WO2013096811A3 - Transmucosal drug delivery devices for use in chronic pain relief - Google Patents

Transmucosal drug delivery devices for use in chronic pain relief Download PDF

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Publication number
WO2013096811A3
WO2013096811A3 PCT/US2012/071330 US2012071330W WO2013096811A3 WO 2013096811 A3 WO2013096811 A3 WO 2013096811A3 US 2012071330 W US2012071330 W US 2012071330W WO 2013096811 A3 WO2013096811 A3 WO 2013096811A3
Authority
WO
WIPO (PCT)
Prior art keywords
chronic pain
drug delivery
buprenorphine
delivery devices
pain relief
Prior art date
Application number
PCT/US2012/071330
Other languages
French (fr)
Other versions
WO2013096811A2 (en
Inventor
Andrew Finn
Niraj Vasisht
Original Assignee
Biodelivery Sciences International, Inc.
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
Priority to CN201280070389.6A priority Critical patent/CN104125828A/en
Priority to KR1020147020237A priority patent/KR102026321B1/en
Priority to IN6117DEN2014 priority patent/IN2014DN06117A/en
Priority to EA201491046A priority patent/EA034529B1/en
Priority to KR1020197027379A priority patent/KR20190110628A/en
Priority to KR1020227011298A priority patent/KR20220047889A/en
Priority to EP12860757.9A priority patent/EP2793870A4/en
Priority to SG11201403075XA priority patent/SG11201403075XA/en
Priority to MX2014007350A priority patent/MX362217B/en
Priority to JP2014548962A priority patent/JP6255349B2/en
Priority to BR112014015329A priority patent/BR112014015329A8/en
Priority to UAA201406826A priority patent/UA118540C2/en
Priority to AU2012358308A priority patent/AU2012358308A1/en
Priority to KR1020207038099A priority patent/KR20210003313A/en
Application filed by Biodelivery Sciences International, Inc. filed Critical Biodelivery Sciences International, Inc.
Priority to CA2859859A priority patent/CA2859859A1/en
Publication of WO2013096811A2 publication Critical patent/WO2013096811A2/en
Priority to IL233075A priority patent/IL233075A0/en
Publication of WO2013096811A3 publication Critical patent/WO2013096811A3/en
Priority to HK15103881.9A priority patent/HK1203365A1/en
Priority to AU2017258916A priority patent/AU2017258916B2/en
Priority to AU2019202602A priority patent/AU2019202602A1/en
Priority to AU2021202042A priority patent/AU2021202042A1/en
Priority to IL285091A priority patent/IL285091A/en

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
    • A61K9/0012—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
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones

Abstract

Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a trarismucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects. In one embodiment, the buprenorphine delivery device comprises a bioerodable mucoadhesive layer comprising a therapeutically effective amount of buprenorphine disposed in a buffered polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6.
PCT/US2012/071330 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief WO2013096811A2 (en)

Priority Applications (21)

Application Number Priority Date Filing Date Title
UAA201406826A UA118540C2 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
IN6117DEN2014 IN2014DN06117A (en) 2011-12-21 2012-12-21
EA201491046A EA034529B1 (en) 2011-12-21 2012-12-21 Method of treating chronic pain in an opioid experienced subject using a transmucosal drug delivery device
KR1020197027379A KR20190110628A (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
KR1020227011298A KR20220047889A (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
EP12860757.9A EP2793870A4 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
SG11201403075XA SG11201403075XA (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
MX2014007350A MX362217B (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief.
KR1020147020237A KR102026321B1 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
BR112014015329A BR112014015329A8 (en) 2011-12-21 2012-12-21 transmucosal drug delivery devices for use in chronic pain relief
JP2014548962A JP6255349B2 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery device for use in reducing chronic pain
CN201280070389.6A CN104125828A (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
KR1020207038099A KR20210003313A (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
AU2012358308A AU2012358308A1 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
CA2859859A CA2859859A1 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief
IL233075A IL233075A0 (en) 2011-12-21 2014-06-11 Transmucosal drug delivery devices for use in chronic pain relief
HK15103881.9A HK1203365A1 (en) 2011-12-21 2015-04-22 Transmucosal drug delivery devices for use in chronic pain relief
AU2017258916A AU2017258916B2 (en) 2011-12-21 2017-11-09 Transmucosal drug delivery devices for use in chronic pain relief
AU2019202602A AU2019202602A1 (en) 2011-12-21 2019-04-15 Transmucosal drug delivery devices for use in chronic pain relief
AU2021202042A AU2021202042A1 (en) 2011-12-21 2021-04-01 Transmucosal drug delivery devices for use in chronic pain relief
IL285091A IL285091A (en) 2011-12-21 2021-07-23 Transmucosal drug delivery devices for use in chronic pain relief

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161578755P 2011-12-21 2011-12-21
US61/578,755 2011-12-21

Publications (2)

Publication Number Publication Date
WO2013096811A2 WO2013096811A2 (en) 2013-06-27
WO2013096811A3 true WO2013096811A3 (en) 2014-07-24

Family

ID=48669710

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/071330 WO2013096811A2 (en) 2011-12-21 2012-12-21 Transmucosal drug delivery devices for use in chronic pain relief

Country Status (16)

Country Link
EP (1) EP2793870A4 (en)
JP (1) JP6255349B2 (en)
KR (4) KR20190110628A (en)
CN (2) CN110123792A (en)
AU (4) AU2012358308A1 (en)
BR (1) BR112014015329A8 (en)
CA (1) CA2859859A1 (en)
EA (2) EA201992762A1 (en)
HK (1) HK1203365A1 (en)
IL (2) IL233075A0 (en)
IN (1) IN2014DN06117A (en)
MX (2) MX362217B (en)
SG (3) SG10201710667YA (en)
UA (1) UA118540C2 (en)
WO (1) WO2013096811A2 (en)
ZA (1) ZA201804381B (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021163529A2 (en) * 2020-02-13 2021-08-19 Biodelivery Sciences International, Inc. Methods of treatment with buprenorphine

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040024003A1 (en) * 1999-12-14 2004-02-05 Bodo Asmussen Flat medicinal preparation for transmucosal administration of oxycodon or a comparable active ingredient in the oral cavity, for use in pain therapy and in addiction therapy
US20090270438A1 (en) * 2006-10-18 2009-10-29 Clive Booles Novel compositions and formulations
US20110189259A1 (en) * 2008-06-23 2011-08-04 Biodelivery Sciences International, Inc. Multidirectional mucosal delivery devices and methods of use
US20110262522A1 (en) * 2006-07-21 2011-10-27 Biodelivery Sciences International, Inc. Transmucosal delivery devices with enhanced uptake

Family Cites Families (14)

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US5800832A (en) 1996-10-18 1998-09-01 Virotex Corporation Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
DE19652188C2 (en) * 1996-12-16 2002-02-14 Lohmann Therapie Syst Lts Flat drug preparation for application and release of buprenorphine or a pharmacologically comparable substance in the oral cavity and process for its preparation
US5968547A (en) * 1997-02-24 1999-10-19 Euro-Celtique, S.A. Method of providing sustained analgesia with buprenorphine
CN1423559A (en) * 2000-02-08 2003-06-11 欧罗赛铁克股份有限公司 Controlled-release compositions containing opioid agonist and antagonist
EP1389621A4 (en) 2001-04-27 2005-05-11 Ajinomoto Kk N-substituted pyrazolyl-o-glycoside derivatives and remedial agent for diabetes containing the same
US20110033542A1 (en) 2009-08-07 2011-02-10 Monosol Rx, Llc Sublingual and buccal film compositions
DE102005007859A1 (en) * 2005-02-21 2006-08-24 Lts Lohmann Therapie-Systeme Ag Procedures for a combination drug treatment, as well as suitable drug combinations
US20060281775A1 (en) * 2005-06-14 2006-12-14 Applied Pharmacy Services, Inc. Two-component pharmaceutical composition for the treatment of pain
BRPI0619806A2 (en) 2005-12-13 2011-10-18 Biodelivery Sciences Int Inc abuse resistant transmucosal drug delivery device
CA2649107A1 (en) 2006-04-12 2007-10-25 Spinal Motion, Inc. Posterior spinal device and method
EP1897543A1 (en) 2006-08-30 2008-03-12 Euro-Celtique S.A. Buprenorphine- wafer for drug substitution therapy
GB0620661D0 (en) * 2006-10-18 2006-11-29 Pharmasol Ltd Novel compounds
GB2447016A (en) * 2007-03-01 2008-09-03 Reckitt Benckiser Healthcare Buprenorphine/naloxone compositions
US8475832B2 (en) 2009-08-07 2013-07-02 Rb Pharmaceuticals Limited Sublingual and buccal film compositions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040024003A1 (en) * 1999-12-14 2004-02-05 Bodo Asmussen Flat medicinal preparation for transmucosal administration of oxycodon or a comparable active ingredient in the oral cavity, for use in pain therapy and in addiction therapy
US20110262522A1 (en) * 2006-07-21 2011-10-27 Biodelivery Sciences International, Inc. Transmucosal delivery devices with enhanced uptake
US20090270438A1 (en) * 2006-10-18 2009-10-29 Clive Booles Novel compositions and formulations
US20110189259A1 (en) * 2008-06-23 2011-08-04 Biodelivery Sciences International, Inc. Multidirectional mucosal delivery devices and methods of use

Also Published As

Publication number Publication date
KR20220047889A (en) 2022-04-19
JP2015500886A (en) 2015-01-08
UA118540C2 (en) 2019-02-11
HK1203365A1 (en) 2015-10-30
IN2014DN06117A (en) 2015-08-14
EA201992762A1 (en) 2020-07-31
MX2014007350A (en) 2014-09-15
SG11201403075XA (en) 2014-07-30
KR102026321B1 (en) 2019-09-27
MX2021012154A (en) 2021-11-03
AU2019202602A1 (en) 2019-05-02
AU2017258916A1 (en) 2017-11-30
AU2021202042A1 (en) 2021-04-29
CN110123792A (en) 2019-08-16
BR112014015329A2 (en) 2017-06-13
IL233075A0 (en) 2014-07-31
AU2012358308A1 (en) 2014-07-24
ZA201804381B (en) 2022-12-21
SG10202012743WA (en) 2021-01-28
MX362217B (en) 2019-01-09
CA2859859A1 (en) 2013-06-27
AU2017258916B2 (en) 2019-01-17
KR20140106720A (en) 2014-09-03
EP2793870A2 (en) 2014-10-29
CN104125828A (en) 2014-10-29
EA201491046A1 (en) 2014-11-28
EA034529B1 (en) 2020-02-18
KR20210003313A (en) 2021-01-11
KR20190110628A (en) 2019-09-30
WO2013096811A2 (en) 2013-06-27
IL285091A (en) 2021-08-31
EP2793870A4 (en) 2016-02-17
JP6255349B2 (en) 2017-12-27
SG10201710667YA (en) 2018-02-27
BR112014015329A8 (en) 2017-06-13

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