AU2013216847B2 - Aqueous pharmaceutical composition with enhanced stability - Google Patents

Aqueous pharmaceutical composition with enhanced stability Download PDF

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Publication number
AU2013216847B2
AU2013216847B2 AU2013216847A AU2013216847A AU2013216847B2 AU 2013216847 B2 AU2013216847 B2 AU 2013216847B2 AU 2013216847 A AU2013216847 A AU 2013216847A AU 2013216847 A AU2013216847 A AU 2013216847A AU 2013216847 B2 AU2013216847 B2 AU 2013216847B2
Authority
AU
Australia
Prior art keywords
composition
therapeutic agent
pharmaceutical composition
typically
guar
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.)
Ceased
Application number
AU2013216847A
Other languages
English (en)
Other versions
AU2013216847A1 (en
Inventor
Jang-Shing Chiou
James W. Davis
Howard Allen Ketelson
David L. Meadows
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.)
Novartis AG
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 AU2013216847A1 publication Critical patent/AU2013216847A1/en
Application granted granted Critical
Publication of AU2013216847B2 publication Critical patent/AU2013216847B2/en
Assigned to NOVARTIS AG reassignment NOVARTIS AG Request for Assignment Assignors: ALCON RESEARCH, LTD.
Ceased 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
    • 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
    • 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

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)
AU2013216847A 2012-02-10 2013-02-08 Aqueous pharmaceutical composition with enhanced stability Ceased AU2013216847B2 (en)

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
AU2013216847A1 AU2013216847A1 (en) 2014-09-04
AU2013216847B2 true AU2013216847B2 (en) 2016-06-23

Family

ID=47750831

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013216847A Ceased AU2013216847B2 (en) 2012-02-10 2013-02-08 Aqueous pharmaceutical composition with enhanced stability

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 (3)

* 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
WO2003072081A1 (en) * 2002-02-22 2003-09-04 Pharmacia Corporation Ophthalmic formulation with gum system
WO2012159064A1 (en) * 2011-05-19 2012-11-22 Alcon Research, Ltd. High concentration olopatadine ophthalmic composition

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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
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

Patent Citations (3)

* 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
WO2003072081A1 (en) * 2002-02-22 2003-09-04 Pharmacia Corporation Ophthalmic formulation with gum system
WO2012159064A1 (en) * 2011-05-19 2012-11-22 Alcon Research, Ltd. High concentration olopatadine ophthalmic composition

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
CN104168885A (zh) 2014-11-26
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

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: NOVARTIS AG

Free format text: FORMER OWNER(S): ALCON RESEARCH, LTD.

MK14 Patent ceased section 143(a) (annual fees not paid) or expired