WO2011017483A3 - Sublingual and buccal film compositions - Google Patents

Sublingual and buccal film compositions Download PDF

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Publication number
WO2011017483A3
WO2011017483A3 PCT/US2010/044488 US2010044488W WO2011017483A3 WO 2011017483 A3 WO2011017483 A3 WO 2011017483A3 US 2010044488 W US2010044488 W US 2010044488W WO 2011017483 A3 WO2011017483 A3 WO 2011017483A3
Authority
WO
WIPO (PCT)
Prior art keywords
sublingual
film compositions
buccal film
narcotic dependence
buccal
Prior art date
Application number
PCT/US2010/044488
Other languages
French (fr)
Other versions
WO2011017483A8 (en
WO2011017483A2 (en
Inventor
Garry L. Myers
Samuel D. Hilbert
Bill J. Boone
B. Arlie Bogue
Pradeep Sanghvi
Madhusudan Hariharan
Original Assignee
Reckitt Benckiser Healthcare (Uk) Limited
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=43428649&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2011017483(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to RU2012108632/15A priority Critical patent/RU2012108632A/en
Priority to EP16151046.6A priority patent/EP3031445B1/en
Priority to MX2012001573A priority patent/MX2012001573A/en
Priority to SG2012007993A priority patent/SG178265A1/en
Priority to DK10740493.1T priority patent/DK2461795T4/en
Priority to KR1020127006096A priority patent/KR101699321B1/en
Priority to AU2010279440A priority patent/AU2010279440B2/en
Priority to EP10740493.1A priority patent/EP2461795B2/en
Priority to CA2770180A priority patent/CA2770180C/en
Priority to ES10740493T priority patent/ES2562634T5/en
Priority to BR112012002817A priority patent/BR112012002817B8/en
Priority to NZ598537A priority patent/NZ598537A/en
Priority to JP2012523937A priority patent/JP5819827B2/en
Priority to CN201080041829.6A priority patent/CN102548535B/en
Application filed by Reckitt Benckiser Healthcare (Uk) Limited filed Critical Reckitt Benckiser Healthcare (Uk) Limited
Publication of WO2011017483A2 publication Critical patent/WO2011017483A2/en
Publication of WO2011017483A3 publication Critical patent/WO2011017483A3/en
Priority to IL217964A priority patent/IL217964A/en
Priority to ZA2012/01647A priority patent/ZA201201647B/en
Publication of WO2011017483A8 publication Critical patent/WO2011017483A8/en
Priority to HK12112940.2A priority patent/HK1171960A1/en
Priority to IL244974A priority patent/IL244974B/en
Priority to HRP20160368TT priority patent/HRP20160368T1/en

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
    • A61K31/47—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
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4355—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having oxygen as a ring hetero atom
    • 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—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
    • A61K9/0012—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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Abstract

The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.
PCT/US2010/044488 2009-08-07 2010-08-05 Sublingual and buccal film compositions WO2011017483A2 (en)

Priority Applications (19)

Application Number Priority Date Filing Date Title
EP16151046.6A EP3031445B1 (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
NZ598537A NZ598537A (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
BR112012002817A BR112012002817B8 (en) 2009-08-07 2010-08-05 sublingual and oral compositions on film
SG2012007993A SG178265A1 (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
DK10740493.1T DK2461795T4 (en) 2009-08-07 2010-08-05 SUBLINGUAL AND BUCCAL MOVIE COMPOSITIONS
KR1020127006096A KR101699321B1 (en) 2009-08-07 2010-08-05 Sublingual and Buccal Film Compositions
AU2010279440A AU2010279440B2 (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
EP10740493.1A EP2461795B2 (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
CA2770180A CA2770180C (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
JP2012523937A JP5819827B2 (en) 2009-08-07 2010-08-05 Film composition for sublingual and buccal administration
MX2012001573A MX2012001573A (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions.
RU2012108632/15A RU2012108632A (en) 2009-08-07 2010-08-05 SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
ES10740493T ES2562634T5 (en) 2009-08-07 2010-08-05 Compositions for sublingual and oral films
CN201080041829.6A CN102548535B (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions
IL217964A IL217964A (en) 2009-08-07 2012-02-06 Film dosage compositions comprising buprenorphine and naloxone, film formulations comprising the same and use thereof for the preparation of medicaments for treating narcotic dependence
ZA2012/01647A ZA201201647B (en) 2009-08-07 2012-03-06 Sublingual and buccal film compositions
HK12112940.2A HK1171960A1 (en) 2009-08-07 2012-12-14 Sublingual and buccal film compositions
IL244974A IL244974B (en) 2009-08-07 2016-04-07 Film dosage compositions comprising buprenorphine and naloxone, film formulations comprising the same and use thereof for the preparation of medicaments for treating narcotic dependence
HRP20160368TT HRP20160368T1 (en) 2009-08-07 2016-04-12 Sublingual and buccal film compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/537,571 2009-08-07
US12/537,571 US8475832B2 (en) 2009-08-07 2009-08-07 Sublingual and buccal film compositions

Publications (3)

Publication Number Publication Date
WO2011017483A2 WO2011017483A2 (en) 2011-02-10
WO2011017483A3 true WO2011017483A3 (en) 2011-06-03
WO2011017483A8 WO2011017483A8 (en) 2012-03-08

Family

ID=43428649

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/044488 WO2011017483A2 (en) 2009-08-07 2010-08-05 Sublingual and buccal film compositions

Country Status (24)

Country Link
US (8) US8475832B2 (en)
EP (2) EP3031445B1 (en)
JP (1) JP5819827B2 (en)
KR (1) KR101699321B1 (en)
CN (1) CN102548535B (en)
AR (1) AR078417A1 (en)
AU (1) AU2010279440B2 (en)
BR (1) BR112012002817B8 (en)
CA (1) CA2770180C (en)
CL (1) CL2012000313A1 (en)
CO (1) CO6511219A2 (en)
DK (2) DK3031445T3 (en)
ES (2) ES2562634T5 (en)
HK (1) HK1171960A1 (en)
HR (1) HRP20160368T1 (en)
IL (2) IL217964A (en)
MX (1) MX2012001573A (en)
MY (1) MY156006A (en)
NZ (1) NZ598537A (en)
PE (1) PE20121136A1 (en)
RU (2) RU2012108632A (en)
SG (2) SG10201601214VA (en)
WO (1) WO2011017483A2 (en)
ZA (1) ZA201201647B (en)

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