AU2007280470B2 - Granule and orally disintegrating tablet comprising oxycodone - Google Patents

Granule and orally disintegrating tablet comprising oxycodone Download PDF

Info

Publication number
AU2007280470B2
AU2007280470B2 AU2007280470A AU2007280470A AU2007280470B2 AU 2007280470 B2 AU2007280470 B2 AU 2007280470B2 AU 2007280470 A AU2007280470 A AU 2007280470A AU 2007280470 A AU2007280470 A AU 2007280470A AU 2007280470 B2 AU2007280470 B2 AU 2007280470B2
Authority
AU
Australia
Prior art keywords
oxycodone
granules
coated
orally disintegrating
subcoat
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
AU2007280470A
Other languages
English (en)
Other versions
AU2007280470A1 (en
Inventor
Didier Hoarau
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.)
Ethypharm SAS
Original Assignee
Ethypharm SAS
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38752477&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2007280470(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ethypharm SAS filed Critical Ethypharm SAS
Publication of AU2007280470A1 publication Critical patent/AU2007280470A1/en
Application granted granted Critical
Publication of AU2007280470B2 publication Critical patent/AU2007280470B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K9/14—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K47/30—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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2007280470A 2006-08-04 2007-07-31 Granule and orally disintegrating tablet comprising oxycodone Active AU2007280470B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US82144906P 2006-08-04 2006-08-04
US60/821,449 2006-08-04
PCT/EP2007/057912 WO2008015220A1 (en) 2006-08-04 2007-07-31 Granule and orally disintegrating tablet comprising oxycodone

Publications (2)

Publication Number Publication Date
AU2007280470A1 AU2007280470A1 (en) 2008-02-07
AU2007280470B2 true AU2007280470B2 (en) 2013-03-14

Family

ID=38752477

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2007280470A Active AU2007280470B2 (en) 2006-08-04 2007-07-31 Granule and orally disintegrating tablet comprising oxycodone

Country Status (15)

Country Link
US (1) US8465776B2 (https=)
EP (1) EP2046285B1 (https=)
JP (1) JP5421775B2 (https=)
KR (1) KR101445757B1 (https=)
CN (1) CN101534792B (https=)
AU (1) AU2007280470B2 (https=)
BR (1) BRPI0714514B8 (https=)
CA (1) CA2659122C (https=)
EA (1) EA017832B1 (https=)
ES (1) ES2667944T3 (https=)
IL (1) IL196741A (https=)
MX (1) MX2009001294A (https=)
NZ (1) NZ574544A (https=)
WO (1) WO2008015220A1 (https=)
ZA (1) ZA200900640B (https=)

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
WO2004084868A1 (en) 2003-03-26 2004-10-07 Egalet A/S Morphine controlled release system
CN101563069B (zh) * 2006-08-04 2012-07-11 爱的发 多层口服崩解片
US8821928B2 (en) 2007-06-04 2014-09-02 Egalet Ltd. Controlled release pharmaceutical compositions for prolonged effect
US8829019B2 (en) * 2008-10-24 2014-09-09 Toray Industries, Inc. Stable tablet containing 4,5-epoxymorphinan derivative
CA2751667C (en) 2009-02-06 2016-12-13 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
JP5845172B2 (ja) * 2009-05-01 2016-01-20 アデア ファーマスーティカルズ，インコーポレイテッド 高および低用量薬物の組み合わせを含む口腔内崩壊錠組成物
NZ597283A (en) 2009-06-24 2013-07-26 Egalet Ltd Controlled release formulations
US9198861B2 (en) * 2009-12-22 2015-12-01 Mallinckrodt Llc Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
WO2012023030A2 (en) * 2010-08-18 2012-02-23 Purdue Pharma L.P. Vacuum avoiding packaging systems and methods thereof
CN102178657B (zh) * 2011-04-11 2017-05-31 浙江华海药业股份有限公司 一种奥氮平口腔崩解片
US9050335B1 (en) 2011-05-17 2015-06-09 Mallinckrodt Llc Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
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
US9827191B2 (en) 2012-05-03 2017-11-28 The Johns Hopkins University Compositions and methods for ophthalmic and/or other applications
AU2013256064B2 (en) 2012-05-03 2018-01-04 Alcon Inc. Pharmaceutical nanoparticles showing improved mucosal transport
KR102310775B1 (ko) 2012-05-03 2021-10-07 칼라 파마슈티컬스, 인크. 개선된 점막 수송을 나타내는 제약 나노입자
US11596599B2 (en) 2012-05-03 2023-03-07 The Johns Hopkins University Compositions and methods for ophthalmic and/or other applications
AU2013285988A1 (en) 2012-07-06 2015-02-12 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
BR112015000320B1 (pt) 2012-07-12 2023-03-07 SpecGx LLC Composições farmacêuticas dissuasivas de abuso e seu processo de preparação
KR101340733B1 (ko) * 2012-12-31 2013-12-12 (주) 에프엔지리서치 신규한 마이크로그래뉼 제형
EP2801349A1 (en) 2013-05-06 2014-11-12 Siegfried AG Oral Pharmaceutical Formulation
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
WO2015065547A1 (en) 2013-10-31 2015-05-07 Cima Labs Inc. Immediate release abuse-deterrent granulated dosage forms
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
CA2955229C (en) 2014-07-17 2020-03-10 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
WO2016064873A1 (en) 2014-10-20 2016-04-28 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
GR1008992B (el) 2015-12-17 2017-03-23 Verisfield (Uk) Ltd, Υποκαταστημα Ελλαδας, Εμπορια Φαρμακων Φαρμακευτικη συνθεση σε μορφη κοκκιων για χορηγηση απο το στομα που περιεχει μετρονιδαζολη ή παραγωγα αυτης και εναν παραγοντα καλυψης της γευσης
EP3421032A4 (en) * 2016-02-23 2019-10-23 Nipro Corporation PARTICULARS OF A PHARMACEUTICAL COMPOSITION, ORAL DECOMPOSITION PREPARATION THEREOF AND METHOD FOR PRODUCING PARTICLES OF A PHARMACEUTICAL COMPOSITION
JP6915258B2 (ja) * 2016-10-21 2021-08-04 ニプロ株式会社 医薬組成物粒子とそれを含む口腔内崩壊製剤、医薬組成物粒子の製造方法
KR102120720B1 (ko) * 2018-07-16 2020-06-10 연성정밀화학(주) 날푸라핀 함유 구강붕해정
CN109512796A (zh) * 2018-12-26 2019-03-26 甘肃普安制药股份有限公司 一种氨酚羟考酮胶囊填充方法
US11324707B2 (en) 2019-05-07 2022-05-10 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine
US12589083B2 (en) 2019-05-07 2026-03-31 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine
CN113842376B (zh) * 2020-06-28 2024-10-11 齐鲁制药有限公司 一种含有利培酮的药物组合物和口溶膜剂及制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000006126A1 (en) * 1998-07-28 2000-02-10 Takeda Chemical Industries, Ltd. Rapidly disintegrable solid preparation
US20030180361A1 (en) * 1991-12-24 2003-09-25 Benjamin Oshlack Orally administrable opioid formulations having extended duration of effect
US6740341B1 (en) * 1998-11-25 2004-05-25 Cima Labs Inc. Taste masking rapid release coating system

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5464632C1 (en) * 1991-07-22 2001-02-20 Prographarm Lab Rapidly disintegratable multiparticular tablet
FR2679451B1 (fr) 1991-07-22 1994-09-09 Prographarm Laboratoires Comprime multiparticulaire a delitement rapide.
US5266331A (en) * 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US5286493A (en) 1992-01-27 1994-02-15 Euroceltique, S.A. Stabilized controlled release formulations having acrylic polymer coating
CA2128820A1 (en) 1993-07-27 1995-01-28 Walter G. Gowan, Jr. Rapidly disintegrating pharmaceutical dosage form and process for preparation thereof
EP1442745A1 (en) * 1993-10-07 2004-08-04 Euro-Celtique Orally administrable opioid formulations having extended duration of effect
US6024981A (en) 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
FR2766089B1 (fr) 1997-07-21 2000-06-02 Prographarm Lab Comprime multiparticulaire perfectionne a delitement rapide
CA2322315C (en) 1998-03-06 2008-09-16 Eurand International S.P.A. Fast disintegrating tablets
FR2785538B1 (fr) 1998-11-06 2004-04-09 Prographarm Laboratoires Comprime a delitement rapide perfectionne
AU753476B2 (en) * 1998-11-25 2002-10-17 Cima Labs, Inc. Taste masking rapid release coating system
FR2790387B1 (fr) 1999-03-01 2001-05-18 Prographarm Laboratoires Comprime orodispersible presentant une faible friabilite et son procede de preparation
SI1416842T1 (sl) 2001-07-18 2009-06-30 Euro Celtique Sa Farmacevtske kombinacije oksikodona in naloksona
US20030044458A1 (en) * 2001-08-06 2003-03-06 Curtis Wright Oral dosage form comprising a therapeutic agent and an adverse-effect agent
ATE510534T1 (de) * 2002-03-14 2011-06-15 Euro Celtique Sa Naltrexonhydrochlorid-zusammensetzungen
FR2850576B1 (fr) * 2003-02-05 2007-03-23 Ethypharm Sa Composition comprenant un melange de principes actifs, et procede de preparation
WO2006127879A1 (en) * 2005-05-26 2006-11-30 Duramed Pharmaceuticals, Inc. Flexible solid dosage forms and methods of making and using the same
US8900637B2 (en) * 2005-12-02 2014-12-02 Lupin Limited Stable taste masked formulations of cephalosporins
CN101563069B (zh) * 2006-08-04 2012-07-11 爱的发 多层口服崩解片

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030180361A1 (en) * 1991-12-24 2003-09-25 Benjamin Oshlack Orally administrable opioid formulations having extended duration of effect
WO2000006126A1 (en) * 1998-07-28 2000-02-10 Takeda Chemical Industries, Ltd. Rapidly disintegrable solid preparation
US6740341B1 (en) * 1998-11-25 2004-05-25 Cima Labs Inc. Taste masking rapid release coating system

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Hermos, JA et al., Arch Intern Med. 2004, Vol.164, pages 2361-2366 *
Palangio, M et al, Clinical Therapeutics, 2002, Vol. 24, No. 1, pages 87-99 *

Also Published As

Publication number Publication date
US20090304792A1 (en) 2009-12-10
JP2009545560A (ja) 2009-12-24
EA017832B1 (ru) 2013-03-29
ZA200900640B (en) 2010-06-30
NZ574544A (en) 2011-12-22
BRPI0714514B1 (pt) 2020-01-07
BRPI0714514B8 (pt) 2021-05-25
KR20090034372A (ko) 2009-04-07
EA200900260A1 (ru) 2009-06-30
KR101445757B1 (ko) 2014-10-02
IL196741A0 (en) 2009-11-18
EP2046285B1 (en) 2018-02-21
EP2046285A1 (en) 2009-04-15
IL196741A (en) 2015-05-31
US8465776B2 (en) 2013-06-18
ES2667944T3 (es) 2018-05-16
WO2008015220A8 (en) 2008-04-03
CN101534792A (zh) 2009-09-16
WO2008015220A1 (en) 2008-02-07
CA2659122A1 (en) 2008-02-07
CA2659122C (en) 2016-08-23
MX2009001294A (es) 2009-05-21
JP5421775B2 (ja) 2014-02-19
AU2007280470A1 (en) 2008-02-07
CN101534792B (zh) 2013-02-20
BRPI0714514A2 (pt) 2013-07-02

Similar Documents

Publication Publication Date Title
AU2007280470B2 (en) Granule and orally disintegrating tablet comprising oxycodone
KR101408315B1 (ko) 다층 경구 붕해 정제
EP1809251B1 (en) Taste-masked multiparticulate pharmaceutical compositions comprising a drug-containing core particle and a solvent-coacervated membrane
EP2046300B1 (en) Multilayer orally disintegrating tablet
HK1125857B (en) Granule and orally disintegrating tablet comprising oxycodone
HK1125857A (en) Granule and orally disintegrating tablet comprising oxycodone
HK1128881B (en) Multilayer orally disintegrating tablet
HK1107272B (en) Taste-masked multiparticulate pharmaceutical compositions comprising a drug-containing core particle and a solvent-coacervated membrane
HK1154515A (en) Taste-masked multiparticulate pharmaceutical composition comprising a drug-containing core particle and a solvent-coacervated membrane

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)