CA2447924C - Olopatadine formulations for topical administration - Google Patents

Olopatadine formulations for topical administration Download PDF

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Publication number
CA2447924C
CA2447924C CA002447924A CA2447924A CA2447924C CA 2447924 C CA2447924 C CA 2447924C CA 002447924 A CA002447924 A CA 002447924A CA 2447924 A CA2447924 A CA 2447924A CA 2447924 C CA2447924 C CA 2447924C
Authority
CA
Canada
Prior art keywords
solution
olopatadine
polyvinylpyrrolidone
composition
physical stability
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.)
Expired - Lifetime
Application number
CA002447924A
Other languages
English (en)
French (fr)
Other versions
CA2447924A1 (en
Inventor
Ernesto J. Castillo
Wesley Wehsin Han
Huixiang Zhang
Haresh G. Bhagat
Onkar N. Singh
Joseph Paul Bullock
Suresh C. Dixit
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.)
Individual
Original Assignee
Alcon Pharmaceuticals Ltd
Novartis AG
Alcon Inc
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=23162841&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2447924(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alcon Pharmaceuticals Ltd, Novartis AG, Alcon Inc filed Critical Alcon Pharmaceuticals Ltd
Publication of CA2447924A1 publication Critical patent/CA2447924A1/en
Application granted granted Critical
Publication of CA2447924C publication Critical patent/CA2447924C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/14Decongestants or antiallergics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA002447924A 2001-06-27 2002-06-19 Olopatadine formulations for topical administration Expired - Lifetime CA2447924C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30131501P 2001-06-27 2001-06-27
US60/301,315 2001-06-27
PCT/US2002/019417 WO2003002093A1 (en) 2001-06-27 2002-06-19 Olopatadine formulations for topical administration

Publications (2)

Publication Number Publication Date
CA2447924A1 CA2447924A1 (en) 2003-01-09
CA2447924C true CA2447924C (en) 2009-11-03

Family

ID=23162841

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002447924A Expired - Lifetime CA2447924C (en) 2001-06-27 2002-06-19 Olopatadine formulations for topical administration

Country Status (20)

Country Link
US (2) US6995186B2 (https=)
EP (1) EP1399127B1 (https=)
JP (5) JP4827374B2 (https=)
KR (1) KR100884711B1 (https=)
CN (1) CN1211125C (https=)
AR (1) AR034619A1 (https=)
AT (1) ATE295149T1 (https=)
AU (1) AU2002310461B2 (https=)
BR (1) BRPI0210707B8 (https=)
CA (1) CA2447924C (https=)
DE (1) DE60204142T2 (https=)
DK (1) DK1399127T3 (https=)
ES (1) ES2238574T3 (https=)
GC (1) GC0000397A (https=)
MX (1) MXPA03011947A (https=)
PL (1) PL205565B1 (https=)
PT (1) PT1399127E (https=)
TW (1) TWI231759B (https=)
WO (1) WO2003002093A1 (https=)
ZA (1) ZA200308771B (https=)

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US7977376B2 (en) 2001-06-27 2011-07-12 Novartis Ag Olopatadine formulations for topical nasal administration
TWI231759B (en) * 2001-06-27 2005-05-01 Alcon Inc Olopatadine formulations for topical administration
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US20070275853A1 (en) * 2004-04-08 2007-11-29 Kyowa Hakko Kogyo Co., Ltd. Solid Products with Improved Stability and Method for Producing the Same
US20070225356A1 (en) * 2004-04-21 2007-09-27 Kyowa Hakko Kogo Co., Ltd Preventive and/or Therapeutic Agent for Chronic Sinusitis
ZA200610350B (en) * 2004-06-28 2008-12-31 Alcon Inc Topical formulations for treating allergic diseases
AU2005309951B2 (en) * 2004-11-24 2011-07-07 Alcon, Inc. Method of delivering nasal spray
WO2006097458A1 (en) * 2005-03-15 2006-09-21 Nycomed Gmbh Novel combination
JP5315051B2 (ja) * 2005-07-08 2013-10-16 千寿製薬株式会社 オロパタジンを含む眼科用経皮吸収型製剤
US20070077302A1 (en) * 2005-09-30 2007-04-05 Azaam Alli Methods for stabilizing ophthalmic compositions
US20080114076A1 (en) * 2006-11-09 2008-05-15 Alcon Manufacturing Ltd. Punctal plug comprising a water-insoluble polymeric matrix
TWI409081B (zh) * 2006-11-09 2013-09-21 Alcon Res Ltd 用於藥物輸送之水不溶性聚合物基質
MX2009006146A (es) * 2006-12-18 2009-06-19 Alcon Res Ltd Dispositivos y metodos para la administracion de farmacos oftalmicos.
WO2008093358A2 (en) * 2007-01-29 2008-08-07 Sun Pharmaceutical Industries Limited Aqueous topical solution containing olopatadine
KR20100014858A (ko) * 2007-02-07 2010-02-11 알콘, 인코퍼레이티드 국소 비강 투여용 올로파타딘 제제
WO2008120249A1 (en) * 2007-03-30 2008-10-09 Sifi S.P.A. Pharmaceutical formulations based on apolar and polar lipids for ophthalmic use
TW200902025A (en) * 2007-04-11 2009-01-16 Alcon Res Ltd Use of an inhibitor of TNF α plus an antihistamine to treat allergic rhinitis and allergic conjunctivitis
EP2189157A4 (en) * 2007-09-06 2012-10-31 Kyowa Hakko Kirin Co Ltd EYE DROPPING WITH DIBENZO [b, e] OXEPINE DERIVATIVE
CA2723954A1 (en) * 2008-05-19 2009-11-26 Alcon Research, Ltd. Pharmaceutical compositions having carboxyvinyl polymer and povidone polymer
AU2009288566A1 (en) * 2008-08-26 2010-03-11 Trutek Corp. Electrostatically charged mask filter products and method for increased filtration efficiency
KR20110056526A (ko) * 2008-08-28 2011-05-30 트루텍 코프. 항히스타민 및 유사-항히스타민 코 외용약, 생성물 및 방법
US9458198B1 (en) 2009-06-26 2016-10-04 Shire Orphan Therapies Gmbh Cyclic peptide-based NPR-B agonists
EP2453872B1 (en) * 2009-07-17 2013-08-21 Alcon Research, Ltd. Olopatadine nasal spray regimen for children
WO2011027322A1 (en) 2009-09-03 2011-03-10 Ranbaxy Laboratories Limited Extended release dosage form containing olopatadine for oral administration
EP2480247B1 (en) * 2009-09-25 2020-02-12 Shire Orphan Therapies GmbH Novel npr-b agonists
US8551938B2 (en) * 2009-09-25 2013-10-08 Alcon Research, Ltd. NPR-B agonists
US20110082145A1 (en) * 2009-10-01 2011-04-07 Alcon Research, Ltd. Olopatadine compositions and uses thereof
AR078446A1 (es) 2009-12-18 2011-11-09 Alcon Res Ltd Agonistas de npr-b. uso.
WO2011075471A2 (en) 2009-12-18 2011-06-23 Alcon Research, Ltd. Novel npr-b agonists and methods of use for the treatment of c-type natriuretic peptide-mediated disorders
US20120022149A1 (en) * 2010-07-21 2012-01-26 Chowhan Masood A Pharmaceutical composition with enhanced solubility characteristics
EP2944319A1 (en) * 2010-11-08 2015-11-18 Arava Bio-Tech Ltd. Buffered ophthalmic compositions and use thereof
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
CN102885767A (zh) * 2012-11-02 2013-01-23 江苏吉贝尔药业有限公司 一种新的盐酸奥洛他定滴眼液及其制备方法
EP3576770A1 (en) 2017-02-01 2019-12-11 Shire Human Genetic Therapies, Inc. Compounds and compositions for the treatment of ophthalmic disorders
JP7037349B2 (ja) * 2017-06-23 2022-03-16 参天製薬株式会社 水溶性粘稠化剤を含有する医薬組成物
WO2018235935A1 (ja) * 2017-06-23 2018-12-27 参天製薬株式会社 水溶性粘稠化剤を含有する医薬組成物
CN114980881A (zh) * 2019-12-06 2022-08-30 东兴药品工业株式会社 包含奥洛他定的鼻用组合物
US20230145529A1 (en) * 2020-03-31 2023-05-11 Santen Pharmaceutical Co., Ltd. Silver salt-containing ophthalmic aqueous composition filled in resin container
CN111700860A (zh) * 2020-07-09 2020-09-25 浙江尖峰药业有限公司 盐酸奥洛他定滴眼液及其制备方法
CN119318630B (zh) * 2024-10-16 2025-08-22 苏州欧康维视生物科技有限公司 一种阿托品药物组合物

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Also Published As

Publication number Publication date
DK1399127T3 (da) 2005-06-13
BRPI0210707B1 (pt) 2015-08-04
BRPI0210707B8 (pt) 2021-05-25
GC0000397A (en) 2007-03-31
JP5328947B2 (ja) 2013-10-30
DE60204142D1 (de) 2005-06-16
ES2238574T3 (es) 2005-09-01
US7402609B2 (en) 2008-07-22
KR100884711B1 (ko) 2009-02-19
PT1399127E (pt) 2005-07-29
JP2010150292A (ja) 2010-07-08
PL205565B1 (pl) 2010-05-31
CN1525849A (zh) 2004-09-01
WO2003002093A1 (en) 2003-01-09
JP2004536096A (ja) 2004-12-02
JP2012107046A (ja) 2012-06-07
AR034619A1 (es) 2004-03-03
MXPA03011947A (es) 2004-03-26
US6995186B2 (en) 2006-02-07
JP4827374B2 (ja) 2011-11-30
KR20040025919A (ko) 2004-03-26
EP1399127A1 (en) 2004-03-24
ATE295149T1 (de) 2005-05-15
CN1211125C (zh) 2005-07-20
AU2002310461B2 (en) 2006-05-18
CA2447924A1 (en) 2003-01-09
JP2009114213A (ja) 2009-05-28
JP2013127005A (ja) 2013-06-27
PL367780A1 (en) 2005-03-07
TWI231759B (en) 2005-05-01
ZA200308771B (en) 2005-01-26
HK1059573A1 (en) 2004-07-09
BR0210707A (pt) 2004-07-20
DE60204142T2 (de) 2005-10-06
US20030055102A1 (en) 2003-03-20
US20050158387A1 (en) 2005-07-21
EP1399127B1 (en) 2005-05-11

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Effective date: 20220620