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(12) Patent Application Publication (10) Pub. No.: US 2007/0249546A1 Sawaya (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2007/0249546A1 Sawaya (43) Pub US 20070249546A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0249546A1 Sawaya (43) Pub. Date: Oct. 25, 2007 (54) OPHTHALMIC AND RELATED AQUEOUS Publication Classification SOLUTIONS CONTAINING ANTIFUNGAL AGENTS, USES THEREFOR AND METHODS (51) Int. Cl. FOR PREPARING THEMI A61K 3 1/7048 (2006.01) A6II 3L/496 (2006.01) (76) Inventor: Assad S. Sawaya, Baiting Hollow, NY A61K 31/4196 (2006.01) (US) A61K 31/4178 (2006.01) (52) U.S. Cl. ...................... 514/28: 514/254.07: 514/383; Correspondence Address: 514/397: 514/772.7 DARBY & DARBY P.C. P.O. BOX 770 Church Street Station (57) ABSTRACT New York, NY 10008-0770 (US) The invention relates generally to concentrates and aqueous (21) Appl. No.: 11/738,451 Solutions for topical application comprising antifungal addi tives or agents as well as to preparation and use of Such (22) Filed: Apr. 20, 2007 concentrates and solutions. More specifically, the invention Related U.S. Application Data relates to preparation and use of Solutions that come in contact with the eyelids and/or eyes, such as but not limited (60) Provisional application No. 60/794.240, filed on Apr. to contact lens Solutions, aqueous ophthalmic rinse solu 22, 2006. tions, and aqueous Surgical scrubs for ophthalmic use. Patent Application Publication Oct. 25, 2007 Sheet 1 of 4 US 2007/0249546 A1 eTest Control - Fusarium Solani o 0.02%TONAFTATE 104 4-hours (100) a 0.02%TOLNAFATE a 0.02%TOLNAFATE 6-hours (100) 24-hours (100) Patent Application Publication Oct. 25, 2007 Sheet 2 of 4 US 2007/0249546 A1 Fig-6 a 0.02%MCONOZOE e O,O296 MCONOZOE 4-hours (100) 6-hours (100) Fig-7 • O.O2%MCONOZOLE 24-hours (100) Patent Application Publication Oct. 25, 2007 Sheet 3 of 4 US 2007/0249546 A1 Fig. 8A OSNFECNG EFFECACY EST 83000 ATHE-1 40 O O 2 O O O O 3600 4300 O 5 1o 15 2O 25 30 EXPOSURE TIME (Hour) Fig. 8B OSNFECTING EFFCACY EST 83000 ATHE-2 O 5 10 5 2O 25 30 EXPOSURE TIME(Hour) Fig. 8C OSNFECTING EFFCACY TEST 90000 ATHE-3 83000 OOO O 5 O 15 2O 25 3O EXPOSURE TIME (Hour) Patent Application Publication Oct. 25, 2007 Sheet 4 of 4 US 2007/0249546 A1 Fig. 9 DSNFECTING EFFICACY TEST (FUSARIUM SOLAN) 6 5 A.9 4. 2 3.61 O 352 l CD 3.26 -- A.HE-1 --A-E-2 1 3 -k-AHE-3 (D O 2 52 45 1 O.97 O S G O 5 O 15 2O 25 30 EXPOSURE TIME (hour) US 2007/0249546 A1 Oct. 25, 2007 OPHTHALMIC AND RELATED AQUEOUS fungal agents could not be used and were not contemplated SOLUTIONS CONTAINING ANTIFUNGAL for use in aqueous solution preparations for ocular use AGENTS, USES THEREFOR AND METHODS FOR because they were inadequately soluble or even dispersible. PREPARING THEM 0006 Conventional ophthalmic solutions and pre-surgi cal eye lid scrubs suffer from similar deficiencies vis a vis REFERENCE TO PROVISIONAL APPLICATION protection against fungal contamination. Such solutions and 0001) This application claims the benefit of U.S. Provi scrubs are Vulnerable to similar fungal contamination, which sional Application No. 60/794,240, filed on Apr. 22, 2006. leaves Subjects using the Solution and/or scrubs Vulnerable to fungal infection. As a result of Such contamination, FIELD OF THE INVENTION Subjects using conventional multipurpose lens solutions 0002 The invention relates generally to concentrates and and/or conventional ophthalmic aqueous Solutions and pre aqueous solutions for topical application comprising anti Surgical eye lid scrubs may develop conditions such as fungal additives or agents as well as to preparation and use Fusarium keratitis eye infections and/or Fusarium conjunc of Such concentrates and solutions. More specifically, the tivitis. Some infections may result to damage to the cornea. invention relates to preparation and use of Solutions that In some cases, corneal transplants are required, and on some come in contact with the eyelids and/or eyes, such as but not occasions the Subjects suffer loss of sight. limited to contact lens solutions, aqueous ophthalmic rinse 0007. The use point, the eye, precludes organic solvents, Solutions, and aqueous Surgical Scrubs for ophthalmic use. such as alcohols, because they are irritant or toxic. While conventional multipurpose lens Solutions contain preserva BACKGROUND OF THE INVENTION tive systems, recent events have demonstrated that Such Solutions are still Vulnerable to contamination by fungal 0003. In conventional antifungal preparations for oph species such as Fusarium Solani, which leaves the Subject thalmic or periophthalmic use, the antifungal agent is sus using conventional Solutions vulnerable to fungal infection." pended in ointments, creams and non-aqueous Solutions of See FDA News, Apr. 10, 2006 reporting the presence of Fusarium in oil-based delivery systems. Conventional antifungal agents multipurpose contact lends solutions manufactured by Bausch & Lomb precipitate when introduced into an aqueous solution, which resulting in 109 cases of Fusarium keratitis. See FDA Update regarding Contact Lenses and Eye Infections dated Apr. 13, 2006 and FDA Statement diminishes or extinguishes their antifungal properties, ren dated Apr. 14, 2006 regarding voluntary recall of Bausch & Lomb Contact dering Such agents impractical for use in aqueous solutions Lens Solution. such as, but not limited to, multipurpose lens solutions. 0008 Heretofore no one has come forward with a method 0004 The prior art lacks methods of preparing oph for providing an effective amount of an antifungal agent in thalmic preparations that are homogenous aqueous solutions an aqueous ophthalmic or periophthalmic solution, wherein comprising antifungal agents for use in and around the eye. the solution is physiologically acceptable for ophthalmic or Instead, the prior art provides ophthalmic preparations com periophthalmic use. Nor has a preparation containing an prising antifungal agents in the form of Suspensions. For antifungal agent in solution in a suitable physiologically example, U.S. Pat. No. 7,056,893 (hereafter the 893 patent) acceptable vehicle been devised such that it can be mixed discloses using a polymeric Suspending agent like polyeth with an aqueous ophthalmic or periophthalmic solution and ylene glycol to prepare an aqueous polymeric Suspension, impart to Such a solution antifungal properties without However, a skilled worker will appreciate that a polymeric precipitating the antifungal agent. Thus, a need for a safe Suspension is not the equivalent of a clear, homogenous antifungal preparation formulated for delivery in the form of aqueous solution, especially for use with the eye. Published a solution that may be used in aqueous Solutions, such as U.S. patent application No. US2004/0198829 discloses the multipurpose lens Solutions and ophthalmic, topical and addition of prostanoids to a suspension comprising a thera Surgical Solutions, is readily apparent. The antifungal prepa peutic agent like an antifungal Such as Voriconazole to rations in the form of an aqueous solution presented herein effectively increase transport and/or penetration of the thera will be effective and safe to reduce the risk of various fungal peutic agent in the eye. However, neither the 893 patent nor infections inherent in the currently available multipurpose US2004/0198829 provides a homogenous ophthalmic or lens Solutions, and ophthalmic, topical and pre-surgical periophthalmic aqueous Solution comprising an effective solutions, which lack the benefit of the technology presented amount of an antifungal agent. herein. The antifungal preparations in the form of an aque 0005 Published U.S. patent application No. US2004/ ous solution presented herein may also increase the shelflife 0266702, another example in the prior art, describes an of conventional ophthalmic Solutions and pre-surgical eye ophthalmic composition that uses a polymeric Suspension lid scrubs. agent such as a carboxy-containing polymer Such as poly mers of acrylic acid to deliver to the eye an azalide antibiotic BRIEF SUMMARY OF THE INVENTION alone or in combination with another agent like an antifun 0009. In accordance with this invention, there is provided gal agent such as miconazole nitrate. US2004/0266702 a method for preparing a concentrate solution containing an discloses that the polymeric Suspension agent may be poly antifungal agent in a form Suitable for Subsequent introduc ethylene glycol and may additionally comprise a surfactant. tion in an aqueous medium Suitable for ophthalmic or The preparations disclosed in US2004/0266702 are aqueous periophthalmic use, the method comprising the steps of: a) polymeric suspensions. US2004/0266702 is silent as to a dissolving an antifungal agent in a physiologically accept Suitable method comprising steps for obtaining an aqueous able non-aqueous vehicle to form a non-aqueous solution of Solution comprising an azalide antibiotic and/or an antifun said antifungal agent said vehicle being miscible with aque gal agent without precipitation of the azalide antibiotic or ous solutions; b) adding a physiologically acceptable Sur antifungal agent. Thus, prior to the current invention, anti factant to said non-aqueous solution in an amount Sufficient US 2007/0249546 A1 Oct. 25, 2007 to stabilize said antifungal agent upon its Subsequent intro contact of the eye of said Subject with an aqueous solution duction in said aqueous medium; and c) mixing the non during ophthalmic or periophthalmic use of said aqueous aqueous Solution and Surfactant mixture until a clear con Solution, the method comprising: providing as the aqueous centrate solution is obtained. Solution used ophthalmically or periophthalmically
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