AU2020363748B2 - Compressed nicotine lozenge - Google Patents

Compressed nicotine lozenge Download PDF

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Publication number
AU2020363748B2
AU2020363748B2 AU2020363748A AU2020363748A AU2020363748B2 AU 2020363748 B2 AU2020363748 B2 AU 2020363748B2 AU 2020363748 A AU2020363748 A AU 2020363748A AU 2020363748 A AU2020363748 A AU 2020363748A AU 2020363748 B2 AU2020363748 B2 AU 2020363748B2
Authority
AU
Australia
Prior art keywords
module
nicotine
weight
lozenge
water
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2020363748A
Other languages
English (en)
Other versions
AU2020363748A1 (en
Inventor
Dorthe Schackinger Boesen
Heidi Ziegler Bruun
Bruno Provstgaard Nielsen
Kent Albin Nielsen
Rikke PRANGER-RASMUSSEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fertin Pharma AS
Original Assignee
Fertin Pharma AS
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
Application filed by Fertin Pharma AS filed Critical Fertin Pharma AS
Publication of AU2020363748A1 publication Critical patent/AU2020363748A1/en
Priority to AU2024201729A priority Critical patent/AU2024201729B2/en
Application granted granted Critical
Publication of AU2020363748B2 publication Critical patent/AU2020363748B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2020363748A 2019-10-11 2020-04-17 Compressed nicotine lozenge Active AU2020363748B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024201729A AU2024201729B2 (en) 2019-10-11 2024-03-15 Compressed nicotine lozenge

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16/599,629 US11759419B2 (en) 2019-10-11 2019-10-11 Compressed nicotine lozenge
US16/599,629 2019-10-11
PCT/DK2020/050103 WO2021069036A1 (en) 2019-10-11 2020-04-17 Compressed nicotine lozenge

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024201729A Division AU2024201729B2 (en) 2019-10-11 2024-03-15 Compressed nicotine lozenge

Publications (2)

Publication Number Publication Date
AU2020363748A1 AU2020363748A1 (en) 2022-04-28
AU2020363748B2 true AU2020363748B2 (en) 2024-04-11

Family

ID=70464804

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2020363748A Active AU2020363748B2 (en) 2019-10-11 2020-04-17 Compressed nicotine lozenge
AU2024201729A Active AU2024201729B2 (en) 2019-10-11 2024-03-15 Compressed nicotine lozenge

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024201729A Active AU2024201729B2 (en) 2019-10-11 2024-03-15 Compressed nicotine lozenge

Country Status (17)

Country Link
US (2) US11759419B2 (https=)
EP (2) EP4445897A3 (https=)
JP (1) JP7574286B2 (https=)
KR (1) KR20220080165A (https=)
CN (1) CN114630653B (https=)
AU (2) AU2020363748B2 (https=)
BR (1) BR112022006691A2 (https=)
CA (1) CA3154225A1 (https=)
DK (1) DK3923910T3 (https=)
ES (1) ES2991040T3 (https=)
FI (1) FI3923910T3 (https=)
MX (1) MX2022004349A (https=)
MY (1) MY206865A (https=)
PL (1) PL3923910T3 (https=)
UA (1) UA129748C2 (https=)
WO (1) WO2021069036A1 (https=)
ZA (1) ZA202204081B (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220354785A1 (en) * 2021-04-22 2022-11-10 Nicoventures Trading Limited Oral lozenge products
US12295412B2 (en) 2022-01-28 2025-05-13 Altria Client Services Llc Oral pouch product
JP2026509969A (ja) * 2023-01-27 2026-03-26 フィリップ・モーリス・プロダクツ・ソシエテ・アノニム 活性成分の経口送達のためのシステム
WO2024156323A1 (en) * 2023-01-27 2024-08-02 Fertin Pharma A/S An adhesive oral disc for sustained release of cannabinoids
WO2025011727A1 (en) * 2023-07-07 2025-01-16 Fertin Pharma A/S Dissolvable orally adhering nicotine tablet
KR20250033557A (ko) * 2023-08-31 2025-03-10 주식회사 케이티앤지 니코틴 파우치 충진제 및 이의 제조방법
KR20250033558A (ko) * 2023-08-31 2025-03-10 주식회사 케이티앤지 니코틴 파우치 충진제 및 이의 제조방법
KR20250033563A (ko) * 2023-08-31 2025-03-10 주식회사 케이티앤지 니코틴 파우치 충진제 및 이의 제조방법
EP4543417A1 (en) * 2023-09-12 2025-04-30 Fertin Pharma A/S Orally disintegrating nicotine tablet for use under lip
CN121445113A (zh) * 2024-08-02 2026-02-03 深圳市吉迩科技有限公司 一种尼古丁组合物及其制备方法、尼古丁制品
WO2026057139A1 (en) * 2024-09-12 2026-03-19 Fertin Pharma A/S Fast dissolvable solid oral dosage form

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010044736A1 (en) * 2008-10-14 2010-04-22 Mcneil Ab Multi portion intra-oral dosage form and use thereof
US20180140591A1 (en) * 2016-11-18 2018-05-24 Fertin Pharma A/S Oral delivery vehicle containing nicotine
US20180333354A1 (en) * 2017-05-22 2018-11-22 Johnson & Johnson Consumer Inc. Lozenge Dosage Form

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CL2009001025A1 (es) 2008-05-01 2010-09-24 Smithkline Beecham Corp Composicion de pastilla para chupar que comprende: a) un granulo patron con al menos: un agente tampon alcalino, un modificador de la disolucion y una carga, b) un principio activo de nicotina definido extragranular y al menos un agente tampon alcalino; procedimiento de preparacion; util para eliminar o reducir el uso de tabaco.
CA2758618C (en) 2009-04-24 2017-03-28 Omya Development Ag Particulate material for controlled release of active ingredients
UA112974C2 (uk) 2010-09-16 2016-11-25 Джеі. Бі. Кемікалс Енд Фармасьютікалс Лімітид Нікотиновмісна композиція (варіанти)
US20130078307A1 (en) 2011-09-22 2013-03-28 Niconovum Usa, Inc. Nicotine-containing pharmaceutical composition
US9351936B2 (en) 2013-10-03 2016-05-31 Altria Client Services Llc Nicotine lozenge
US20170172995A1 (en) * 2015-09-08 2017-06-22 Venkateswara Rao Repaka Pharmaceutical compositions of Nicotine and process for preparation thereof
CA2916077C (en) 2015-12-22 2023-06-20 Euro-Pharm International Canada Inc. Nicotine-containing solid oral formulations and uses thereof
RU2736072C1 (ru) 2016-11-18 2020-11-11 Фертин Фарма А/С Таблетка, содержащая отдельное связывающее вещество и эритрит

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010044736A1 (en) * 2008-10-14 2010-04-22 Mcneil Ab Multi portion intra-oral dosage form and use thereof
US20180140591A1 (en) * 2016-11-18 2018-05-24 Fertin Pharma A/S Oral delivery vehicle containing nicotine
US20180333354A1 (en) * 2017-05-22 2018-11-22 Johnson & Johnson Consumer Inc. Lozenge Dosage Form

Also Published As

Publication number Publication date
EP4445897A2 (en) 2024-10-16
MX2022004349A (es) 2022-06-08
PL3923910T3 (pl) 2024-11-18
US12478579B2 (en) 2025-11-25
ES2991040T3 (es) 2024-12-02
EP3923910A1 (en) 2021-12-22
FI3923910T3 (fi) 2024-10-24
DK3923910T3 (da) 2024-11-11
ZA202204081B (en) 2024-08-28
EP3923910B1 (en) 2024-09-11
UA129748C2 (uk) 2025-07-23
JP2022551314A (ja) 2022-12-08
BR112022006691A2 (pt) 2022-07-12
CN114630653B (zh) 2026-01-30
AU2024201729B2 (en) 2025-10-09
AU2020363748A1 (en) 2022-04-28
CA3154225A1 (en) 2021-04-15
EP4445897A3 (en) 2025-01-15
MY206865A (en) 2025-01-10
US20240000706A1 (en) 2024-01-04
KR20220080165A (ko) 2022-06-14
US11759419B2 (en) 2023-09-19
CN114630653A (zh) 2022-06-14
AU2024201729A1 (en) 2024-04-04
US20210106521A1 (en) 2021-04-15
JP7574286B2 (ja) 2024-10-28
WO2021069036A1 (en) 2021-04-15

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FGA Letters patent sealed or granted (standard patent)