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WO2007033020A2 - Formulation ophtalmique conçue pour le traitement de la secheresse oculaire - Google Patents

Formulation ophtalmique conçue pour le traitement de la secheresse oculaire Download PDF

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Publication number
WO2007033020A2
WO2007033020A2 PCT/US2006/035069 US2006035069W WO2007033020A2 WO 2007033020 A2 WO2007033020 A2 WO 2007033020A2 US 2006035069 W US2006035069 W US 2006035069W WO 2007033020 A2 WO2007033020 A2 WO 2007033020A2
Authority
WO
WIPO (PCT)
Prior art keywords
composition
synthetic
dry eye
preservative
treatment
Prior art date
Application number
PCT/US2006/035069
Other languages
English (en)
Other versions
WO2007033020A3 (fr
Inventor
Robert J. Meyering
Original Assignee
Bausch & Lomb Incorporated
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 Bausch & Lomb Incorporated filed Critical Bausch & Lomb Incorporated
Publication of WO2007033020A2 publication Critical patent/WO2007033020A2/fr
Publication of WO2007033020A3 publication Critical patent/WO2007033020A3/fr

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
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

Definitions

  • This invention relates to formulations for topical use comprising US FDA monograph approved "Dry eye” active ingredients in combination with electrolytes synthetic glycoproteins, synthetic proteins, synthetic enzymes and/or synthetic peptides in both a preservative and preservative free formulation/system for the treatment of dry eye and attendant inflammation.
  • formulations for topical use comprising US FDA monograph approved "Dry eye” active ingredients in combination with electrolytes, synthetic glycoproteins, synthetic proteins, synthetic enzymes and/or synthetic peptides in both a preservative and preservative free formulation/system for the treatment of dry eye and attendant inflammation.
  • Therapeutic suspensions for ophthalmic uses are made by aseptic preparation. Purity levels of all materials employed in the suspensions of the invention exceed those required by regulation.
  • ophthalmic demulcents are listed in Title 21 sec. 12 of the United States Code and include cellulose derivatives, carboxymethylcellulose sodium, hydroxyethyl cellulose; hypromellose, methylcellulose, dextran 70, gelatin, liquid polyols, glycerin, polyethylene glycol 300, polyethylene glycol 400, polysorbate 80, propylene glycol, polyvinyl alcohol and povidone.
  • the amount of these demulcents allowable in ophthalmic formulations ranges from about 0.01 to about 4 percent by weight depending upon the demulcent and the other agents that may be present in the formulation.
  • a preferred stable formulation further comprises balanced salts.
  • the balanced salts of certain embodiments preferably include NaCl, KCl, CaCl 2 and MgCl 2 in a ratio that provides an osmolality range of about 140 to about 400, preferably about 240 to about 330 m ⁇ sm/kg, preferably about 260 to about 300 m ⁇ sm/kg, with the most preferred osmolality of approximately 270 mOsm/kg.
  • NaCl ranges from about 0.1 to about 1 % w/v.
  • KCl ranges from about 0.02 to about 0.5% w/v., preferably about 0.05 to about 0.3 % w/v, more preferably about 0.14%w/v
  • CaCl 2 ranges from about 0.00005 to about 0.1 % w/v, preferably about 0.0005 to about 0.1 % w/v, preferably about 0.005 to about 0.08 w/v, more preferably about 0.06 % w/v.
  • ophthalmic preparations shall include a preservative.
  • Gentle preservatives such as stabilized oxy-chloro complex (available commercially as OcuPure TM from Advanced medical optics, Purite ⁇ from Allergan, and Purogene from Biocide have received some recommendation as preservatives that cause less irritation to the end user.
  • the formulations of the invention herein may be preservative free.
  • Preferred formulations are prepared using standard compounding, filtration, fill and packaging equipment. In one embodiment preferred formulations are prepared in scaled up version capable of mass production. In another embodiment preferred formulations are prepared in small laboratory scale batches.
  • the packaging used consists of single use containers. In some single use embodiments, an alternative formulation may include non-preserved formulations. The non-preserved embodiments may also replace the borate/boric acid buffer system with a milder buffer system such as about 0.3% sodium lactate. In another embodiment, the formulation is packaged in eye dropper bottles of varying sizes. Preferred packaging includes, but is not limited to, materials that will shield the invention from light and/or oxygen. One embodiment of the packaging consists of teal bottles. Other embodiments include bottles of various colors, for example blue, opaque white, black, or brown bottles can be used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne des formulations pour usage topique comprenant des ingrédients actifs 'sécheresse oculaire' homologués de la monographie de la FDA des USA en combinaison d'électrolytes, de glycoprotéines synthétiques, de protéines synthétiques, d'enzymes synthétiques et/ou de peptides synthétiques dans des formulations/systèmes de conservation et sans agents de conservation pour le traitement de la sécheresse oculaire et de l'inflammation associée.
PCT/US2006/035069 2005-09-13 2006-09-08 Formulation ophtalmique conçue pour le traitement de la secheresse oculaire WO2007033020A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US71672405P 2005-09-13 2005-09-13
US60/716,724 2005-09-13

Publications (2)

Publication Number Publication Date
WO2007033020A2 true WO2007033020A2 (fr) 2007-03-22
WO2007033020A3 WO2007033020A3 (fr) 2007-07-19

Family

ID=37865463

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/035069 WO2007033020A2 (fr) 2005-09-13 2006-09-08 Formulation ophtalmique conçue pour le traitement de la secheresse oculaire

Country Status (1)

Country Link
WO (1) WO2007033020A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015168140A1 (fr) * 2014-04-28 2015-11-05 Hampton Technologies Compositions ophtalmiques, et procédés de traitement des yeux

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5652209A (en) * 1994-04-29 1997-07-29 University Of Miami Use of secretory products of human lacrimal gland acinar epithelia for tear replacement therapy
JP3058920B2 (ja) * 1996-04-19 2000-07-04 一男 坪田 アルブミンを有効成分とする医薬組成物
US20040126419A1 (en) * 2001-01-30 2004-07-01 Isis Innovation Limited Artificial tear formulation
GB0404693D0 (en) * 2004-03-02 2004-04-07 Univ London Pharmaceutical preparations for the treatment of ocular surface and other disorders

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015168140A1 (fr) * 2014-04-28 2015-11-05 Hampton Technologies Compositions ophtalmiques, et procédés de traitement des yeux

Also Published As

Publication number Publication date
WO2007033020A3 (fr) 2007-07-19

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