WO2014169895A1 - Procédé de production d'une solution de rinçage intra-oculaire stérile, et solution de rinçage correspondante - Google Patents

Procédé de production d'une solution de rinçage intra-oculaire stérile, et solution de rinçage correspondante Download PDF

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Publication number
WO2014169895A1
WO2014169895A1 PCT/DE2014/000213 DE2014000213W WO2014169895A1 WO 2014169895 A1 WO2014169895 A1 WO 2014169895A1 DE 2014000213 W DE2014000213 W DE 2014000213W WO 2014169895 A1 WO2014169895 A1 WO 2014169895A1
Authority
WO
WIPO (PCT)
Prior art keywords
solution
solutions
sterile
irrigating solution
aseptically
Prior art date
Application number
PCT/DE2014/000213
Other languages
German (de)
English (en)
Inventor
Peter Halfwassen
Jaime Guardiola
Original Assignee
Peter Halfwassen
Jaime Guardiola
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 Peter Halfwassen, Jaime Guardiola filed Critical Peter Halfwassen
Publication of WO2014169895A1 publication Critical patent/WO2014169895A1/fr

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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
    • A61K47/06—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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Definitions

  • IOL artificial ocular lens
  • Such rinse solutions are sterile aqueous electrolyte-containing solutions.
  • the qualitative and quantitative composition is usually isotonic to keep eye pressure constant. They have a composition that is compatible with human blood or eye fluid.
  • the first part solution I contains i.a. Sodium chloride, potassium chloride, sodium monohydrogen phosphate, sodium
  • Hydrogen carbonate, hydrochloric acid or sodium hydroxide for pH adjustment and water for injections.
  • the second part solution is a sterile concentrate with calcium chloride, magnesium chloride, glucose, glutathione in oxidized form and also water for injection purposes.
  • a particular advantage of the mixed sterile isotonic intraocular irrigation solution is that all components also occur physiologically in the eye.
  • In vivo studies have demonstrated the safety and efficacy of the intraocular irrigating solution in surgical procedures, e.g. in pars plana vitrectomy, phacoemulsification, cataract extraction of the lens etc.
  • the second part solution can not be sterilized in an autoclave together with the first part solution because of the sugar component glucose, so that the differently sterilized part solutions are offered in their own containers and are mixed together just before the surgical operation.
  • a mixture of the two part solutions is not stable for a long time.
  • the preparation of the sterile final solution must be carried out very carefully, so that the sterility chain is not interrupted during mixing.
  • the preparation also needs time during the operation by mixing the two part solutions. There is always some risk that the steps will not be optimally performed without contamination.
  • the second part solution in which glucose and glutathione are present, can not be heat-sterilized.
  • This partial solution is prepared separately from the partial solution 1 of the end product, but a non-physiological pH is obtained.
  • the invention has for its object to provide a method by which the handling of sterile intraocular irrigation solutions is simplified, which are offered as combination preparations and can not be heat sterilized together.
  • an easy-to-use rinsing solution should be specified.
  • the so-called blow-fill seal method which has been used for many years in the industrial production of sterile solutions.
  • the concept of this method is that a container for holding the substances to be used e.g. molded from plastic, then filled with the desired substances and then sealed. All this takes place in a continuous process in a sterile clean room. This process is also used for the aseptic production of sterile pharmaceutical liquids.
  • the two part solutions are then aseptically mixed together, e.g. using the mentioned Blowfi11 Seal method.
  • additives can be added that physiologically improve and enhance the irrigation solution from a medical point of view.
  • hyaluronic acid or its salt Natriumhyaluronat in a small percentage up to 5%, especially added by 2%. This agent is used to moisten the ocular surface and overall improves the formulation of the rinse solution.
  • a rinsing solution according to the invention contains in the simplest case an electrolyte solution, glutathione and glucose and buffer substances. Instead of glucose, another sugar, such as maltose, can also be used. In addition to these components, acetylcysteine can be used in addition to or instead of glutathione to stabilize the total mixture.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un procédé de production d'une solution de rinçage intra-oculaire stérile, et une telle solution de rinçage, qui comprend deux constituants ne pouvant être stérilisés ensemble par la chaleur. Les deux constituants sont chacun produits de manière stérile, puis mélangés aseptiquement l'un avec l'autre, par exemple au moyen d'un procédé de formage-remplissage-scellage.
PCT/DE2014/000213 2013-04-17 2014-04-17 Procédé de production d'une solution de rinçage intra-oculaire stérile, et solution de rinçage correspondante WO2014169895A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013006596.8 2013-04-17
DE102013006596.8A DE102013006596A1 (de) 2013-04-17 2013-04-17 Verfahren zum Herstellen einer sterilen intraokularen Spül-Lösung und Spül-Lösung

Publications (1)

Publication Number Publication Date
WO2014169895A1 true WO2014169895A1 (fr) 2014-10-23

Family

ID=50932926

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2014/000213 WO2014169895A1 (fr) 2013-04-17 2014-04-17 Procédé de production d'une solution de rinçage intra-oculaire stérile, et solution de rinçage correspondante

Country Status (2)

Country Link
DE (1) DE102013006596A1 (fr)
WO (1) WO2014169895A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4443432A (en) * 1981-10-05 1984-04-17 Alcon Laboratories, Inc. Ophthmalic irrigating solution
US5304724A (en) * 1988-09-09 1994-04-19 Entravision, Inc. Tissue irrigating solution
US5409904A (en) * 1984-11-13 1995-04-25 Alcon Laboratories, Inc. Hyaluronic acid compositions and methods
US6001853A (en) * 1996-01-26 1999-12-14 The United States Of America As Represented By The Department Of Health And Human Services Hydroxylamine compositions for the prevention or retardation of cataracts
DE19853007A1 (de) * 1998-11-17 2000-05-31 Matthias Meyer Hyaluronsäure enthaltende Irrigationslösung für Operationen am Auge
WO2003011249A2 (fr) * 2001-07-23 2003-02-13 Farmigea S.P.A. Contenant de la n-acetyle-cysteine pour le traitement du syndrome de la keratoconjonctivite seche
US20050250737A1 (en) * 2003-11-12 2005-11-10 Allergan, Inc. Therapeutic ophthalmic compositions containing retinal friendly excipients and related methods
US20090092665A1 (en) * 2007-10-08 2009-04-09 Lux Biosciences, Inc. OPHTHALMIC COMPOSITIONS COMPRISING CALCINEURIN INHIBITORS OR mTOR INHIBITORS
EP2446878A1 (fr) * 2008-03-03 2012-05-02 Allergan, Inc. Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998019678A1 (fr) * 1996-11-06 1998-05-14 Alcon Laboratories, Inc. Solution d'irrigation intraoculaire amelioree contenant un antagoniste de la polyamine
US20060275278A1 (en) * 2005-06-02 2006-12-07 Choy Camus K M Method and ophthalmic formulation for eye protection or treatment
GB201114725D0 (en) * 2011-08-25 2011-10-12 Altacor Ltd Ophthalmic formulations

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4443432A (en) * 1981-10-05 1984-04-17 Alcon Laboratories, Inc. Ophthmalic irrigating solution
US5409904A (en) * 1984-11-13 1995-04-25 Alcon Laboratories, Inc. Hyaluronic acid compositions and methods
US5304724A (en) * 1988-09-09 1994-04-19 Entravision, Inc. Tissue irrigating solution
US6001853A (en) * 1996-01-26 1999-12-14 The United States Of America As Represented By The Department Of Health And Human Services Hydroxylamine compositions for the prevention or retardation of cataracts
DE19853007A1 (de) * 1998-11-17 2000-05-31 Matthias Meyer Hyaluronsäure enthaltende Irrigationslösung für Operationen am Auge
WO2003011249A2 (fr) * 2001-07-23 2003-02-13 Farmigea S.P.A. Contenant de la n-acetyle-cysteine pour le traitement du syndrome de la keratoconjonctivite seche
US20050250737A1 (en) * 2003-11-12 2005-11-10 Allergan, Inc. Therapeutic ophthalmic compositions containing retinal friendly excipients and related methods
US20090092665A1 (en) * 2007-10-08 2009-04-09 Lux Biosciences, Inc. OPHTHALMIC COMPOSITIONS COMPRISING CALCINEURIN INHIBITORS OR mTOR INHIBITORS
EP2446878A1 (fr) * 2008-03-03 2012-05-02 Allergan, Inc. Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire

Also Published As

Publication number Publication date
DE102013006596A1 (de) 2014-10-23

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