KR102047954B1 - 증대된 안정성을 갖는 수성 약제학적 조성물 - Google Patents

증대된 안정성을 갖는 수성 약제학적 조성물 Download PDF

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Publication number
KR102047954B1
KR102047954B1 KR1020147024529A KR20147024529A KR102047954B1 KR 102047954 B1 KR102047954 B1 KR 102047954B1 KR 1020147024529 A KR1020147024529 A KR 1020147024529A KR 20147024529 A KR20147024529 A KR 20147024529A KR 102047954 B1 KR102047954 B1 KR 102047954B1
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South Korea
Prior art keywords
composition
pharmaceutical composition
olopatadine
typically
eye
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Expired - Fee Related
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KR1020147024529A
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English (en)
Korean (ko)
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KR20140120932A (ko
Inventor
데이빗 엘. 메도우스
하워드 알렌 케텔슨
제임스 더블유. 데이비스
장-싱 치오우
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알콘 리서치, 리미티드
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    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K31/335—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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • 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)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Ophthalmology & Optometry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020147024529A 2012-02-10 2013-02-08 증대된 안정성을 갖는 수성 약제학적 조성물 Expired - Fee Related KR102047954B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261597416P 2012-02-10 2012-02-10
US61/597,416 2012-02-10
PCT/US2013/025376 WO2013119974A1 (en) 2012-02-10 2013-02-08 Aqueous pharmaceutical composition with enhanced stability

Publications (2)

Publication Number Publication Date
KR20140120932A KR20140120932A (ko) 2014-10-14
KR102047954B1 true KR102047954B1 (ko) 2019-11-22

Family

ID=47750831

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KR1020147024529A Expired - Fee Related KR102047954B1 (ko) 2012-02-10 2013-02-08 증대된 안정성을 갖는 수성 약제학적 조성물

Country Status (12)

Country Link
US (2) US20130210812A1 (https=)
EP (1) EP2811979B1 (https=)
JP (1) JP6180443B2 (https=)
KR (1) KR102047954B1 (https=)
CN (1) CN104168885A (https=)
AU (1) AU2013216847B2 (https=)
BR (1) BR112014019742A8 (https=)
CA (1) CA2864165A1 (https=)
MX (1) MX356050B (https=)
RU (1) RU2014136715A (https=)
TW (1) TW201336527A (https=)
WO (1) WO2013119974A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10744153B1 (en) * 2019-07-01 2020-08-18 Cloudbreak Therapeutics Llc Compositions and methods for treating meibomian gland dysfunction
WO2025137749A1 (pt) * 2023-12-27 2025-07-03 Eurofarma Laboratórios S.A. Processo de solubilização de olopatadina e seu uso

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001054687A1 (en) * 2000-01-25 2001-08-02 Alcon Universal Ltd. Ophthalmic anti-allergy compositions suitable for use with contact lenses

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4027020A (en) 1974-10-29 1977-05-31 Millmaster Onyx Corporation Randomly terminated capped polymers
US3931319A (en) 1974-10-29 1976-01-06 Millmaster Onyx Corporation Capped polymers
US4525346A (en) 1981-09-28 1985-06-25 Alcon Laboratories, Inc. Aqueous antimicrobial ophthalmic solutions
US4407791A (en) 1981-09-28 1983-10-04 Alcon Laboratories, Inc. Ophthalmic solutions
US4836986A (en) 1984-09-28 1989-06-06 Bausch & Lomb Incorporated Disinfecting and preserving systems and methods of use
JPS6310784A (ja) 1986-03-03 1988-01-18 Kyowa Hakko Kogyo Co Ltd 抗アレルギー剤
US5037647A (en) 1988-09-15 1991-08-06 Alcon Laboratories, Inc. Aqueous antimicrobial opthalmic solutions comprised of quaternary ammonium compound, citric acid, citrate and sodium chloride
US5145643A (en) 1990-01-05 1992-09-08 Allergan, Inc. Nonoxidative ophthalmic compositions and methods for preserving and using same
US5376645A (en) 1990-01-23 1994-12-27 University Of Kansas Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
KR0166088B1 (ko) 1990-01-23 1999-01-15 . 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도
US5300287A (en) 1992-11-04 1994-04-05 Alcon Laboratories, Inc. Polymeric antimicrobials and their use in pharmaceutical compositions
GB9711643D0 (en) * 1997-06-05 1997-07-30 Janssen Pharmaceutica Nv Glass thermoplastic systems
EP0889056B1 (en) 1997-07-01 2006-04-12 Pfizer Products Inc. Process for making a cyclodextrin
DE69839355T2 (de) * 1997-07-29 2009-06-04 Alcon Laboratories, Inc., Fort Worth Ophthalmische Zusammensetzungen enthaltend Galaktomannanpolymere und Borat
MXPA04008171A (es) * 2002-02-22 2004-11-26 Pharmacia Corp Formulacion oftalmica con sistema de goma.
US20040198828A1 (en) * 2003-01-17 2004-10-07 Abelson Mark B. Combinational use of long-acting and short-acting anti-histamines for ocular allergies
WO2008015695A2 (en) * 2006-05-15 2008-02-07 Sun Pharmaceutical Industries Limited Inclusion complex of olopatadine and cyclodextrin
TWI434926B (zh) 2006-12-11 2014-04-21 Alcon Res Ltd 眼用組成物中聚氧化乙烯-聚氧化丁烯（ｐｅｏ-ｐｂｏ）嵌段共聚物之使用
PT2114367E (pt) * 2007-02-07 2016-02-01 Novartis Ag Formulações de olopatadina para administração nasal tópica
ZA200904917B (en) * 2007-02-09 2010-09-29 Alcon Inc Ophthalmic compositions containing a synergistic combination of three polymers
AR066901A1 (es) * 2007-05-18 2009-09-23 Alcon Mfg Ltd Composiciones fodfolipidicas para elcuidado de lentes de contacto y conservacion de composiciones farmaceuticas
US7635773B2 (en) 2008-04-28 2009-12-22 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions
EP2393837A1 (en) 2009-02-05 2011-12-14 Alcon Research, Ltd. Process for purifying guar
PH12012501111A1 (en) * 2009-12-03 2016-09-09 Novartis Ag Carboxyvinyl polymer-containing nanoparticles suspensions
TWI478730B (zh) * 2009-12-03 2015-04-01 Alcon Res Ltd 眼科乳劑
CA2798069C (en) * 2010-05-05 2016-07-05 Howard Allen Ketelson Stabilized ophthalmic galactomannan formulations
WO2011141929A2 (en) * 2010-05-11 2011-11-17 Cadila Healthcare Limited Aqueous pharmaceutical compositions of fluticasone and olopatadine
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001054687A1 (en) * 2000-01-25 2001-08-02 Alcon Universal Ltd. Ophthalmic anti-allergy compositions suitable for use with contact lenses

Also Published As

Publication number Publication date
TW201336527A (zh) 2013-09-16
AU2013216847A1 (en) 2014-09-04
US20130210812A1 (en) 2013-08-15
MX2014009573A (es) 2015-04-08
BR112014019742A8 (pt) 2017-07-11
WO2013119974A1 (en) 2013-08-15
CA2864165A1 (en) 2013-08-15
MX356050B (es) 2018-05-11
CN104168885A (zh) 2014-11-26
AU2013216847B2 (en) 2016-06-23
KR20140120932A (ko) 2014-10-14
US20140364422A1 (en) 2014-12-11
RU2014136715A (ru) 2016-03-27
EP2811979B1 (en) 2018-05-02
BR112014019742A2 (https=) 2017-06-20
EP2811979A1 (en) 2014-12-17
JP2015509933A (ja) 2015-04-02
JP6180443B2 (ja) 2017-08-16

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KR102047954B1 (ko) 증대된 안정성을 갖는 수성 약제학적 조성물
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