AU2018216970B2 - Intranasal composition comprising betahistine - Google Patents

Intranasal composition comprising betahistine Download PDF

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Publication number
AU2018216970B2
AU2018216970B2 AU2018216970A AU2018216970A AU2018216970B2 AU 2018216970 B2 AU2018216970 B2 AU 2018216970B2 AU 2018216970 A AU2018216970 A AU 2018216970A AU 2018216970 A AU2018216970 A AU 2018216970A AU 2018216970 B2 AU2018216970 B2 AU 2018216970B2
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AU
Australia
Prior art keywords
betahistine
dose
pharmaceutical composition
cps
intranasal
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.)
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Application number
AU2018216970A
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English (en)
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AU2018216970A1 (en
Inventor
Thomas Meyer
Christopher John Wraight
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.)
Otolanum AG
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Otolanum AG
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Publication date
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Publication of AU2018216970A1 publication Critical patent/AU2018216970A1/en
Application granted granted Critical
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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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • 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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2018216970A 2017-02-02 2018-02-02 Intranasal composition comprising betahistine Active AU2018216970B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762453931P 2017-02-02 2017-02-02
US62/453,931 2017-02-02
PCT/EP2018/052695 WO2018141922A1 (en) 2017-02-02 2018-02-02 Intranasal composition comprising betahistine

Publications (2)

Publication Number Publication Date
AU2018216970A1 AU2018216970A1 (en) 2019-08-22
AU2018216970B2 true AU2018216970B2 (en) 2023-12-21

Family

ID=61187302

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018216970A Active AU2018216970B2 (en) 2017-02-02 2018-02-02 Intranasal composition comprising betahistine

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US (2) US10456386B2 (enExample)
EP (2) EP3474850B1 (enExample)
JP (3) JP7714323B2 (enExample)
KR (1) KR102653545B1 (enExample)
CN (2) CN118356397A (enExample)
AR (1) AR111699A1 (enExample)
AU (1) AU2018216970B2 (enExample)
CA (1) CA3051725A1 (enExample)
CL (1) CL2019002145A1 (enExample)
CO (1) CO2019008657A2 (enExample)
DK (2) DK3698791T3 (enExample)
EA (1) EA201991817A1 (enExample)
ES (2) ES2969301T3 (enExample)
FI (1) FI3698791T3 (enExample)
HR (2) HRP20201137T1 (enExample)
HU (2) HUE065336T2 (enExample)
IL (1) IL268353B2 (enExample)
LT (2) LT3698791T (enExample)
MA (1) MA46778B1 (enExample)
MX (1) MX381932B (enExample)
MY (1) MY196333A (enExample)
NZ (1) NZ755931A (enExample)
PH (1) PH12019501785B1 (enExample)
PL (2) PL3474850T3 (enExample)
PT (2) PT3474850T (enExample)
RS (2) RS60554B1 (enExample)
SA (1) SA519402324B1 (enExample)
SG (1) SG11201906980YA (enExample)
SI (2) SI3474850T1 (enExample)
TN (1) TN2019000220A1 (enExample)
TW (1) TWI760429B (enExample)
WO (1) WO2018141922A1 (enExample)
ZA (1) ZA201904955B (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018170532A1 (en) * 2017-03-22 2018-09-27 Franz, Lilian Ann Treatment method
EP4135658A1 (en) * 2020-04-14 2023-02-22 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Nasal spray formulation with moisturizing benefits
CN116209454A (zh) * 2020-04-22 2023-06-02 萨诺蒂泽研究开发公司 治疗上呼吸道感染的组合物和方法
WO2026062705A1 (en) 2024-09-23 2026-03-26 Troikaa Pharmaceuticals Limited Oromucosal liquid compositions of betahistine or its pharmaceutically acceptable salt(s) and processes for preparation thereof

Citations (2)

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Publication number Priority date Publication date Assignee Title
EP0397025A1 (en) * 1989-05-08 1990-11-14 PRODOTTI FORMENTI S.r.l. [2-(2-pyridyl)ethyl]-methylamine salts
WO2009143572A1 (en) * 2008-05-27 2009-12-03 The University Of Melbourne Methods of treating mammals with eustachian tube dysfunctions

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JPH03287535A (ja) * 1990-03-31 1991-12-18 Bairon Boeki Kk プラノプロフェン水溶液
JP3203056B2 (ja) * 1992-08-13 2001-08-27 株式会社ティ・ティ・エス技術研究所 メシル酸ベタヒスチンの経皮吸収製剤用組成物および経皮吸収製剤
US5897858A (en) * 1994-02-03 1999-04-27 Schering-Plough Healthcare Products, Inc. Nasal spray compositions exhibiting increased retention in the nasal cavity
JPH10139667A (ja) * 1996-11-15 1998-05-26 Yoshitomi Pharmaceut Ind Ltd 水性液剤
CA2446904A1 (en) 2001-05-24 2003-04-03 Alexza Pharmaceuticals, Inc. Delivery of drug esters through an inhalation route
US7090830B2 (en) 2001-05-24 2006-08-15 Alexza Pharmaceuticals, Inc. Drug condensation aerosols and kits
JP3555598B2 (ja) 2001-06-27 2004-08-18 株式会社村田製作所 積層型インダクタ
JP2004196676A (ja) * 2002-12-16 2004-07-15 Rohto Pharmaceut Co Ltd 点鼻剤
JP4733333B2 (ja) * 2002-12-26 2011-07-27 ライオン株式会社 点鼻剤又は洗鼻剤
ES2258694T3 (es) 2003-11-11 2006-09-01 Mattern, Udo Sistema de administracion de liberacion controlada de hormonas sexuales para aplicaciones nasales.
US7728015B2 (en) * 2004-04-22 2010-06-01 Mor Research Applications Ltd. Compositions for weight management
CA2553309A1 (en) * 2004-04-22 2005-11-03 Mor Research Applications Ltd. Method of food intake management
AU2006202950A1 (en) * 2004-04-22 2006-10-19 Mor Research Applications Ltd. Methods and Compositions for Weight Management
US20060046962A1 (en) 2004-08-25 2006-03-02 Aegis Therapeutics Llc Absorption enhancers for drug administration
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WO2007022345A2 (en) * 2005-08-17 2007-02-22 Fleming And Company, Pharmaceuticals Vitamin b12 nasal spray and method of use
WO2007076140A2 (en) 2005-12-23 2007-07-05 University Of Cincinnati Treatment methods employing histamine h3 receptor antagonists, including betahistine
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Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
EP0397025A1 (en) * 1989-05-08 1990-11-14 PRODOTTI FORMENTI S.r.l. [2-(2-pyridyl)ethyl]-methylamine salts
WO2009143572A1 (en) * 2008-05-27 2009-12-03 The University Of Melbourne Methods of treating mammals with eustachian tube dysfunctions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Pilicheva, B. et al., "Investigation of betahistine dihydrochloride biocompatibility and nasal permeability in vitro", JOURNAL OF APPLIED BIOMEDICINE, 2016, vol. 14, no. 4, pages 299-305, DOI: 10.1016/j.jab.2016.06.001 *

Also Published As

Publication number Publication date
SI3474850T1 (sl) 2020-09-30
EP3474850A1 (en) 2019-05-01
DK3474850T3 (da) 2020-08-03
PH12019501785A1 (en) 2020-07-06
JP2022051872A (ja) 2022-04-01
KR20190116341A (ko) 2019-10-14
HRP20201137T1 (hr) 2021-01-22
CN118356397A (zh) 2024-07-19
PL3474850T3 (pl) 2020-09-21
CN110418643A (zh) 2019-11-05
US20180214432A1 (en) 2018-08-02
WO2018141922A1 (en) 2018-08-09
US10456386B2 (en) 2019-10-29
PH12019501785B1 (en) 2024-02-28
MX381932B (es) 2025-03-13
EP3698791B1 (en) 2023-10-25
RS65099B1 (sr) 2024-02-29
SG11201906980YA (en) 2019-08-27
JP2024019731A (ja) 2024-02-09
DK3698791T3 (da) 2024-01-15
MX2019008961A (es) 2019-10-15
TN2019000220A1 (en) 2021-01-07
MY196333A (en) 2023-03-24
HUE050829T2 (hu) 2021-01-28
EP3474850B1 (en) 2020-04-22
US20200022963A1 (en) 2020-01-23
PL3698791T3 (pl) 2024-04-08
TW201831179A (zh) 2018-09-01
ZA201904955B (en) 2021-05-26
JP2020506930A (ja) 2020-03-05
AU2018216970A1 (en) 2019-08-22
ES2969301T3 (es) 2024-05-17
NZ755931A (en) 2022-07-29
LT3698791T (lt) 2024-02-12
SA519402324B1 (ar) 2023-03-16
MA46778A1 (fr) 2021-04-30
FI3698791T3 (fi) 2024-01-11
SI3698791T1 (sl) 2024-05-31
PT3698791T (pt) 2024-01-12
CA3051725A1 (en) 2018-08-09
CO2019008657A2 (es) 2020-01-17
EP3698791A1 (en) 2020-08-26
PT3474850T (pt) 2020-07-27
CL2019002145A1 (es) 2019-11-04
KR102653545B1 (ko) 2024-04-04
HUE065336T2 (hu) 2024-05-28
MA46778B1 (fr) 2022-08-31
RS60554B1 (sr) 2020-08-31
AR111699A1 (es) 2019-08-14
BR112019015687A2 (pt) 2020-04-28
IL268353B2 (en) 2023-10-01
IL268353A (en) 2019-09-26
HRP20231706T1 (hr) 2024-03-15
EA201991817A1 (ru) 2020-01-27
ES2807798T3 (es) 2021-02-24
JP7714323B2 (ja) 2025-07-29
LT3474850T (lt) 2020-08-10
TWI760429B (zh) 2022-04-11
IL268353B1 (en) 2023-06-01

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