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
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Otolanum AG
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Otolanum AG
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Publication of AU2018216970A1 publication Critical patent/AU2018216970A1/en
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    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/0043Nose
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals

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

Country Status (33)

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

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
CA3179806A1 (en) * 2020-04-14 2021-10-21 Glaxosmithkline Consumer Healthcare Holdings (Us) Llc Nasal spray formulation with moisturizing benefits
JP2023523410A (ja) * 2020-04-22 2023-06-05 サノタイズ リサーチ アンド ディベロップメント コープ. 上気道感染症を治療するための組成物および方法
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)

* Cited by examiner, † Cited by third party
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

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2397840B1 (https=) 1977-07-22 1981-03-20 Cherqui Jean
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
US7090830B2 (en) 2001-05-24 2006-08-15 Alexza Pharmaceuticals, Inc. Drug condensation aerosols and kits
JP2005503425A (ja) 2001-05-24 2005-02-03 アレックザ モレキュラー デリヴァリー コーポレイション 所定の吸入ルートによる薬剤エステルの送出
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
ATE319426T1 (de) 2003-11-11 2006-03-15 Mattern Udo Nasenformulierung mit kontrollierter freisetzung von sexualhormonen
US7728015B2 (en) * 2004-04-22 2010-06-01 Mor Research Applications Ltd. Compositions for weight management
AU2006202950A1 (en) * 2004-04-22 2006-10-19 Mor Research Applications Ltd. Methods and Compositions for Weight Management
JP2007533733A (ja) 2004-04-22 2007-11-22 モル リサーチ アプリケーションズ リミテッド 食物摂取管理の方法
US20060046962A1 (en) 2004-08-25 2006-03-02 Aegis Therapeutics Llc Absorption enhancers for drug administration
WO2006025882A2 (en) 2004-08-25 2006-03-09 The Uab Research Foundation Absorption enhancers for drug administration
WO2007022345A2 (en) * 2005-08-17 2007-02-22 Fleming And Company, Pharmaceuticals Vitamin b12 nasal spray and method of use
US8242148B2 (en) * 2005-12-23 2012-08-14 Nelson Erik B Treatment methods employing histamine H3 receptor antagonists, including betahistine
WO2007076140A2 (en) * 2005-12-23 2007-07-05 University Of Cincinnati Treatment methods employing histamine h3 receptor antagonists, including betahistine
US20080066739A1 (en) 2006-09-20 2008-03-20 Lemahieu Edward Methods and systems of delivering medication via inhalation
BRPI0821647A2 (pt) * 2007-12-21 2015-06-16 Schering Plough Healthcare Realce da fotosestabillização de oximetazolina
EP2278999B1 (en) * 2008-04-21 2025-01-29 Dompé farmaceutici S.p.A. Auris formulations for treating otic diseases and conditions
ES2589915T3 (es) * 2008-10-08 2016-11-17 Xgene Pharmaceutical Inc Conjugados de GABA y métodos de utilización de los mismos
US10471040B2 (en) * 2014-10-03 2019-11-12 Lachesis Biosciences Limited Intranasal compositions for treatment of neurological and neurodegenerative diseases and disorders

Patent Citations (2)

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

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