2003-08-06 2007-10-01 Gruenenthal Gmbh Indgivelsesform, som er sikret mod misbrug
US7201920B2 (en) 2003-11-26 2007-04-10 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of opioid containing dosage forms
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
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.
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
WO2006002883A1 (de) 2004-07-01 2006-01-12 Grünenthal GmbH Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreichungsform unter verwendung eines planetwalzenextruders
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
BRPI0608609A2 (pt) 2005-05-10 2010-01-19 Novartis Ag processo de extrusço para preparaÇço de composiÇÕes com compostos terapÊuticos fracamente compressÍveis
US8652529B2 (en) 2005-11-10 2014-02-18 Flamel Technologies Anti-misuse microparticulate oral pharmaceutical form
US20070292508A1 (en) 2006-06-05 2007-12-20 Balchem Corporation Orally disintegrating dosage forms
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
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
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
BRPI0912014A2 (pt) 2008-05-09 2019-03-06 Grünenthal GmbH processo para a preparação de uma formulação em pó intermediária e uma forma de dosagem sólida final sob uso de uma etapa de congelamento por atomização
GB0909680D0 (en) 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
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
RU2015138422A (ru) 2009-07-22 2018-12-25 Грюненталь Гмбх Стабильная при окислении, прочная на излом лекарственная форма
US9579285B2 (en) 2010-02-03 2017-02-28 Gruenenthal Gmbh Preparation of a powdery pharmaceutical composition by means of an extruder
BR112013005234A2 (pt) 2010-09-02 2016-05-03 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo um polímero aniônico.
BR112013005195A2 (pt) 2010-09-02 2016-07-12 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo um polímero aniônico
NZ607392A (en) 2010-09-02 2015-03-27 Gruenenthal Chemie Tamper resistant dosage form comprising inorganic salt
EP2635258A1 (en) 2010-11-04 2013-09-11 AbbVie Inc. Drug formulations
GB201020895D0 (en) * 2010-12-09 2011-01-26 Euro Celtique Sa Dosage form
US8858963B1 (en) * 2011-05-17 2014-10-14 Mallinckrodt Llc Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
RS56527B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
PE20141638A1 (es) 2011-07-29 2014-11-22 Gruenenthal Chemie Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
FR2979242A1 (fr) 2011-08-29 2013-03-01 Sanofi Sa Comprime contre l'usage abusif, a base de paracetamol et d'oxycodone
CN103998025A (zh) 2011-10-06 2014-08-20 格吕伦塔尔有限公司 包含阿片样物质激动剂和阿片样物质拮抗剂的防篡改口服药物剂型
WO2013072395A1 (en) 2011-11-17 2013-05-23 Grünenthal GmbH Tamper-resistant oral pharmaceutical dosage form comprising a pharmacologically active ingredient, an opioid antagonist and/or aversive agent, polyalkylene oxide and anionic polymer
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
WO2013127830A1 (en) 2012-02-28 2013-09-06 Grünenthal GmbH Tamper-resistant pharmaceutical dosage form comprising nonionic surfactant
TW201722406A (zh) * 2012-03-02 2017-07-01 羅德製藥公司 抗破壞性立即釋出型調製劑類
DK2838512T3 (en) 2012-04-18 2018-11-19 Gruenenthal Gmbh MANIPULATED AND DOSAGE DUMPED PHARMACEUTICAL DOSAGE FORM
EP2846835B1 (en) 2012-05-11 2017-09-06 Grünenthal GmbH Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US9517208B2 (en) * 2013-03-15 2016-12-13 Purdue Pharma L.P. Abuse-deterrent dosage forms
AR096439A1 (es) 2013-05-29 2015-12-30 Gruenenthal Gmbh Forma de dosificación resistente al uso indebido que contiene una o más partículas
JP6445537B2 (ja) 2013-05-29 2018-12-26 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 １個または複数の粒子を含有する改変防止（ｔａｍｐｅｒ−ｒｅｓｉｓｔａｎｔ）剤形
CA2817728A1 (en) 2013-05-31 2014-11-30 Pharmascience Inc. Abuse deterrent immediate release formulation
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer

Also Published As

Publication number Publication date
US20160310437A1 (en) 2016-10-27
MX2017013633A (es) 2018-03-08
AU2016251851A1 (en) 2017-11-09
WO2016170094A1 (en) 2016-10-27
CA2983634A1 (en) 2016-10-27
BR112017022856A2 (pt) 2018-07-17
EP3285747A1 (en) 2018-02-28

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