Pharmaceutical formulations for the treatment of dry eye and methods for fabricating and using thereof

1. A method for improving tear production in a mammalian subject suffering from an insufficient secretion thereof, comprising administering to an eye of the subject a pharmaceutical formulation comprising:

(a) a therapeutically effective amount of at least one compound selected from the group consisting of pentoxifylline, lisofylline, aminophylline, enprofylline, isbufylline and combinations thereof, or a pharmaceutically acceptable salt(s), solvate(s) or hydrate(s) thereof;

(b) a therapeutically effective amount of an immunosuppressant selected from the group consisting of cyclosporine, tacrolimus and combinations thereof; and

(c) a pharmaceutically acceptable carrier or excipient comprising a non-ionic polyoxyethylene-polyoxypropylene block copolymer, at a concentration of between about 0.01 mass % and about 1.0 mass % of the entire formulation,

thereby improving tear production in the subject.

2. The method of claim 1 , wherein the excipient further comprises a polymer selected from the group consisting of poly(acrylic acid), methylcellulose, hydroxypropyl methylcellulose and combinations thereof.

3. The method of claim 1 , wherein the pharmaceutical formulation further comprises an active agent selected from the group consisting of at least one anti-bacterial agent, at least one antiviral medicament, at least one antifungal medicament, at least one immunosuppressant and combinations thereof.

4. The method of claim 3 , wherein the anti-bacterial agent is selected from the group consisting of moxifloxacin, gatifloxacin, nalidixic acid, oxolinic acid, piromidic acid, pipemidic acid, rosoxacin, enoxacin, fleroxacin, lomefloxacin, nadifloxacin, ofloxacin, pefloxacin, rufloxacin, balofloxacin, levofloxacin, norfloxacin, ciprofloxacin, pazufloxacin, sparfloxacin, tosufloxacin, clinafloxacin, gemifloxacin, sitafloxacin, prulifloxacin, vancomycin, teicoplanin, telavancin, decaplanin, ramoplanin, azitromycin, gentamicin, tobramycin, amikacin, cefuroxime, mitomycin, neomycin, neosporin, amoebicides, polymyxin, clindamycin, bacitracin, chloramphenicol, erythromycin, natamycin, blephamide, sulfacetamide, sodium bicarbonate, povidone-iodine and combinations thereof.

5. The method of claim 3 , wherein the antiviral medicament is selected from the group consisting of idoxuridine, vidarabine and combinations thereof.

6. The method of claim 3 , wherein the antifungal medicament is selected from the group consisting of ketoconazole, fluconazole and combinations thereof.

7. The method of claim 1 , wherein the concentration of the compound in the formulation is between about 0.03 millimoles and about 3 millimoles of the compound per 1 μL of the formulation.

8. The method of claim 1 , wherein the insufficient tear secretion is caused by a disease, syndrome or pathology selected from the group consisting of keratoconjunctivitis sicca, Stevens-Johnson syndrome, age-related dry eye, ocular cicatricial pemphigoid, neurotrophic ocular surface disease and blepharitis.

9. The method of claim 8 , wherein the disease is keratoconjunctivitis sicca.

10. The method of claim 1 , further comprising administering artificial tears comprising hyaluronic acid, carboxymethyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, or hydroxypropyl cellulose, or derivatives thereof.

11. The method of claim 10 , wherein the administering of the formulation comprising the at least one compound and of the artificial tears is simultaneous or consecutive.

12. The method of claim 1 , wherein the administering of the formulation is topical.

13. The method of claim 1 , wherein the compound is pentoxifylline or a pharmaceutically acceptable salt thereof.

14. The method of claim 13 , wherein the pharmaceutical formulation is administered as eye drops.