CA2677281C - Transoral dosage forms comprising sufentanil and naloxone - Google Patents

Transoral dosage forms comprising sufentanil and naloxone Download PDF

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Publication number
CA2677281C
CA2677281C CA2677281A CA2677281A CA2677281C CA 2677281 C CA2677281 C CA 2677281C CA 2677281 A CA2677281 A CA 2677281A CA 2677281 A CA2677281 A CA 2677281A CA 2677281 C CA2677281 C CA 2677281C
Authority
CA
Canada
Prior art keywords
dosage form
minutes
sufentanil
vitro administration
dosing period
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.)
Expired - Fee Related
Application number
CA2677281A
Other languages
English (en)
French (fr)
Other versions
CA2677281A1 (en
Inventor
Su Yum
Jaymin Shah
Sung Yun Kwon
Xiaoping Song
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.)
Durect Corp
Original Assignee
Durect Corp
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 Durect Corp filed Critical Durect Corp
Publication of CA2677281A1 publication Critical patent/CA2677281A1/en
Application granted granted Critical
Publication of CA2677281C publication Critical patent/CA2677281C/en
Expired - Fee Related 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
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • 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
    • 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
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • 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
    • A61K9/2009—Inorganic 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Pain & Pain Management (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
CA2677281A 2007-02-09 2008-02-08 Transoral dosage forms comprising sufentanil and naloxone Expired - Fee Related CA2677281C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US90066107P 2007-02-09 2007-02-09
US60/900,661 2007-02-09
US90458507P 2007-03-02 2007-03-02
US60/904,585 2007-03-02
PCT/US2008/001711 WO2008100434A1 (en) 2007-02-09 2008-02-08 Transoral dosage forms comprising sufentanil and naloxone

Publications (2)

Publication Number Publication Date
CA2677281A1 CA2677281A1 (en) 2008-08-21
CA2677281C true CA2677281C (en) 2019-10-29

Family

ID=39472527

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2677281A Expired - Fee Related CA2677281C (en) 2007-02-09 2008-02-08 Transoral dosage forms comprising sufentanil and naloxone

Country Status (5)

Country Link
US (4) US20100010031A1 (Direct)
JP (1) JP2010518086A (Direct)
AU (1) AU2008216867B2 (Direct)
CA (1) CA2677281C (Direct)
WO (1) WO2008100434A1 (Direct)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110033542A1 (en) * 2009-08-07 2011-02-10 Monosol Rx, Llc Sublingual and buccal film compositions
SI2054031T1 (sl) 2006-07-21 2016-09-30 Biodelivery Sciences International, Inc. Transmukozne naprave za administracijo z izboljšanim vnosom
US20090246256A1 (en) * 2008-03-27 2009-10-01 Al-Ghananeem Abeer M Compositions and Methods for Transmucosal Delivery of Lofexidine
US8475832B2 (en) * 2009-08-07 2013-07-02 Rb Pharmaceuticals Limited Sublingual and buccal film compositions
ES2443847T3 (es) 2009-11-12 2014-02-20 Acacia Pharma Limited Uso de betanecol para el tratamiento de xerostomía
GB2476494A (en) * 2009-12-24 2011-06-29 Norwich Pharma Technologies Ltd Formulation for the sublingual delivery of sufentanil
EP3524259B1 (en) * 2010-04-30 2021-10-13 Allovate, LLC Oral strip for allergic desensitization via the vestibular mucosal surface
EP3305319A1 (en) 2010-04-30 2018-04-11 Allovate, LLC Methods and articles for preventing or reducing risk of developing a hyperallergenic immune system
GB201107533D0 (en) 2011-05-06 2011-06-22 Acacia Pharma Ltd Formulaiton
CA2845634C (en) * 2011-08-18 2021-07-13 Biodelivery Sciences International, Inc. Abuse-resistant mucoadhesive devices for delivery of buprenorphine
US9901539B2 (en) 2011-12-21 2018-02-27 Biodelivery Sciences International, Inc. Transmucosal drug delivery devices for use in chronic pain relief
US9418672B2 (en) * 2012-06-05 2016-08-16 Apple Inc. Navigation application with adaptive instruction text
MX381426B (es) * 2015-05-27 2025-03-12 Mallinckrodt Llc Preparacion de citrato de sufentanilo y base de sufentanilo.
EP4100012A4 (en) 2020-02-05 2024-02-07 Summit Biosciences Inc. Drug products for intranasal administration and uses thereof

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4671953A (en) * 1985-05-01 1987-06-09 University Of Utah Research Foundation Methods and compositions for noninvasive administration of sedatives, analgesics, and anesthetics
US5288497A (en) * 1985-05-01 1994-02-22 The University Of Utah Compositions of oral dissolvable medicaments
NZ246091A (en) * 1991-12-24 1995-08-28 Yamanouchi Pharma Co Ltd Intrabuccally disintegrating preparation containing an active ingredient, agar, and lactose and/or mannitol
TR199802305T2 (xx) * 1996-05-13 2002-06-21 Norvartis Consumer Health S.A. Yanaktan uygulama y�ntemi.
DE19749724A1 (de) * 1997-11-11 1999-06-10 Gruenenthal Gmbh Verwendung einer Kombination aus Opioid und alpha-adrenergem Agonisten in Schmerzmitteln
US6103257A (en) * 1998-07-17 2000-08-15 Num-Pop, Inc. System for delivering pharmaceuticals to the buccal mucosa
US6368625B1 (en) * 1998-08-12 2002-04-09 Cima Labs Inc. Orally disintegrable tablet forming a viscous slurry
SE9803239D0 (sv) * 1998-09-24 1998-09-24 Diabact Ab Composition for the treatment of acute pain
US6552024B1 (en) * 1999-01-21 2003-04-22 Lavipharm Laboratories Inc. Compositions and methods for mucosal delivery
US6264981B1 (en) * 1999-10-27 2001-07-24 Anesta Corporation Oral transmucosal drug dosage using solid solution
US6394306B1 (en) * 2000-06-23 2002-05-28 Delsys Pharmaceutical Corp. Medication dispenser for dispensing flat dosage forms
US20020160043A1 (en) * 2001-02-27 2002-10-31 Dennis Coleman Compositions and method of manufacture for oral dissolvable dosage forms
US20050042281A1 (en) * 2003-08-21 2005-02-24 Singh Nikhilesh N. Compositions for delivering therapeutic agents across the oral mucosa
US20050065175A1 (en) * 2003-09-24 2005-03-24 Xanodyne Pharmacal, Inc. Oral transmucosal methadone
WO2005065319A2 (en) * 2003-12-31 2005-07-21 Cima Labs Inc. Generally linear effervescent oral fentanyl dosage form and methods of administering
FR2883179B1 (fr) * 2005-03-18 2009-04-17 Ethypharm Sa Comprime enrobe
US20070104763A1 (en) * 2005-11-10 2007-05-10 Navinta Llc Composition of fentanyl citrate oral solid transmucosal dosage form, excipient and binding material therefore, and methods of making
CA2629046C (en) * 2005-12-13 2014-04-08 Biodelivery Sciences International, Inc. Abuse resistant transmucosal drug delivery device
US8252328B2 (en) * 2006-01-06 2012-08-28 Acelrx Pharmaceuticals, Inc. Bioadhesive drug formulations for oral transmucosal delivery
US8865743B2 (en) 2006-01-06 2014-10-21 Acelrx Pharmaceuticals, Inc. Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
DK2604257T3 (en) 2007-08-07 2017-08-28 Acelrx Pharmaceuticals Inc ORAL TRANSMUCOSAL DOSAGE FORMS INCLUDING SUFENTANIL AND TRIAZOLAM
US9264981B2 (en) 2008-03-14 2016-02-16 Lg Electronics Inc. Scanning method in wireless system
US8945592B2 (en) 2008-11-21 2015-02-03 Acelrx Pharmaceuticals, Inc. Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same

Also Published As

Publication number Publication date
CA2677281A1 (en) 2008-08-21
US20180228792A1 (en) 2018-08-16
WO2008100434A1 (en) 2008-08-21
US20160158215A1 (en) 2016-06-09
US20200281915A1 (en) 2020-09-10
US20100010031A1 (en) 2010-01-14
AU2008216867A1 (en) 2008-08-21
US10603312B2 (en) 2020-03-31
JP2010518086A (ja) 2010-05-27
AU2008216867B2 (en) 2014-01-30

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Effective date: 20130130

MKLA Lapsed

Effective date: 20220208