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HRP20161228T1 - Vrećica s nikotinom u obliku slobodne soli - Google Patents

Vrećica s nikotinom u obliku slobodne soli Download PDF

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Publication number
HRP20161228T1
HRP20161228T1 HRP20161228TT HRP20161228T HRP20161228T1 HR P20161228 T1 HRP20161228 T1 HR P20161228T1 HR P20161228T T HRP20161228T T HR P20161228TT HR P20161228 T HRP20161228 T HR P20161228T HR P20161228 T1 HRP20161228 T1 HR P20161228T1
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HR
Croatia
Prior art keywords
nicotine
product according
product
powder
mixtures
Prior art date
Application number
HRP20161228TT
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English (en)
Inventor
Per-Gunnar Nilsson
Original Assignee
Nyz Ab
Wm17 Holding Ag
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46888836&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20161228(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Nyz Ab, Wm17 Holding Ag filed Critical Nyz Ab
Publication of HRP20161228T1 publication Critical patent/HRP20161228T1/hr

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    • 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
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • 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
    • A61K31/465—Nicotine; Derivatives 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
    • A61K47/02—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
    • A61K47/12—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
    • A61K47/36—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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/14—Disinfection, sterilisation or deodorisation of air using sprayed or atomised substances including air-liquid contact processes
    • 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
    • A61P25/34—Tobacco-abuse

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Addiction (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (21)

1. Proizvod za oralno uzimanje nikotina koji ima jezgru koja sadrži prašak s a) barem jednom slobodnom soli nikotina b) barem jednom tvari za podešavanje pH c) barem jednim punilom i vodonepropusnu vrećicu, gdje je ta vrećica propusna za slinu i u njoj otopljene dijelove praška, pri čemu taj proizvod u doticaju s pročišćenom vodom daje pH od najmanje 6.
2. Proizvod prema zahtjevu 1, gdje je ta sol nikotina topljiva u vodi.
3. Proizvod prema zahtjevima 1- 2, gdje se ta sol nikotina odabire iz skupine koju čine nikotin klorovodik, nikotin diklorovodik, nikotin monotartarat, nikotin bitartarat, nikotin bitartarat dihidrat, nikotin sulfat, nikotin cink klorid monohidrat i nikotin salicilat, te njihove smjese.
4. Proizvod prema zahtjevu 3, gdje je sol nikotina nikotin bitartarat dihidrat.
5. Proizvod prema zahtjevima 1-4, gdje se tvar za podešavanje pH odabire iz skupine koju čine karbonati, uključujući monokarbonat, bikarbonat i seskvikarbonat, acetati, glicinati, glukonati, borati, glicerofosfati ili citrati alkalijskih metala ili amonijaka, fosfatni sustavi uključujući monohidrogenfosfat, dihidrogenfosfat i trihidrogenfosfat, metalni hidroksidi kao što je natrijev hidroksid i kalijev hidroksid, te njihove smjese.
6. Proizvod prema zahtjevu 5, gdje je tvar za podešavanje pH natrijev bikarbonat ili natrijev karbonat, i njihove smjese.
7. Proizvod prema zahtjevima 5-6, gdje je tvar za podešavanje pH u kapsuli ili je ugrađena.
8. Proizvod prema zahtjevu 7, gdje je tvar za podešavanje pH u kapsuli ili je ugrađena s polimerom koji fizički odvaja tvar za podešavanje pH od nikotinske soli.
9. Proizvod prema zahtjevima 1-8, gdje se punilo odabire iz skupine koju čine polisaharidi, polioli, šećeri, prirodna vlakna, mikrokristalična celuloza, celuloza i derivati celuloze, te njihove smjese.
10. Proizvod prema bilo kojem od prethodnih zahtjeva, gdje taj proizvod sadrži barem jedno punilo koje je sladilo ili aroma.
11. Proizvod prema zahtjevu 10 gdje se sladilo odabire iz skupine koju čine mono-, di-, tri- i polisaharidi, polioli kao manitol i maltitol, prirodna i umjetna sladila kao saharoza, glukoza, dekstroza, maltoza, fruktoza, saharin, aspartam, acesulfam, sukralozs, saharin i ciklamati, te njihove smjese.
12. Proizvod prema zahtjevu 10 gdje se aroma odabire iz skupine koju čine bergamot, eukaliptus, naranča, mandarina, citrusi, limun, pepermint, mint, mentol, sladić, zimzelen, duhan, kava, vanilija, limeta, jabuka, breskva, te njihove smjese.
13. Proizvod prema bilo kojem od prethodnih zahtjeva, gdje je vrećica napravljena od materijala odabranog iz skupine koju čine farmaceutski prikladni membranski materijali.
14. Proizvod prema bilo kojem od prethodnih zahtjeva, gdje taj proizvod sadrži nikotin u količini od 0.1 do 10 mg po pojedinačnoj dozi izračunato kao nikotin u baznom obliku.
15. Proizvod prema zahtjevu 14, gdje taj proizvod sadrži nikotin u količini od 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 ili 9.0 mg po pojedinačnoj dozi izračunato kao nikotin u baznom obliku.
16. Proizvod prema bilo kojem od prethodnih zahtjeva, gdje taj proizvod sadrži od 50 mg do 1000 mg praška.
17. Proizvod prema zahtjevu 16, gdje taj proizvod sadrži 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900 ili 950 mg praška.
18. Proizvod prema bilo kojem od prethodnih zahtjeva, gdje je prašak granuliran.
19. Postupak izrade proizvoda koji obuhvaća korake a) dobivanje praška barem jedne slobodne soli nikotina i barem jedne tvari za podešavanje pH i barem jednog punila, te u vodi netopljive vrećice b) dobivanje proizvoda prema bilo kojem od zahtjeva 1-18.
20. Postupak prema zahtjevu 19 gdje taj postupak obuhvaća dodatni korak kapsuliranja ili ugrađivanja tvari za podešavanje pH.
21. Postupak prema zahtjevima 19-20 gdje taj postupak obuhvaća dodatni korak granuliranja praška.
HRP20161228TT 2011-03-29 2016-09-26 Vrećica s nikotinom u obliku slobodne soli HRP20161228T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SE1150273A SE535587C2 (sv) 2011-03-29 2011-03-29 Produkt innehållande ett fritt nikotinsalt och en ej vattenlöslig påse
US201161470264P 2011-03-31 2011-03-31
PCT/SE2012/050336 WO2012134380A1 (en) 2011-03-29 2012-03-28 Pouch containing nicotine in free salt form
EP12765290.7A EP2691096B8 (en) 2011-03-29 2012-03-28 Pouch containing nicotine in free salt form

Publications (1)

Publication Number Publication Date
HRP20161228T1 true HRP20161228T1 (hr) 2016-12-02

Family

ID=46888836

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20161228TT HRP20161228T1 (hr) 2011-03-29 2016-09-26 Vrećica s nikotinom u obliku slobodne soli

Country Status (20)

Country Link
US (2) US9161908B2 (hr)
EP (1) EP2691096B8 (hr)
JP (1) JP6047697B2 (hr)
KR (1) KR101908157B1 (hr)
CN (1) CN103491958B (hr)
CA (1) CA2831715C (hr)
CY (1) CY1121328T1 (hr)
DK (1) DK2691096T3 (hr)
ES (1) ES2595158T3 (hr)
HR (1) HRP20161228T1 (hr)
HU (1) HUE029642T2 (hr)
LT (1) LT2691096T (hr)
PL (1) PL2691096T3 (hr)
PT (1) PT2691096T (hr)
RS (1) RS55329B1 (hr)
RU (1) RU2608902C2 (hr)
SE (1) SE535587C2 (hr)
SI (1) SI2691096T1 (hr)
SM (1) SMT201600348B (hr)
WO (1) WO2012134380A1 (hr)

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