HUE026162T2 - Olopatadin készítmény helyi nazális adagolásra - Google Patents

Olopatadin készítmény helyi nazális adagolásra Download PDF

Info

Publication number
HUE026162T2
HUE026162T2 HUE07750153A HUE07750153A HUE026162T2 HU E026162 T2 HUE026162 T2 HU E026162T2 HU E07750153 A HUE07750153 A HU E07750153A HU E07750153 A HUE07750153 A HU E07750153A HU E026162 T2 HUE026162 T2 HU E026162T2
Authority
HU
Hungary
Prior art keywords
olopatadine
phosphate
composition
salt
compositions
Prior art date
Application number
HUE07750153A
Other languages
English (en)
Inventor
Onkar N Singh
G Michael Wall
Rajni Jani
Masood A Chowhan
Wesley Wehsin Han
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Publication of HUE026162T2 publication Critical patent/HUE026162T2/hu

Links

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
    • A61K9/0043—Nose
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (2)

  1. Oicpatadin készítmény helyi nazális adagolásra: Szafeadáfrai igénypontok !.. Készítmény, mely lényegében a kivetkező alkotórészekből áli: a) 0.54 ~ 0.62 tömeg/térfogaf% otopatadín szabad bázis vagy egyenértéknyi mennyiségű gyógyászati lag etfogádbalő oiopatadin-só; b) 0.2 - 0.8 iöroeg/térfogat% díbázlkus nétriumfoszfátnak megfelelő mennyiségű íoszfátsó, ahol a foszfátsó monobázikus nátriumfoszfát; d 1 bá z s kusnátriomfoszfát; tríiazikos natnumfoszfáf; monobázskus káíiumfoszfát; dibázikus káíiumfoszfát; és ifiiázíkis káíiumfoszfát közül választott; c) 0.3 - 0.6 tőmep^éifogat5^ NaCi; d) á készítmény pinának 3,6 - 3.8 értékre állításához elegendő mennyiségű pH-beállító iszer; a) 0.005 - 0.015 tome§/térfogat% benzalkonium kloríd; f) Ö.00S ~ 0.015 tömeg/térfogat% edetát dinátrium; és 9) víz, ahoi a készítmény nem tartalmaz poliyinilpirroildont, poiisztlrol-szulfomavat, poiivlniiaikoholt, pbiíyióliikfiiísáysfe,. hldroxípropi 1 metiI -celluiózt. nátrium karboximetil· csiuldzt vagy xantán-gumlt,
  2. 2. Az 1, igénypont szerinti készítmény, mely lényegében a következő alkotórészekből áll:; a) 0,6 tameg,/tárfogat% olopatadín szabadi bázis vagy egyenértéknyí mennyiségű gyógy-ásxalíiag elfogadható piopatadin-só; b) 0.4 - 0,6 fömeg/térfogat% dibázikus nátriumfoszfát; e| 0.3S · 0.45 tomeg/térfogat% NaCi; d) a készítmény pH -jának 3,6 ~ 3.8 értékre ávitásához elegendő mennyiségű pH-beállító szer, ábdl a pH-beállífö szer NaOH és HGI közöl választott; é) 0.01 tömegeiériogató benzalkonium kiorid; f) 0.Ö1 fömeg/térfogat% edetát dinátrium.; és g) víz.
HUE07750153A 2007-02-07 2007-02-07 Olopatadin készítmény helyi nazális adagolásra HUE026162T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/003285 WO2008097220A1 (en) 2007-02-07 2007-02-07 Olopatadine formulations for topical nasal administration

Publications (1)

Publication Number Publication Date
HUE026162T2 true HUE026162T2 (hu) 2016-05-30

Family

ID=38542957

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE07750153A HUE026162T2 (hu) 2007-02-07 2007-02-07 Olopatadin készítmény helyi nazális adagolásra

Country Status (16)

Country Link
EP (2) EP2977042B1 (hu)
JP (1) JP5149308B2 (hu)
KR (1) KR20100014858A (hu)
CN (1) CN101621989A (hu)
AU (1) AU2007346121B2 (hu)
BR (1) BRPI0721255B8 (hu)
CA (1) CA2677631C (hu)
DK (1) DK2114367T3 (hu)
ES (2) ES2557939T3 (hu)
HK (1) HK1217090A1 (hu)
HU (1) HUE026162T2 (hu)
MX (1) MX2009008548A (hu)
PL (1) PL2114367T3 (hu)
PT (1) PT2114367E (hu)
SI (1) SI2114367T1 (hu)
WO (1) WO2008097220A1 (hu)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011001317A (ja) * 2009-06-19 2011-01-06 Fumakilla Ltd 鼻用洗浄剤
PT2453872E (pt) * 2009-07-17 2013-10-30 Alcon Res Ltd Regime de pulverização nasal de olopatadina para crianças
KR101271925B1 (ko) * 2011-02-10 2013-06-05 비. 김 로버트 미네랄 알칼리수
TW201336527A (zh) * 2012-02-10 2013-09-16 Alcon Res Ltd 具增強的穩定性之水性藥學組成物
CN103830219A (zh) * 2012-11-20 2014-06-04 深圳大佛药业有限公司 一种稳定的奥洛他定组合物
US20230018472A1 (en) * 2019-12-06 2023-01-19 Toko Yakuhin Kogyo Co., Ltd. Rhinenchysis composition containing olopatadine

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8520662D0 (en) 1985-08-17 1985-09-25 Wellcome Found Tricyclic aromatic compounds
US4923892A (en) 1985-08-17 1990-05-08 Burroughs Wellcome Co. Tricyclic aromatic compounds
JPS6310784A (ja) 1986-03-03 1988-01-18 Kyowa Hakko Kogyo Co Ltd 抗アレルギー剤
JP3662944B2 (ja) * 1993-08-24 2005-06-22 協和醗酵工業株式会社 点鼻剤
US5641805A (en) 1995-06-06 1997-06-24 Alcon Laboratories, Inc. Topical ophthalmic formulations for treating allergic eye diseases
DE60109742T2 (de) * 2000-01-25 2005-08-18 Alcon Inc. Antiallergische ophthalmische zubereitungen, geeignet zur anwendung mit kontaktlinsen
TWI231759B (en) * 2001-06-27 2005-05-01 Alcon Inc Olopatadine formulations for topical administration
US20040097474A1 (en) * 2002-11-12 2004-05-20 Alcon, Inc. Use of an anti-allergy agent and a steroid to treat nasal conditions
WO2006057769A2 (en) 2004-11-24 2006-06-01 Alcon, Inc. Method of delivering nasal spray

Also Published As

Publication number Publication date
CA2677631C (en) 2014-05-13
AU2007346121A1 (en) 2008-08-14
CA2677631A1 (en) 2008-08-14
BRPI0721255A2 (pt) 2013-01-01
MX2009008548A (es) 2009-08-18
HK1217090A1 (zh) 2016-12-23
ES2557939T3 (es) 2016-01-29
WO2008097220A1 (en) 2008-08-14
SI2114367T1 (sl) 2016-01-29
BRPI0721255B1 (pt) 2019-08-27
JP5149308B2 (ja) 2013-02-20
EP2114367A1 (en) 2009-11-11
AU2007346121B2 (en) 2012-08-23
EP2114367B1 (en) 2015-11-04
JP2010518075A (ja) 2010-05-27
PT2114367E (pt) 2016-02-01
BRPI0721255B8 (pt) 2021-05-25
KR20100014858A (ko) 2010-02-11
DK2114367T3 (en) 2015-12-07
EP2977042B1 (en) 2020-01-01
PL2114367T3 (pl) 2016-03-31
ES2781090T3 (es) 2020-08-28
CN101621989A (zh) 2010-01-06
EP2977042A1 (en) 2016-01-27

Similar Documents

Publication Publication Date Title
US7977376B2 (en) Olopatadine formulations for topical nasal administration
JP3090125B2 (ja) ソフトコンタクトレンズ用の眼科用組成物、ソフトコンタクトレンズの濡れ増強方法およびテルペノイドの吸着抑制方法
EP2453872B1 (en) Olopatadine nasal spray regimen for children
RU2406499C2 (ru) Профилактическое или терапевтическое средство для лечения кератоконъюнктивитных нарушений
CN107362157A (zh) 用于医学和兽医学的眼科药物组合物
JPS62178514A (ja) 眼局所投与用眼圧降下剤
JPH05213757A (ja) 水性液剤
DK2114367T3 (en) Olopatadine formulations for topical nasal administration
JPWO2008044734A1 (ja) ガチフロキサシン含有水性液剤
WO2007007894A1 (ja) キサンタンガムおよびテルペノイドを含有する点眼剤
JP2003026575A (ja) 医薬組成物
CA2159288A1 (en) Aqueous nasal suspension
CN100362989C (zh) 治疗眼干综合症的包含n-乙酰-半胱氨酸的眼科组合物
JPH11189533A (ja) 点眼薬
JP3662944B2 (ja) 点鼻剤
JP2021167349A (ja) 水性医薬組成物
JPH02193931A (ja) 角膜疾患治療用点眼剤
JP2001172183A (ja) 眼科用医薬組成物
JPH1192368A (ja) ベンゾピラン誘導体を主成分とする水性液剤
JP5087233B2 (ja) 角結膜障害の予防または治療剤
JPH0930968A (ja) 緑内障及び高眼圧症治療用点眼剤
BR112020018377A2 (pt) Métodos de uso e composições farmacêuticas de um inibidor de syk seletivo
JPH08231393A (ja) 眼局所用アレルギー性結膜炎治療剤