AU2019209214B2 - Ophthalmic compositions comprising bilastine, a beta-cyclodextrin and at least one gelling agent - Google Patents

Ophthalmic compositions comprising bilastine, a beta-cyclodextrin and at least one gelling agent Download PDF

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Publication number
AU2019209214B2
AU2019209214B2 AU2019209214A AU2019209214A AU2019209214B2 AU 2019209214 B2 AU2019209214 B2 AU 2019209214B2 AU 2019209214 A AU2019209214 A AU 2019209214A AU 2019209214 A AU2019209214 A AU 2019209214A AU 2019209214 B2 AU2019209214 B2 AU 2019209214B2
Authority
AU
Australia
Prior art keywords
cyclodextrin
bilastine
pharmaceutical composition
ophthalmic pharmaceutical
pharmaceutically acceptable
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
AU2019209214A
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English (en)
Other versions
AU2019209214A1 (en
Inventor
Victoria DÍAZ TOMÉ
Anxo FERNÁNDEZ FERREIRO
Nieves FERNÁNDEZ HERNANDO
Ana GONZALO GOROSTIZA
Tania GONZÁLEZ GARCÍA
Gonzalo HERNÁNDEZ HERRERO
Pablo MORÁN POLADURA
Francisco Javier Otero Espinar
Paloma Tato Cerdeiras
Arturo ZAZPE ARCE
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.)
Faes Farma SA
Original Assignee
Faes Farma SA
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 Faes Farma SA filed Critical Faes Farma SA
Publication of AU2019209214A1 publication Critical patent/AU2019209214A1/en
Application granted granted Critical
Publication of AU2019209214B2 publication Critical patent/AU2019209214B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2019209214A 2018-01-18 2019-01-09 Ophthalmic compositions comprising bilastine, a beta-cyclodextrin and at least one gelling agent Active AU2019209214B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18382021 2018-01-18
EP18382021.6 2018-01-18
PCT/EP2019/050433 WO2019141563A1 (en) 2018-01-18 2019-01-09 Ophthalmic compositions comprising bilastine, a beta-cyclodextrin and at least one gelling agent

Publications (2)

Publication Number Publication Date
AU2019209214A1 AU2019209214A1 (en) 2020-08-13
AU2019209214B2 true AU2019209214B2 (en) 2023-11-23

Family

ID=61017875

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019209214A Active AU2019209214B2 (en) 2018-01-18 2019-01-09 Ophthalmic compositions comprising bilastine, a beta-cyclodextrin and at least one gelling agent

Country Status (28)

Country Link
US (2) US20210128544A1 (cg-RX-API-DMAC7.html)
EP (2) EP3740191B1 (cg-RX-API-DMAC7.html)
JP (1) JP7309729B2 (cg-RX-API-DMAC7.html)
KR (1) KR102695627B1 (cg-RX-API-DMAC7.html)
CN (1) CN111727035B (cg-RX-API-DMAC7.html)
AR (1) AR114216A1 (cg-RX-API-DMAC7.html)
AU (1) AU2019209214B2 (cg-RX-API-DMAC7.html)
CA (1) CA3088740A1 (cg-RX-API-DMAC7.html)
CL (1) CL2020001895A1 (cg-RX-API-DMAC7.html)
CO (1) CO2020009992A2 (cg-RX-API-DMAC7.html)
CY (1) CY1124270T1 (cg-RX-API-DMAC7.html)
DK (1) DK3740191T3 (cg-RX-API-DMAC7.html)
EA (1) EA202091725A1 (cg-RX-API-DMAC7.html)
ES (1) ES2878107T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20211037T1 (cg-RX-API-DMAC7.html)
HU (1) HUE054594T2 (cg-RX-API-DMAC7.html)
LT (1) LT3740191T (cg-RX-API-DMAC7.html)
MA (1) MA51612B1 (cg-RX-API-DMAC7.html)
MX (1) MX2020007692A (cg-RX-API-DMAC7.html)
PL (1) PL3740191T3 (cg-RX-API-DMAC7.html)
PT (1) PT3740191T (cg-RX-API-DMAC7.html)
PY (1) PY1903392A (cg-RX-API-DMAC7.html)
SA (1) SA520412443B1 (cg-RX-API-DMAC7.html)
SI (1) SI3740191T1 (cg-RX-API-DMAC7.html)
TW (1) TWI833727B (cg-RX-API-DMAC7.html)
UY (1) UY38055A (cg-RX-API-DMAC7.html)
WO (1) WO2019141563A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA202005077B (cg-RX-API-DMAC7.html)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2025508704A (ja) * 2022-02-17 2025-04-10 ファエス・ファルマ・ソシエダッド・アノニマ １日１回非経口投与のためのビラスチン組成物
CN116211795B (zh) * 2022-12-26 2025-09-26 深圳市贝美药业有限公司 一种比拉斯汀口服液体制剂及其制备方法
CN115970066B (zh) * 2022-12-29 2024-09-27 成都爱睿康乐医疗器械有限公司 基于主客体相互作用的载药纳米凝胶生物润滑剂及其制备方法和应用
WO2024224326A1 (en) * 2023-04-27 2024-10-31 Leiutis Pharmaceuticals Llp Liquid parenteral formulations of bilastine
WO2024224308A1 (en) * 2023-04-27 2024-10-31 Leiutis Pharmaceuticals Llp Liquid parenteral formulations of bilastine free of cyclodextrins
WO2024256956A1 (en) * 2023-06-13 2024-12-19 Leiutis Pharmaceuticals Llp Stable formulations of bilastine for nasal and ophthalmic use

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070265247A1 (en) * 2005-08-19 2007-11-15 Yerxa Benjamin R Method of reducing contact lens intolerance with non-drying antihistamines
CN103784462A (zh) * 2014-02-25 2014-05-14 宋俊智 包含比拉斯汀及甾族化合物的药物制剂

Family Cites Families (17)

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IT1229075B (it) * 1985-04-05 1991-07-17 Fidia Farmaceutici Medicamenti per uso topico, ottenuti tramite l'impiego dell'acido ialuronico
ES2048109B1 (es) 1992-07-20 1994-12-16 Espanola Prod Quimicos Procedimiento de preparacion de nuevos derivados piperidicos del bencimidazol.
JP3527256B2 (ja) 1992-12-09 2004-05-17 ロート製薬株式会社 抗アレルギー点眼剤
TW401300B (en) * 1992-12-25 2000-08-11 Senju Pharma Co Antiallergic composition for ophthalmic or nasal use
ES2124167B1 (es) 1996-06-04 1999-09-16 Espanola Prod Quimicos Nuevos derivados del bencimidazol con actividad antihistaminica.
DE10161149B4 (de) * 2001-12-12 2007-03-08 Ursapharm Arzneimittel Gmbh & Co. Kg Verwendung von Heparin-haltigem Ophthalmikum
CA2484460C (en) 2002-04-19 2009-09-29 Faes Farma, S.A. Polymorph of 4-[2-[4-[1-(2-ethoxyethyl)-1h-benzimidazole-2-yl]-1-piperidinyl]ethyl]-.alpha..alpha. dimethyl-benzeneacetic acid
US20050239745A1 (en) * 2004-03-03 2005-10-27 Ophthalmic Research Associates, Inc. Novel topical ophthalmic formulations
WO2007047253A2 (en) 2005-10-11 2007-04-26 Eastman Chemical Company Pharmaceutical formulations of cyclodextrins and antifungal azole compounds
UA94938C2 (ru) * 2006-03-31 2011-06-25 ВИСТЕКОН ФАРМАСЬЮТИКАЛС, ЭлЭлСи Офтальмическая композиция для лечения клинических симптомов глазной аллергии, которая содержит алкафтадин или его производное (варианты)
SG170044A1 (en) * 2006-03-31 2011-04-29 Vistakon Pharmaceuticals Llc Ocular allergy treatments
JP2010531898A (ja) 2007-06-28 2010-09-30 サイデックス・ファーマシューティカルズ・インコーポレイテッド 鼻および眼へのコルチコステロイド水溶液送達
JP2012520880A (ja) * 2009-03-17 2012-09-10 アーシエックス セラピューティックス， インコーポレイテッド ケトチフェンの眼科用製剤および使用方法
TWI544922B (zh) 2011-05-19 2016-08-11 愛爾康研究有限公司 高濃度歐羅派特錠（ｏｌｏｐａｔａｄｉｎｅ）眼用組成物
CN103110575B (zh) * 2013-03-07 2014-11-05 宁夏康亚药业有限公司 一种美洛昔康滴眼液及其制备方法和应用
WO2014150899A1 (en) * 2013-03-15 2014-09-25 Chapin Matthew J Topical ophthalmic formulations for treating migraine
EP3040334A1 (en) 2014-12-29 2016-07-06 Faes Farma, S.A. New benzimidazole derivatives as antihistamine agents

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070265247A1 (en) * 2005-08-19 2007-11-15 Yerxa Benjamin R Method of reducing contact lens intolerance with non-drying antihistamines
CN103784462A (zh) * 2014-02-25 2014-05-14 宋俊智 包含比拉斯汀及甾族化合物的药物制剂

Also Published As

Publication number Publication date
ZA202005077B (en) 2024-12-18
CA3088740A1 (en) 2019-07-25
EP3740191B1 (en) 2021-04-28
HRP20211037T1 (hr) 2021-10-01
KR102695627B1 (ko) 2024-08-16
AU2019209214A1 (en) 2020-08-13
DK3740191T3 (da) 2021-06-07
PL3740191T3 (pl) 2021-11-29
CN111727035B (zh) 2024-05-28
BR112020014265A2 (pt) 2020-12-08
CY1124270T1 (el) 2022-07-22
MA51612A (fr) 2020-11-25
UY38055A (es) 2019-08-30
KR20200111727A (ko) 2020-09-29
PT3740191T (pt) 2021-07-09
MA51612B1 (fr) 2021-06-30
ES2878107T3 (es) 2021-11-18
MX2020007692A (es) 2020-09-14
CO2020009992A2 (es) 2021-01-18
HUE054594T2 (hu) 2021-09-28
WO2019141563A1 (en) 2019-07-25
PY1903392A (es) 2019-08-01
JP7309729B2 (ja) 2023-07-18
TWI833727B (zh) 2024-03-01
LT3740191T (lt) 2021-08-10
JP2021511317A (ja) 2021-05-06
SI3740191T1 (sl) 2021-09-30
AR114216A1 (es) 2020-08-05
SA520412443B1 (ar) 2022-09-01
EP3740191A1 (en) 2020-11-25
EA202091725A1 (ru) 2020-10-12
TW201932110A (zh) 2019-08-16
US20260027099A1 (en) 2026-01-29
CL2020001895A1 (es) 2020-12-04
EP3915539A1 (en) 2021-12-01
CN111727035A (zh) 2020-09-29
US20210128544A1 (en) 2021-05-06

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