WO2014169895A1 - Method for producing a sterile intraocular irrigating solution and irrigating solution - Google Patents
Method for producing a sterile intraocular irrigating solution and irrigating solution Download PDFInfo
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- 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
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- solution
- solutions
- sterile
- irrigating solution
- aseptically
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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
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.
Abstract
What is proposed is a method for producing a sterile intraocular irrigating solution and such an irrigating solution, which consists of two partial solutions which cannot be sterilized together by heat. The two partial solutions are respectively produced in a sterile manner and subsequently mixed together in an aseptic manner, for example by means of a blow-fill-seal method.
Description
Verfahren zum Herstellen einer sterilen intraokularen Method for producing a sterile intraocular
Spül-Lösung und Spül-Lösung Rinse solution and rinse solution
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 surgery, e.g. the removal of a natural eye lens and replacement of this lens with an artificial ocular lens (IOL) requires sterile intraocular irrigation solutions. 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 of sterile production of such rinse solutions is to fill them in a heat-stable container, seal them tightly and seal the finished product in an autoclave at e.g. 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.
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. There are compounds which are heat-sensitive, ie they decompose upon such heat treatment to form at least one other chemical compound. Such a product can no longer be used as a sterile rinsing solution. 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-The first part solution I contains i.a. Sodium chloride, potassium chloride, sodium monohydrogen phosphate, sodium
Hydrogencarbonat , Salzsäure oder Natriumhydroxit zur pH- Einstellung und Wasser für Injektionszwecke. Hydrogen carbonate, 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 Inj ektions zwecke . The second part solution is a sterile concentrate with calcium chloride, magnesium chloride, glucose, glutathione in oxidized form and also water for injection purposes.
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.
Bei der Vermischung sind strenge Anforderungen an eine aseptische Handhabung zu stellen, ähnlich wie bei der Zubereitung intravenöser Lösungen. 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. 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 hitze- sterilisierbar . 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, 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.
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.
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. 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, which are sterilized, for example with heat, are aseptically mixed with the other non-co-sterilizable components. 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 Zubereitungs zeit 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 combined preparation obtained according to the invention, e.g. 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.
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- Fi11-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, e.g. using the mentioned Blowfi11 Seal method.
Zu der sterilen intraokularen Spül-Lösung können Zusätze beigefügt werden, die aus medizinischer Sicht die Spül-Lösung physiologisch verbessern und aufwerten.
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. To the sterile intraocular irrigation solution, additives can be added that physiologically improve and enhance the irrigation solution from a medical point of view. 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
1. Verfahren zum Herstellen einer sterilen intraokularen Spül-Lösung, die aus zwei separat und mit unterschiedlichen Verfahren sterilisierten Teil- Lösungen besteht, wobei die Teil-Lösungen aseptisch miteinander vermischt werden. 1. A method for producing a sterile intraocular irrigation solution, which consists of two separately sterilized and with different methods partial solutions, wherein the partial solutions are mixed aseptically with each other.
2. Verfahren nach Anspruch 1, wobei die erste Teil-Lösung mit Hitze und die zweite Teil-Lösung aseptisch hergestellt werden, wobei die beiden Teil-Lösungen aseptisch miteinander vermischt werden. 2. The method of claim 1, wherein the first part solution with heat and the second part solution are prepared aseptically, wherein the two part solutions are aseptically mixed together.
3. Verfahren nach Anspruch 1 oder 2, wobei die beiden Teil-Lösungen aseptisch durch ein Blow-Fill-Seal- Verfahren vermischt werden. 3. The method of claim 1 or 2, wherein the two part solutions are aseptically mixed by a blow-fill-seal method.
4. Verfahren nach einem der vorhergehenden Ansprüche, wobei während der Herstellung der Spül-Lösung Natriumhyaluronat zugesetzt wird. 4. The method according to any one of the preceding claims, wherein sodium hyaluronate is added during the preparation of the rinsing solution.
5. Spül-Lösung, die folgende Komponenten enthält: 5. rinsing solution containing the following components:
- eine Elektrolyt-Lösung, an electrolyte solution,
- Glutathion, Glutathione,
- eine Zuckerkomponente, insbesondere Glucose oder Maltose.
a sugar component, in particular glucose or maltose.
6. Spül-Lösung nach Anspruch 5, dadurch gekennzeichnet, dass die Lösung statt Glutathion oder zusätzlich 6. rinsing solution according to claim 5, characterized in that the solution instead of glutathione or in addition
Acethylcystein enthält. Contains acetylcysteine.
7. Spül-Lösung nach Anspruch 5 oder 6, dadurch gekennzeichnet, dass der Spül-Lösung Hyaluronsäure bzw. deren Salz Natriumhyaluronat zugesetzt ist.
7. rinsing solution according to claim 5 or 6, characterized in that the rinsing solution hyaluronic acid or its salt sodium hyaluronate is added.
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DE102013006596.8 | 2013-04-17 | ||
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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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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Citations (9)
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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 (en) * | 1998-11-17 | 2000-05-31 | Matthias Meyer | Irrigation solution for eye surgery, especially cataract surgery, containing hyaluronic acid to protect corneal endothelium |
WO2003011249A2 (en) * | 2001-07-23 | 2003-02-13 | Farmigea S.P.A. | Ophthalmic composition containing n-acetylcysteine for the treat ment of dry-eye syndrome |
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 (en) * | 2008-03-03 | 2012-05-02 | Allergan, Inc. | Ketorolac tromethamine compositions for treating or preventing ocular pain |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE69614577D1 (en) * | 1996-11-06 | 2001-09-20 | Alcon Lab Inc | INTRAOCULAR IRRIGATION SOLUTION CONTAINING POLYAMINE ANTAGONISTS |
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 |
-
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 (9)
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 (en) * | 1998-11-17 | 2000-05-31 | Matthias Meyer | Irrigation solution for eye surgery, especially cataract surgery, containing hyaluronic acid to protect corneal endothelium |
WO2003011249A2 (en) * | 2001-07-23 | 2003-02-13 | Farmigea S.P.A. | Ophthalmic composition containing n-acetylcysteine for the treat ment of dry-eye syndrome |
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 (en) * | 2008-03-03 | 2012-05-02 | Allergan, Inc. | Ketorolac tromethamine compositions for treating or preventing ocular pain |
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