AU2018351502B2 - Pharmaceutical dosage forms - Google Patents

Pharmaceutical dosage forms Download PDF

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Publication number
AU2018351502B2
AU2018351502B2 AU2018351502A AU2018351502A AU2018351502B2 AU 2018351502 B2 AU2018351502 B2 AU 2018351502B2 AU 2018351502 A AU2018351502 A AU 2018351502A AU 2018351502 A AU2018351502 A AU 2018351502A AU 2018351502 B2 AU2018351502 B2 AU 2018351502B2
Authority
AU
Australia
Prior art keywords
weight
matrix formulation
active agent
dosage form
core
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
AU2018351502A
Other languages
English (en)
Other versions
AU2018351502A1 (en
Inventor
Ozgur Akcan
Stephen Harris
Richard Mannion
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 AU2018351502A1 publication Critical patent/AU2018351502A1/en
Application granted granted Critical
Publication of AU2018351502B2 publication Critical patent/AU2018351502B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K9/209Layered 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
    • 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
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)
AU2018351502A 2017-10-20 2018-10-19 Pharmaceutical dosage forms Active AU2018351502B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762574978P 2017-10-20 2017-10-20
US62/574,978 2017-10-20
PCT/US2018/056724 WO2019079729A1 (en) 2017-10-20 2018-10-19 PHARMACEUTICAL DOSAGE FORMS

Publications (2)

Publication Number Publication Date
AU2018351502A1 AU2018351502A1 (en) 2020-03-26
AU2018351502B2 true AU2018351502B2 (en) 2024-09-05

Family

ID=66173867

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018351502A Active AU2018351502B2 (en) 2017-10-20 2018-10-19 Pharmaceutical dosage forms

Country Status (6)

Country Link
US (2) US12053464B2 (enExample)
EP (1) EP3697393A4 (enExample)
JP (1) JP7293209B2 (enExample)
AU (1) AU2018351502B2 (enExample)
CA (1) CA3075292A1 (enExample)
WO (1) WO2019079729A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
AU2018351502B2 (en) * 2017-10-20 2024-09-05 Purdue Pharma L.P. Pharmaceutical dosage forms

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1715856B1 (en) * 2003-12-31 2012-07-11 Actavis Group PTC ehf. Atomoxetine formulations
US20140010875A1 (en) * 2010-12-22 2014-01-09 Purdue Pharma L.P. Encased Tamper Resistant Controlled Release Dosage Forms
US20160243107A1 (en) * 2013-12-23 2016-08-25 Purdue Pharma L.P. Opioid Antagonist Formulations

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4486436A (en) * 1982-07-22 1984-12-04 Analgesic Associates Analgesic and anti-inflammatory compositions comprising caffeine and methods of using same
US5286493A (en) * 1992-01-27 1994-02-15 Euroceltique, S.A. Stabilized controlled release formulations having acrylic polymer coating
US5472712A (en) * 1991-12-24 1995-12-05 Euroceltique, S.A. Controlled-release formulations coated with aqueous dispersions of ethylcellulose
US5914129A (en) * 1996-07-23 1999-06-22 Mauskop; Alexander Analgesic composition for treatment of migraine headaches
US20060240105A1 (en) * 1998-11-02 2006-10-26 Elan Corporation, Plc Multiparticulate modified release composition
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
SI1299104T1 (sl) * 2000-02-08 2009-10-31 Euro Celtique Sa Oralne formulacije opioidnih agonistov, varne pred zlorabo
CA2510465A1 (en) * 2002-12-18 2004-07-08 Pain Therapeutics Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats
WO2005034859A2 (en) * 2003-10-03 2005-04-21 Elite Laboratories Inc. Extended release formulations of opioids and method of use thereof
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
EP2380564B1 (en) * 2007-04-04 2014-10-22 Sigmoid Pharma Limited An oral pharmaceutical composition
EP2262367A4 (en) * 2008-03-08 2011-04-20 Theraquest Biosciences Inc PHARMACEUTICAL ORAL COMPOSITIONS OF BUPRENORPHINE AND METHOD FOR THEIR USE
PT2149372E (pt) * 2008-07-31 2014-07-25 Universität Ulm Utilização de opióides do grupo da metadona para o tratamento de pacientes com cancros resistentes
NZ597283A (en) * 2009-06-24 2013-07-26 Egalet Ltd Controlled release formulations
ES2641437T3 (es) 2011-09-16 2017-11-10 Purdue Pharma Lp Formulaciones farmacéuticas resistentes a la manipulación indebida
HK1206978A1 (en) * 2012-04-17 2016-01-22 Purdue Pharma L.P. Systems and methods for treating an opioid-induced adverse pharmacodynamic response
TW201613590A (en) 2014-09-12 2016-04-16 Purdue Pharma Lp Systems and methods for attenuating opioid-induced euphoria
US9849124B2 (en) 2014-10-17 2017-12-26 Purdue Pharma L.P. Systems and methods for treating an opioid-induced adverse pharmacodynamic response
US20160220498A1 (en) * 2015-01-29 2016-08-04 Aneesh SONI Fully or partially biodegradable device for controlled drug delivery
JP2017211168A (ja) 2016-05-27 2017-11-30 シャープ株式会社 冷蔵庫、および広告表示プログラム
US20190054024A1 (en) * 2017-08-16 2019-02-21 HUMANWELL PHARMACEUTICAL US, Inc. Solid Dosage Forms
AU2018351502B2 (en) * 2017-10-20 2024-09-05 Purdue Pharma L.P. Pharmaceutical dosage forms

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1715856B1 (en) * 2003-12-31 2012-07-11 Actavis Group PTC ehf. Atomoxetine formulations
US20140010875A1 (en) * 2010-12-22 2014-01-09 Purdue Pharma L.P. Encased Tamper Resistant Controlled Release Dosage Forms
US20160243107A1 (en) * 2013-12-23 2016-08-25 Purdue Pharma L.P. Opioid Antagonist Formulations

Also Published As

Publication number Publication date
WO2019079729A1 (en) 2019-04-25
CA3075292A1 (en) 2019-04-25
EP3697393A1 (en) 2020-08-26
US20250017917A1 (en) 2025-01-16
JP2021500316A (ja) 2021-01-07
AU2018351502A1 (en) 2020-03-26
JP7293209B2 (ja) 2023-06-19
EP3697393A4 (en) 2021-10-13
US20210205295A1 (en) 2021-07-08
US12053464B2 (en) 2024-08-06

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