DK2023958T3 - Farmaceutisk produkt til intraoral levering af nikotin omfattende trometamol som buffermiddel - Google Patents

Farmaceutisk produkt til intraoral levering af nikotin omfattende trometamol som buffermiddel Download PDF

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Publication number
DK2023958T3
DK2023958T3 DK07748029.1T DK07748029T DK2023958T3 DK 2023958 T3 DK2023958 T3 DK 2023958T3 DK 07748029 T DK07748029 T DK 07748029T DK 2023958 T3 DK2023958 T3 DK 2023958T3
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Prior art keywords
nicotine
oral formulation
disease
oral
tobacco
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DK07748029.1T
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English (en)
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DK2023958T4 (da
Inventor
Darek Dymitrowics
Roland Olsson
Fredrik Nicklasson
Anette Schlüter
Kristina Thyresson
Seema K Mody
Katarina Lindell
Andreas Hugerth
Bengt Bosson
Magnus Pålsson
Per Steen
Åsa Waltermo
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Mcneil Ab
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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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • 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
    • A61K9/0058—Chewing gums
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—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
    • A61K9/70—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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nutrition Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Physiology (AREA)
  • Neurology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Bufret farmaceutisk oral formulering i form af en mundspray omfattende nikotin, kendetegnet ved at formuleringen er bufret med mindst trometamol som den eneste buffer, eller som hovedbufferen.
2. Oral formulering ifølge krav 1, der er bufret på en sådan måde at under oral administration af den orale formulering til et individ er individets pH af spyttet steget med 0,2 - 4 pH-enheder, fortrinsvis 0,5 - 2 pH-enheder.
3. Oral formulering ifølge krav 1 eller krav 2 bufret med trometamol sammen med en buffer valgt fra gruppen bestående af carbonat, såsom bicarbonat eller sesquicarbonat, glycinat, phosphat, glycerophosphat, citrat af et alkalimetal, såsom kalium eller natrium, eller ammonium, og blandinger deraf.
4. Oral formulering ifølge et hvilket som helst af kravene 1-3, hvor nikotinen er i en hvilken som helst form valgt fra gruppen bestående af et nikotinsalt; den frie baseform af nikotin; et nikotinderivat, såsom en nikotinkationbytter; et nikotininklusionskompleks; eller nikotin i en hvilken som helst ikke-kovalent binding; nikotin bundet til zeolitter; nikotin bundet til cellulose eller stivelsesmikrosfærer; og blandinger deraf.
5. Oral formulering ifølge et hvilket som helst af kravene 1-4, hvor nikotinen i en hvilken som helst form er til stede i en mængde på 0,05 - 8 mg beregnet som den frie baseform af nikotin pr. dosisenhed af den orale formulering.
6. Oral formulering ifølge et hvilket som helst af kravene 1-5, omfattende mindst ét eller flere additiver valgt fra gruppen bestående af opløsningsmidler, co-opløsningsmidler, stabilisatorer, konserveringsmidler, antioxidanter, blødgørere, fortykningsmidler, bindemidler, fyldstofmidler, solubiliseringsmidler, gummier, lipidbarrierer, filmdannende midler, emulgatorer, glittemidler, smøremidler, coatingmidler, smeltebindemidler, sødemidler, smagsforstærkere, aromastoffer, kølemidler, forstærkere, farvestofmidler, vitaminer, mineraler, fluor, åndeforfriskere, tandblegningsmidler og blandinger deraf.
7. Oral formulering ifølge krav 1 - 6 til anvendelse i opnåelse af en fast og/eller langvarig og/eller fuldstændig reduktion af trangen til at ryge og anvendelse af tobak eller til at tilvejebringe en følelse af rygning uden at ryge.
8. Oral formulering ifølge et hvilket som helst af kravene 1 - 6 til anvendelse i levering af nikotin til et individ.
9. Formulering ifølge et hvilket som helst af kravene 1-6, hvor formuleringen er en nikotin-indeholdende mundspray omfattende nikotinfri base, ethanol eller et andet opløsningsmiddel, trometamol, poloxamer eller et andet solubiliseringsmiddel, tetracemindinatrium eller et andet stabiliseringsmiddel, og kunstige sødemidler.
10. Formulering ifølge krav 9, hvor trometamol er udskiftet med trometamol i kombination med en buffer valgt fra gruppen bestående af carbonat omfattende bicarbonat eller sesquicarbonat, glycinat, phosphat, glycerophosphat eller citrat af et alkalimetal, såsom kalium eller natrium, eller ammonium, herunder trinatriumphosphat, dinatriumhydrogenphosphat; trikaliumphosphat, dikaliumhydrogenphosphat, og calcium hydroxid, natriumglycinat; og blandinger deraf.
11. Formulering ifølge et hvilket som helst af kravene 1-6 eller krav 9 til anvendelse i terapi.
12. Formulering ifølge krav 11, hvor terapien er behandling afen sygdom valgt fra gruppen bestående af tobak- eller nikotinafhængighed, Alzheimer's sygdom, Crohn's sygdom, Parkinson's sygdom, Tourette's syndrom, ulcerøs colitis og post-rygnings-ophørs-vægtkontrol.
13. Anvendelse af nikotin til fremstillingen af et produkt ifølge et hvilket som helst af kravene 1-6 eller krav 9 til behandlingen af en sygdom valgt fra gruppen bestående af tobaks- eller nikotinafhængighed, Alzheimer's sygdom, Crohn's sygdom, Parkinson's sygdom, Tourette's syndrom, ulcerøs colitis og post-rygnings-ophørs-vægtkontrol.
14. Anvendelse af nikotin til fremstilling afen oral formulering ifølge et hvilket som helst af kravene 1-6 eller krav 9 til behandlingen af en sygdom valgt fra gruppen bestående af tobaks- eller nikotinafhængighed, Alzheimer's sygdom, Crohn's sygdom, Parkinson's sygdom, Tourette's syndrom, ulcerøs colitis og post-rygnings-ophørs-vægtkontrol.
DK07748029.1T 2006-05-16 2007-04-18 Farmaceutisk produkt til intraoral levering af nikotin omfattende trometamol som buffermiddel DK2023958T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE0601089 2006-05-16
PCT/SE2007/000364 WO2007133140A1 (en) 2006-05-16 2007-04-18 Pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent

Publications (2)

Publication Number Publication Date
DK2023958T3 true DK2023958T3 (da) 2017-12-04
DK2023958T4 DK2023958T4 (da) 2020-08-10

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ID=38694148

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DK07748029.1T DK2023958T4 (da) 2006-05-16 2007-04-18 Farmaceutisk produkt til intraoral levering af nikotin omfattende trometamol som buffermiddel

Country Status (24)

Country Link
US (1) US20070269386A1 (da)
EP (1) EP2023958B2 (da)
JP (1) JP5710121B2 (da)
KR (1) KR20090033330A (da)
CN (1) CN101484188A (da)
AR (1) AR060932A1 (da)
AU (1) AU2007250588B2 (da)
BR (1) BRPI0711692A2 (da)
CA (1) CA2652499C (da)
CY (1) CY1119764T1 (da)
DK (1) DK2023958T4 (da)
ES (1) ES2649268T5 (da)
HU (1) HUE035266T2 (da)
LT (1) LT2023958T (da)
MX (1) MX2008014725A (da)
NO (1) NO342308B1 (da)
NZ (1) NZ572759A (da)
PL (1) PL2023958T5 (da)
PT (1) PT2023958T (da)
RU (1) RU2436566C2 (da)
SI (1) SI2023958T2 (da)
TW (1) TW200803916A (da)
WO (1) WO2007133140A1 (da)
ZA (1) ZA200810617B (da)

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AU2007250588A1 (en) 2007-11-22
PL2023958T5 (pl) 2020-11-16
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EP2023958B2 (en) 2020-07-22
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AU2007250588B2 (en) 2013-01-31
KR20090033330A (ko) 2009-04-02
CA2652499A1 (en) 2007-11-22
SI2023958T2 (sl) 2020-12-31
PT2023958T (pt) 2018-01-11
EP2023958A1 (en) 2009-02-18
JP2009537513A (ja) 2009-10-29
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