DE102013006596A1 - A method of making a sterile intraocular irrigation solution and irrigation solution - Google Patents
A method of making a sterile intraocular irrigation solution and irrigation solution Download PDFInfo
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- 229940113601 irrigation solution Drugs 0.000 title claims description 7
- 238000004519 manufacturing process Methods 0.000 title abstract description 5
- 239000000243 solution Substances 0.000 claims abstract description 33
- 238000000034 method Methods 0.000 claims abstract description 14
- 239000012487 rinsing solution Substances 0.000 claims abstract description 12
- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 8
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 7
- 108010024636 Glutathione Proteins 0.000 claims description 7
- 239000008103 glucose Substances 0.000 claims description 7
- 229960003180 glutathione Drugs 0.000 claims description 7
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 5
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 2
- 229960004308 acetylcysteine Drugs 0.000 claims description 2
- 239000008151 electrolyte solution Substances 0.000 claims description 2
- 229920002674 hyaluronan Polymers 0.000 claims description 2
- 229960003160 hyaluronic acid Drugs 0.000 claims description 2
- 229920002385 Sodium hyaluronate Polymers 0.000 claims 2
- 229940010747 sodium hyaluronate Drugs 0.000 claims 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- -1 salt sodium hyaluronate Chemical class 0.000 claims 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims 1
- 239000000203 mixture Substances 0.000 description 9
- 239000000126 substance Substances 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 230000002262 irrigation Effects 0.000 description 2
- 238000003973 irrigation Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 208000002177 Cataract Diseases 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000003855 balanced salt solution Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 239000013010 irrigating solution Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000005923 long-lasting effect Effects 0.000 description 1
- 229910001629 magnesium chloride Inorganic materials 0.000 description 1
- 239000002991 molded plastic Substances 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
Classifications
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- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Ophthalmology & Optometry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
Es wird ein Verfahren zur Herstellung einer sterilen intraokularen Spül-Lösung und eine solche Spül-Lösung vorgeschlagen, die aus zwei Teil-Lösungen besteht, die durch Hitze nicht miteinander sterilisiert werden können. Die beiden Teil-Lösungen werden jeweils steril hergestellt und anschliessend aseptisch miteinander vermischt, z. B. mit einem Blow-Fill-Seal-Verfahren.A method for the production of a sterile intraocular rinsing solution and such a rinsing solution are proposed which consist of two partial solutions which cannot be sterilized with one another by heat. The two partial solutions are each made sterile and then mixed aseptically with each other, e.g. B. with a blow-fill-seal method.
Description
Bei intraokularen Operationen, z. B. bei der Entfernung einer natürlichen Augenlinse und einem Ersatz dieser Linse durch eine künstliche Okularlinse (IOL) werden sterile intraokulare Spül-Lösungen benötigt. Dies gilt auch für Operationen, die eine relativ lang andauernde intraokulare Perfusion erforderlich machen.For intraocular operations, e.g. For example, in the removal of a natural eye lens and replacement of this lens by an artificial ocular lens (IOL), sterile intraocular irrigation solutions are needed. This also applies to operations that require relatively long-lasting intraocular perfusion.
Solche Spül-Lösungen sind sterile wässrige elektrolythaltige Lösungen. Die qualitative und quantitative Zusammensetzung ist in der Regel isoton, um den Augendruck konstant zu halten. Sie haben eine Zusammensetzung, die mit dem menschlichen Blut bzw. der Augenflüssigkeit kompatibel ist.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.
Das übliche Verfahren, um solche Spül-Lösungen steril zu produzieren, besteht darin, sie in ein hitzestabiles Behältnis abzufüllen, dicht zu verschliessen, und das fertige Produkt in einem Autoklaven bei z. B. 121°C während etwa 15 Minuten zu sterilisieren.The usual method for sterile production of such rinse solutions is to fill them in a heat-stable container, close tightly, and the finished product in an autoclave at z. B. 121 ° C for about 15 minutes to sterilize.
Es gibt Verbindungen, die hitzeempfindlich sind, d. h. sie zersetzen sich bei einer solchen Hitzebehandlung, wobei mindestens eine andere chemische Verbindung entsteht. Ein solches Produkt kann nicht mehr als sterile Spül-Lösung eingesetzt werden.There are compounds that are heat sensitive, i. H. they decompose in such a heat treatment, whereby at least one other chemical compound is formed. Such a product can no longer be used as a sterile rinsing solution.
Eine üblicherweise verwendete Spül-Lösung wird unter der Bezeichnung BSS PLUS von der Firma Alcon Laboratories, Inc. angeboten. Diese Spül-Lösung ist eine Kombinationspräparat, in dem mehr als eine Verbindung enthalten ist. In einem solchen Fall kann es auftreten, dass zwei an sich thermisch stabile Substanzen bei Hitze miteinander reagieren. Dies ist bei der genannten Spül-Lösung der Fall. Sie besteht aus zwei Teil-Lösungen, die jeweils in einem eigenen Behälter enthalten sind und erst kurz vor der Operation gemischt werden.A commonly used rinse solution is sold under the designation BSS PLUS by Alcon Laboratories, Inc. This rinse solution is a combination preparation containing more than one compound. In such a case, it may happen that two thermally stable substances react with each other under heat. This is the case with the said rinsing solution. It consists of two sub-solutions, each contained in its own container and mixed only shortly before the operation.
Die erste Teil-Lösung I enthält u. a. Natriumchlorid, Kaliumchlorid, Natrium-Monohydrogenphosphat, Natrium-Hydrogencarbonat, Salzsäure oder Natriumhydroxit zur pH-Einstellung und Wasser für Injektionszwecke.The first part solution I contains u. a. Sodium chloride, potassium chloride, sodium monohydrogen phosphate, sodium bicarbonate, hydrochloric acid or sodium hydroxide for pH adjustment and water for injections.
Die zweite Teil-Lösung ist ein steriles Konzentrat mit Calciumchlorid, Magnesiumchlorid, Glucose, Glutathion in oxydierter Form und ebenfalls Wasser für Injektionszwecke.The second part solution is a sterile concentrate with calcium chloride, magnesium chloride, glucose, glutathione in oxidized form and also water for injections.
Ein besonderer Vorteil der vermischten sterilen isotonischen intraokularen Spül-Lösung ist, dass alle Bestandteile auch physiologisch im Auge vorkommen. In-vivo-Studien haben die Unbedenklichkeit und Wirksamkeit der intraokularen Spül-Lösung bei chirurgischen Eingriffen belegt, z. B. bei der Pars-plana-Vitrektomie, Phako-Emulsifikation, Kataraktextraktion der Linse etc.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.
Die zweite Teil-Lösung kann wegen der Zuckerkomponente Glucose nicht in einem Autoklaven gemeinsam mit der ersten Teil-Lösung sterilisiert werden, sodass die unterschiedlich sterilisierten Teil-Lösungen in eigenen Behältern angeboten werden und erst kurz vor der chirurgischen Operation miteinander vermischt werden. Eine Mischung der zwei Teil-Lösungen ist steril nicht lange haltbar.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.
Bei der Vermischung sind strenge Anforderungen an eine aseptische Handhabung zu stellen, ähnlich wie bei der Zubereitung intravenöser Lösungen.When mixing, strict requirements for aseptic handling are to be made, similar to the preparation of intravenous solutions.
Die Zubereitung der sterilen Endlösung muss sehr sorgfältig durchgeführt werden, damit die Sterilitätskette bei dem Vermischen nicht unterbrochen wird. Die Zubereitung braucht während der Operation durch das Vermischen der zwei Teil-Lösungen zudem Zeit. Es verbleibt stets ein gewisses Risiko, dass die Schritte ohne Kontamination nicht optimal durchgeführt werden.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.
Ausserdem müssen nicht benutzte Reste der Mischung verworfen werden.In addition, unused residues of the mixture must be discarded.
Bei der bekannten Spül-Lösung ist die zweite Teil-Lösung, in der Glucose und Glutathion enthalten sind, nicht hitzesterilisierbar. Diese Teil-Lösung wird getrennt von der Teil-Lösung 1 des Endproduktes hergestellt, wobei jedoch ein nicht physiologischer pH-Wert erhalten wird.In the known rinsing solution, the second part solution, which contains glucose and glutathione, is not heat sterilizable. This partial solution is prepared separately from the partial solution 1 of the end product, but a non-physiological pH is obtained.
Der Erfindung liegt die Aufgabe zugrunde, ein Verfahren anzugeben, mit dem die Handhabung von sterilen intraokularen Spül-Lösungen vereinfacht wird, die als Kombinationspräparate angeboten werden und gemeinsam nicht hitzesterilisiert werden können. Ausserdem soll eine einfach anzuwendende Spül-Lösung angegeben werden.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. In addition, an easy-to-use rinsing solution should be specified.
Diese Aufgabe ist gemäss der Erfindung durch die Merkmale der Patentansprüche 1 und 5 gelöst.This object is achieved according to the invention by the features of claims 1 and 5.
Es hat sich überraschenderweise herausgestellt, dass alle Komponenten der Spül-Lösung miteinander vermischt werden können und auf lange Zeit haltbar sind, wenn die Bestandteile der Gesamtmischung, die z. B. mit Hitze sterilisiert werden, mit den anderen, nicht gemeinsam sterilisierbaren Bestandteilen aseptisch gemischt werden.It has surprisingly been found that all components of the rinsing solution can be mixed together and are durable for a long time, when the components of the total mixture, the z. B. are sterilized with heat, are mixed aseptically with the other non-sterilizable components.
Überraschenderweise bleibt eine solche Mischung, die auch einen geeigneten pH-Wert hat, für eine lange Zeit stabil: In Versuchen wurde nachgewiesen, dass eine solche Mischung zumindest für sechs Monate stabil bleibt.Surprisingly, such a mixture, which also has a suitable pH, remains stable for a long time: In experiments it has been demonstrated that such a mixture remains stable for at least six months.
Damit entfällt die Notwendigkeit, die einzelnen Bestandteile der sterilen intraokularen Spül-Lösung erst kurz vor der chirurgischen Operation miteinander zu vermischen. Die Zubereitungszeit bei einer Operation kann damit verkürzt werden. Ausserdem ist das Risiko einer Unterbrechung der Sterilitätskette unterbunden, die bei der herkömmlichen Vermischung der Teil-Lösungen kurz vor der Operation auftreten kann.This eliminates the need to mix the individual components of the sterile intraocular irrigation solution until shortly before the surgical operation. The preparation time during an operation can thus be shortened. It also eliminates the risk of interrupting the sterility chain, which can occur during conventional mixing of partial solutions just before surgery.
Für die Produktion des gemäss der Erfindung erhaltenen sterilen Kombinationspräparates kommt z. B. das sog. Blow-Fill-Seal-Verfahren in Frage, welches seit vielen Jahren in der industriellen Herstellung von sterilen Lösungen Anwendung findet. Das Konzept dieses Verfahrens liegt darin, dass ein Behälter zur Aufnahme der zu verwendenden Stoffe z. B. aus Plastik geformt, anschliessend mit den gewünschten Substanzen gefüllt und dann versiegelt wird. All dies erfolgt in einem kontinuierlichen Prozess in einem sterilen Reinraum. Dieses Verfahren wird auch zur aseptischen Herstellung von sterilen pharmazeutischen Flüssigkeiten benutzt.For the production of the sterile combination preparation obtained according to the invention z. As the so-called. Blow-fill-seal method in question, which is used for many years in the industrial production of sterile solutions. The concept of this method is that a container for receiving the substances to be used for. B. molded 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.
Für den vorliegenden Fall bedeutet dieses, dass die nicht mit Hitze zu sterilisierenden Komponenten wie Gluthation und Glucose oder einer anderen Zuckerkomponente getrennt von den anderen mit Hitze zu sterilisierenden Komponenten aseptisch hergestellt werden. Die beiden Teil-Lösungen werden dann aseptisch miteinander vermischt, z. B. mithilfe des erwähnten Blow-Fill-Seal-Verfahrens.In the present case, this means that the non-heat-sterilizable components, such as glutathione and glucose or another sugar component, are to be aseptically prepared separately from the other components to be heat-sterilized. The two part solutions are then aseptically mixed together, for. B. using the aforementioned blow-fill-seal method.
Zu der sterilen intraokularen Spül-Lösung können Zusätze beigefügt werden, die aus medizinischer Sicht die Spül-Lösung physiologisch verbessern und aufwerten.To the sterile intraocular irrigation solution, additives can be added that physiologically improve and enhance the irrigation solution from a medical point of view.
Insbesondere wird gemäss der Erfindung Hyaluronsäure bzw. deren Salz Natriumhyaluronat in einem geringen Prozentsatz bis zu 5%, insbesonders um 2% hinzugefügt. Dieses Mittel dient zur Befeuchtung der Augenoberfläche und verbessert insgesamt die Rezeptur der Spül-Lösung.In particular, according to the invention 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.
Eine Spül-Lösung gemäss der Erfindung enthält im einfachsten Fall eine Elektrolyt-Lösung, Glutathion sowie Glucose und Puffersubstanzen. Statt Glucose kann auch ein anderer Zucker, etwa Maltose verwendet werden. Neben diesen Komponenten kann zur Stabilisierung der Gesamtmischung neben oder anstelle von Glutathion Acetylcystein eingesetzt werden.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.
Claims (7)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102013006596.8A DE102013006596A1 (en) | 2013-04-17 | 2013-04-17 | A method of making a sterile intraocular irrigation solution and irrigation solution |
| PCT/DE2014/000213 WO2014169895A1 (en) | 2013-04-17 | 2014-04-17 | Method for producing a sterile intraocular irrigating solution and irrigating solution |
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| Application Number | Priority Date | Filing Date | Title |
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| DE102013006596.8A DE102013006596A1 (en) | 2013-04-17 | 2013-04-17 | A method of making a sterile intraocular irrigation solution and irrigation solution |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19853007C2 (en) * | 1998-11-17 | 2000-11-30 | Matthias Meyer | Hyaluronic acid-containing irrigation solution for eye surgery |
| EP0939635B1 (en) * | 1996-11-06 | 2001-08-16 | Alcon Laboratories, Inc. | Improved intraocular irrigating solution containing a polyamine antagonist |
| WO2008003242A1 (en) * | 2006-06-28 | 2008-01-10 | The Hong Kong Polytechnic University | Method and ophthalmic formulation for eye protection or treatment |
| WO2013027065A1 (en) * | 2011-08-25 | 2013-02-28 | Altacor Limited | Ophthalmic formulations |
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| 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 |
| WO1997026879A1 (en) * | 1996-01-26 | 1997-07-31 | The United States Of America, Represented By The Secretary, Department Of Health And Human Services, The National Institutes Of Health | Hydroxylamine compositions for the prevention or retardation of cataracts |
| ITRM20010438A1 (en) * | 2001-07-23 | 2003-01-23 | Farmigea Spa | N-ACETYLCISTEIN-BASED OPHTHALMIC PREPARATION FOR THE TREATMENT OF DRY EYE SYNDROME. |
| WO2006043965A1 (en) * | 2004-10-14 | 2006-04-27 | Allergan, Inc. | Therapeutic ophthalmic compositions containing retinal friendly excipients and related methods |
| EP2197461B1 (en) * | 2007-10-08 | 2018-02-21 | Aurinia Pharmaceuticals Inc. | Ophthalmic compositions comprising calcineurin inhibitors or mtor inhibitors |
| US7842714B2 (en) * | 2008-03-03 | 2010-11-30 | Allergan, Inc. | Ketorolac tromethamine compositions for treating ocular pain |
-
2013
- 2013-04-17 DE DE102013006596.8A patent/DE102013006596A1/en not_active Withdrawn
-
2014
- 2014-04-17 WO PCT/DE2014/000213 patent/WO2014169895A1/en active Application Filing
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0939635B1 (en) * | 1996-11-06 | 2001-08-16 | Alcon Laboratories, Inc. | Improved intraocular irrigating solution containing a polyamine antagonist |
| DE19853007C2 (en) * | 1998-11-17 | 2000-11-30 | Matthias Meyer | Hyaluronic acid-containing irrigation solution for eye surgery |
| WO2008003242A1 (en) * | 2006-06-28 | 2008-01-10 | The Hong Kong Polytechnic University | Method and ophthalmic formulation for eye protection or treatment |
| WO2013027065A1 (en) * | 2011-08-25 | 2013-02-28 | Altacor Limited | Ophthalmic formulations |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014169895A1 (en) | 2014-10-23 |
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