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Wo 2007/002780 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 4 January 2007 (04.01.2007) WO 2007/002780 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K9/00 (2006.01) A61K 47/34 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 47/18 (2006.01) A61L 12/14 (2006.01) AT,AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, (21) International Application Number: GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP, PCT/US2006/025239 KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV,LY,MA, MD, MG, MK, MN, MW, MX, MZ, NA, (22) International Filing Date: 28 June 2006 (28.06.2006) NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, (25) Filing Language: English SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 60/694,486 28 June 2005 (28.06.2005) US GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), (71) Applicant (for all designated States except US): BAUSCH European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, & LOMB INCORPORATED [US/US]; One Bausch & FR, GB, GR, HU, IE, IS, IT, LT, LU, LV,MC, NL, PL, PT, Lomb Place, Rochester, NY 14604-2701 (US). RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, (72) Inventors; and GN, GQ, GW, ML, MR, NE, SN, TD, TG). (75) Inventors/Applicants (for US only): LEVER, William, Jr. [US/US]; 14 Fenimore Drive, Pittsford, NY 14534 Published: (US). XIA, Erning [US/US]; 93 Chippenham Drive, Pen- — without international search report and to be republished field, NY 14526 (US). upon receipt of that report (74) Agents: LAVOIE, Paul, T. et al.; Bausch & Lomb In For two-letter codes and other abbreviations, refer to the "G uid corporated, One Bausch & Lomb Place, Rochester, NY ance Notes on Codes and Abbreviations" appearing at the beg in 14604-2701 (US). ning of each regular issue of the PCT Gazette. (54) Title: TOPICAL PRESERVATIVECOMPOSITIONS (57) Abstract: The use of one or more compositions of one or more preserving agents at a relatively high osmolality to disinfect contact lenses and preserve topical agents and ophthalmic lens compositions is described. Ophthalmic lens solutions containing one or more compositions of one or more preserving agents at a relatively high osmolality and methods of making and using the same are also described. TOPICAL PRESERVATIVECOMPOSITIONS Field of the Invention: The present invention is directed toward a composition with enhanced preservation. Background of the Invention: The most prevalent method of delivering an ocular pharmaceutical to the eye of a patient is to administer it topically in the form of drops, gels or ointments. To sell any topical ophthalmic pharmaceutical in the U.S for use over an extended period of time, the composition must prevent growth of microorganisms as defined in the preservative efficacy test. In the pharmaceutical industry, benzalkonium chloride is one of the most popular preservatives for topical ophthalmic formulations. However, benzalkonium chloride can destabilize the tear film and cause irritation. Benzalkonium chloride used with a medical device such as a contact lens can potentially bind to the medical device such as a contact lens. There is a need in the pharmaceutical industry for preservatives of topically applied compositions such as ophthalmic solutions, pharmaceuticals, artificial tears and comfort drops with a gentle preservative at as low possible volumes in the topically applied compositions. One class of solutions that are used of solution is a contact lens care solution, particularly contact lens care solutions that are not rinsed from the lens before a patient installs the lens in the eye. Multi-purpose lens care solutions both clean and disinfect the contact lens. Thus, higher levels of a disinfectant/preservative are required for multi-purpose lens care solutions. Particularly, to disinfect a lens, a disinfecting amount of a preservative/ disinfectant is needed. Potent, yet gentle, preservatives have been discovered that are sufficiently strong to disinfect a contact lens but will not cause considerable irritation when placed in the eye of the patient. U.S. Patent Number 4,758,595 discloses a contact lens disinfectant and preservative containing a biguanide or a water-soluble salt thereof in combination with a buffer, preferably a borate buffer, e.g., boric acid, sodium borate, potassium tetraborate, potassium metaborate or mixtures of the same. Alexidine is the trade name for 1,1'-hexamethylene-bis[5-(2- ethylhexyl)biguanide]. It is currently used as a disinfectant in a contact lens care solutions. Alexidine is known to be a gentle and potent antimicrobial agent in contact lenses. Poly(hexamethylene biguanide) or Alexidine are listed as one of several preservatives can be used to preserve topical ophthalmic formulations. No topical ophthalmic formulations have used poly(hexamethylene biguanide) or Alexidine as a preservative have been known to date. Nonetheless, there exists a need for a topical ophthalmic formulation that is gentle and effectively reduces the quantity of preservative that is required in solution. The present invention addresses these and other needs. Summary of the Invention The present invention relates to gentle preservative compositions useful for preserving topically applied agents such as ophthalmic solutions, pharmaceuticals, artificial tears and comfort drops against microbial contamination, and for preserving contact lens solutions. The subject preservative compositions are non-toxic, simple to use and do not cause ocular irritation. Additionally, preservative compositions of the present invention are suitable for use with all types of contact lenses, including rigid gas permeable contact lenses. Compositions formulated in accordance with the present invention include a relatively lower level, or a reduced volume-preserving amount, of one or more preservative agents in solution at a relatively higher osmolality for enhanced preservation. Such solutions including one or more compositions of the present invention at a higher osmolality are useful for preserving, soaking, rinsing, wetting and conditioning all types of contact lenses, including rigid gas permeable contact lenses. The higher osmolality of solutions of the present invention allows for the use of a relatively lowered level, or a reduced volume preserving amount, of one or more preservative agents while still achieving effective preservation of pharmaceuticals, ophthalmic solutions, medical devices and the like. Due to the presence of a lower level or a reduced volume- preserving amount of one or more preserving agents, patient comfort is increased and side effects are avoided. Hence, a more gentle preservative system is achieved. By reduced volume preserving amount it is meant an amount that is less than the minimum amount required to preserve a solution at an osmolality of 220 mOsmo/Kg. Accordingly, in one embodiment of the present invention the compositions and solutions have enhanced preserving activity useful in the manufacture of ophthalmic systems. Accordingly, in another embodiment of the present invention there is a method for using compositions with enhanced preserving activity in the preservation of contact lens care solutions. Accordingly, in one embodiment of the present invention the compositions and solutions have enhanced preservative activity useful in preserving ophthalmic systems from microbial contamination. Accordingly, in still another embodiment of the present invention there is a method of making compositions with enhanced preserving activity useful in ophthalmic systems. Accordingly, in an embodiment of the present invention there is a method of making compositions with enhanced preserving activity useful as preservative agents. In one embodiment, there is a composition comprising water and a reduced volume preserving amount of said one or more preserving agents selected from the group consisting of poly(hexamethylene biguanide), 1,1'- hexamethylene-bis[5-(2-ethylhexyl)biguanide] and combinations thereof. The composition has a high osmolality. In another embodiment, the composition further comprises water and a preserving amount of said one or more preserving agents selected from the group consisting of poly(hexamethylene biguanide), 1,1'-hexamethylene-bis[5- (2-ethylhexyl)biguanide] and combinations thereof. The composition further comprises a pharmaceutical agent. Optionally, the composition has a high osmolality. These and other objectives and advantages of the present invention, some of which are specifically described and others that are not, will become apparent from the detailed description and claims that follow. Detailed Description of the Invention Compositions of the present invention include one or more preserving agents. Suitable preserving agents for use in the present invention include for example but are not limited to 1,1'-hexamethylene-bis[5~(p- chlorophenyl)biguanide] (Chlorhexidine) or water soluble salts thereof, 1,1'- hexamethylene-bis[5-(2-ethylhexyl)biguanide] (Alexidine) or water soluble salts Thereof, poly(hexamethylene biguanide)
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