DK2293786T3 - Tabletterbare tyggegummier omfattende nikotin og et pufferstof - Google Patents

Tabletterbare tyggegummier omfattende nikotin og et pufferstof Download PDF

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Publication number
DK2293786T3
DK2293786T3 DK09749811.7T DK09749811T DK2293786T3 DK 2293786 T3 DK2293786 T3 DK 2293786T3 DK 09749811 T DK09749811 T DK 09749811T DK 2293786 T3 DK2293786 T3 DK 2293786T3
Authority
DK
Denmark
Prior art keywords
nicotine
gum
chewing gum
chewing
coating
Prior art date
Application number
DK09749811.7T
Other languages
English (en)
Inventor
Markus Rudolph
Giovanna Marzano
Isabelle Rault
Original Assignee
Novartis Ag
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=39873257&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2293786(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Application granted granted Critical
Publication of DK2293786T3 publication Critical patent/DK2293786T3/da

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Classifications

    • 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
    • A61K31/465Nicotine; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • A61K9/0058Chewing gums
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34Tobacco-abuse

Claims (10)

1. Tyggegummi omfattende en komprimerbar tyggegummibasis, der tillader tyggegummiet at fremstilles ved tablettering, mindst ét aktivt nikotin valgt fra gruppen bestående af farmaceutisk acceptable salte af nikotin og farmaceutisk acceptable nikotinkomplekser og -harpikser til anvendelse ved ni kotin erstatningsterapi, hvilket tyggegummi tilvejebringer hurtig frigivelse af nikotin i mundhulen og hurtig - men ikke-toksisk, farmaceutisk acceptabel - buccal absorption af nikotin, kendetegnet ved, at det omfatter to forskellige pufferstoffer, natriumcarbonat og natriumbicarbonat i form af overtrukne partikler, hvilke overtrukne partikler omfatter en kerne af natriumbicarbonat og et yderlag af natriumcarbonat.
2. Tyggegummi ifølge krav 1, hvori det mindst ene aktive nikotin og pufferstoffet i form af overtrukne partikler findes i homogen blanding.
3. Tyggegummi ifølge krav 1 eller krav 2, hvori det mindst ene aktive nikotin er valgt fra gruppen bestående af farmaceutisk acceptable salte af nikotin.
4. Tyggegummi ifølge et hvilket som helst af kravene 1-3, kendetegnet ved at omfatte det mindst ene aktive nikotin i en mængde svarende til fra 0,2 til 8 mg fri nikotinbase.
5. Tyggegummi ifølge et hvilket som helst af kravene 1-4, som er overtrukket.
6. Tyggegummi ifølge krav 5, som er overtrukket med et overtræk, der omfatter maltitol.
7. Tyggegummi ifølge krav 5 eller krav 6, som er overtrukket med et overtræk, der omfatter maltitol i en mængde på 80-95% af hele overtræksmassen og pebermynteolie i en mængde fra 0,5-3% af hele overtræksmassen.
8. Tyggegummi ifølge et hvilket som helst af kravene 5-7, hvori overtrækket omfatter et bindemiddel valgt fra gruppen bestående af gummi arabicum, tragantgummi, guargummi, akaciegummi, xanthangummi, alginsyre, salte af alginsyre, gellangummi, glucomannangummi, carrageenangummi, karayagummi, Johannesbrødgummi, taragummi, gelatine og vilkårlige blandinger deraf.
9. Tyggegummi ifølge et hvilket som helst af kravene 5-8, hvori overtrækket omfatter et overtræksblødgørende stof valgt fra gruppen bestående af glycerol, polyethylen-glycol, propylenglycol, povidon (polyvinylpyrrolidon), copovidon (= vinylpyrrolidon-vinylacetat-copolymer), hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulosephthalat, diethylphthalat, dibutylphthalat, diacetin, triacetin, triethylcitrat, dibutylcitrat, acetyltributylcitrat, acetyltriethylcitrat, 2-pyrrolidon og vilkårlige blandinger deraf.
10. Tyggegummi til anvendelse ved nikotinerstatningsterapi ifølge et hvilket som helst af kravene 1-9 til anvendelse ved tilvejebringelse af lindring af nikotintrang.
DK09749811.7T 2008-05-21 2009-05-19 Tabletterbare tyggegummier omfattende nikotin og et pufferstof DK2293786T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08156636 2008-05-21
PCT/EP2009/056032 WO2009141321A2 (en) 2008-05-21 2009-05-19 Tablettable chewing gums

Publications (1)

Publication Number Publication Date
DK2293786T3 true DK2293786T3 (da) 2015-02-23

Family

ID=39873257

Family Applications (1)

Application Number Title Priority Date Filing Date
DK09749811.7T DK2293786T3 (da) 2008-05-21 2009-05-19 Tabletterbare tyggegummier omfattende nikotin og et pufferstof

Country Status (12)

Country Link
US (2) US9511021B2 (da)
EP (1) EP2293786B1 (da)
JP (1) JP5587298B2 (da)
KR (1) KR20110015561A (da)
CN (1) CN102036657A (da)
AR (1) AR071850A1 (da)
DK (1) DK2293786T3 (da)
ES (1) ES2529297T3 (da)
PT (1) PT2293786E (da)
RU (1) RU2501551C2 (da)
TW (1) TW200950821A (da)
WO (1) WO2009141321A2 (da)

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US9675102B2 (en) 2010-09-07 2017-06-13 R. J. Reynolds Tobacco Company Smokeless tobacco product comprising effervescent composition
US20130177646A1 (en) * 2012-01-05 2013-07-11 Mcneil Ab Solid Nicotine-Comprising Dosage Form with Reduced Organoleptic Disturbance
SE536491C2 (sv) * 2012-03-26 2013-12-27 Bionicotine Ab Påse innehållande nikotin och en tuggummikomposition
US10357054B2 (en) 2013-10-16 2019-07-23 R.J. Reynolds Tobacco Company Smokeless tobacco pastille
US11612183B2 (en) * 2015-12-10 2023-03-28 R.J. Reynolds Tobacco Company Protein-enriched tobacco composition
US11311623B2 (en) 2016-04-21 2022-04-26 Fertin Pharma A/S Nicotine delivery product, related uses and oral dosage forms, and methods of production
CN106578316A (zh) * 2016-12-20 2017-04-26 大连丹特生物技术有限公司 一种烟碱木糖醇口香糖及其制备方法
DE102017104026A1 (de) 2017-02-27 2018-08-30 Lts Lohmann Therapie-Systeme Ag Nicotin enthaltendes transparentes transdermales therapeutisches System
SE541358C2 (en) * 2017-05-30 2019-08-13 Enorama Pharma Ab Nicotine-containing chewing gum compositions
CN107259057A (zh) * 2017-08-08 2017-10-20 佛山科学技术学院 一种环保的提神口香糖及其制备方法
US11083765B2 (en) * 2017-12-15 2021-08-10 Andrew Scott Davis Hemp leaf chew composition and method for producing
JP7214755B2 (ja) * 2018-05-17 2023-01-30 フェルティン ファルマ アー/エス 医薬品活性成分に適した錠剤化チューインガム
US11826462B2 (en) 2019-12-09 2023-11-28 Nicoventures Trading Limited Oral product with sustained flavor release
US20210169788A1 (en) * 2019-12-09 2021-06-10 Nicoventures Trading Limited Oral product and method of manufacture
US11793230B2 (en) 2019-12-09 2023-10-24 Nicoventures Trading Limited Oral products with improved binding of active ingredients
US11872231B2 (en) 2019-12-09 2024-01-16 Nicoventures Trading Limited Moist oral product comprising an active ingredient
AU2021207269A1 (en) * 2020-01-15 2022-09-08 Mcneil Ab Product and method of manufacturing a gum
CN114945359A (zh) * 2020-01-15 2022-08-26 麦克内尔股份公司 口香糖的产品和制备方法

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US3845217A (en) 1972-11-16 1974-10-29 Helsingborg L Ab Buffered smoking substitute compositions
US5549906A (en) 1993-07-26 1996-08-27 Pharmacia Ab Nicotine lozenge and therapeutic method for smoking cessation
US6358060B2 (en) 1998-09-03 2002-03-19 Jsr Llc Two-stage transmucosal medicine delivery system for symptom relief
US20020098264A1 (en) 1998-11-27 2002-07-25 Cherukuri Subraman R. Medicated chewing gum delivery system for nicotine
US6344222B1 (en) 1998-09-03 2002-02-05 Jsr Llc Medicated chewing gum delivery system for nicotine
US7163705B2 (en) 1998-12-15 2007-01-16 Wm. Wrigley Jr. Company Coated chewing gum product and method of making
US6355265B1 (en) * 1999-04-06 2002-03-12 Wm. Wrigley Jr. Company Over-coated chewing gum formulations
AU2001261744A1 (en) 2000-05-19 2001-12-03 Npd Llc Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements
SE0102197D0 (sv) * 2001-06-20 2001-06-20 Pharmacia Ab New product and use and manufacture thereof
US20050175733A1 (en) * 2002-07-02 2005-08-11 Bitten Thorengaard Compressed resin moderated chewing gum
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Also Published As

Publication number Publication date
US9511021B2 (en) 2016-12-06
ES2529297T3 (es) 2015-02-18
US20110129517A1 (en) 2011-06-02
EP2293786B1 (en) 2014-11-26
RU2501551C2 (ru) 2013-12-20
JP2011520938A (ja) 2011-07-21
PT2293786E (pt) 2015-02-25
RU2010152012A (ru) 2012-06-27
AR071850A1 (es) 2010-07-21
WO2009141321A3 (en) 2010-10-28
CN102036657A (zh) 2011-04-27
TW200950821A (en) 2009-12-16
US20170042879A1 (en) 2017-02-16
WO2009141321A2 (en) 2009-11-26
KR20110015561A (ko) 2011-02-16
EP2293786A2 (en) 2011-03-16
US9763929B2 (en) 2017-09-19
JP5587298B2 (ja) 2014-09-10

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