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Guar gum and many of its derivatives are commercially available from Rhone-Poulenc Cranbury, N. Wilmington, Del. Belcamp, Md. The concentration of guar in the compositions of the present invention will generally range from 0. They are commercially available from sources such as Noveon, Inc. Carbopol polymers are crosslinked, acrylic acid-based polymers. They are crosslinked with allyl sucrose or allylpentaerythritol. Carbopol copolymers are polymers of acrylic acid, modified by C alkyl acrylates, and crosslinked with allylpentaerythritol.

The concentration of carbomer in the compositions of the present invention will generally range from 0. HEC is commercially available from Hercules Inc. The concentration of HEC in the compositions of the present invention will generally range from 0. Hyaluronic acid is commercially available from a variety of sources, including Genzyme and Hyaluron Inc. Hyaluronic acid is available in many grades, with molecular weights ranging from , to greater than 3 million dalton. As used herein, hyaluronic acid also encompasses the sodium salt form of hyaluronic acid, known as sodium hyaluronate, which is also commercially available.

The aqueous compositions of the present invention contain one of the specified combinations of polymers in a total polymer concentration range of 0. In addition to the required combination of two polymeric ingredients, the aqueous compositions of the present invention may contain other ingredients as excipients.

Preferably, the aqueous composition does not contain any polymeric ingredients, other than the synergistic combination of the two polymeric ingredients specified above, with the exception of polymeric preservatives for compositions that contain a preservative. If the compositions contain a carbomer as one of the two polymers, then the compositions of the present invention do not contain any ionic tonicity-adjusting agent, such as sodium chloride, or other ionic excipients, such as boric acid, as these ingredients have a significant, detrimental effect on the composition's viscosity.

The compositions of the invention have a pH in the range of , preferably , and most preferably 6. If the compositions contain a carbomer, it is critical that the compositions are formulated so that the target pH is not exceeded. Once a target pH has been exceeded in compositions containing a carbomer, adding an acid such as hydrochloric acid to adjust the pH downward can compromise the synergistic viscosity. It is known that relatively small amounts of acid or salts, on the order of 0.

The aqueous compositions of the present invention are suitable for use as artificial tear products to relieve symptoms of dry eye. Alternatively, the compositions of the present invention may act as a vehicle for an ophthalmic drug. The compositions of the present invention may also be used as irrigating solutions for ophthalmic or other surgical procedures.

Ophthalmic drugs suitable for use in the compositions of the present invention include, but are not limited to: anti-glaucoma agents, such as beta-blockers including timolol, betaxolol, levobetaxolol, carteolol, miotics including pilocarpine, carbonic anhydrase inhibitors, prostaglandins, seretonergics, muscarinics, dopaminergic agonists, adrenergic agonists including apraclonidine and brimonidine; anti-angiogenesis agents; anti-infective agents including quinolones such as ciprofloxacin, and aminoglycosides such as tobramycin and gentamicin; non-steroidal and steroidal anti-inflammatory agents, such as suprofen, diclofenac, ketorolac, rimexolone and tetrahydrocortisol; growth factors, such as EGF; immunosuppressant agents; and anti-allergic agents including olopatadine.

The ophthalmic drug may be present in the form of a pharmaceutically acceptable salt, such as timolol maleate, brimonidine tartrate or sodium diclofenac. Compositions of the present invention may also include combinations of ophthalmic drugs, such as combinations of i a beta-blocker selected from the group consisting of betaxolol and timolol, and ii a prostaglandin selected from the group consisting of latanoprost; keto latanoprost; travoprost; and unoprostone isopropyl.

The compositions of the present invention are preferably not formulated as solutions that gel upon administration to the eye.

The compositions illustrated in the Examples below do not gel upon administration to the eye. The compositions of the present invention may be topically applied to the eye or injected into the eye, depending upon the target site and disease or condition to be treated.

To treat diseases or conditions inside the eye rather than at the surface of the eye, the compositions of the present invention may, for example, be administered by intravitreal injection, subconjunctival injection, sub-tenon injection, retrobulbar injection, suprachoroidal injection, or periocular injection.

A syringe apparatus including an appropriately sized needle, for example, a 27 gauge needle or a 30 gauge needle, can be effectively used to inject the composition into the posterior segment of an eye of a human or animal. The combination of polymers may be particularly advantageous for injections into the eye for the following reasons: prevention of reflux, prolonged duration of action so as to increase the period of time between repeat injections, and reduction in the total amount of polymer required to achieve a target viscosity, thereby reducing the polymer disposition from back of the eye.

The following examples are presented to illustrate further various aspects of the present invention, but are not intended to limit the scope of the invention in any respect. A representative formulation for an artificial tear product according to the present invention is shown in Table 1.

The composition shown in Table 1 can be prepared by at least two methods. An alternative method of preparing the composition shown in Table 1 is as follows.

The averages of each set of results are shown in Table 2. Synergy Yes Yes Yes Subst. The averages of each set of results are shown in Table 3. Water Viscosity 1. The averages of each set of results are shown in Table 4. Airvol S is a commercially available polyvinyl alcohol polymer. Chondroitin sulfate is a commercially available polymer. PVP K90 is a commercially available polyvinyl pyrrolidone polymer.

The averages of each set of results are shown in Table 5. K90 is a commercially available polyvinylpyrrolidone polymer.

The averages of each set of results are shown in Table 6. The compositions shown below in Table 7 were prepared to determine the effect of the addition of salt NaCl on viscosity.

The results are shown in Table 7. The compositions shown below in Table 8 were prepared to determine the effect of the addition of boric acid on viscosity. The results are shown in Table 8. The compositions shown in Table 9 were prepared.

The results are shown in Table 9. The compositions shown in Table 10 were prepared. The results are shown in Table The invention has been described by reference to certain preferred embodiments; however, it should be understood that it may be embodied in other specific forms or variations thereof without departing from its spirit or essential characteristics.

The embodiments described above are therefore considered to be illustrative in all respects and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description. An aqueous composition suitable for ophthalmic administration comprising a viscosity enhancing amount of combination of two polymers having a synergistic effect on the composition's viscosity and wherein the combination of two polymers is selected from the group consisting of hydroxypropyl methylcellulose and guar gum; a carboxyvinyl polymer and guar gum; and hyaluronic acid and guar gum, provided that if the composition comprises a carboxyvinyl polymer then the composition does not contain sodium chloride or boric acid wherein the total concentration of the two polymers ranges from 0.

The composition of claim 1 wherein the combination of two polymers is a combination of a hydroxypropyl methylcellulose and guar gum. The composition of claim 1 wherein the combination of two polymers is a combination of a carboxyvinyl polymer and guar gum.

The composition of claim 1 wherein the combination of two polymers is a combination of hyaluronic acid and guar gum. The composition of claim 3 wherein the carboxyvinyl polymer is a polymer of acrylic acid crosslinked with allyl sucrose or allylpentaerythritol, the hydroxypropyl methylcellulose has a number average molecular weight of approximately 86, dalton, the guar gum is hydroxypropyl guar, and the hyaluronic acid is sodium hyaluronate.

The composition of claim 1 wherein the total concentration of the two polymers ranges from 0. The composition of claim 1 further comprising an ingredient selected from the group consisting of pharmaceutically acceptable buffering agents; preservatives; tonicity-adjusting agents; surfactants; solubilizing agents; stabilizing agents; comfort-enhancing agents; emollients; pH-adjusting agents; and lubricants.

The composition of claim 1 further comprising an ophthalmic drug. The composition of claim 8 wherein the ophthalmic drug is selected from the group consisting of anti-glaucoma agents; anti-angiogenesis agents; anti-infective agents; non-steroidal and steroidal anti-inflammatory agents; growth factors; immunosuppressant agents; and anti-allergic agents.

An aqueous composition suitable for ophthalmic administration comprising: an ophthalmic drug; and. The composition of claim 10 provided that if the composition comprises a carboxyvinyl polymer then the composition does not contain sodium chloride or boric acid.

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