CA2468664A1 - Ketorolac tromethamine compositions for treating or preventing ocular pain - Google Patents

Ketorolac tromethamine compositions for treating or preventing ocular pain Download PDF

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Publication number
CA2468664A1
CA2468664A1 CA002468664A CA2468664A CA2468664A1 CA 2468664 A1 CA2468664 A1 CA 2468664A1 CA 002468664 A CA002468664 A CA 002468664A CA 2468664 A CA2468664 A CA 2468664A CA 2468664 A1 CA2468664 A1 CA 2468664A1
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CA
Canada
Prior art keywords
ketorolac tromethamine
octoxynol
adjust
hydrochloric acid
effective amount
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.)
Granted
Application number
CA002468664A
Other languages
French (fr)
Other versions
CA2468664C (en
Inventor
Christopher A. Muller
Janet K. Cheetham
Theresa H. Kuan
David F. Power
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.)
Allergan Inc
Original Assignee
Allergan Inc
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Filing date
Publication date
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Application filed by Allergan Inc filed Critical Allergan Inc
Publication of CA2468664A1 publication Critical patent/CA2468664A1/en
Application granted granted Critical
Publication of CA2468664C publication Critical patent/CA2468664C/en
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Classifications

    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Compositions comprising ketorolac tromethamine at a therapeutically effective concentration of less than 0.5% are disclosed herein. Methods of treating or preventing ocular pain using said compositions are also disclosed herein.

Claims (17)

1. An aqueous topical ophthalmic composition comprising from 0.35% to 0.45% ketorolac tromethamine.
2. The aqueous topical ophthalmic composition of claim 1 comprising 0.4% ketorolac tromethamine.
3. The aqueous topical ophthalmic composition of claim 1 comprising from 0.001% to 0.05% edetate disodium, from 0.004% to 0.007% benzalkonium chloride, and from 0.001 % to 0.005% Octoxynol-40®.
4. The aqueous topical ophthalmic composition of claim 1 comprising 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
5. The aqueous topical ophthalmic composition of claim 1 consisting essentially of 0.4% ketorolac tromethamine, 0.006%
benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79% sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
6. The aqueous topical ophthalmic composition of claim 1 consisting of 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
7. A method of treating or preventing ocular pain in a person comprising topically administering to said patient a sterile composition comprising from 0.35% to 0.45% ketorolac tromethamine.
8. The method of claim 7 wherein said ocular pain is a result of photorefractive keratectomy surgery.
9. The method of claim 7 wherein said composition comprises 0.4% ketorolac tromethamine.
10. The method of claim 7 wherein said composition comprises 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
11. The method of claim 7 wherein said composition consists essentially of 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
12. The method of claim 7 wherein said composition consists of 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79% sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
13. The method of claim 8 wherein said composition comprises 0.4% ketorolac tromethamine.
14. The method of claim 8 wherein said composition comprises 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
15. The method of claim 8 wherein said composition consists essentially of 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79%
sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
16. The method of claim 8 wherein said composition consists of 0.4% ketorolac tromethamine, 0.006% benzalkonium chloride, 0.015% edetate disodium, 0.003% Octoxynol-40®, 0.79% sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from 7.2 to 7.6.
17. An aqueous solution comprising less than 0.5% ketorolac tromethamine wherein said solution is suitable for topical ophthalmic use and wherein a therapeutically effective concentration of ketorolac tromethamine is present.
CA2468664A 2003-06-03 2004-05-28 Ketorolac tromethamine compositions for treating or preventing ocular pain Active CA2468664C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47568303P 2003-06-03 2003-06-03
US60/475,683 2003-06-03

Publications (2)

Publication Number Publication Date
CA2468664A1 true CA2468664A1 (en) 2004-12-03
CA2468664C CA2468664C (en) 2012-03-06

Family

ID=33563745

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2468664A Active CA2468664C (en) 2003-06-03 2004-05-28 Ketorolac tromethamine compositions for treating or preventing ocular pain

Country Status (2)

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US (10) US8008338B2 (en)
CA (1) CA2468664C (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005014046A2 (en) * 2003-08-07 2005-02-17 Allergan, Inc. Compositions for delivery of therapeutics into the eyes and methods for making and using the same
US20100130580A1 (en) * 2006-01-25 2010-05-27 Aciex Therapeutics, Inc. Formulations and Methods for Treating Dry Eye
US20070249546A1 (en) * 2006-04-22 2007-10-25 Sawaya Assad S Ophthalmic and related aqueous solutions containing antifungal agents, uses therefor and methods for preparing them
CA2687717A1 (en) * 2007-05-24 2008-12-18 Aciex Therapeutics, Inc. Formulations and methods for treating dry eye
US9192571B2 (en) * 2008-03-03 2015-11-24 Allergan, Inc. Ketorolac tromethamine compositions for treating or preventing ocular pain
US7842714B2 (en) * 2008-03-03 2010-11-30 Allergan, Inc. Ketorolac tromethamine compositions for treating ocular pain
WO2011085361A1 (en) 2010-01-11 2011-07-14 Inotek Pharmaceuticals Corporation Combination, kit and method of reducing intraocular pressure
US8476247B2 (en) 2010-03-26 2013-07-02 Inotek Pharmaceuticals Corporation Method of reducing intraocular pressure in humans
AU2013211957B2 (en) 2012-01-26 2017-08-10 Inotek Pharmaceuticals Corporation Anhydrous polymorphs of (2R,3S,4R,5R)-5-(6-(cyclopentylamino)-9H-purin-9-yl)-3,4-dihydroxytetrahydrofuran-2-yl) } methyl nitrate and processes of preparation thereof
CA2903114A1 (en) * 2013-03-15 2014-09-25 Inotek Pharmaceuticals Corporation Ophthalmic formulations
RU2635185C2 (en) * 2013-12-17 2017-11-09 Иван Дмитриевич Захаров Pharmaceutical preparation for prevention and treatment of progressive myopia
US20190083462A1 (en) 2016-03-18 2019-03-21 The Texas A&M University System Prevention of nsaid enteropathy with microbiota-derived tryptophan-metabolite
KR102275012B1 (en) 2016-08-12 2021-07-07 실크 테크놀로지스 리미티드 Silk-derived protein for the treatment of inflammation

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US4454151A (en) 1982-03-22 1984-06-12 Syntex (U.S.A.) Inc. Use of pyrrolo pyrroles in treatment of ophthalmic diseases
CA1328614C (en) 1987-09-11 1994-04-19 Cherng-Chyi Roger Fu Preservative system for ophthalmics formulations
US5110493A (en) 1987-09-11 1992-05-05 Syntex (U.S.A.) Inc. Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant
US5414011A (en) 1987-09-11 1995-05-09 Syntex (U.S.A.) Inc. Preservative system for ophthalmic formulations
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US5558876A (en) 1995-03-29 1996-09-24 Alcon Laboratories, Inc. Topical ophthalmic acidic drug formulations

Also Published As

Publication number Publication date
US20170216253A1 (en) 2017-08-03
US20160243079A1 (en) 2016-08-25
US20150057327A1 (en) 2015-02-26
US20080027120A1 (en) 2008-01-31
US20130197051A1 (en) 2013-08-01
US20040248962A1 (en) 2004-12-09
US20130203833A1 (en) 2013-08-08
US8207215B2 (en) 2012-06-26
US20120190722A1 (en) 2012-07-26
US9216167B2 (en) 2015-12-22
US8377982B2 (en) 2013-02-19
US8541463B2 (en) 2013-09-24
CA2468664C (en) 2012-03-06
US8906950B2 (en) 2014-12-09
US20130203834A1 (en) 2013-08-08
US8008338B2 (en) 2011-08-30
US8946281B2 (en) 2015-02-03
US20130137742A1 (en) 2013-05-30
US8648107B2 (en) 2014-02-11

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