AU2018378648B2 - Nicotine tablet - Google Patents

Nicotine tablet Download PDF

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Publication number
AU2018378648B2
AU2018378648B2 AU2018378648A AU2018378648A AU2018378648B2 AU 2018378648 B2 AU2018378648 B2 AU 2018378648B2 AU 2018378648 A AU2018378648 A AU 2018378648A AU 2018378648 A AU2018378648 A AU 2018378648A AU 2018378648 B2 AU2018378648 B2 AU 2018378648B2
Authority
AU
Australia
Prior art keywords
nicotine
tablet
seconds
oral administration
fdt
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
AU2018378648A
Other languages
English (en)
Other versions
AU2018378648A1 (en
Inventor
Bruno Provstgaard Nielsen
Kent Albin Nielsen
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64744343&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018378648(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fertin Pharma AS filed Critical Fertin Pharma AS
Publication of AU2018378648A1 publication Critical patent/AU2018378648A1/en
Application granted granted Critical
Publication of AU2018378648B2 publication Critical patent/AU2018378648B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K31/465—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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Addiction (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Neurology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2018378648A 2017-12-08 2018-12-07 Nicotine tablet Active AU2018378648B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA201770925 2017-12-08
DKPA201770925 2017-12-08
PCT/DK2018/050335 WO2019110072A1 (en) 2017-12-08 2018-12-07 Nicotine tablet

Publications (2)

Publication Number Publication Date
AU2018378648A1 AU2018378648A1 (en) 2020-07-23
AU2018378648B2 true AU2018378648B2 (en) 2021-06-03

Family

ID=64744343

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018378648A Active AU2018378648B2 (en) 2017-12-08 2018-12-07 Nicotine tablet

Country Status (10)

Country Link
US (3) US11738016B2 (enExample)
EP (2) EP3720418B1 (enExample)
JP (1) JP7278281B2 (enExample)
CN (1) CN111447921B (enExample)
AU (1) AU2018378648B2 (enExample)
CA (1) CA3085062C (enExample)
DK (1) DK3720418T3 (enExample)
ES (1) ES2890975T3 (enExample)
PL (1) PL3720418T3 (enExample)
WO (1) WO2019110072A1 (enExample)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2018378648B2 (en) 2017-12-08 2021-06-03 Fertin Pharma A/S Nicotine tablet
EP3720497A1 (en) 2017-12-08 2020-10-14 Fertin Pharma A/S High nicotine concentration
US12310959B2 (en) 2019-12-09 2025-05-27 Nicoventures Trading Limited Oral compositions with reduced water content
US11793230B2 (en) 2019-12-09 2023-10-24 Nicoventures Trading Limited Oral products with improved binding of active ingredients
US12433321B2 (en) 2019-12-09 2025-10-07 Nicoventures Trading Limited Oral composition with beet material
US11826462B2 (en) 2019-12-09 2023-11-28 Nicoventures Trading Limited Oral product with sustained flavor release
US11872231B2 (en) 2019-12-09 2024-01-16 Nicoventures Trading Limited Moist oral product comprising an active ingredient
US12439952B2 (en) 2019-12-09 2025-10-14 Nicoventures Trading Limited Moist oral compositions
US11969502B2 (en) 2019-12-09 2024-04-30 Nicoventures Trading Limited Oral products
US11617744B2 (en) 2019-12-09 2023-04-04 Nico Ventures Trading Limited Moist oral compositions
US12439949B2 (en) 2019-12-09 2025-10-14 Nicoventures Trading Limited Oral compositions with reduced water activity
CA3181912A1 (en) 2020-06-08 2021-12-16 Anthony Richard Gerardi Effervescent oral composition comprising an active ingredient
US11382861B1 (en) * 2020-12-17 2022-07-12 Nirajkumar Karneshbhai Patel Nicotine pouch
CA3223902A1 (en) 2021-06-25 2022-12-29 Richard Svensson Oral products and method of manufacture
JP2024530905A (ja) 2021-07-30 2024-08-27 ニコベンチャーズ トレーディング リミテッド 微結晶性セルロースを含むエアロゾル生成基材
CN113827575A (zh) * 2021-11-02 2021-12-24 上海普康药业有限公司 一种利伐沙班片剂及其制备方法
CN115969898A (zh) * 2023-02-09 2023-04-18 东莞市吉纯生物技术有限公司 一种防治口腔溃疡的口含烟含片及其制备方法
US20250082579A1 (en) 2023-09-12 2025-03-13 Fertin Pharma A/S Orally disintegrating nicotine tablet for use under lip
EP4543417A1 (en) 2023-09-12 2025-04-30 Fertin Pharma A/S Orally disintegrating nicotine tablet for use under lip

Citations (4)

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WO2008140371A1 (en) * 2007-05-16 2008-11-20 Mcneil Ab Oral nicotine formulation buffered with amino acid
WO2013091631A1 (en) * 2011-12-22 2013-06-27 Fertin Pharma A/S Method of releasing nicotine from chewing gum
US20130289079A1 (en) * 2008-05-01 2013-10-31 GlaxoSmithKline, LLC Nicotine Lozenge Composition

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GB9310412D0 (en) * 1993-05-20 1993-07-07 Danbiosyst Uk Nasal nicotine system
US5549906A (en) 1993-07-26 1996-08-27 Pharmacia Ab Nicotine lozenge and therapeutic method for smoking cessation
US5810018A (en) * 1994-12-29 1998-09-22 Monte; Woodrow C. Method, composition and apparatus for reducing the incidence of cigarette smoking
WO2000024380A1 (en) 1998-10-27 2000-05-04 Fuisz Technologies Ltd. Microparticles containing peg and/or peg glyceryl esters
US20010016593A1 (en) 1999-04-14 2001-08-23 Wilhelmsen Paul C. Element giving rapid release of nicotine for transmucosal administration
US6583160B2 (en) 1999-04-14 2003-06-24 Steve Smith Nicotine therapy method and oral carrier for assuaging tobacco-addiction
US6248760B1 (en) 1999-04-14 2001-06-19 Paul C Wilhelmsen Tablet giving rapid release of nicotine for transmucosal administration
US6544552B2 (en) 2001-01-11 2003-04-08 Particle And Coating Technologies, Inc. Method of producing porous tablets with improved dissolution properties
NZ530439A (en) 2001-04-20 2004-11-26 Lavipharm Lab Inc Intraoral delivery of nicotine for smoking cessation
US20060057207A1 (en) 2001-11-30 2006-03-16 Pfizer Inc Fast-disintegrating dosage forms of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene
SE0104388D0 (sv) 2001-12-27 2001-12-27 Pharmacia Ab New formulation and use and manufacture thereof
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TW200514579A (en) 2003-07-24 2005-05-01 Smithkline Beecham Corp Orally dissolving films
US7387788B1 (en) * 2003-10-10 2008-06-17 Antares Pharma Ipl Ag Pharmaceutical compositions of nicotine and methods of use thereof
WO2005055945A2 (en) * 2003-12-08 2005-06-23 Gel-Del Technologies, Inc. Mucoadhesive drug delivery devices and methods of making and using thereof
US20070196474A1 (en) 2004-04-30 2007-08-23 Withiam Michael C Rapidly disintegrating low friability tablets comprising calcium carbonate
ES2403167T3 (es) 2005-12-21 2013-05-14 Basf Se Polivinilpirrolidona entrelazada finamente dividida como agente desintegrador de tabletas
US20070269492A1 (en) * 2006-05-16 2007-11-22 Per Steen New product and use and manufacture thereof
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US10092715B2 (en) 2006-09-27 2018-10-09 Niconovum Usa, Inc. Directional use
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WO2009007771A1 (en) 2007-07-06 2009-01-15 Gumlink A/S High volume compressed chewing gum tablet
SI2177213T1 (sl) 2008-09-17 2013-03-29 Siegfried Ltd. Nikotin vsebujoč granulat
EP2361081B1 (en) * 2008-10-14 2016-06-29 McNeil AB Multi portion intra-oral dosage form and use thereof
US20110274628A1 (en) 2010-05-07 2011-11-10 Borschke August J Nicotine-containing pharmaceutical compositions
JP6521564B2 (ja) 2010-12-22 2019-05-29 ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ 速崩性の固体被覆剤形
SE535587C2 (sv) 2011-03-29 2012-10-02 Chill Of Sweden Ab Produkt innehållande ett fritt nikotinsalt och en ej vattenlöslig påse
TW201318650A (zh) 2011-11-02 2013-05-16 Hua Yu Wuxi Pharmaceutical Co Ltd 口崩片組成物
US20130177646A1 (en) * 2012-01-05 2013-07-11 Mcneil Ab Solid Nicotine-Comprising Dosage Form with Reduced Organoleptic Disturbance
US11779045B2 (en) * 2013-10-03 2023-10-10 Altria Client Services Llc Dissolvable-chewable exhausted-tobacco tablet
CN106659696B (zh) 2014-07-08 2021-08-20 费尔廷制药公司 包含两个隔室的经口递送系统
US20170172995A1 (en) 2015-09-08 2017-06-22 Venkateswara Rao Repaka Pharmaceutical compositions of Nicotine and process for preparation thereof
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WO2019110073A1 (en) 2017-12-08 2019-06-13 Fertin Pharma A/S Solid oral nicotine formulation
EP3720499A1 (en) 2017-12-08 2020-10-14 Fertin Pharma A/S Nicotine mouth spray
EP3720497A1 (en) 2017-12-08 2020-10-14 Fertin Pharma A/S High nicotine concentration
AU2018378648B2 (en) 2017-12-08 2021-06-03 Fertin Pharma A/S Nicotine tablet
EP3720498A1 (en) 2017-12-08 2020-10-14 Fertin Pharma A/S High nicotine absorption

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1366759A1 (en) * 2001-03-06 2003-12-03 Kyowa Hakko Kogyo Co., Ltd. Tablets quickly disintegrating in oral cavity
WO2008140371A1 (en) * 2007-05-16 2008-11-20 Mcneil Ab Oral nicotine formulation buffered with amino acid
US20130289079A1 (en) * 2008-05-01 2013-10-31 GlaxoSmithKline, LLC Nicotine Lozenge Composition
WO2013091631A1 (en) * 2011-12-22 2013-06-27 Fertin Pharma A/S Method of releasing nicotine from chewing gum

Also Published As

Publication number Publication date
EP3720418B1 (en) 2021-08-04
WO2019110072A1 (en) 2019-06-13
US12433881B2 (en) 2025-10-07
US20240285610A1 (en) 2024-08-29
CA3085062A1 (en) 2019-06-13
JP2021505546A (ja) 2021-02-18
US11738016B2 (en) 2023-08-29
JP7278281B2 (ja) 2023-05-19
PL3720418T3 (pl) 2021-12-20
CA3085062C (en) 2022-08-16
ES2890975T3 (es) 2022-01-25
CN111447921B (zh) 2023-10-13
US20190175581A1 (en) 2019-06-13
EP3720418A1 (en) 2020-10-14
US20230346768A1 (en) 2023-11-02
EP3906916A1 (en) 2021-11-10
US12005058B2 (en) 2024-06-11
CN111447921A (zh) 2020-07-24
DK3720418T3 (da) 2021-10-11
AU2018378648A1 (en) 2020-07-23

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FGA Letters patent sealed or granted (standard patent)