CN104168885A - 具有增强的稳定性的水性药物组合物 - Google Patents

具有增强的稳定性的水性药物组合物 Download PDF

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Publication number
CN104168885A
CN104168885A CN201380014179.XA CN201380014179A CN104168885A CN 104168885 A CN104168885 A CN 104168885A CN 201380014179 A CN201380014179 A CN 201380014179A CN 104168885 A CN104168885 A CN 104168885A
Authority
CN
China
Prior art keywords
composition
pharmaceutical composition
guar gum
eye
olopatadine
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.)
Pending
Application number
CN201380014179.XA
Other languages
English (en)
Chinese (zh)
Inventor
D·L·梅多斯
H·A·凯特尔森
J·W·达维斯
J-S·丘
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.)
Alcon Research LLC
Original Assignee
Alcon Manufacturing Ltd
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 Alcon Manufacturing Ltd filed Critical Alcon Manufacturing Ltd
Publication of CN104168885A publication Critical patent/CN104168885A/zh
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K47/44Oils, 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
    • 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
    • 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
    • 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
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/34Macromolecular 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
    • 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
    • A61K47/40Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/50Medicinal 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
    • 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
    • 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
    • A61P27/04Artificial tears; Irrigation solutions
    • 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
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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)
  • 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)
CN201380014179.XA 2012-02-10 2013-02-08 具有增强的稳定性的水性药物组合物 Pending CN104168885A (zh)

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 (1)

Publication Number Publication Date
CN104168885A true CN104168885A (zh) 2014-11-26

Family

ID=47750831

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380014179.XA Pending CN104168885A (zh) 2012-02-10 2013-02-08 具有增强的稳定性的水性药物组合物

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 (6)

* 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
US20030232089A1 (en) * 2002-02-22 2003-12-18 Singh Satish K. Ophthalmic formulation with novel gum composition
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
WO2011141929A2 (en) * 2010-05-11 2011-11-17 Cadila Healthcare Limited Aqueous pharmaceutical compositions of fluticasone and olopatadine
CN103458894A (zh) * 2011-05-19 2013-12-18 爱尔康研究有限公司 高浓度奥洛他定眼用组合物

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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
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

Patent Citations (6)

* 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
US20030232089A1 (en) * 2002-02-22 2003-12-18 Singh Satish K. Ophthalmic formulation with novel gum composition
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
WO2011141929A2 (en) * 2010-05-11 2011-11-17 Cadila Healthcare Limited Aqueous pharmaceutical compositions of fluticasone and olopatadine
CN103458894A (zh) * 2011-05-19 2013-12-18 爱尔康研究有限公司 高浓度奥洛他定眼用组合物

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
KR102047954B1 (ko) 2019-11-22
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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Legal Events

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C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20141126

RJ01 Rejection of invention patent application after publication