PE20121136A1 - Composiciones de pelicula sublinguales y bucales - Google Patents

Composiciones de pelicula sublinguales y bucales

Info

Publication number
PE20121136A1
PE20121136A1 PE2012000175A PE2012000175A PE20121136A1 PE 20121136 A1 PE20121136 A1 PE 20121136A1 PE 2012000175 A PE2012000175 A PE 2012000175A PE 2012000175 A PE2012000175 A PE 2012000175A PE 20121136 A1 PE20121136 A1 PE 20121136A1
Authority
PE
Peru
Prior art keywords
amount
buprenorphine
sublingual
naloxone
pharmaceutically acceptable
Prior art date
Application number
PE2012000175A
Other languages
English (en)
Inventor
Garry L Myers
Samuel D Hilbert
Bill J Boone
B Arlie Bogue
Pradeep Sanghvi
Madhusudan Hariharan
Original Assignee
Rb Pharmaceuticals Ltd
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=PE20121136(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Rb Pharmaceuticals Ltd filed Critical Rb Pharmaceuticals Ltd
Publication of PE20121136A1 publication Critical patent/PE20121136A1/es

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

REFERIDA A UNA COMPOSICION DE DOSIFICACION DE PELICULA QUE COMPRENDE: A) UNA METRIZ PORTADORA POLIMERICA; B) UNA CANTIDAD TERAPEUTICAMENTE EFICAZ DE BUPRENORFINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE EN UNA CANTIDAD DE 2-16 mg POR DOSIFICACION; C) NALOXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE EN UNA CANTIDAD DE 0,5%-4mg DE NALOXONA; D) TAMPON EN UNA CANTIDAD PARA PROPORCIONAR UN pH DE 3-4 PARA OPTIMIZAR LA OBSORCION DE DICHA BUPRENORFINA EN UNA CANTIDAD DE 2:1 HASTA 1:5 EN PESO CON RESPECTO A BUPRENORFINA SELECCIONADA DE ACIDO ACETICO, ACETATO DE SODIO Y COMBINACIONES DE LOS MISMOS. REFERIDA ADEMAS A UN PROCEDIMIENTO DE PREPARACION. DICHA COMPOSICION ES UTIL PARA TRATAR LA DEPENDENCIA A NARCOTICOS A LA VEZ QUE SE PROPORCIONA UNA ADEHESION BUCAL SUFICIENTE DE LA FORMA DE DOSIFICACION
PE2012000175A 2009-08-07 2010-08-05 Composiciones de pelicula sublinguales y bucales PE20121136A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PE20121136A1 true PE20121136A1 (es) 2012-08-30

Family

ID=43428649

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2012000175A PE20121136A1 (es) 2009-08-07 2010-08-05 Composiciones de pelicula sublinguales y bucales

Country Status (24)

Country Link
US (8) US8475832B2 (es)
EP (2) EP2461795B2 (es)
JP (1) JP5819827B2 (es)
KR (1) KR101699321B1 (es)
CN (1) CN102548535B (es)
AR (1) AR078417A1 (es)
AU (1) AU2010279440B2 (es)
BR (1) BR112012002817B8 (es)
CA (1) CA2770180C (es)
CL (1) CL2012000313A1 (es)
CO (1) CO6511219A2 (es)
DK (2) DK3031445T3 (es)
ES (2) ES2757814T3 (es)
HK (1) HK1171960A1 (es)
HR (1) HRP20160368T1 (es)
IL (2) IL217964A (es)
MX (1) MX2012001573A (es)
MY (1) MY156006A (es)
NZ (1) NZ598537A (es)
PE (1) PE20121136A1 (es)
RU (2) RU2018121855A (es)
SG (2) SG178265A1 (es)
WO (1) WO2011017483A2 (es)
ZA (1) ZA201201647B (es)

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MY156006A (en) 2015-12-31
WO2011017483A2 (en) 2011-02-10
IL217964A (en) 2016-05-31
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US20140005218A1 (en) 2014-01-02
CN102548535A (zh) 2012-07-04
US20110033541A1 (en) 2011-02-10
EP3031445B1 (en) 2019-11-06
US20140378497A1 (en) 2014-12-25
EP2461795B2 (en) 2019-06-19
ZA201201647B (en) 2013-05-29
KR20120059538A (ko) 2012-06-08
RU2012108632A (ru) 2013-09-20
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BR112012002817A8 (pt) 2017-10-24
MX2012001573A (es) 2012-06-19
ES2757814T3 (es) 2020-04-30
CA2770180A1 (en) 2011-02-10
HRP20160368T1 (hr) 2016-06-03
US20170209431A1 (en) 2017-07-27
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